ISO 9001 Certifications Top 1M Mark

(ISO: Geneva) -- The principal highlights of “The ISO Survey of Certifications 2009” are that ISO 9001, the global benchmark for quality management, has topped one million certifications, and that certifications to ISO 22000 for food safety management systems, and to ISO/IEC 27001 for information security management systems have rocketed.

SO states in the introduction to the survey that the 8-percent increase in ISO 9001 certificates, compared with the 3-percent increase in 2008, “confirms the importance of ISO 9001 in the global supply chains and as the pioneering model on which subsequent management system standards have been built and flourish.”

Safe food supply chains are a global priority. ISO 22000 certifications reached at least 13,881 certificates in 127 countries and economies—a rise of 69 percent.

The increasing importance organizations give to information security was demonstrated by the 40-percent increase in ISO/IEC 27001 certifications, which reached 12,934 in 117 countries.

“Each year, the release of the latest ISO Survey is an eagerly awaited event as the primary source of information on the importance of ISO’s management system standards to the global economy,” says ISO secretary-general Rob Steele. “For the first time, the new edition is being published on a CD-ROM containing Excel files of the surveys from the first, in 1993, up to the end of 2009. Making this data available in one place will facilitate comparison and extrapolation and make the survey an even more useful business tool.”
ISO 9001

ISO 9001 (certifications to 2000 and 2008 editions cumulated), which gives the requirements for quality management systems, is now firmly established as the globally implemented standard for providing assurance about the ability to satisfy quality requirements and to enhance customer satisfaction in supplier-customer relationships.

Up to the end of December 2009, at least 1,064,785 ISO 9001 (2000 and 2008) certificates had been issued in 178 countries and economies. The 2009 total represents an increase of 81,953 (more than 8%) over 2008, when the total was 982,832 in 176 countries and economies.
ISO 14001

ISO 14001, which gives the requirements for environmental management systems, retains its global relevance for organizations wishing to operate in an environmentally sustainable manner.

Up to the end of December 2009, at least 223,149 ISO 14001 certificates had been issued in 159 countries and economies. Annual growth is stabilized at almost the same level as in 2008—34,334 in 2009, compared to 34,242 in 2008, when the total was 188,815 in 155 countries and economies.
ISO/TS 16949

ISO/TS 16949 (certifications to 2002 and 2009 editions cumulated) gives the requirements for the application of ISO 9001:2000 by suppliers in the automotive sector. Up to the end of December 2009, at least 41,240 ISO/TS 16949 certificates had been issued in 83 countries and economies.
ISO 13485

ISO 13485 gives quality management requirements for the medical device sector for regulatory purposes. Up to the end of December 2009, at least 16,424 ISO 13485 certificates had been issued in 90 countries and economies. The 2009 total represents an increase of 3,190 (about 24%) over 2008 when the total was 13,234 in 88 countries and economies.
ISO/IEC 27001

ISO/IEC 27001 gives the requirements for information security management systems. At the end of 2009, at least 12,934 ISO/IEC 27001 certificates had been issued in 117 countries and economies. The 2009 total represents an increase of 3,688 (more than 40%) over 2008 when the total was 9,246 in 82 countries and economies.
ISO 22000

ISO 22000 gives the requirements for food safety management systems. Up to the end of December 2009, at least 13,881 ISO 22000 certificates had been issued in 127 countries and economies. The 2009 total represents an increase of 5,675 (more than 69%) over 2008 when the total was 8,206 in 112 countries and economies.
Survey on CD-ROM

For the first time, ISO is making the survey available on a CD-ROM in Excel files covering 1993 to 2009, which allows comparisons since the survey was launched.

ISO makes available the principal findings of the survey free of charge on the ISO website. More information, including industry sector breakdowns, can be found in “The ISO Survey of Certifications 2009,” on a CD-ROM. It is available from ISO national member institutes (see the complete list with contact details).
source : www.iso.org

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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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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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ISO standards contribute to meeting World Food Day 2008 challenge

World Food Day 2008 addresses what has been categorized by many as one of the greatest challenges of our time: climate change and its impact on food security. ISO has here an important contribution to make, not only through its numerous International Standards on food related issues, but also through standards that help quantify and mitigate climate change.

World Food Day is organized by the United Nations Food and Agriculture Commission (FAO) each year on the 16 October. The event provides an opportunity to highlight the plight of the 862 million undernourished people in the world – a number that FAO warns could be pushed even higher if the threat of global warming and the consequences of a rising demand for bioenergy are not addressed.

ISO’s portfolio of environmental standards provides practical tools for addressing these issues. Among these are ISO 14001 which has become the global benchmark for environmental management systems, ISO 14064 which gives the requirements for quantifying, monitoring and reporting on greenhouse gas (GHG) emissions and ISO 14065 which specifies accreditation requirements for organizations validating or verifying GHG emission assertions.

ISO Secretary-General Alan Bryden comments: “Climate change mitigation, energy efficiency, water supply and food security are inter-related challenges – all of which ISO addresses through its existing standards and current developments.”

Issues directly related to food are mainly addressed through ISO/TC 34, the ISO technical committee developing standards on food products. The committee currently offers 725 standards and related documents.

Its work covers practically all agricultural products for human consumption and animal feeding stuffs ranging from fruits to cereals to poultry and coffee to name a few. About 65 % of its standards concern testing and analytical methods, and are directly targeted at agricultural producers, food manufacturers, laboratories, merchants/retailers, consumers and regulators.

Among ISO developments of recent years relating to the concerns of World Food Day are the following:

• a new subcommittee of ISO/TC 34 to develop standards on the topical subject of biomarkers
• the ISO 22000 series of standards for safe food supply chains, already implemented by an estimated 4 000 organizations in 93 countries at the end of 2007
• standards for the detection of genetically modified organisms and derived products in food
• guidelines for quantitative ingredient declarations to help consumers know what they are eating
• waste reduction by biotechnological methods and enhancement of the conversion of waste materials for the manufacturing of new added value products.

Fifty-four countries participate in the work of ISO/TC 34 and another 53 have observer status. Representatives from these countries are coming together on 16-17 October, 2008 for a plenary meeting in Paris, France. The event will provide an opportunity to discuss current projects and propose new areas of work, as well as to address organizational and administrative issues.

Other ISO committees develop standards that can contribute to the goals of World Food Day, including ISO/TC 234, a recently formed committee developing standards for sustainable fishing and aquaculture.

ISO has a strong partnership with many United Nations agencies concerned with food issues. They participate as liaison organizations in a number of ISO committees: among them are the World Health Organization (WHO), FAO, and the Codex Alimentarius Commission (CAC).

Another noteworthy example of partnership is that between ISO and the International Dairy Federation (IDF) who work together to prepare and publish analytical methods. Following recent concerns with melamine found in milk products, IDF and ISO are jointly investigating how to tackle this issue through the standards they develop.

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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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An Implementation Guide for Small & Medium-Sized Organizations

Content :

Introduction . I

Section I: Why Your Organization Should Have an EMS……………… 3
Section 2: Key EMS Concepts ………………………………………..6
Section 3: Step-by-Step Action Plan …………………………………..8
Section 4: Key Elements of an EMS II
Section 5: The Registration Process ……………………………………56
Section 6: Sources of Assistance ………………………………………63

Appendices

Appendix A - Case Studies
Milan Screw Products ………………………………………………..65
Hach Company ………………………………………………………70
Appendix B - Background on ISO 14000 and Other EMS Standards ….75
Appendix C - Sources of Information and Other Contacts ……………..80
Glossary of Acronyms ………………………………………………..89
Bibliography ………………………………………………………….90
Appendix D - Tool Kit
Sample Environmental Policies ………………………………………..92
Sample Process Flow Chart ………………………………………….96

Descriptions of Environmental Aspect Identification Techniques ……….98
Sample Procedure: Environmental Aspects Identification ……………..100
Resources for Tracking Environmental Laws and Regulations …………104
Sample Procedure: Tracking Environmental Laws and Regulations ……106
Worksheet: Setting Objectives and Targets ……………………………109
Sample Procedure: Setting Objectives and Targets ……………………113
Sample Tool: Environmental Management Program ……………………116
Sample Schedule for EMS Action Plan ………………………………118
Responsibility Matrix …………………………………………………120
Environmental Training Log ……………………………………………123
Sample Procedure: Internal Communications……………………………125
Sample Procedure: Communications with External Parties ………………128
Sample Document Index ………………………………………………131
Outline of Sample EMS Manual, Other Documents ……………………133
Sample Procedure: Document Control …………………………………135
Sample Procedure: Corrective Action (Includes Tracking Log) …………139
Environmental Records Organizer ………………………………………144
Sample Procedure: EMS Audits ………………………………………..148
Sample Procedure: Management Review ……………………………….154

Download the file here

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Fully Networked Car workshop addresses climate change

The third edition of the Fully Networked Car workshop, organized in partnership by ISO, IEC and ITU on 5-7 March at the Geneva International Motor Show 2008, focused on standards that will facilitate the convergence of information and communication technologies (ICT) in motor vehicles, as well as addressing this year's special theme of climate change.

ITU Secretary General, Dr. Hamadoun I. Touré, commented in his presentation at the opening of the workshop: “Today, ICTs are an integral part of keeping vehicles on our roads safe and secure… This merging of technology requires that the World Standard Cooperation partners, ITU, ISO and IEC, take into account each other’s work and co-operate at points of technological interface so that manufacturers can use our standards to deliver a final product to customers that functions as expected.”

At the opening session, ISO Secretary-General Alan Bryden stated (see full speech): “This event is the opportunity to underline that innovation and standardization go hand in hand and how ICT support progress in the performance, safety and functionalities of transportation, It also shows how the collaboration between ISO, IEC and ITU optimizes the channeling of world expertise and best practices into globally relevant international standards.”

He indicated that ISO has been directly associated with three major, recent meetings of global significance:

• the UN Framework Convention on Climate Change in Bali in December 2007 which gave an opportunity for highlighting the contribution of the ISO 14000 series on environmental management, particularly the ISO 14064 and ISO 14065 standards relating to the accounting and verification of greenhouse gas emissions
• the 2nd UN Stakeholders Forum on Global Road Safety in April 2007. ISO has recently decided to embark on the development of a road safety management system standard that will provide public services and private companies operating fleets of vehicles, including transportation services, freight and car rentals, with a specific and globally recognized framework for improving road safety
• the 2008 meeting of the World Economic Forum in Davos, Switzerland in January, which focused on the “power of collaborative innovation”.

Jack Sheldon, on behalf of IEC General Secretary Aharon Amit, declared: “The IEC – and this applies equally to ISO and the ITU – has an ongoing commitment to provide the market with timely and relevant standards. This commitment embraces a vast spectrum of industries, and automobiles are a significant part of the market. This workshop is an opportunity to study who wants what and who needs to work with whom to provide integrated systems for networked cars”.

The main purpose of the workshop is to establish a constructive dialogue among market stakeholders and identify how standards help the the motor industry to make vehicles more efficient and safer, with lower impact on the environment.

A feature of this year's Fully Networked Car exhibition is the Honda Racing F1 Team’s new Formula-1 “Earthdreams ” car whose design emphasizes environmental features and points towards green automotive technologies of the future. (source www.iso.org)

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Emergency Response and Preparedness Plan

Salah satu element ISO 14000 adalah adanya Emergency Response dan Preparedness, tetapi secara luas juga merupakan keharusan suatu industri untuk menyiapkan Rencana Tanggap Darurat dan Kesiapsiagaan diatas dalam hal keselamatan dan merupakan persyaratan utama dalam menjamin adanya program Health, Safety and Environtment dalam perusahaan.

Tujuan Rencana tanggap darurat adalah agar jika terjadi suatu keaadaan darurat seperti kebakaran atau kecelakaan kerja terdapat tindakan penanggulangan yang cepat dan tepat agar kerugian yang diderita dapat diminimalisasi. "Cepat dan Tepat "adalah kata kunci dalam penyunsunan Rencana Tanggap Darurat (RTD), artinya prosedur yang bertele-tele harus dihindari dan jalur komunikasi harus sesederhana mungkin agar penyampaian laporan ke pimpinan serta keputusan yang diambil dapat secepat mungkin dilaksanakan.

Berikut akan disajikan panduan pembuatan manual RTD dan beberapa contoh kecil point-point dalam manual RTD tersebut. Untuk format dokumennya dapat dibuat sesuai dengan Manual ISO 9000 atau ISO 14000 yang banyak kita jumpai.

Manual Rencana Tanggap Darurat dan Kesiapsiagaan.

Umum

Perusahaan . Pada bagian ini dapat dijelaskan mengenai jenis perusahaan, proses operasi, kondisi geografi, keadaan masyarakat, permasalahan yang ada sehubungan dengan bahaya atau keadaan darurat serta komitmen manajemen dalam rencana tanggap darurat. Misalnya jika perusahaan berada didaerah yang sebagaian besar penduduknya tani atau tambak maka dapat dijelaskan pentingnya pencegahan kebocoran atau tumpahan bahan kimia ke sungai atau tanah.

Maksud danTujuan . Pada bagian maksud menjelaskan mengapa diperlukan RTD misalnya untuk perlindungan lingkungan atau kondisi perusahaan yang memproduksi bahan yang mudah terbakar, Efektifitas jika keadaan darurat atau yang lainnya. Sedangkan tujuan dibentuknya RTD secara umum adalah mempersiapkan komponen perusahaan agar dapat mengatasi keadaan darurat secara cepat dan tepat.

Ruang Lingkup . Menjelaskan ruang lingkup RTD


Landasan Kebijakan.

• Perundangan. Dapat menyebutkan UU Lingkungan misalnya UU No. 23 1997 tentang Pengelolaan Lingkungan Hidup, No. 27 1999 mengenai AMDAL, serta UU lingkungan lainnya. Dapat juga memasukkan UU tentang K3 atau peraturan internasional.
• Strategi Penanggulangan. Dalam perincian strategi penanggulangan yang diambil harus menyertakan adanya memprioritaskan Keselamatan Jiwa dan Lingkungan serta mencegah penyebaran bahaya.

Dampak dan Sumber Dampak.

• Dampak. Penjelasan mengenai dampak yang dapat terjadi karena keadaan darurat tentunya berbeda-beda setiap perusahaan karena tergantung jenis perusahaan dan keadaan geografis perusahaan. Tetapi secara umum dapat disusun sebagai berikut.
• Bahaya Kebakaran memberikan dampak kerusakan lingkungan baik tanah, air, atau udara dan bahkan jiwa.
• Bahaya Tumpahan atau bocoran Bahan Kimia. Menyebabkan pencemaran air dan tanah untuk bahan cair dan padat serta polusi udara untuk bahan berupa gas.
• Bahaya Banjir. Dapat mengakibatkan pencemaran lingkungan karena adanya limbah yang meluap pada unit pengolahan limbah.
• Bahaya Gempa. Menyebabkan kerusakan bangunan dan peralatan pabrik yang dapat menimbulkan akibat lebih lanjut antara lain kebocoran dan kecelakaan kerja.
• Bahaya Kecelakaan Kerja. Mengakibatkan kerugian jiwa, material dan baik secara langsung atau tidak dapat mengakibatkan pencemaran lingkungan.
• Bahaya Ledakan. Menyebabkan kerusakan lingkungan dan timbulnya gas beracun.

Sumber Dampak.

Bahaya Kebakaran.

• Listrik Konsleting. Data menunjukkan bahwa sebagian besar kebakaran disebabkan karena arus pendek yang kita kenal sebagai konsleting. Konsleting terjadi pada saat maintenance peralatan listrik yang unsafety, atau perawatan peralatan listrik yang tidak teratur. Penggunaan perlatan listrik yang explosion prove sangat diperlukan jika berada atau dekat dari lokasi penyimpanan atau pengolahan bahan mudah terbakar.
• Pembakaran Sampah. Pembakaran sampah memerlukan tempat yang sesuai, yaitu cukup jauh dari pabrik, rumput kering, dan terlindung dari tiupan angin.
• Drum kosong atau setengah kosong sisa bahan bakar. Drum kosong atau hampir kosong mempunyai kadar uap bahan bakar yang tinggi, sehingga sangat mudah terbakar atau meledak terutama jika saat membuka, ada goncangan yang berlebihan saat memindah drum, atau suhu lingkungan yang tinggi.
• Bahan mudah terbakar flammable dan auto flammable. Lokasi penyimpanan bahan bakar harus spesifik atau dapat dilihat pada standard internasional yang berlaku seperti API atau NFPA
• Listrik Statis (pompa, tangki). Listrik statis terjadi karena perbedaan muatan yang dapat terjadi karena fluida yang bergerak atau gesekan seperti angin pada top storage tank, atau pipa transfer. Untuk itu sebagai pengaman diperlukan bonding dan grounding untuk mengalirkan arus listrik statis.
• Kecelakaan kendaraan bermotor. Kecelakaan kendaraan bermotor di lokasi perusahaan harus dihindari karena semua kendaraan bermotor membawa bahan bakar sehingga dapat mengakibatkan kebakaran.
• Sistem Operasi. Adanya kondisi operasi yang diluar kontrol dan mesin yang out of control dapat manebabkan kerusakan yang berakibat kebakaran.
• Petir. Pemakaian penyalur petir yang tepat pada posisi yang tepat sangat diperlukan agar petir dapat tersalur dengan baik dan lokasi perusahaan dapat terlindungi sepenuhnya.
• Nyala api. Nyala api dapat terjadi baik secara langsung seperti korek api, kompor, pembakaran, tungku atau secara tidak langsung seperti lampu.
• LPG. Liquefied Petroleum Gas dan Liquefied Natural Gas (LNG) adalah gas yang sangat mudah terbakar dan meledak pencegahan kebocoran secara dini serta lokasi penyimpanan yang tepat sangat diperlukan.
• Kerja dengan api (pengelasan). Pengelasan menghasilkan api dengan suhu yang sangat tinggi yaitu lebih dari 1000 oC. Hot work harus selalu dipantau dan memerlukan ijin khusus.
• Gelombang Radio. Gelombang merupakan salah satu bentuk energy semakinkecil panjang gelombang maka energy yang terkandung semakin besar, karena itu penggunaan microwave di sekitar bahan mudah terbakar sepatutnya dilarang. Penggunaan peralatan komunikasi termasuk salah satu sumber gelombang tersebut antara lain HT dan Handphone.

• Bahaya Tumpahan atau bocoran Bahan Kimia.
• Drum bocor.
• Tangki bocor.
• Pipa transfer rusak.
• Kecelakaan mobil pengangkut.
• Kemasan rusak bagi bahan solid.
• Valve venting bocor untuk bahan gas

Bahaya Banjir. Saluran air tidak lancar. Pembuatan lay out perusahaan yang memperhatikan aspek aliran air sangat membantu mengurangi resiko banjir. Karena banjir juga akan dapat menggangu proses produksi atau menyebabkan kerusakan alat.

• Bencana Alam.
• Bahaya Gempa.
• Bahaya Kecelakaan Kerja.

Pengoperasian salah. Untuk mengurangi resiko ini training dan intruksi kerja yang jelas dan telah dimengerti oleh karyawan diterapkan sepenuhnya sesuai dengan ketentuan yang berlaku dalam ISO 9000.

Mesin Trouble. Perawatan dan monitoring peralatan secara rutin diperlukan agar mesin selalu berada kondisi optimal.

Bekerja diruang tertutup. Bekerja diruang tertutup sangat berbahaya karena ada kemungkinan bahwa kurangnya kadar Oksigen atau terdapatnyan uap beracun (CO,phenol,HCN dan lainnya) dapat menyebakan kematian bagi pekerja. Diperlukan ijin kerja khusus untuk bekerja diruangan tertutup seperti tandon air, sumur, Tangki penampung, Saluran pembuangan limbah, dan tempat lannya.

Bekerja di ketinggian. Bekerja di ketinggian seperti di atap pabrik, tiang lampu, atap tangki, Dinding Tangki dan lainnya sangat besar resiko kecelakaannya terutama jika kondisi tidak memungkinkan seperti licin karena hujan atau bahan lapuk. Untuk itu diperlukan ijin khusus jika bekerja diketinggian.

Bahan beracun dan berbahaya (B3). Penanganan B3 baik itu transfer atau saat operasi harus dilaksanakan jika operator telah menggunakan alat keselamatan kerja yang lengkap.

• Bahaya Ledakan Tekanan operasi terlalu tinggi
• Drum kosong bekas flamabel
• Gas Bertekanan
• LPG
• Bahan mudah meledak (explosive material)
• Ledakan debu (dust) karena tekanan terlalu tinggi

Organisasi

• Struktur Organisasi. Ketua. Ketua RTD adalah pemimpin atau pemegang kekuasaan tertinggi dalam operaional sehari-hari perusahaan tersebut, misalnya Direktur atau Plant Manager.
• Wakil Ketua. Wakil Ketua dijabat oleh orang yang paling ahli dalam masalah HSE dalam hal ini adalah Manager atau Kepala Department HSE.
• Bagian External Affair. External affair dijabat oleh orang yang mengerti hukum atau lobi misalnya Manager Personalia atau Humas.
• Bagian Keamanan. Dapat dirangkap oleh bagian external affair
• Bagian Evakuasi. Penjabat harus orang yang mempunyai pengetahuan mengenai transportasi perusahaan misalnya bagian warehouse atau General affair.
• Bagian Adminitrasi. Mempunyai kemampuan dokumentasi dan pengolahan data yang baik.
• Bagian Penaggulangan Keadaan Daurat. Mempunyai anggota-anggota lintas bagian yang telah diberikan pelatihan khusus RTD dan diketuai oleh HSE officer atau HSE engineer.
• Komandan Operasi pertama. Semua kepala seksi atau supervisor pada bagian masing-masing yang bertugas sebagai ketua operasi sementara jika Komandan RTD dan ketua operasi belum berada ditempat.

Tugas dan Tanggung Jawab


Ketua.

• Memberi laporan ke pihak manajemen.
• Meminta bantuan ke luar perusahaan.
• Memberikan fasilitas yang memadai bagi team RTD
• Memerintahkan pemberhentian operasi.

Wakil Ketua.

• Sebagai komandan RTD jika terjadi keadaan darurat. Memimpin semua bagian team RTD dalam melaksanakan kegiatan saat keadaan darurat.
• Menggantikan tugas Ketua jika tidak berada ditempat.
• Meminta bantuan ke pihak luar untuk penanganan lebih lanjut bila dirasa perlu.
• Memimpin pertemuan rutin sebagai wakil dari ketua RTD jika berhalangan hadir.
• Membuat peraturan-peraturan tertulis untuk mencegah terjadinya keadaan darurat.
• Menyunsun agenda training RTD baik internal atau external.
• Memimpin internal audit RTD.
• Memimpin kegiatan pasca kejadian seperti investivigasi dan rehabilitasi.
• Mengajukan persetujuan pembelian peralatan yang dibutuhkan oleh RTD.
• Memberikan laporan ke ketua RTD.

Bagian External Affair.

• Memberikan informasi kepada masyarakat sekitar atau pers mengenai kejadian.
• Memberikan laporan kepada pemerintah atau instansi yang terkait.

Bagian Keamanan.

• Mencegah masyarakat untuk mendekati area berbahaya.
• Mengatur lalu lintas di dalam pabrik
• Membantu team evakuasi

Bagian Evakuasi.

• Memimpin evakuasi karyawan atas intruksi Komandan RTD
• Memimpin evakuasi inventaris perusahaan.

Bagian Adminitrasi.

• Melaporkan kegiatan RTD
• Melaporkan kerugian yang diderita
• Sebagai sekretaris saat pertemuan bulanan.
• Mengontrol dokumen RTD

Bagian Penaggulangan Keadaan Daurat.

• Sebagai ketua operasi saat keadaan darurat dengan memberikan intruksi kepada team penanggulangan dan team lingkungan.
• Memberikan internal training kepada karyawan perusahaan
• Membuat prosedur penanggulangan.
• Mengajukan peralatan yang dibutuhkan dan spesifikasinya kepada wakil ketua RTD.
• Membuat kegiatan checking dan monitoring peralatan HSE dan RTD
• Melaksanakan tugas wakil ketua RTD jika berhalangan.

Komandan Operasi pertama.

• Sebagai ketua sementara dalam langkah pertama penanggulangan hingga ketua operasi tiba.
• Memberikan informasi mengenai masalah yang dihadapi kepada ketua RTD saat tiba dilokasi.
• Membantu ketua operasi saat penanganan.

Kegiatan Penanggulangan



Jalur Komunikasi Saat Kejadian. Jalur komunikasi harus singkat dan tepat, yaitu dari penemu bahaya hingga komandan hanya 1 atau 2 kali tahap saja. Baru kemudian menghubungi anggota RTD lainnya tetapi dengan konsekwensi salah satu dari wakil ketua RTD dan ketua penanggulangan berada dilokasi perusahaan. Contohnya adalah sebagai berikut dimana pihak keamanan sebagai petugas penghubung team RTD. Orang pertama yang menemukan bahaya meminta pertolongan ke supervisor sekaligus melakukan tindakan pertama.

• Memberitahukan Ketua Penanggulangan dan bagian keamanan (security).
• Security Menghubungi ke ketua RTD, Wakil Ketua dan team RTD yang lain.
• Wakil ketua meminta persetujuan ketua jika membutuhkan bantuan luar
• Meminta bantuan luar.
• Team RTD lainnya melakukan kewajiban masing-masing

Kegiatan Penanggulangan. Pada saat penanggulangan di bentuk dua team yang mempunyai tugas spesifik yang berbeda yaitu team penanggulangan dan team lingkungan. Team penanggulangan mempunyai tugas untuk menyelesaikan sumber dampak, sedangkan team lingkungan mempunyai tugas mencegah dampak meluas ke lingkungan. Selain itu orang pertama jika memungkinkan melakukan langkah tindakan penanggulangan awal. Masing-masing sumber dampak atau bahaya potensial dibuatkan intruksi kerja tersendiri. Salah satu contoh adalah sebagai berikut:


Orang Pertama dan komandan penanggulangan sementara.

(kebakaran) Tutup semua valve bahan yang dapat terbakar yang berhubungan, matikan pompa yang sedang bekerja. Gunakan Alat Pemadam api ringan (extinguisher) jika mungkin, nyalakan alarm. Meminta bantuan kepada supervisor setempat.

Untuk kecelakaan kerja lakukan pertolongan pertama pada kecelakaan.

• Team Penaggulangan (Untuk kebakaran) Mempersiapkan peralatan perlindungan diri.
• Menyiapkan alat pemadam dan media yang tepat.
• Mengamati situasi lapangan. Arah angin dan bangunan sekitar.
• Memadamkan kebakaran dengan peralatan dan media yang tepat (Foam untu cairan kimia, CO2 untuk listrik, Dry Chemical untuk bahan logam, air untuk rumput dan sampah)
• Jika keadaan diatasi memberitahukan ke ketua penanggulangan
• Team Lingkungan. Mempersiapkan alat perlindungan diri yang sesuai.
• Amati kondisi lapangan, arah angin.
• Matikan listrik sekitar area, tutup semua valve yang ada.
• Gunakan alat pemadam yang sesuai dan semprotkan media pemadam di sekitar area yang terbakar untuk mencegah kebakaran meluas serta barang-barang yang potensial terbakar.
• Isolasi aliran air ke luar area jika mungkin, untuk mencegah pencemaran lingkungan.
• Jika area sekitar dan resiko pencemaran sudah aman membantu tugas team penanggulangan.

Bagian Evakuasi. Mengkoordinasi karyawan agar berkumpul di assemly point.

• Mengkoordinasi evakuasi karyawan atas intruksi komandan RTD.
• Mengkoordinasi evakuasi dokume serta inventaris lainnya.

Bagian Keamanan. Setelah mendengar alarm menghubungi ketua penanggulangan, komandan RTD, dan atas intruksi komandan RTD menghubungi anggota RTD yang lain.

• Mengatur lalu-lintas yang masuk.
• Membantu evakusi.
• Mencegah orang luar masuk ke lokasi tanpa ijin RTD.

Kegiatan Pasca Penanggulangan



Pemulihan. Tujuan pemulihan adalah untuk persiapan dalam meneruskan operasi perusahaan, membuat fasilitas dan peralatan kembali seperti semula,menjaga agar tidak terjadi kejadian lanjutan serta merehabilitasi lingkungan yang tercemar agar dampak lingkungan tidak menjadi lebih parah.. Pemulihan dilaksanakan secepat mungkin setelah kejadian diatasi untuk mengindari kerugian waktu terbuang yang lebih besar. Pemulihan idkoordinasi oleh ketua RTD. Hal-hal yang perlu diperhatikan saat pemulihan antara lain: Pastikan areal tersebut tertutup untuk orang yang tidak berkepentingan.

• Pastikan tempat kejadian sudah aman.
• Gunakan alat perlindungan diri yang sesuai.
• Serap bahan pencemar sesegera dan sebanyak mungkin. Dan kemudian netralkan atau kurangi kadar bagian yang tidak terserap.
• Utamakan yang mendesak terlebih dahulu.

Investivigasi dan Evaluasi. Investivigasi adalah untuk mencari sebab kejadian agar tidak terjadi kejadian yang sama pada masa yang akan datang. Investivigasi dilakukan bersama-sama dengan pemulihan dan dapat dilakukan dengan metode analisa yang telah kita kenal seperti PDCA/PDSA, Analisa resiko dalam Risk Manajemen atau Analisa Bahaya dalam HAZOP. Kegiatan investivigasi mencangkup: Sebab dan sumber dampak.

• Menentukan langkah pencegahan sementara.
• Menentukan langkah pencegahan agar tidak terulang.

Pelaporan. Laporan harus dibuat setelah kejadian dan disampaikan dalam 24 jam kepada Plant Manager, Management, dan Intansi terkait. Laporan berisi tentang : Deskripsi kejadian.

• Sumber Dampak
• Langkah Mengatasinya
• Jumlah kerugian
• Dampak lingkungan
• Langkah Pencegahan

Kesiapsiagaan.


Kegiatan yang membutuhkan kesiapsiagaan. Pada keadaan atau pekerjaan tertentu yang mempunyai resiko yang besar maka untuk mencegah terjadinya dampak maka diperlukan tindakan kesiapsiagaan. Pekerjaan tersebut misalnya ; Transfer bahan bakar dari mobil tangki

• Pekerjaan pengelasan
• Perbaikan instalasi listrik
• Pembersihan Unit Pengolahan Limbah
• Pembersihan Dust Collector
• Bekerja di ruangan tertutup.

Prosedur kesiapsiagaan. Prosedur kesiapsiagaan harus disertai pengawasan oleh petugas safety / SHS, dan terdapat alat keselamatan yang tersedia. Misalnya untuk transfer bahan bakar/bahan kimia antara lain; Gunakan alat keselamatan diri yang sesuai.

• Cek keadaan secara manual dari mobil tangki ke tangki penampung apakah tidak ada kebocoran.
• Pasang grounding ke mobil tangki.
• Buka tutup atas mobil tangki, agar tidak timbul kondisi vacuum di mobil tangki.
• Check kondisi vent tangki, agar tekanan dalam tangki penampung tidak melebihi kapasitas.
• Siapkan Absorber jika terjadi tumpahan.
• Siapkan APAR/Extinguisher didekat mobil/pompa
• Siapkan Hose Box dan Foam
• Kondisi drencher stand by

Surat Ijin Kerja. Setiap pekerjaan yang membutuhkan kesiapsiagaan diperlukan ijin khusus dari petugas HSE


Sumber Daya. Sumber daya dalam RTD meliputi Sumber Daya Manusia, Peralatan dan Fasilitas, serta Standarisasi Intruksi Kerja. Sumber Daya Manusia. Pengelolaan Sumber daya manusia merupakan hal yang paling penting dalam program Rencana tanggap Darurat. Dalam mengelola SDM RTD diperlukan beberapa tindakan kongkret oleh perusahaan, antara lain; Training . Perserta yang harus mengikuti Training yaitu; Anggota RTD

• Supervisor sebagai Komandan sementara
• Karyawan Perusahaan

• Materi Training; Tugas dan Kegiatan RTD
• Pengenalan Api dan Kebakaran
• Pemadaman Api
• Alat keselamatan Kerja
• Pertolongan Pertama Pada Kecelakaan

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• Jenis Training. Internal Training
• External Training
• Simulasi Penanggulangan
• Simulasi Koordinasi

Penghargaan. Penghargaan tidak selalu berupa materia tetapi dapat berupa sertifikat atau perhatian yang lebih dari pihak manajemen perusahaan.

Peralatan. Peralatan dan perlengkapan merupakan hal yang harus dimiliki oleh team RTD. Ada beberapa peralatan khusus atau fasilitas penunjang yang dapat meringankan kerja team penanggulangan. Peralatan-peralatan tersebut antara lain; Peralatan pelindungan diri ; Kacamata anti chemical, Face Shield, Chemical Boots, Electrical Boots, Chemical Gloves, Baju Tahan kimia, Respirator, Breathing Apparatus, Safety Belt, Jacket Tahan Api.

Peralatan Pemadam Kebakaran; Hose, Water Nozzle, Foom Nozzle, Foam, Extinguisher (CO2 dan dry chemical) serta karung. Peralatan tersebut harus diletakkan pada tempat yang sesuai yang memudahkan saat penanggulangan.

Alat perlindungan lingkungan. Absorber (dapat terbuat dari kain atau serbuk kayu), Plastik atau karet isolasi (mencegah cairan semakin meluber), dust collector, Hand pump.


Sedangkan Fasilitas yang sepatutnya telah tersedia di perusahaan antara lain; Unit Pengolahan limbah yang sesuai

• Penampung limbah sementara.
• Drencher dan sprinkler
• Line Hydrant, water pump dan tandon air untuk pemadaman
• Filter Gas buangan

Prosedur dan Manual. Jika SDM dan peralatan sudah memadai maka diperlukan suatu manual dan prosedur kerja dari RTD yang dapat menanggulangi keadaan darurat dengan efektif dan mudah dipahami seluruh perusahaan. Untuk membuat Manual dan RTD yang baik maka diperlukan referensi-referensi yang memadai baik dari nasional (dari BSN, PMK daerah atau Bappedal). Atau juga dari internasional seperti didapat dari Organization Health and Safety of America (OHSA), API, NFPA , BSI dan sebagainya


LAMPIRAN.

Dalam manual RTD juga harus dilengkapi oleh beberapa lampiran seperti dibawah ini ;

• Lay out Perusahaan dan lokasi peralatan RTD
• Spesifikasi peralatan dan fasilitas yang ada dan jumlahnya
• Jalur Emergency dan Evakuasi
• Nomor Telephone dan alamat semua anggota RTD
• Nomor Telephone perusahaan tetangga, PMK, Rumah Sakit, Kepolisian, Kelurahan, Dinas Lingkungan Hidup.
• Material Safety Data Sheet (MSDS)
• Serta intruksi-intruksi kerja Penanggulangan Dampak. (jika terpisah dari manual RTD)

Semua bagian dalam panduan manual rencana tanggap darurat dan kesiapsiagaan ini harus disesuaikan dulu dengan perusahaan atau jenis industri karena berhubungan dampak apa yang paling mungkin terjadi dan seberapa besar resiko yang dihadapi.

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Energizing your Internal Audits

by Robert Badner

Planning for the Internal Audit

The key to an effective, thorough and value added internal audit is in the preparation. If internal auditors are spending one to two hours preparing for an internal audit, it is not enough time. To properly prepare for an audit, it should take twice to three times that. If the actual audit time will take an hour, there should be at between two and three hours spent in preparation. A good rule of thumb to spend about two and half times as much time in preparation as the audit will take. Often times, auditors plan for a two hour internal audit and spend 1 hour preparing which leads to them running out of questions about 30 minutes into the audit. I can't stress this enough if you want to be a successful internal auditor or manage a successful internal audit program then make certain you spend adequate time in preparation for the audit.

This sounds easy, but it is actually very difficult. The major obstacles to allocating enough time for preparation are time restrictions placed on the internal auditors. Chances are they have other responsibilities aside from internal auditing that compete for their precious time. One method to help remove that obstacle is to have as many trained internal auditors as possible to spread the work load.

Effective planning for an internal audit requires following a few simple steps that are listed below.

1. Learn the process (turtle diagram)
2. Identify the interfaces with the standard
3. Document review (compliance to standard)
4. Identify potential process failure modes (pFMEA)

1. Learn the process

Before you can audit a process you must become familiar with it. You need to learn how it is supposed to work, what it supposed to do, what are the inputs, outputs, activities, resources and controls. The first step would be to create a turtle diagram of the process (This may have already been done by the organization as part of their documentation, or in previous audits). A turtle diagram looks at the suppliers, inputs, activities, controls, resources, outputs, and customers. A turtle diagram is laid out such that the process activity is a box in the middle, the inputs come in from the left and outputs exit from the right of the box. The supplier is listed in the upper left hand corner and the customer is listed in the upper right hand corner. The controls are above the process activity and the resources are below the process activity. The feedback loop is an arrow from the output to the input. Let's do an example of a turtle diagram for a process. For this example, the process will be one that applies to about every business in some way and that's purchasing.

Inputs:
This is what the process needs for the activity. It can be in the form of information or a product. For this example the inputs are: Demand (what is driving the purchase), Quantity, Type, Specifications and Requirements, Due date and Budget (how much can be spent).

Supplier:
This is who is supplying the inputs to the process. The supplier can supply information or a material product. For our example the supplier would be whoever is specifying what to purchase, when to purchase and how many to purchase.

Process Activity:
This is the process. There are a number of associated tasks contributing to the process. For our example the process activity is purchasing

Outputs:
This is the result of the process. It can be information, energy or material. In our example the output of the purchasing process is the desired product or service delivered when needed. For our example it could be a product like a computer or piece of test equipment. It could be information such as a failure analysis, training materials, book or manual. It could also be a service such as mowing the grass, doing the laundry or processing payroll.

Controls:
These are the items that regulate the rate at which inputs are converted to outputs. Without controls, the process would operate continuously generating the output. The controls for our example could be the material requirements planning software, the purchase requisition approval process and inventory analysis.

Resources:
These are the items used or consumed in the process activity. It could be people's time, machine time or money. For our example, the resources would be the buyer or purchasing agent, money, the representative for the company supplying the product or service and possibly other support functions who have input for the purchase. Additional resources are in the form of computers, material planning software, phones, fax, office space, etc.

Customer:
The customer is the group that takes the output and uses it. It is most likely used as an input to another process or as a resource.

Feedback Loop:
This is the mechanism used to monitor the process. What metric is used to tell the process owner how the process is performing and when action needs to be taken to correct it. For a purchasing process it could be supplier performance, dollars spent, on-time delivery or receiving inspection information.

2. Identify the Interfaces to the Standard

The interfaces are the points where the process intersects the standard. In simple terms it is where the requirements of the ISO 9001:2000 standard are applicable to the process being audited. The easiest way to accomplish this is to use a matrix with the elements of the standard on one axis and the process name on the other. To better discern the interfaces of the process to the standard you could break the elements down into the sub elements. For example, 7.2 Customer Related Processes is comprised of 7.2.1 Determination of requirements related to the product, 7.2.2 Review of requirements related to the product and 7.2.3 Customer communication. The left side of the matrix would become larger, but you would have a more definitive intersection of the process and standard. This activity provides you with the understanding of what areas of the standard apply to the process. You will be developing questions to ensure compliance to the standard and this tells you what areas of the standard to focus on.

3. Document Review

The document review section requires reading and understanding the associated documentation for the process you are auditing. Start with the level 1 document, the quality manual. The quality manual should provide an overview of the process and should describe how the process fits into the overall quality system. The quality manual will explain what processes feed the process you are auditing and what processes are supported by it. It will describe the interaction and interrelationship of processes within the quality system.

The main output from the review of the quality manual will be an understanding of all the processes that make up the quality system and how they interact. The quality manual should provide a good description of how the processes work.

Next, review the level 2 documentation or procedures. Procedures should describe the process in more detail than the quality manual. There could be many procedures outlining the quality system, or there could be the minimum required by the ISO 9001:2000 standard, six. The six required procedures are:

Control of documents
Control of records
Internal Audits
Control of nonconforming product
Corrective action
Preventive action

Since the ISO 9001:2000 standard requires less documentation than previous versions of ISO 9000, there may not be as many procedures to evaluate. In this case the document review portion will be reduced. During the document review of the manual and procedures your are trying to understand the process and the system and ensure the requirements of the standard are met.

4. Identify Potential Process Failure Modes

Another tool we want to utilize is the pFMEA, which stands for "process failure modes and effects analysis. You may have some background in FMEA's and you may not. Either way is alright because we are not going in depth in the FMEA process. An pFMEA is a method to identify potential problems with a process before the process is implemented. It is a preventive measure that aims to resolve problems before they occur. For our purposes we will be concerned with the process function, the failure mode and the cause of the failure mode. Below is an example of an pFMEA for the purchasing process:

Process Function Failure Mode Potential Cause

get good product bad product requirements not understood supplier is not capable not inspected enough

product on time product is late lack of capacity ordered late supplier out of product

low total cost too costly excessive rework excessive freight excessive testing

pFMEA's are an exhaustive approach that generates a large quantity of potential audit directions. By evaluating the prospective problems associated with a process, you can develop audit questions and an audit approach to ensure the potential problems are addressed. This can lead to some findings that can have positive impact on the quality management system.

This process can help develop a foundation to create a checklist for the internal audit. With your developed checklist you can drive improvement in the quality system with the audit results.

About the Author

Robert Badner is a freelacne writer for Innovations for Quality, LLC, which spealializes in live, online training for iSO 9000 and ASQ Certification. You can visit their websites at http://www.asqcertification.org and http://www.iso9000training.org.

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Handbook for Basic Process Improvement

BPIHNDBK.PDF

This handbook has been developed to assist team leaders at all levels who are involved in process improvement efforts. Together with the Basic Tools for Process Improvement, or "tools kit," it provides the practical information you need to initiate and successfully carry out process improvement activities.

The approach and tools described in the handbook follow a Basic Process Improvement Model. This model differs in many respects from the Process Improvement Flowchart found in the CNO-sponsored Starter Kit for Basic Process Improvement distributed to commanding officers several years ago. The Basic Process Improvement Model is much more detailed, in keeping with the "how to" approach used in the new handbook. Together, the model and handbook explain the actual actions teams must take to improve a process.

Tools for Basic Process Improvement

File	Size	Description
AFFINITY.PDF	425 KB	Affinity Diagram
BRAINSTM.PDF	318 KB	What is Brainstorming?
C-EDIAG.PDF	412 KB	Cause and Effect Diagram
CONTROL.PDF	885 KB	Control Chart
DATACOLL.PDF	655 KB	Data Collection
DESCNTLS.PDF	421 KB	Decision Making Tools
FLOWCHRT.PDF	430 KB	Flowchart
HISTGRAM.PDF	487 KB	Histogram
OPDEF.PDF	507 KB	Operational Definitions
PARETO.PDF	570 KB	Pareto Chart
RUNCHART.PDF	535 KB	Run Chart

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