ISO 9001:2008 WILL BE UPDATE TO ISO 9001:2015

The ISO’s most pupolar standard – ISO 9001 now is under revision and updating. The survey’s been completed, the drafts discussion was started and the time frames was tentatively proposed; ISO 9001 - is now under revision with the new working title as ‘ISO 9001:2015’.

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ISO 9001:2008 Brings More Clarity to QMS Standard

Although the recently released ISO 9001:2008 contains no new requirements compared to the 2000 edition, it does clarify existing requirements of ISO 9001:2000.

Released last November, ISO 9001:2008 is the latest edition of the International Standard used by many automotive companies and other organizations as the framework for their quality management systems (QMS). The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines relating to quality management systems and related supporting standards.

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What is ISO 9000 and Should I Care?

The ISO 9000 series of standards

ISO 9000 consists of a series of Quality Management System standards that are designed to facilitate the establishment of business processes aiming to ensure that customer requirements are met or exceeded. They can be applied in any manufacturing industry or service sector.

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Why is ISO 9000 / ISO 9001:2000 Certification So Important?

First of all it provides a system for managers and organizations to achieve excellence and opens the door for American manufacturers and/or service organizations seeking a larger role in both international trade and with other American organizations. Many organizations require their suppliers to be certified or at a minimum to be working toward certification on ISO 9000 / ISO 9001:2000 to do business.

Consider the facts (source MORI/SGS-ICS) that with ISO certification:

• 83% realized improved management control
• 82% realized improved customer satisfaction
• 62% said it improved the ability to win work
• 61% stated a more motivated workforce
• 60% realized improved productivity
• 60% saw reduced waste
• 52% stated it improved marketing
• 50% had reduced costs
• 49% realized increased market share

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RECORDS REQUIRED BY ISO9000

Section	Description
4.2.1 General	Reference to records required by the standard
4.2.3 Control of documents	For records are controlled according to 4.2.4
4.2.4 Control of records	Records are established and maintained to provide evidence of conformity
5.6.1 Management Review – GeneralReview	Management Review records
6.2.2 Competence, Awareness, and Training	Education, training, skills, and experience
7.1 Planning a product realization	Evidence is recorded that the realization processes and resulting product meet requirements
7.2.2 Review of requirements related to the product	Results of the review and actions are rising from the review
7.3.2 Design and development inputs	Inputs relating to product requirements
7.3.4 Design and development review	Results of the reviews and any necessary actions
7.3.5 Design and development verification	Results of the verification and any necessary actions
7.3.6 Design and development of validation	Records of the results of validation and any necessary actions
7.3.7 Control of design and development changes	Results of the review of changes in any necessary actions
7.4.1 Purchasing process	Results of supplier evaluations and any necessary actions are rising from the valuation
7.5.2 Validation of processes for production and service provision	Requirements for records as applicable
7.5.3 Identification and traceability	Where traceability is a requirement, the unique identification of the product
7.5.4 Customer property	Records of customer property that has lost, damaged, or unsuitable for use
7.6 Control of monitoring and measuring devices	Where no standards exist, bases used for calibration is recorded Records of the results of calibration and verification are maintained
8.2.2 Internal audit	Records of audit results Implied records for reporting verification follow up activities and results
8.2.4 Monitoring and measurement of product	Records indicates the person(s) authorizing the release of the product
8.3 Control of non-conforming product	The nature of nonconformities and any subsequent actions taken, including concessions obtained
8.5.2 Corrective action	Records for corrective action results taken
8.5.3 Preventive action	Records for preventive action results taken

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Is ISO Standards always good for Your Company?

I have worked with many companies to achieve a variety of registrations. As a sales manager, auditor, consultant and trainer, I have noticed that a number of companies haven’t realized the benefits that they expected from standards registration. Some of them have actually become worse off than before they started.

“What am I missing?” I’m often asked. “My compliance to this standard isn’t improving my systems, and it isn’t increasing my customers’ satisfaction.” The answer to this question varies by company and types of implementation, but the solution is straightforward.

Companies that aren’t getting the desired results of standards registration are generally one or more of the following:

• Companies that over documented the management system
• Lean companies with ambitious schedules and deadlines
• Businesses with strong management styles that have become disillusioned with customer-required standards and programs. Personnel charged with implementing documented systems don’t have any more respect for them than top management demonstrates.
• Inadequate training and unnecessary restrictions through over documentation can set any quality system up for failure. Additionally, employees must understand the benefits and restrictions of the system. International standards are written to allow the flexibility needed for companies to be compliant without giving up efficiency and effectiveness.

Once this ineffective, formal ISO 9001 or ISO/TS16949 documented system is in place, what’s on paper hinders getting products shipped or services completed. It becomes almost impossible to deliver products or perform services efficiently, and to complete all of the paperwork and other system requirements. In the end, management begins telling staff, “Just get the job done, get the paperwork later.” This may be appropriate in the short term. If all the extra paperwork and requirements are completed, the company may not be around to solve the over documentation issue.

Over documentation can be a result of many different factors, including:

• Incomplete understanding of the requirements and intent of the standards
• The wrong approach to corrective actions
• Not fully addressing what’s important to the business or management when creating the documentation
• Consultants focusing on delivering more paperwork for your implementation dollar

If the quality system is set up based on any combination of these situations, personnel begin to ignore it and companies begin taking short cuts.

Eventually, employees become uncertain of what’s required, what’s a guideline and what can generally be ignored. This can be done while maintaining good quality products and services, but, again, only for the short term. Employees, over time, don’t know what paperwork or system to attend to and which to overlook. Nothing written can be considered important. The overriding culture requires pleasing management, shipping product and ignoring paperwork and other system requirements. Such companies end up worse off because they’ve lost the informal systems and culture that made them successful in the first place. The implicit culture familiar to employees holds that no paperwork is valuable and the “boss” doesn’t do what he says through the formal, documented system.

One telltale sign of this condition is a scramble to prepare for registrar audits by completing requirements and paperwork. The company may do well on an audit, but it’s like winning money you can’t spend. Fabricated paperwork after the fact adds no value for the company or the customer.

The natural progression from this scenario is that these documented systems begin to fail. The usual issues, like employee turnover and new product launches, add to the bottleneck. Negative trends show up in your metrics, quality concerns increase and profits diminish. Safety and environmental issues may begin to surface. Your documented system has become an exceptional-looking “show car” that has nothing inside. It looks good, but it won’t take you anywhere. You spend all of your time fixing problems instead of improving your processes. Your company culture doesn’t support the system or the changes. This adds to the idea that ISO 9001 or ISO/TS 16949 isn’t working when, in fact, it was never properly implemented.

In truth, if a good system is put in place and if employees are trained and motivated to use it properly, compliance to the standards should benefit the entire company. A correctly documented and implemented system will take no additional time and will be able to drive improvement and keep a company competitive.

Following are some solutions to keep your documented system working properly:

• Get rid of all unnecessary paperwork. It’s better to start with less and fine-tune as you go.
• Train everyone—management and employees—on a simpler system.
• Motivate employees to follow the system and to recommend changes.
• Set goals and keep everyone in the company accountable.
• Continuously improve systems.

I would rather see a company reduce more paperwork than it should. At least this way its employees would always have time to complete their tasks, with no contradictions from management. We can always add as we find the need. This isn’t an extraordinary amount of work, but it requires a true commitment by the management team.

This can be done effectively in several ways, including:

• Implementing lean or kaizen events
• Reducing documentation girth during an upgrade to a new revision of the standard (e.g. ISO 9000 to ISO/TS 16949)
• Constantly asking why. A very effective trainer, lean guru and planner once told me that most adults should take a lesson from a 6-year-old child and start asking

“Why?” again. Why do we need to fill out four forms to accept a $1,000 order from a loyal customer? The answer is, “You don’t.” When companies are properly documented, the culture will be one of reinforcement. Employees will be completing procedures and forms because they support the company’s management and business goals. It doesn’t mean that they’ll understand the purpose of every document they touch, but it does mean that the overwhelming majority of the documentation makes good sense to the staff who use them.

So next time you pick up a procedure or complete a form, take a second glance at it and ask why it’s there. If you don’t know the answer, find someone who should. If you can’t find anyone who knows and the document isn’t legal in nature, try removing it from your system and determine the effects.

When formal documented systems are implemented to meet ISO 9001 or ISO/TS 16949 in the proper way, they add value to a business and make great sense to all concerned.

Author : Brandon Kerkstra, the president of Management Solutions Group Inc., write for qualitydiggest.com

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Quality management system - What is it for?

The concept quality management system (QMS) - that is absolutely central concept in quality management realizations in all organizations - has largely been misused. Still many organizations are using the obsolete concept “quality system” although it does not exist any more in the ISO 9000 standards.

ISO 9000 quality management system is not defined by ISO 9001 only. One must necessarily take into account also ISO 9004 topics. In fact, ISO 9001 is a part of ISO 9004.

According to ISO 9000, a quality management system refers specifically to the management system, i.e. the system used for business management and leadership, comprised of organizational structures, approaches, processes, and resources, and which meets primarily business needs of the organization. “Quality” is an attribute of the management system implying, that appropriate professional management and leadership principles and means are applied within the organization’s management and leadership system in order to ensure and increase its effectiveness and efficiency. Thus, quality management system equals to quality of management system.

Applying the ISO 9000 definition of concept quality to management system we may get the formal definition for the quality of management system. That is: "Degree to which a set of inherent characteristics of a management system fulfils the needs and expectations of organization’s stakeholders". The management system includes both strategic and operational management activities.

The standards present a standardized approach for these principles and means. In real business environments the genuine quality management system can never be a distinct system and only for a quality expertise. A real quality management system is always seamlessly integrated or embedded into the leadership system of a business. The quality management system is realized especially through combining business processes with professional quality methodology. Distinct management systems, including quality systems, upheld by different organizational (support) functions and different specialized experts, will sooner or later generally entail negative effects to the business.

Factually each organization can have only one holistic business management system, and when that system creates sustainable business success it can be called “quality management system”.

(source : qiblog.blogspot.com)

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Internal Audit Nonconformance/NC is not closed, is it a nonconformity at CB assessment?

Several times ago, I’m find a question that makes me surprised. It’s a question from Peters from Poland at Elsmar.com forum at June 2007.

The question is like this. “Internal Audit Nonconformance/NC is not closed, is it a nonconformity at CB assessment? “ He also explained like this. “These were some minor nonconformity from latest internal audits. Some (only some!) corrective actions began but are not finished and closed. Lead Auditor from CB had doubts that he can accept this. He was not sure it conforms to the requirements. We couldn't find in rules any information about such problem. Do internal audit nonconformities have to be closed before certification audit? Organization began corrective actions but these actions are not closed. Is there any requirement in Rules that this situation is nonconformity in certification audit?”

Several in the cove have answered this question.


Stijloor from North Caroline as the forum moderator’s was response like this. “No not necessarily. The corrective action may have to be monitored for a while to demonstrate its effectiveness before a CAR can be (finally) closed. Your CAR log should show the status of the CAR. Inactions (delays, etc.,) are bad”. He also told, “Now, if the Certification Body's auditor issues nonconformity, then it must be closed within a pre-determined time limit. In other words, a certificate of registration can not be issued unless all NC's have been closed to the satisfaction of the CB”.

Trainerbob from Michigan, USA response like this, “There should be no problem with a third party auditor and a corrective action for an internal audit problem as long there seems to be a reasonable plan in place to eliminate the problem and verify the effectiveness of it. If there is no reasonable plan in place to solve the problem, then the third party auditor would probably have a probably have a problem. As Stiljoor said there is a difference between a corrective action from an Internal Audit and a third party audit. Your third party auditor or his/her organization will have guidelines that they use for the closing of non-conformances found during their audits.

Spartan Kim as Shy poster at Elsmar.com response like this, “I agree with Stijloor and would say the requirement is implied. If an internal audit nonconformance is about a requirement of a standard that is not being done, then that certainly would create a new nonconformance at registration audit time from the registrar. But a departure from an internal, documented process that shows progress in meeting the target completion date (as opposed to no progress for days or weeks) should not create a new nonconformance from a registration audit”.

Sidney Vianna from Long Beach, California response like this, “I don't have my copy of the IATF rules handy, at this moment. So, I can not answer for sure if under the IATF rules that would be a nonconformity or not. But, if this was an ISO 9001 audit, conducted under the requirements of ISO 17021, I would have to ask you further questions. For example, are ALL corrective actions emanating from your internal audit process unresolved/open? If that were the case, how can an external auditor assess the effectiveness of your corrective action process? Further, since results of internal audits and status of corrective actions should be part of your management review, can an external audit assess if your management review activities are done? If we were to assume that a percentage of your corrective actions, originated from your internal audit were "closed" and the external auditor can verify the process is working, I would emphatically agree that there is no requirement mandating all corrective action requests to be closed, prior to the certification audit. However, if NONE of the actions have been closed, verified for implementation and effectiveness, myself as an auditor could not attest that a key process of the QMS, namely the corrective action process, is effectively implemented”.

Howste from Utah response like this, “The Rules are not specifically mentioned what you are talking about. Originally Posted by TS Rules 3rd Edition, the audit team shall record all findings of nonconformity when detected and identify the nonconformities to the client. The identified nonconformities shall not be closed during the audit. If there are still nonconformities present in the system, and the audit team finds them, they must record them. So if a corrective action has been initiated, and correction has taken place, there would be no nonconformity - even if the full corrective action is not complete. If the corrective action has been initiated, and the nonconformity still exists, it must be a nonconformity”.

Arios from Juarez-Chihuahua-Mexico response like this, “Corrective Actions derived from internal audits may still be open provided that the issue does not compromise registration. If for instance you have an internal audit finding and a Corrective Action open because the Management Review meetings have not been performed, then to me is a big issue and I would not take the Corrective Action as a waiver for not meeting a requirement in the management standard.

Raffy from Manila-Philippine response like this, “Hi peters, two years ago we also have the same problem as they are some NC from the internal audits were not closed. This was noted by our CB during our pre-assessment audit and likewise suggests that these items should be immediately addressed by our organization. As regards to the problem, during the certification audit, there also some NC that were not closed and status were not indicated, that's why it was called out against the requirement of the clause 8.2.2 & 8.5.2.1 of ISO/TS16949. Lesson learned, there should be a status of each NC and these should be tracked and monitored. If these are not yet finished and remain Open. Escalation Process must be immediately implemented”.

And I was resuming that stated opinion like this, “I think that is no problem if you have a complete planning about the corrective action. That is including the monitoring of your corrective action progress. And I think that was an excessive finding if that is as a nonconformity. It should be an observation finding not a minor or major finding”.

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FMEA – More than a Form

By Michael Down

Failure cannot be eliminated, but if potential failures are identified and analyzed early on, you can take action to minimize the potential impact. The Failure Mode and Effects Analysis (FMEA) process provides the framework.

Does this sound familiar? A problem arises and a solution is needed. Resources are marshaled and hypotheses fly. Alternative actions are identified and tested until the solution is found and applied.

The problem is apparently solved—until some time later, when “the solution” triggers a bigger problem.

These events are not intentional. Most of the time, people are doing their best, trying to help the situation. Sometimes they underestimate the level of impact of the change and assume everything will be fine. Other times, they don’t take into account a change in usage or the environment. They often don’t realize the problem they’ve created.

The good news is that these unintentional events can often be avoided. Whether it’s a new idea, design, process, or a potential solution, the risk of failure always exists. Failure cannot be eliminated, but if potential failures are identified and analyzed early on, mitigating actions can be taken to minimize the impact if the failure occurs. The Failure Mode and Effects Analysis (FMEA) process provides the framework within which this can occur.

Purpose of FMEA
FMEA is an analytical methodology used throughout the product and process development cycle to ensure that potential problems have been identified, considered and addressed. Its most visible results are the documentation of the collective knowledge of cross-functional teams and the action items which mitigate the potential risk.

Through the Advanced Product Quality Planning (APQP) process, OEMs and suppliers identify areas of concern or risk in the design that would require a FMEA analysis. During this discussion, the Potential Failure Modes and Effects Analysis Reference Manual, 4th Ed. is used as a reference to identify key areas and methods needed to evaluate the product or process design.
Key Elements of a Quality FMEA

A FMEA can be prepared to examine the design of a single part, an assembly, the entire system or the processes used to produce them. The following required elements are common for all:

• Appropriate scope. The first step is to establish the depth and level of the analysis. This is accomplished by first identifying and scoping the area of the product or process design, by some form of boundary, block, or flowchart. The complexity of the scope will determine if a single FMEA or multiple (system level and component) FMEAs are required.
• Early start. No value exists in doing an FMEA after the design is completed or the manufacturing process has been developed. The greatest benefit is received by doing it as early as possible. Partial FMEAs can be done at the conception of design to identify key requirements and risks early in the design development cycle, and updated as the design progresses.
• Knowledgeable team. The FMEA is the collaborative effort of a team. Individual team members can affect the scope, direction, or quality of the analysis. The best FMEAs are obtained when teams include subject-matter experts associated with the design or process under review.
• Structured analysis. Simple techniques such as brainstorming can be used to evaluate risk associated with a single event, but evaluating multiple events and their possible interactions requires the structured approach offered by a FMEA. Use of FMEA assures that:

1. All potential failures are identified.
2. Effects (impact to the customer) are identified.
3. Risk assessment (severity, causes, design prevention and controls, occurrence) is made for each failure mode.

• Good discussion and dissection. The FMEA form should not drive the FMEA discussion. A “good” discussion gets down to the “mechanism” of failure or the physics of how a design or system works. If your FMEA meeting is just filling out the form, it’s a waste of time.
• Risk mitigation. Identifying and assessing risks is not enough. Actions such as redesign, elimination or reduction of the causes, or provision for early detection must be taken to mitigate their impact upon the customer. The key is to assign someone on the team to either resolve the issue or follow-up with the team members needed to resolve the issue(s).
• Proper documentation. Finally, the collaborative efforts of the team – the structured analysis, the “good” discussion and the risk mitigation – need to be captured so that the same issues are not duplicated in the future and improvements can be made. Enough detail must be documented so that the FMEA can be picked up in a year and fully understood. The FMEA should not be archived until all action items have been completed and all risks identified by the team have been resolved.

Conclusions

Today, no company can assume everything will be fine. Even simple issues can create problems that eventually lead to a loss of customers and sales. The FMEA process can be a powerful tool to reduce quality issues, cam[BS1]paigns, and warranty. FMEA should become a regular tool used by all engineers in both the manufacturing and the service industry.


Michael Down is with GMNA Advanced Vehicle Engineering – Validation-FMEA & DFM Group and chairman of the SPC, MSA, FMEA Manual Subcommittees. Source : http://aiag.informz.net

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(IAQG: Warrendale, Pennsylvania) -- In an effort to improve product quality and prompt delivery of products, the International Aerospace Quality Group (IAQG) released a revision to AS9100, the quality management system (QMS) standard for the aviation, space, and defense industries.
The AS9100 quality standard is based on ISO 9001, adding requirements specific to the aviation, space, and defense industry. To make significant improvements in quality and reduce cost throughout the value stream, teams worked together to implement initiatives while striving to meet the needs of stakeholders. With this goal in mind, nearly 700 comments and change recommendations were reviewed by the IAQG AS9100 team.

Some of the changes to 9100 include:
• Expansion of scope to include land and sea based systems for defense
applications
• Risk management
• Project management
• Configuration management
• Critical items and special requirements
The release later this year of the revised quality management system standard is a vital step toward achieving the IAQG goal of transforming the on-time, on-quality, delivery (OTOQD) performance of the aviation, space, and defense industry, according to Bill Black, IAQG president.
“Our mission in IAQG is to raise dramatically the OTOQD performance of our industry for the benefit of our customers and our shareholders,” says Black. “This collaborative effort of the major industrial players takes a great leap forward with the next issue of the AS9100 standard that defines the foundation of our business operations.”
The standard can be can be obtained from national and regional standards publication bodies. The IAQG will provide and post on their web site AS9100 deployment support material to accompany the release of AS9100.
For more information on IAQG, visit www.iaqg.org.

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How to Reap Real Benefit from a Layered Process Audit

Not sure if you are getting the maximum benefit from your LPAs? It’s time to leave the minimal compliance mindset behind, and instead, understand and apply what LPAs can do for your company’s overall performance.

Since General Motors Corp. (GM) initially introduced layered process audits (LPAs) to suppliers in 2002, hundreds of companies rushed to implement the system. Chrysler made LPAs a supplier requirement in 2004, and GM suppliers implementing GM’s Quality Systems Basic Training are also required to implement LPAs. Furthermore, to reduce the variation in interpretations, the Automotive Industry Action Group (AIAG) published CQI-8—Layered Process Audits Guideline in December 2005.

However, while about one-third of North American automotive suppliers have some form of LPA in place (perhaps a bit higher among the Tier One group), some experts say that many suppliers rushed to implement the LPA strategy simply to satisfy a new customer requirement—not to examine and fully utilize the benefits of the strategy itself.

A layered process audit is an ongoing chain of simple verification checks that ensure a defined process is followed correctly. It is a powerful management tool that can improve safety, quality and cost savings by amplifying problem solving systems and making continuous improvement almost routine. Through observation, evaluation and conversations on the manufacturing floor, these checks ensure key work steps are performed properly. LPA interactions are also an excellent way for managers to show respect for frontline workers.

“To meet the new requirements, suppliers quickly created audit checksheets and questions, but never thought about what process elements and what audit questions would actually reduce risk, prevent problems, and reduce costs,” notes Murray Sittsamer, president of The Luminous Group LLC. “I would guess only about half of the companies currently doing LPAs are doing them in a way that is truly helpful to their own business performance.”

Sittsamer says OEMs see LPAs as one of the most powerful strategies to take a good supplier and make them better; or take a great supplier and keep their quality metrics from declining. “By assuring that standardized procedures are in place, an organization can move from minimally complying to an organization where quality and conformance to product and process requirements is the number-one priority,” he says.

Benefits of LPAs
Here are some of the many benefits suppliers have realized from implementing LPAs:

• Protecting operators from injury.
• Eliminating the shipping of nonconforming products.
• Saving money because it’s less costly to have fewer injuries and manufacture products correctly the first time.
• Focusing on process inputs that help achieve first-time quality.
• Ensuring that processes run correctly because you are able to personally verify them.
• Helping top management become more familiar with shop-floor activities and building a relationship between management and shop floor personnel.

“LPAs are not the typical audit of the product,” Sittsamer explains. “Instead, they are an audit of the process. In a process audit, you check to see that the operator is following the defined process. LPAs ensure that the critical process parameters, such as machine settings, temperatures, flow rates and gages, were set correctly. If the defined parameters were set correctly, the process will make good parts.”

The industry can learn more about LPAs through AIAG’s one-day Layered Process Audit Implementation Workshop. This “Train-the-Trainer” course is for individuals who will be leading their site’s implementation of Layer Process Audits to fulfill recent OEM requirements. AIAG also offers a Layered Process Audit Executive Overview for company owners, presidents, plant managers and their leadership teams. It’s designed to layout the LPA strategy, including the benefits, approach, overview of what’s required, leadership’s role, and how to monitor LPA effectiveness.

To register for these and other AIAG training, visit www.aiag.org or contact AIAG Customer Service at (248) 358-3003.

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ISO launches development of future standard on energy management

The first meeting of ISO’s new project committee PC 242 which is to develop an International Standard on energy management was held on 8-10 September in Washington, DC, USA.

The future ISO 50001 will establish a framework for industrial plants, commercial facilities or entire organizations to manage energy. Targetting broad applicability across national economic sectors, the standard could influence up to 60 % of the world’s energy use.

The meeting was attended by delegates from the ISO national member bodies of 25 countries from all regions of the world, as well as representation from the United Nations Industrial Development Organization (UNIDO), which has liaison status with PC 242. All the participating countries have existing activities on energy management and have a strong interest in also developing a harmonized solution at the international level.

As part of the proceedings, delegates described their various initiatives in detail. For example, a presentation was given by UNIDO on the preparatory work the organization has carried out to support the ISO process by researching energy management needs in developing countries.

This gave PC 242 an insight into the different policies and situations around the world which need to be taken into account in the development of a globally relevant International Standard for energy management.

Excellent progress was made in the technical discussions and a first working draft has already been created. A major point of discussion is the need to ensure compatibility with the existing suite of ISO management system standards. The committee therefore took the key decision to base the draft on the common elements found in all of ISO’s management system standards.

This will ensure maximum compatibility with key standards such as ISO 9001 for quality management and ISO 14001 for environmental management.

The project committee is fully committed to an ambitious schedule and aims to have ISO 50001 ready for publication by the end of 2010.

ISO Secretary-General Alan Bryden commented: "This first meeting of PC 242 marks the launch of a new global approach to systematically address energy performance in organizations – pragmatically addressing energy efficiency and related climate change impacts. It is fully in line with and supportive of the global mobilization on these major challenges, and with the IEA-ISO position paper on the contribution of International Standards."

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Can ISO Standards Be Bad for Your Company?

“What am I missing?” I'm often asked. “My compliance to this standard isn’t improving my systems, and it isn’t increasing my customers' satisfaction.” The answer to this question varies by company and types of implementation, but the solution is straightforward.

Companies that aren't getting the desired results of standards registration are generally one or more of the following:

• Companies that overdocumented the management system
• Lean companies with ambitious schedules and deadlines
• Businesses with strong management styles that have become disillusioned with customer-required standards and programs. Personnel charged with implementing documented systems don't have any more respect for them than top management demonstrates.
• Inadequate training and unnecessary restrictions through overdocumentation can set any quality system up for failure. Additionally, employees must understand the benefits and restrictions of the system. International standards are written to allow the flexibility needed for companies to be compliant without giving up efficiency and effectiveness.

Once this ineffective, formal ISO 9001 or ISO/TS 16949 documented system is in place, what's on paper hinders getting products shipped or services completed. It becomes almost impossible to deliver products or perform services efficiently, and to complete all of the paperwork and other system requirements. In the end, management begins telling staff, “Just get the job done, get the paperwork later.” This may be appropriate in the short term. If all the extra paperwork and requirements are completed, the company may not be around to solve the overdocumentation issue.

Overdocumentation can be a result of many different factors, including:

• Incomplete understanding of the requirements and intent of the standards
• The wrong approach to corrective actions
• Not fully addressing what's important to the business or management when creating the documentation
• Consultants focusing on delivering more paperwork for your implementation dollar

If the quality system is set up based on any combination of these situations, personnel begin to ignore it and companies begin taking short cuts.

Eventually, employees become uncertain of what's required, what's a guideline and what can generally be ignored. This can be done while maintaining good quality products and services, but, again, only for the short term. Employees, over time, don't know what paperwork or system to attend to and which to overlook. Nothing written can be considered important. The overriding culture requires pleasing management, shipping product and ignoring paperwork and other system requirements. Such companies end up worse off because they've lost the informal systems and culture that made them successful in the first place. The implicit culture familiar to employees holds that no paperwork is valuable and the “boss” doesn't do what he says through the formal, documented system.

One telltale sign of this condition is a scramble to prepare for registrar audits by completing requirements and paperwork. The company may do well on an audit, but it’s like winning money you can’t spend. Fabricated paperwork after the fact adds no value for the company or the customer.

The natural progression from this scenario is that these documented systems begin to fail. The usual issues, like employee turnover and new product launches, add to the bottleneck. Negative trends show up in your metrics, quality concerns increase and profits diminish. Safety and environmental issues may begin to surface. Your documented system has become an exceptional-looking “show car” that has nothing inside. It looks good, but it won't take you anywhere. You spend all of your time fixing problems instead of improving your processes. Your company culture doesn’t support the system or the changes. This adds to the idea that ISO 9001 or ISO/TS 16949 isn’t working when, in fact, it was never properly implemented.

In truth, if a good system is put in place and if employees are trained and motivated to use it properly, compliance to the standards should benefit the entire company. A correctly documented and implemented system will take no additional time and will be able to drive improvement and keep a company competitive.

Following are some solutions to keep your documented system working properly:

• Get rid of all unnecessary paperwork. It's better to start with less and fine-tune as you go.
• Train everyone—management and employees—on a simpler system.
• Motivate employees to follow the system and to recommend changes.
• Set goals and keep everyone in the company accountable.
• Continuously improve systems.

I would rather see a company reduce more paperwork than it should. At least this way its employees would always have time to complete their tasks, with no contradictions from management. We can always add as we find the need. This isn't an extraordinary amount of work, but it requires a true commitment by the management team.

This can be done effectively in several ways, including:

• Implementing lean or kaizen events
• Reducing documentation girth during an upgrade to a new revision of the standard (e.g. QS 9000 to ISO/TS 16949)
• Constantly asking why. A very effective trainer, lean guru and planner once told me that most adults should take a lesson from a 6-year-old child and start asking

“Why?” again. Why do we need to fill out four forms to accept a $1,000 order from a loyal customer? The answer is, “You don’t.” When companies are properly documented, the culture will be one of reinforcement. Employees will be completing procedures and forms because they support the company’s management and business goals. It doesn’t mean that they’ll understand the purpose of every document they touch, but it does mean that the overwhelming majority of the documentation makes good sense to the staff who use them.

So next time you pick up a procedure or complete a form, take a second glance at it and ask why it's there. If you don't know the answer, find someone who should. If you can't find anyone who knows and the document isn't legal in nature, try removing it from your system and determine the effects.

When formal documented systems are implemented to meet ISO 9001 or ISO/TS 16949 in the proper way, they add value to a business and make great sense to all concerned.

About the author

Brandon Kerkstra has extensive experience in product testing, inspection and quality in the military, nuclear, aerospace and automotive industries. He is the president of Management Solutions Group Inc., a training and consulting firm based in Grand Rapids, Michigan.

Source : www.qualitydigest.com

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Root Cause Analysis

Root cause analysis (RCA) is a class of problem solving methods aimed at identifying the root causes of problems or events. The practice of RCA is predicated on the belief that problems are best solved by attempting to correct or eliminate root causes, as opposed to merely addressing the immediately obvious symptoms. By directing corrective measures at root causes, it is hoped that the likelihood of problem recurrence will be minimized. However, it is recognized that complete prevention of recurrence by a single intervention is not always possible. Thus, RCA is often considered to be an iterative process, and is frequently viewed as a tool of continuous improvement.

Root cause analysis is not a single, sharply defined methodology; there are many different tools, processes, and philosophies of RCA in existence. However, most of these can be classed into five, very-broadly defined "schools" that are named here by their basic fields of origin: safety-based, production-based, process-based, failure-based, and systems-based.

• Safety-based RCA descends from the fields of accident analysis and occupational safety and health.
• Production-based RCA has its origins in the field of quality control for industrial manufacturing.
• Process-based RCA is basically a follow-on to production-based RCA, but with a scope that has been expanded to include business processes.
• Failure-based RCA is rooted in the practice of failure analysis as employed in engineering and maintenance.
• Systems-based RCA has emerged as an amalgamation of the preceding schools, along with ideas taken from fields such as change management, risk management, and systems analysis.

Despite the seeming disparity in purpose and definition among the various schools of root cause analysis, there are some general principles that could be considered as universal. Similarly, it is possible to define a general process for performing RCA.

General principles of root cause analysis

1. Aiming corrective measures at root causes is more effective than merely treating the symptoms of a problem.
2. To be effective, RCA must be performed systematically, and conclusions must be backed up by evidence.
3. There is usually more than one root cause for any given problem.

General process for performing and documenting an RCA-based Corrective Action

Notice that RCA (in steps 3, 4 and 5) forms the most critical part of successful corrective action, because it directs the corrective action at the root of the problem.

1. Define the problem.
2. Gather data/evidence.
3. Identify issues that contributed to the problem.
4. Find root causes.
5. Develop solution recommendations.
6. Implement the recommendations.
7. Observe the recommended solutions to ensure effectiveness.

[edit] Root cause analysis techniques

• 5 Whys
• Failure mode and effects analysis
• Pareto analysis
• Fault tree analysis
• Bayesian inference
• Ishikawa diagram, also known as the fishbone diagram or cause and effect diagram
• Barrier analysis - a technique often used in particularly in process industries. It is based on tracing energy flows, with a focus on barriers to those flows, to identify how and why the barriers did not prevent the energy flows from causing harm.
• Change analysis - an investigation technique often used for problems or accidents. It is based on comparing a situation that does not exhibit the problem to one that does, in order to identify the changes or differences that might explain why the problem occurred.
• Causal factor tree analysis - a technique based on displaying causal factors in a tree-structure such that cause-effect dependencies are clearly identified.

Basic Elements of Root Cause

• Materials

- Defective Raw Material

- Wrong type for job

- Lack of raw material

• Machine/Equipment

- Incorrect tool selection

- Poor maintenance or design

- Poor equipment or tool placement

- Defective Equipment or tool

• Environment

- Orderly workplace

- job design or layout of work

- Surfaces poorly maintained

- Physical demands of the task

- Forces of Nature

• Management

- No or poor management involvement

- Inattention to task

- Task hazards not guarded properly

- Other (horseplay, inattention....)

- Stress demands

• Methods

- No or poor procedures

- Practices are not the same as written procedures

- Poor communication

• Management System

- Training or education lacking

- Poor employee involvement

- Poor recognition of hazard

- Previously identified hazards were not eliminated

Here Some Scheme matrix of RCA Download it HERE

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Publication of new edition of ISO 9001 expected in October-November 2008

A new edition of ISO 9001, the world's most widely used quality management system standard, is being submitted for voting as a Final Draft International Standard and, subject to formal approval by the ISO membership, the publication of the revised version should be in the October-November 2008 time frame.

The proposed ISO 9001:2008 does not introduce additional requirements compared to the last edition in 2000 and does not change the intent of ISO 9001:2000.

The draft International Standard was approved at the 19-23 May 2008 meeting of ISO technical committee ISO/TC 176, Quality management and quality assurance, held in Novi Sad, Serbia, and hosted by the Serbian national standards body, ISS. ISO 9001 will be circulated in July as a Final Draft International Standard, on which ISO's national member bodies as a whole may vote.

ISO 9001 provides the requirements for a quality management system (QMS), which is a framework for an organization to control its processes in order to achieve objectives including customer satisfaction, regulatory compliance and continual improvement. Organizations that implement the standard can choose to have their QMS independently certified as conforming to the requirements of ISO 9001, as means of increasing the confidence of their business partners, customers and regulators in their products and services.

Although certification is not compulsory, it is estimated that over one million ISO 9001 certificates have been issued to organizations in private and public sectors, in manufacturing and services, and in 170 countries. The new edition, however, will not require any specific reassessment for certification.

ISO 9001:2008 will be the fourth edition of the standard which was first published in 1987. The third edition, published in 2000, represented a thorough revision, including new requirements and a sharpened customer focus, reflecting developments in quality management and experience gained since the publication of the initial version.

ISO's rules for the development of standards require their periodic review to decide if they need revising, maintaining or withdrawing. Compared to the 2000 revision, ISO 9001:2008 represents fine-tuning, rather than a thorough overhaul. It introduces clarifications to the requirements existing in ISO 9001:2000, based on user experience over the last eight years, and changes that are intended to improve further compatibility with the ISO 14001:2004 standard for environmental management systems.

To accompany the publication of the new versions, ISO is now working on implementation guidance for ISO 9001:2008, a reference table comparing and contrasting ISO 9001:2000 and ISO 9001:2008 and answers to Frequently Asked Questions. ISO is collaborating with the International Accreditation Forum (IAF) concerning accredited certification.

ISO 9001 is one of 17 standards (plus a corrigendum) developed by ISO/TC 176 on quality management supporting tools. These include ISO 9004:2000, Quality management systems – Guidelines for performance improvements, which is undergoing revision and expected to be published as a new edition in 2009.

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Internal Auditing Tips

On this page we will be adding tips to assist you in your auditing efforts. Feel free to contact us with your tips. We will not only post them, but we will make sure you get the credit.
As always...Good Auditing!

Free Tip #1:
Contact auditees at least four times about their scheduled audit. The first contact would come when the annual audit schedule is generated. The second should be about one month prior to the audit. This allows the auditee time to prepare for any additional resources necessary (They shouldn't need extra time to "get their areas squared away".). The third contact should be about a week before the audit. At this time, you can give the auditee a detailed schedule about exact times, and locations of audit activities. For example, you will be auditing receiving inspection at 10:45. Each of these contacts should be in writing (email is just as good). The day before the audit, place a quick phone call (or voicemail) to verify the audit.
Of course, you still need to have an opening meeting, and that is in addition to the above. The reason for the multiple contacts is simply, we tend to forget things due to our work load. Audits should never be a surprise, this ensures the auditee has every chance to prepare.

Free Tip #2:
When preparing the audit schedule take into account such things as:

• Available resources
• Audit Scope
• Sample Size

The key is not to bite off more than your auditors can chew [Translation: Don't over-commit your resources]. Smaller, but more frequent audits may be better than comprehensive three-day audits. Inadequate resources may indicate lace of Executive Management commitment. You can get more information on the above from November's and December's newsletters.

Free Tip #3:

One of the hardest things to do is get a quick turn-around time on corrective actions. Auditors are frequently frustrated by lower and mid-management's foot dragging on responding to audit findings. One way to get faster action is to have executive management place effective corrective action turn-around time in management's performance appraisals. By tying in corrective actions to performance appraisals, bonuses, etc., you virtually force management into timely, effective corrective actions. This could also work with audits completed on time, etc. It also shows lower and mid-management that executive management is committed to the process.
Tip takes from December's issue

Free Tip #4:

If you company has email…try to set up a paperless audit system where the only thing you would need to "print out" and hand write would by your audit worksheet, which you take withy you to collect your evidence/samples. We have a paperless system here - we are able to email out notification forms and audit summaries without ever printing a sheet. It works EXCELLENTLY! We even File our paperless paperwork electronically for when our third -party auditors come to audit!Write your procedures in Flowchart style. This helps to make the workflows appear that much clearer for new and veteran auditors alike. By having all of our procedures in flowchart style, we have cut down on our audit time by half and increased audit accuracy tremendously!Jill Chavanne, Internal Audit Program Manager, Weiss-aug. Co

Free Tip #5:
Auditors are frequently frustrated by lower and mid-management's foot dragging on responding to audit findings. One way to improve the timeliness of audit finding responses is to issue reminder notifications. Our audit finding response due dates are normally two weeks from the issue date of the finding. I typically issue two "Reminder of Approaching due date" notifications, one at 50% of allotted response time and the other at 75%. This method can be modified to fit your particular system, i.e. issuing only one notice for lessor response time allotments. This documentation can be in the form of a manual memorandum/form or the more efficient e-mailed memorandum/form. Issuing reminder notifications demonstrates a monitored system and can also prove useful if elevation of the finding becomes necessary. David A. Wimer, BAE SYSTEMS

Free Tip #6:
"Be sure to follow-up on corrective actions from previous audits: don't only audit to see the corrective actions have been implemented. Make sure the corrective action corrected the problem that caused the corrective action in the first place."
Betsy Hsiao, Quest Analytical

Free Tip #7:
In order to have an effective Corrective Action, Nonconformities must have three attributes:
They must be Understandable: If the auditee does not understand the nonconformity, they will not know how to deal with it. They must be Actionable: If there is no action that can be taken, the Corrective Action cannot be achieved. They must be Unarguable (that is not a word, but it fits): If an auditee can argue ANY part of a nonconformity, they will argue rather than correct.

Free Tip #8:
Auditing is all about asking questions. As an auditor, you have to make sure you ask the right person, the right question. You also have to make sure YOU understand the question you are about to ask. If you don't understand the question, how can you expect to understand the answer. You must also ask questions in a manner that the auditee will understand them.

source http://www.internal-auditor.com/tips.htm

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ISO and IAF announce schedule for implementation of accredited certification to ISO 9001:2008

ISO (International Organization for Standardization) and the IAF (International Accreditation Forum) have agreed on an implementation plan to ensure a smooth transition of accredited certification to ISO 9001:2008, the latest version of the world's most widely used standard for quality management systems (QMS). The details of the plan are given in the joint communiqué by the two organizations which appears below.

Like all of ISO's more than 17 000 standards, ISO 9001 is periodically reviewed to ensure that it is maintained at the state of the art and a decision taken to confirm, withdraw or revise the document.

ISO 9001:2008, which is due to be published before the end of the year, will replace the year 2000 version of the standard which is implemented by both business and public sector organizations in 170 countries. Although certification is not a requirement of the standard, the QMS of about one million organizations have been audited and certified by independent certification bodies (also known in some countries as registration bodies) to ISO 9001:2000.

ISO 9001 certification is frequently used in both private and public sectors to increase confidence in the products and services provided by certified organizations, between partners in business-to-business relations, in the selection of suppliers in supply chains and in the right to tender for procurement contracts.

ISO is the developer and publisher of ISO 9001, but does not itself carry out auditing and certification. These services are performed independently of ISO by certification bodies. ISO does not control such bodies, but does develop voluntary International Standards to encourage good practice in their activities on a worldwide basis. For example, ISO/IEC 17021:2006 specifies the requirements for bodies providing auditing and certification of management systems.

Certification bodies that wish to provide further confidence in their services may apply to be "accredited" as competent by an IAF recognized national accreditation body. ISO/IEC 17011:2004 specifies the requirements for carrying out such accreditation. IAF is an international association whose membership includes the national accreditation bodies of 49 economies.

ISO technical committee ISO/TC 176, Quality management and quality assurance, which is responsible for the ISO 9000 family of standards, is preparing a number of support documents explaining what the differences are between ISO 9001:2008 and the year 2000 version, why and what they mean for users. Once approved, these documents will be posted on the ISO Web site – probably in October 2008.

Joint IAF-ISO communiqué

Implementation of accredited certification to ISO 9001:2008

ISO (International Organization for Standardization) and the IAF (International Accreditation Forum) have agreed an implementation plan to ensure a smooth migration of accredited certification to ISO 9001:2008, after consultation with international groupings representing quality system or auditor certification bodies, and industry users of ISO 9001 certification services.

ISO 9001:2008 does not contain any new requirements

They have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 based on eight years of experience of implementing the standard world wide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with ISO14001:2004

The agreed implementation plan in relation to accredited certification is therefore the following:

Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO 9001:2008 as an International Standard.

Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issued after official publication of ISO 9001:2008 (which should take place before the end of 2008) and after a routine surveillance or recertification audit against ISO 9001:2008.

Validity of certifications to ISO 9001:2000

One year after publication of ISO 9001:2008 all accredited certifications issued (new certifications or recertifications) shall be to ISO 9001:2008.

Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid.

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ISO 9001:2008 proposed changes

The main changes being introduced into the revised standard are as follows:-

Clause 0.2 (Process approach)
Text added to emphasize the importance of processes being
capable of achieving desired outputs

Clause 1.1 (Scope)
Clarification that “product” also includes intermediate product
Explanation regarding statutory, regulatory and legal requirements

Clause 4.1 (General requirements)
Notes added to explain more about outsourcing
Types of control that may be applied to outsourced processes
Relationship to clause 7.4 (Purchasing)
Clarification that outsourced processes are still responsibility of the
organization and must be included in the quality management
system

Clause 4.2.1 (Documentation)
Clarification that QMS documentation also includes records
Documents required by the standard may be combined
ISO 9001 requirements may be covered by more than one
documented procedure

Clause 4.2.3 (Document control)
Clarification that only external documents relevant to the QMS need
to be controlled

Clause 4.2.4 (Records control)
Editorial changes only (better alignment with ISO 14001)

Clause 5.5.2 (Management rep)
Clarifies that this must be a member of the organization’s own
management

Clause 6.2.1 (Human resources)
Clarification that competence requirements are relevant for any
personnel who are involved in the operation of the quality
management system

Clause 6.3 (Infrastructure)
Includes information systems as example

Clause 6.4 (Work environment)
Clarifies that this includes conditions under which work is
performed and includes, for example physical, environmental and
other factors such as noise, temperature, humidity, lighting, or
weather

Clause 7.2.1 (Customer related processes)
Clarifies that post-delivery activities may include:
Actions under warranty provisions
Contractual obligations such as maintenance services
Supplementary services such as recycling or final disposal

Clause 7.3.1 (Design & development planning)
Clarifies that design and development review, verification and
validation have distinct purposes
These may be conducted and recorded separately or in any
combination as suitable for the product and the organization

Clause 7.3.3(Design & development outputs)
Clarifies that information needed for production and service
provision includes preservation of the product

Clause 7.5.4 (Customer property)
Explains that both intellectual property and personal data should be
considered as customer property

Clause 7.6 (Now retitled Control of Monitoring and Measuring
equipment)
Explanatory notes added regarding the use of computer software:
“Confirmation of the ability of computer software to satisfy the
intended application would typically include its verification and
configuration management to maintain its suitability for use.”

Clause 8.2.1 (Customer satisfaction)
Note added to explain that monitoring of customer perception may
include input from sources such as customer satisfaction surveys,
customer data on delivered product quality, user opinion surveys,
lost business analysis, compliments, and dealer reports

Clause 8.2.3 (Monitoring / Measurement of process)
Note added to clarify that when deciding on appropriate methods,
the organization should consider impact on the conformity to
product requirements and on the effectiveness of the quality
management system.

Download the detail here or here

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Daftar Istilah Dalam Sistem Manajemen Mutu

Mutu :
Gambaran dan karakteristik menyeluruh dari barang atau jasa, yang menunjukkan kemampuannya dalam memuaskan kebutuhan yang ditentukan atau yang tersirat.

Mutu barang :
Kondisi atau ukuran kualitatif suatu barang yang umumnya menjadi persyaratan yang harus dipenuhi agar suatu barang diperbolehkan untuk dipasarkan, atau menjadi ukuran untuk memenuhi selera atau tuntutan konsumen sekaligus menjadi faktor yang dapat mendorong kesadaran serta kemampuan para eksportir dan produsen.

Kebijakan Mutu :
Keseluruhan maksud dan tujuan organisasi yang berkaitan dengan mutu yang dinyatakan secara formal oleh pimpinan puncak.

Jaminan Mutu :
Seluruh perencanaan dan kegiatan sistematik yang diperlukan untuk memberikan suatu keyakinan yang memadai bahwa suatu barang atau jasa akan memenuhi persyaratan mutu.

Manajemen Mutu :
Aspek dari seluruh fungsi manajemen yang menetapkan dan melaksanakan kebijakan mutu.

Sistem Mutu :
Merupakan struktur organisasi, tanggung jawab, prosedur, proses dan sumberdaya

Pengendalian Mutu :
Teknik dan kegiatan operasional yang digunakan untuk memenuhi persyaratan mutu.

Audit Mutu :
Pengujian yang sistematik dan mandiri untuk menetapkan apakah kegiatan mutu dan hasil yang berkaitan sesuai dengan pengaturan yang direncanakan dan apakah pengaturan-pengaturan yang disebut ini diterapkan secara efektif dan sesuai untuk pencapaian tujuan.

HACCP (Hazard Analysis Critical Control Point) :
Suatu sistem mutu, manajemen mutu dan pengendalian mutu melalui pendekatan sistematik mengenai identifikasi bahaya (hazard), pengamatan dan pengawasan untuk menjamin keamanan makanan.

Titik Kontrol (Control Poit) :
Setiap tahapan dalam proses yang diawasi secara fisika, kimia maupun biologis (microbiologis).

Tindakan Perbaikan (Corrective Action) :
Prosedur yang dilakukan apabila kesalahan atau penyimpangan terjadi atau batas kritis tidak tercapai atau terlewati.

Titik-titik kritis (Critical Control Point = CCP) :
Tiap tahapan dalam proses yang apabila tidak diawasi dengan baik dapat mengganggu keamanan (safety), mutu (quality), keselamatan (wholesomeness) atau menimbulkan penipuan/penyimpangan secara ekonomi (economic fraud).

Penyimpangan/Kekurangan (Critical Defisiensi) :
Penyimpangan terhadap ketentuan yang telah ditetapkan untuk mempertahankan keamanan (safety), kesehatan dan kebersihan (Wholesomeness) serta untuk mencegah terjadinya kerugian ekonomi.

Batas Kritis (Critical Limit) :
Tetapan ambang/batas yang tidak boleh dilewati yang mana harus diawasi setiap ccp.

Rancangan HACCP (HACCP Plan) :
Dokumen yang menjelaskan sistem pengawasan mutu berdasarkan HACCP dari suatu perusahaan.

Bahaya/potensi bahaya :
Resiko atau peluang adanya sifat-sifat pada makanan yang tidak dapat diterima secara biologis (microbiologis), fisika dan kimia yang mana dapat menyebabkan terganggunya kesehatan konsumen ataupun menyebabkan terjadinya penyimpangan produk dari kriteria yang telah ditentukan.

Analisa Bahaya (Hazard) :
Proses untuk mengidentifikasi peluang atau resiko terjadinya bahaya (hazard) baik yang bersifat biologis, fisika, kimia maupun ekonomi (economic fraud).

HACCP-Based System :
Cara pendekatan non tradisional dalam pemeriksaan produk untuk mengontrol bahaya (hazard) dalam makanan. Sistem ini adalah hasil dari penerapan rencana HACCP.

Produk Beresiko Kecil (Low Risk Product) :
Produk (seafood) yang beresiko kecil bagi kesehatan konsumen apabila disiapkan diolah/disiapkan dengan cara tradisional/konvensional.

Kekurangan Secara Mayor (Major Deffisiensi) :
Penyimpangan besar dari rencana yang telah ditetapkan yang dapat menghambat tujuan mempertahankan keamanan produk, kesehatan dan kebersihan, serta mencegah terjadi penipuan ekonomi (economic fraud).

Kekurangan Minor (Minor Deffisiensi) :
Kegagalan suatu bagian sistem HACCP yang tidak memberi pengaruh-pengaruh besar terhadap kemampuan fasilitas yang ada untuk memenuhi persyaratan sanitasi yang dapat dipertanggung jawabkan.

Prosedur Monitoring (Monitoring Prosedure) :
Jadwal pengujian/pengamatan yang dicatat oleh petugas perusahaan untuk laporan dari temuan ditiap ccp.

Tindakan Pencegahan (Preventive Measures) :
Tiap tindakan yang akan menghambat/mencegah timbulnya bahaya (hazard) pada produk.

Proses :
Suatu kegiatan atau operasi untuk memanen, memproduksi, menyimpan, menangani, mendistribusikan atau menjual produk.

Kekurangan/Kesalahan Serius (Serius Diffesiensi) :
Penyimpangan yang serius dari rencana yang telah dibuat untuk mempertahankan terpeliharanya keamanan, kesehatan dan kebersihan, serta mencegah terjadinya economic fraud. Dan apabila penyimpangan itu terus berlanjut akan menyebabkan produk tidak aman, tidak sehat dan higiene serta tidak sesuai dengan spesifikasi produk (misbranded).

Produk Beresiko Tinggi (Substantial Risk Product) :
Produk (seafood) yang dapat mengakibatkan bahaya terhadap kesehatan konsumen apabila disiapkan/diolah dengan cara tradisional/konvensional. Sebagai contoh adalah produk-produk siap dimakan dan siap dihidangkan, yang mana apabila mengandung bakteri pathogen biotoxin atau terkontaminasi zat kimi ata fisika dapat membahayakan kesehatan konsumen.

Pemeriksaan Terhadap Sistem (System Audit) :
Pemeriksaan mendadak (tanpa pemberitahuan) terhadap keefektifan perusahaan melaksanakan rancangan HACCP yang telah disetujui (sesuai dengan validasi).

Validasi (Validation) :
Evaluasi terhadap kesempurnaan, keberfungsian dan keefektifan dari perusahaan dalam melaksanakan rancangan/program HACCP.

Verifikasi (Verification) :
Peninjauan secara periodik oleh perusahaan untuk menentukan keefektifan secara keseluruhan dalam rancangan HACCP.

Verifikasi Audit (Audit Verification) :
Peninjauan mendadak oleh petugas pemerintah (Competent Authority) sesuai prosedur yang telah ada.

Verifikasi :
Suatu proses persetujuan dan pengesahan penerapan sistem HACCP dan/atau SNI Seri 9000 melalui proses audit dan review.

Review :
Pemantauan kembali pelaksanaan sistem HACCP dan/atau SNI Seri 19-9000 melalui auditing.

Inspeksi :
Kegiatan-kegiatan seperti : pengukuran pemeriksaan, pengujian, pengukuran dengan perbandingan satu atau lebih karakteristik barang atau jasa, dan dibandingkan dengan persyaratan tertentu untuk menetapkan kesesuaian.

Lembaga Sertifikasi :
Lembaga yang mempunyai tugas melakukan kegiatan penilaian kesesuaian terhadap persyaratan tertentu, dimana hasil penilaian dinyatakan dengan sertifikat (sistem manajemen mutu, sistem manajemen lingkungan, produk, personel, sistem keamanan pangan (Hazard Analysis and Critical Control Point - HACCP)

Inspeksi Teknis :
Kegiatan pemeriksaan dan/atau pengujian terhadap suatu pekerjaan, produk dan atau jasa, proses, sarana dan prasarana yang spesifik, yang mengacu kepada spesifikasi teknis dengan memperhatikan segi keamanan, keselamatan dan lingkungan yang ditentukan.

Sertifikasi :
Proses yang berkaitan dengan pemberian sertifikat oleh suatu lembaga sertifikasi.

Sertifikasi Sistem Mutu :
Kegiatan pemberian sertifikat sistem mutu kepada perusahaan yang telah mampu menerapkan sistem mutu menurut SNI seri 19-9000 dan/atau HACCP yang diacu dan akui di dalam kegiatan organisasinya untuk menghasilkan produk dan/atau jasa tertentu.

Sertifikasi Produk :
Kegiatan pemberian sertifikat produk dan/atau jasa kepada perusahaan yang telah mampu menghasilkan suatu produk dan/atau jasa sesuai dengan SNI dan telah mendapat sertifikat mutu.

Sertifikasi Hasil Uji :
Kegiatan pemberian sertifikat yang menyatakan bahwa pengujian atas contoh produk yang telah diuji sesuai dengan standar/spesifikasi teknis tertentu.

Sertifikasi Inspeksi Teknis :
Kegiatan pemberian sertifikat yang menyatakan hasil inspeksi teknis terhadap kelaikan kerja suatu produk/sistem/instalasi yang telah sesuai dengan spesifikasi/standar tertentu.

Sertifikasi Personil :
Kegiatan pemberian sertifikat yang menyatakan bahwa personil yang bersangkutan telah memenuhi persyaratan teknis tertentu yang dipersyaratkan dalam pelaksanaan kegiatan yang berkaitan dengan standardisasi.

Sertifikat :
Adalah jaminan tertulis yang diberikan oleh Lembaga/laboratorium yang telah diakreditasi untuk menyatakan bahwa barang, jasa, proses, sistem atau personel telah memenuhi standar yang dipersyaratkan.

Tanda Sertifikasi Sistem Mutu :
Tanda sertifikasi yang dipergunakan oleh perusahaan yang telah memperoleh sertifikat sistem mutu.

Pemeriksaan (Audit) :
Kegiatan pemeriksaan yang dilakukan oleh lembaga sertifikasi terhadap perusahaan yang telah mendapat sertifikat.

Asesmen Mutu :
Pengujian sistematik dan mandiri untuk mengetahui apakah kegiatan yang berkaitan dengan mutu telah dilakukan sesuai dengan rencana, konsisten dan efektif mencapai tujuan.

Sistem :
Prosedur yang orientasinya meliputi pencegahan dan perbaikan terhadap hal-hal yang menyimpang dari standar spesifikasi pada setiap proses produksi sedini mungkin.

Asesor (Pengawas Mutu) :
Petugas yang telah disertifikasi dan dikualifikasi untuk melaksanakan asesmen dalam rangka akreditasi.

Penilik Mutu (Inspektor) :
Petugas yang telah disertifikasi dan dikualifikasi untuk melaksanakan pengawasan mutu di lingkungan Departemen Pertanian.

Spesifikasi :
Dokumen yang menguraikan persyaratan barang atau jasa yang harus dipenuhi.

Mawujud (entity) :
Sesuatu, berwujud atau tanwujud yang dapat dijelaskan dan dipertimbangkan secara individu. Sebagai contoh, mawujud dapat berupa :
a) kegiatan atau proses
b) produk
c) organisasi, system atau orang atau
d) kombinasinya

Proses :
Rangkaian sumber daya dan kegiatan yang saling terkait yang mengubah masukan menjadi keluaran.

Prosedur :
Cara yang ditentukan untuk melaksanakan kegiatan.

Produk :
Hasil dari kegiatan atau proses.

Jasa :
Sesuatu yang dihasilkan untuk memenuhi kebutuhan pelanggan melalui kegiatan pada titik temu antara pemasok dengan pelanggan dan kegiatan internal pemasok.

Penyampaian Jasa :
Kegiatan pemasok yang diperlukan untuk memberikan jasa.

Organisasi :
Perusahaan, korporasi, firma, badan, usaha atau lembaga atau bagiannya baik gabungan atau tidak, pemerintah atau swasta yang memiliki fungsi dan administrasi sendiri.

Struktur Organisasi :
Tanggung jawab, wewenang dan hubungan yang disusun dalam suatu pola yang digunakan oleh suatu organisasi untuk melaksanakan fungsinya.

Pelanggan :
Penerima produk yang diberikan oleh pemasok.

Pemasok :
Organisasi yang memberikan produk kepada pelanggan.

Pembeli :
Pelanggan dalam situasi kontrak.

Kontraktor :
Pemasok dalam situasi kontrak.

Sub Kontraktor :
Organisasi yang memberikan produk kepada pemasok.

Tingkat :
Kategori atau peringkat yang dierikan pads
mawujud yang mempunyai fungsi penggunaan yang sama, dengan persyaratan mutu yang berbeda.

Persyaratan Masyarakat :
Kewaiiban karena hukum, peraturan, aturan, kode, undang-undang atau pertimbangan lain.

Ketergantungan :
istilah kolektif yang digunakan untuk menjelaskan ketersediaan dan faktor-faktor yang mempengaruhinya.

Kesetaraan :
Kemampuan dari mawujud untuk dipergunakan bersama-sama pada kondisi tertentu untuk memenuhi persyaratan yang berkaitan.

Mampu tukar :
Kemampuan dari mawujud untuk dipergunakan ditempat lain, tanpa perubahan untuk memenuhi persyaratan yang sama.

Keselamatan :
Keadaan dimana . risiko cadera (terhadap orang) atau kerusakan dibatasi pada suatu tingkat yang dapat diterima.

Kesesuaian :
Pemenuhan terhadap persyaratan yang ditentukan.

Ketidaksesuaian :
Tidak terpenuhinya persyaratan yang ditentukan.

Cacat :
Tidak memenuhi persyaratan untuk penggunaan yang diingikan atau harapan yang wajar termasuk yang berkaitan dengan keselamatan.

Liabilitas Produk :
Istilah umum yang digunakan untuk menjelaskan tangung jawab produsen atau pihak lain, untuk memberikan ganti rugi yang berhubungan dengan kecelakaan pribadi, kerusakan harta atau kerusakan lain yang disebabkan oleh produkla

Proses Kualifikasi :
Proses peragaan apakah mawujud mampu memenuhi persyaratan yang ditentukan.

Berkualifikasi :
Status yang diberikan terhadap mawujud jika kemampuan persyaratan yang ditentukan telah diperagakan.

Bukti Objektif :
Informasi yang dapat dibuktikan benar berdasarkan fakta yang diperoleh melalui observasi, pengukuran, pengujian atau cara lain.

Kelas :
Indikator dad kategori atau peringkat yang sesuai dengan gambaran atau karakteristik yang mencakup berbagai perangkat kebutuhan berbecla untuk barang atau jasa yang ditunjukan untuk fungsi sama.

Perencanaan Mutu :
Kegiatan yang menetapkan sasaran dan persyaratan mutu dan penerapan dari unsur system mutu.

Manajemen Mutu Terpadu :
Pendekatan manajemen dari suatu organisasi yang dipusatkan pada masalah mutu, didasarkan pada partisipasi seluruh anggotanya dan bertujuan mencapai keberhasilan dalam jangka panjang melalui kepuasan pelanggan dan bermanfaat bagi seluruh anggota organisasi dan masyarakat.

Peningkatan Mutu :
Tindakan yang diambil diseluruh organisasi untuk meningkatkan efektivitas dan efisiensi dari kegiatan dan proses agar memberikan manfaat tambahan bagi organisasi maupun pelanggannya.

Tinjauan Manajemen :
Evaluasi formal oleh pimpinan puncak mengenai status dan kecukupan system mutu dalam hubungannya terhadap kebijakan mutu dan sasaran.

Tinjauan Kontrak :
Kegiatan sistematis yang dilakukan oleh pemasok sebelum menandatangani kontrak untuk memastikan bahwa persyaratan mutu didefinisikan secukupnya, bebas dari keracunan, didokumentasikan dan dapat diwujudkan oleh pemasok.

Tinjauan Desain :
Pemeriksaan terdokumentasikan, komprehensif dan sistematis terhadap suatu desain untuk mengevaluasi kemampuannya dalam memenuhi persyaratan mutu, mengidentifikasi masalah-masalah, jika ada, dan mengusulkan pengembangan penyelesaiannya.

Pedoman Mutu :
Dokumen yang menyatakan kebijakan mutu dan menjelaskan system mutu dari organisasi.

Rencana Mutu :
Dokumen yang berisikan pelaksanaan mutu, sumber daya dan urutan kegiatan tertentu yang terkait terhadap produk, proyek atau kontrak tertentu.

Spesifikasi :
Dokumen yang menyatakan persyaratan.

Rekaman :
Dokumen yang memberikan bukti objectif daRI kegiatan yang dilaksanakan atau hasil yang dicapai.

Ketertelusuran :
Kemampuan untuk menelusuri riwayat penerapan atau lokasi dari mawujud dengan cara identifikasi yang terekam.

Rangkaian Mutu :
Model konseptual dari kegiatan yang saling berkaitan yang mempengaruhi mutu pada berbagai tahapan mulai dari identifikasi kebutuhan sampai pada asesmen apakah kebutuhan telah terpenuhi.

Biaya yang berhubungan dengan mutu :
Biaya-biaya yang terjadi didalam memastikan dan menjamin mutu yang memuaskan, demikian juga kerugian yang terjadi jika mutu yang memuaskan tidak terpenuhi.

Kerugian Mutu :
Kerugian yang disebabkan oleh tidak terealisasinya potensi sumber daya dalam proses.

Model Jaminan Mutu :
Seperangkat persyaratan system mutu yang dibakukan atau dipilih serta dikombinasikan untuk memenuhi kebutuhan jaminan mutu pada situasi tertentu.

Tingkat peragaan :
Cokupan bukti yang dihasilkan untuk memberi keyakinan bahwa persyaratan yang ditentukan terpenuhi.

Evaluasi Mutu :
Pemeriksaan sistematis terhadap cakupan dimana mawujud mampu memenuhi persyaratan yang ditentukan.

Pengawasan Mutu :
Pemantauan dan verifikasi secara terus menerus tentang status mawujud dan analisa rekaman untuk menjamin bahwa persyaratan yang ditentukan tetap dipenuhi.

Titik Tahan :
Titik yang ditentukan didalam dokumen yang sesuai, dimana suatu kegiatan selanjutnya tidak boleh diteruskan tanpa persetujuan dari organisasi yang ditunjuk atau berwenang.

Observasi audit mutu :
Pernyataan fakta yang dibuat selama audit mutu dan diperkuat dengan bukti objektif.

Auditor Mutu :
Orang yang mempunyai kualifikasi untuk melaksanakan audit mutu.

Tindakan Koreksi :
Tindakan yang dilakukan untuk menghilangkan ketidak sesuaian yang ada, cacat atau situasi lain yang tidak diinginkan untuk mencegah perulangan.

Disposisi Ketidaksesuaian :
Tindakan yang diambil untuk menangani ketidak sesuaian mawujud yang ada dalam rangka menyelesaikan ketidaksesuaian.

Izin produksi, Izin penyimpangan :
Pengesahan tertulis terhadap penyimpangan dad persyaratan awal yang ditetapkan bagi produk sebelum produksinya.

Penghindari, Konsesi :
Pengesahan tertulis untuk penggunaan atau pelepasan produk yang tidak memenuhi persyaratan yang ditetapkan.

Perbaikan :
Tindakan yang dilakukan terhadap produk yang tidak sesuai sehingga akan memenuhi persyaratan penggunaon yang diinginkan walaupun mungkin tidak memenuhi persyaratan awal yang ditetapkan.

Pengerjaan ulang :
Tindakan yang dilakukan terhadap produk yang tidak sesuai, sehingga akan memenuhi persyaratan yang ditetapkan.

Akreditasi :
Pengakuan formal terhadap unit/Institusi untuk melakukan kegiatan standardisasi tertentu sesuai dengan persyaratan dan kriteria yang diterapkan oleh Badan Standardisasi Nasional.

Grading :
Klasifikasi hasil-hasil pertanian kedalam beberapa golongan mutu yang berbeda-beda masing-masing dengan nama dan etiket tertentu.

Perumusan Standar :
Kegiatan sejak pengumpulan dan pengolahan data untuk menyusun konsep standar sampai tercapainya kesepakatan (konsensus) dari semua pihak.

Penerapan Standar :
Kegiatan menggunakan Standar Nasional Indonesia sebagaimana yang ditetapkan oleh instansi teknis.

Pengawasan SNI :
Kegiatan pengawasan terhadap penerapan SNI.

Laboratorium :

Laboratorium yang melakukan kegiatan pengujian dan atau kalibrasi, dimana hasil pengujian dan atau kalibrasi dinyatakan dengan sertifikat/laporan hasil uji atau sertifikat kalibrasi.

Badan Akreditasi :

Institusi yang melaksanakan dan mengelola suatu kegiatan akreditasi dan memberikan akreditasi.

Penerapan Standar :

Kegiatan menggunakan standar oleh pelaku usaha.

Lembaga Inspeksi :

Lembaga yang melakukan pemeriksaan kesesuaian barang dan atau jasa terhadap persyaratan tertentu, dimana hasil pemeriksaan dinyatakan dengan sertifikat hasil inspeksi.

Mutual Recognation Arrangement - MRA :

Kesepakatan diantara dua pihak atau lebih untuk saling mengakui atau menerima beberapa atau keseluruhan aspek satu dengan yang lain dalam hal hasil-hasil penilaian kesesuaian (misal laporan pengujian).

Standar :

Spesifikasi teknis atau sesuatu yang dibakukan termasuk tatacara dan metode yang disusun berdasarkan konsensus semua pihak yang terkait dengan memperhatikan syarat-syarat keselamatan, keamanan, kesehatan lingkungan hidup, perkembangan ilmu pengetahuan dan teknologi, serta pengalaman, perkembangan masa kini dan masa yang akan datang untuk memperoleh manfaat yang sebesar-besarnya.

Standardisasi :

Proses merumuskan, menetapkan, menerapkan dan merevisi standar di bidang pertanian, yang dilaksanakan secara tertib dan bekerjasama dengan semua pihak.

Standar Nasional Indonesia (SNI) :
Standar yang direkomendasikan oleh panitia teknis dan ditetapkan oleh instansi teknis setelah mendapat persetujuan dari Badan Standar Nasional dan berlaku secara nasional di Indonesia.

Instansi Teknis :

Departemen atau lembaga pemerintah yang melakukan kegiatan standardisasi

SNI-Wajib :
Standar yang diterapkan secara wajib bersifat spesifikasi dan klasifikasi, ditetapkan oleh Menteri Pertanian setelah mendapat persetujuan dari Badan Standar Nasional.

SNI-Sukarela :
Standar sukarela/rekomendasi yang ditetapkan oleh Menteri Pertanian setelah mendapat persetujuan dari Badan Standardisasi Nasional dan berlaku secara nasional.

Tanda SNI :
Tanda sertifikasi yang merupakan suatu tanda pada produk dan/atau jasa sertifikat yang menyatakan bahwa produk dan/atau jasa tersebut memenuhi persyratan SNI.

Rancangan Standar Nasional Indonesia (RSNI) :

Rancangan standar di bidang pertanian yang dirumuskan oleh panitia teknis setelah tercapai konsensus dari semua pihak yang terkait.

Perumusan Rancangan Standar Nasional Indonesia :

Rangkaian kegiatan sejak pengumpulan dan pengolahan data untuk menyusun Rancangan Standar Nasional Indonesia bidang pertanian sampai tercapainya konsensus dari semua pihak yang terkait.

Penetapan Standar Nasional Indonesia :

Kegiatan menetapkan Rancangan Standar Nasional Indonesia bidang pertanian menjadi Standar Nasional indonesia.

Penerapan Standar Nasional Indonesia :

Kegiatan menggunakan Standar Nasional Indonesia bidang pertanian oleh pelaku usaha di bidang pertanian.

Revisi Standar Nasional Indonesia :

Kegiatan penyempurnaan Standar Nasional Indonesia bidang pertanian sesuai dengan kebutuhan.

Barang Pertanian :

Setiap barang dan atau benda pertanian baik bergerak maupun tidak bergerak, dapat dihabiskan maupun tidak dapat dihabiskan, yang dapat diperdagangkan, dipakai, dipergunakan, atau dimanfaatkan oleh konsumen.

Sistem Standardisasi Pertanian (SSP) :

Tatanan jaringan sarana dan kegiatan standardisasi pada sektor pertanian yang serasi, selaras dan terpadu serta berwawasan nasional, yang meliputi perumusan standar, penerapan standar, pembinaan dan pengawasan standardisasi, kerjasama dan pemasyarakatan standardisasi, akreditasi serta penelitian dan pengembangan

Pusat Standardisasi dan Akreditasi (PSA) :

Unit Kerja di lingkungan Departemen Pertanian yang bertanggung jawab dalam mengkoordinasikan kegiatan standardisasi, baik secara struktural maupun fungsional.

Panitia Teknis Departemen Pertanian :

Panitia yang ditetapkan oleh BSN atas usul dari Departemen Pertanian yang keanggotaannya terdiri dari unsur-unsur Pemerintah Pusat, Pemerintah Daerah, Dunia Usaha, Cendekiawan dan Konsumen.

Sub Panitia Teknik :

Kelompok kerja yang dibentuk oleh Panitia Teknis Departemen Pertanian untuk membantu tugas-tugas teknis tertentu dalam rangka proses penyusunan dan/atau revisi SNI bidang pertanian.

Sanitary and Phytosanitary (SPS) :

Segala tindakan yang dilakukan untuk tujuan melindungi kehidupan atau kesehatan manusia, hewan dan tumbuhan.

Notification Body :

Instansi yang bertanggungjawab untuk memberitahukan kepada negara-negara anggota WTO melalui organisasi perdagangan dunia tentang rancangan peraturan-peraturan yang berkaitan dengan SPS yang akan diberlakukan.

Enquiry Point :

Instansi yang bertanggung jawab untuk melayani semua pertanyaan yang datang dari luar negeri berkaitan dengan masalah-masalah SPS kesesuaian serta mengusahakan penyelesaian masalah yang mungkin timbul, bekerjasama dengan Direktorat Jenderal terkait.

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