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We recently reported an update to the Sanctioned Interpretations to QS-9000. Well, it seems that we were a bit premature. Less than a month after they announced the new interpretation for 4.6, they "clarified" their interpretation. You can find more by going direct to the IASG website at: http://www.qs-9000.org |
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Title: The Quality Audit for ISO 9001: 2000 : A Practical Guide Author: David Wealleans Publisher: Gower Pub Co Notes: This book aims to teach the entire process of auditing without any of the dogmatism so common in quality management. I have tried to make it comprehensive yet flexible so that it is of use to novices and beginners. The approach, especially for internal audits, is geared towards improvement and assessing objectives, as I have always taught - this now fits in well with the philosophy of the 2000 version of ISO 9001 and so I have included a chapter explaining what the new standard requires.
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You can order this book from internal-auditor.com at: http://www.internal-auditor.com/books.htm |
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This Month's Feature ArticleOn-Time Auditing It is time once again for the internal audit. Everything is ready. The auditees have been duly notified, and anxiously await your arrival. You have taken the time to prepare, studying the requirements and procedures. You have looked at the previous audits and checklists. Your checklist is up to date, and you have your sampling plan and you know what evidence you will be looking for. The opening meeting is scheduled at 8:30, and you are there, the auditees are there, and everyone is ready to go. Sounds like a nearly perfect start to a nearly perfect audit, doesn't it? But is it really? Are you auditing what you should be auditing, when it should be audited? What I am trying to ask is this the best time to audit that particular subject? Does it make a difference what you audit when? On-time auditing means you are auditing that function or activity at the exact time necessary to have the greatest impact on the QMS, the organization and the auditing program. The standard requires that audits be scheduled based on the activity's relative importance, the status and the results of previous audits. But in scheduling audits, we must look way beyond that to develop a schedule that will yield the greatest benefit for the organization. In order to accomplish this, we must look at two things. The long-term, big picture and the short term. We must balance strategic needs, those having impact on the entire QMS, and tactical needs, those that impact an individual audit. Strategic: Strategic needs are those that have long-term implications to the QMS and the operation. With strategic issues, we need to think of the auditing process as a path to self-improvement. The yearly audit schedule is a strategic event. Few of us look at the audit schedule as a tool that can be leveraged to maximize our continual improvement efforts. But we can. Our scheduling of audits can have a great impact on how the QMS is viewed and how individuals and departments react to the QMS. Here are some factors that need to be considered in the strategic planning of internal audits.
Independence: Those activities that have the greatest impact on the quality of the product, or service need to have the greatest attention. Unfortunately, those activities also tend to be the busiest. The key is to find a way to audit them with the minimal amount of disruption. On-time auditing means that you have scheduled the audit at the time that least impacts the auditee, yet has the greatest impact on the audit program. In too many cases, the audit schedule is generated without any input from the auditee. Status: When considering on-time auditing, you must also take into account the history of the activity you are about to audit. When determining on-time auditing, you might very will dedicate more auditing time to those activities that need it. At the strategic level means you audit more often. The tactical level means you dedicate a little more time to the actual audit. Seasonality: When scheduling your audits, take into account seasonality issues. If the summer is your busiest time of year, then try not to schedule audits then. Likewise, scheduling audits near holidays and major events (like hunting season) might cause problems. Also consider the time of month. End of the month activities might make auditing difficult as well. An on-time audit will consider the auditee's time and the auditor's time. Independence: With independence, we are looking at how well the particular activity performs when no one is looking. Do they have integrity in their QMS operation? You undoubtedly know which departments do the best job, in relation to the QMS. We know that we cannot allow activities to audit themselves, but we can use this knowledge in our strategic planning for on-time auditing. Politics: There is a side of internal auditing that is political in nature. It is the area that most Management Reps and Lead Auditors hate the most. Organizational politics often lead to frustration, anger and is the driving force behind many internal auditors resignation. We will dedicate a Monthly Feature to the political side of auditing next year. In relation to the strategic, or for that matter, the tactical on-time auditing, you might have to play some political games to ensure your audits are on-time. Tactical: Tactical events are those day-to-day activities that carry out our strategic initiatives. Scheduling of a particular audit is tactical in nature. Whereas the strategic is dealt with in the yearly audit plan, tactical deals with the timing of individual audits. Here too, we must consider many things in order to maintain on-time auditing. A few of those items are:·
Size of activity: It is relativity intuitive that the larger the activity, the more time must be dedicated to auditing it. Don't be fooled here. This is not always the case. Size must be considered, but it is just one factor. Related to size is proximity. A department, or activity might take up more than one location. Travel between locations must also be considered to ensure on-time auditing. Process complexity: Process complexity is more important of an issue than physical size. The more inputs, outputs and processing that takes place, the greater volume of potential objective evidence that will be available. You need to account for and consider process complexity in your audit plan. Strategic issues: You can't ignore strategic issues in your tactical planning. Most of the mentioned strategic issues have a tactical impact as well. You need to consider these in the audit plan as well. Audit Planning for On-Time Auditing First, begin with the yearly audit schedule. Involve as many of the auditees as practical. Take into account the strategic issues and once you are finished, stick to the plan (as best you can). Make sure all lines of communication stay open and the auditees are continually informed of the plan. On the tactical side, once you have your audit plan and schedule developed for the actual audit, ensure it is communicated to all concerned. Make sure you have enough auditors and they are prepared well in advance, so you can maximize the time allocated to the audit. Keeping to the audit schedule is tough, at times. Auditors must do their best to maintain the schedule. When it is not possible, then the auditees need to be informed. If you are scheduled to be in purchasing at 1:00 and don't arrive until 3:00, the audit will probably not be as effective as you would desire. We have some tips listed in Tips/Tricks/Laughter section of this newsletter. This can help make the audit more on-time. Summary: On-time auditing is an essential part of an effective audit program. It takes a lot of work to have audits performed on-time. Proper planning can go a long way in ensuring your audits are timely and on-time. Auditor competence cannot be stressed enough, as this is a leading cause of audits falling behind schedule. Organizational politics are another major cause. As auditors, we must be ever vigilant in our quest for the perfect audit, and audit timing is a giant step in that direction. As always...Good Auditing! |
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Question and Answers: Q – I am the Management Rep and the owner thinks I should attend Lead Auditor training. Is this training really useful? A – It depends on why you are attending. I think most Management Reps can gain a lot from attending a Lead Auditor class. This class can show you the standard from your auditor's viewpoint. It will also give you insight into what the auditor must go through during an audit. However, if you are planning on using the training for implementation, instead of hiring a consultant, you might be better off, finding a class on implementation instead. You do not need a consultant, but an implementation class might be a better use of your resources. After you have implemented, then look at Lead Auditor classes. |
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Tips, Tricks, Laughter
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Observations from the Field Proving your employees are competent need not be a major concern. Just ask yourself: "How do I know my employees can do the their jobs?" If your answer is you're not really sure they can, then you have a big problem. If you can answer the question with confidence, then ask the second question: "What can I use to prove they are competent?" This is a very important question. The answer will undoubtedly take into account the complexity of your process, and the number of employees. In one shop, I deal with, only has seven employees. Their registrar's auditor has no problem with their comment that they just know. Very little documentation is required. Another plant has over 1500 hourly production employees. The documentation is much more detailed, including a formal Skills Management Program. |
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Element Understanding: ISO 9000: 6.2.1 Human Resources "Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience." This is very similar to the language in the old 4.18 element of the 1994 version. The key difference is the word "qualified" used in the previous edition is now "competent". There is more than just a spelling difference. We all know individuals who are qualified to do something, but they can't perform. The object is to make sure that the folks that do quality affecting work can actually do the job. How you demonstrate competence is up to you. There are several choices. You can use education, training, skills and experience. |
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Monthly Scenario Explained: November 2000’s question: While auditing Element 4.4 Design Control. You ask the Design Engineer to see the evidence of the formal documented reviews required in Clause 4.4.6. She responds that she is the only person involved in design because product design is straightforward, and the only changes are modification to the base design. Because this does concern her, she maintains a checklist to ensure nothing is left out. She completes the checklist as she goes, so a formal review is not necessary. Why have a formal review when she would be the only person there? She states the checklist meets all of the requirements, and intent of the review, as well as serves as the required review record. She adds that she has done it this way for over eight years without any problems. The
answer: In this case, the auditor wrote a non-conformance against 4.4.6. The Design Engineer challenged the non-conformance with the President. The President felt that even though he was not trained as an auditor, it appeared to him that the requirements were in fact being met. The auditor persuaded the Design Engineer to revise the design procedures to clearly show that the checklist is the formal design review process. During a subsequent surveillance audit, the auditor noticed the record of the overturned non-conformance. As she reviewed the situation, she noted that not only was the checklist conforming, but also this was a good example of how an internal audit should work when there is a question. |
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The Back Page:
The recent "clarification" of the Sanctioned Interpretations of QS-9000 set of requirements by the IASG (http://www.qs-9000.org) shows clear evidence in the problem with official interpretations. This is an excellent example of how politics enters into what should be a non-political arena. QS-9000 originally required suppliers to develop their vendors using Section I of QS-9000 as the guide. For years, the intent was to have vendors meet the intent of QS-900, without requiring registration. This spring, the IASG came out with an interpretation that stated that to meet the intent, the vendor would have to be registered to at least ISO 9001 within 18 months of July, 2001. Less than a month later, they clarified the interpretation to say that certain 2nd party audits would qualify to meet the intent. Many automotive suppliers are already suspicious of the QS process. Now this double flip-flop only adds fuel to their argument that QS-9000 is not about product quality, but Big-3 politics. I really cannot disagree with that statement. It is about time for the Big-3 to come back to reality. One would have thought that the recent downturn would get their attention. Perhaps in time it still may. Dave ...Good auditing!
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Because this site uses information from many different sources, it must be pointed out that any advice, tips, information, etc., provided should be regarded as opinion and not fact! What works well for one company may be a disaster for another. Also, what one registrar, or auditor may allow, another may not. As always, reflect on what you read, see if it fits into your own quality system, and if it conflicts with your auditor...you've got to make a decision |
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