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Title: How to Plan an Audit : ASQ Quality Audit Technical Committee Author: Charles B. Robinson Publisher: ASQ Notes: Audit planning is the crucial first step in a successful audit. The ASQ Quality Technical Committee has developed an instrumental tool to assist audit managers in planning the successful audit. Edited by Charles Robinson and published by the ASQ, you know this book will be a valued member of your professional library!
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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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Feature Article Auditing ISO/TS 16949:2002Ordinarily, we wouldn't run a feature on auditing any particular standard, or requirement. But we are making an exception for ISO/TS 16949:2002. There are enough things that are different about the second edition of 16949, that we thought it was a good idea. Historically, we have conducted audits based on the particular requirement using checklists based on either the standard, or our procedures. Some of us dared to be different enough to actually perform process audits (we'll discuss them later). In many cases, we audited for compliance rather than for impact. ISO 9001:2000 began to move us from compliance auditing to process auditing. ISO/TS 16949 makes the transition more concrete. Let's look at ISO/TS 16949:2002 and see how it changes our auditing practices. ISO/TS 16949:2002 is based on ISO 9001:2000. It uses 9001 as its base document and adds additional requirements unique to 16949. One such case is in Clause 8; specifically 8.2.2 (Internal audit). 16949 keeps the 9001 language, but adds specifics on QMS audits, process audits, product audits and audit plans. These new requirements (most were not present in QS 9000) will substantially change the manner in which we audit. The checklist keeps the auditor on track and ensures that all aspects of the audited area become audited. But the checklist is only as good as the auditor preparation. An inadequately prepared checklist will do little to ensure the adequacy of the audit. 8.2.2.1 Quality management system audit The organization shall audit its quality management system to verify compliance with this Technical Specification and any additional quality management system requirements. This is why we audited for many years. We determined compliance to the standard, and any other requirement that either we or others imposed on our QMS. This would include our own procedures and other documentation. It would also include any additional customer or regulatory requirements. Our audits would follow the standard and be scheduled based on the layout of the standard. 8.2.2.2 Manufacturing process audit The organization shall audit each manufacturing process to determine its effectiveness. More advanced organizations have been performing process audits for years. 16949 makes the process audit mandatory. These are in addition to the system audits. Refer to Clause .2 for more information on processes and the Process Approach. A future issue will discuss in great detail the process audit. 8.2.2.3 Product audit The organization shall audit products at appropriate stages of production and delivery to verify conformity to all specified requirements, such as product dimensions, functionality, packaging and labelling, at a defined frequency. Most organizations audit product, in some form, as a routine. Your regular inspection techniques are an example of product auditing. Dock audits were required under QS, so this requirement should not be anything new. 8.2.2.4 Internal audit plans Internal audits shall cover all quality management related processes, activities and shifts, and shall be scheduled according to an annual plan. When internal/external nonconformities or customer complaints occur, the audit frequency shall be appropriately increased. This is another rewording of the QS requirements. Once again, this should not be a problem with 16949. One improvement is the change from requiring "an audit schedule updated annually" to "according to an annual plan". The difference is that one could argue that you could not deviate, nor update the annual schedule according to QS. That is not what they meant, but it could be (and is) interpreted that way. 8.2.2.5 Internal auditor qualification The organization shall have internal auditors who are qualified to audit the requirements of the Technical Specification. This requirement is a combination of the old 4.18, Training and 4.1 Resources. Auditing this requirement may be a bit difficult, because you are auditing yourself. The above identifies the differences in just in auditing to ISO/TS 16949:2000. There are some other additional requirements that must also be dealt with. Here are some highlights: 1.2 Application: ISO 9001:2000 allows permissible exclusions in Clause 7, provided they do not affect the ability/responsibility to provide acceptable product. 16949 limits the exclusions to 7.3 Design and Development. Process design cannot be excluded. 5.4 Planning: The business plan required in QS is not specifically required, however it is referenced as though it is expected. 6.2 Human Resources: Organizations need a process to motivate and empower employees. 7.3 Design and Development: Design has been expanded to include process design. PPAP is referenced only as "a product and manufacturing process approval procedure recognized by the customer". 7.4 Purchasing "Unless specified by the customer, suppliers to the organization shall be third party registered to ISO 9001:2000 by an accredited third-party certification body." Not a lot of wiggle room here. Most of the other additional requirements are similar to the QS mandates we are all familiar with. This was intended to give you insight on how ISO/TS 16949 will affect your auditing. Summary: ISO/TS 16949 is probably here to stay. This means that if you are in the automotive supply chain it might become a requirement for you (see The Back Page for details). Auditing to the new standard will contain new challenges while continuing some of the old battles. We will keep you updated as we go. As always...Good Auditing!
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Resources:
Two resources for ISO/TS 16949 are the Automotive Industry Action Group (AIAG) and the International Automotive Oversight Bureau (IAOB) at . Others are:·
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Question and Answers: Q – We are QS. Do have to use the QSA? A – Not unless you want to. Remember the QSA only reflects the requirements of QS-9000. It will not address your procedures and work instructions. You might want to create a supplement to QSA for your documentation requirements. |
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Element Understanding: ISO/TS 16949:2002 Clause 7.5.1.8 Service agreement with customer "When there is a service agreement with the customer, the organization shall verify the effectiveness of…." One of the parts of QS 9000 that most of us were unsure how to deal with was Element 4.19 Servicing. Well, servicing did not go away, but it did change for the better. Servicing now is much more clearly defined, and a procedure is no longer mandated. The beginning "When there is" indicates that this sub-clause only applies if there is a service agreement. Similar to the old Traceability. If there is no such agreement, then you have to do nothing. If there is a service agreement, then you must comply with the balance of the sub-clause. |
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Monthly Scenario Explained: August 2001's question: You are auditing manufacturing with the scope of 4.9 (QS-9000). Along one wall is a door that is clearly marked "Emergency Exit". It also has an exit sign above the door. The door is blocked with a rather large piece of machinery. You are sure the fire regulations do not allow exits to be blocked, which is a violation of 4.9 c). When brought to the auditees attention, he states that unless you can quote the part of the fire code that prohibits the blocked exit, you cannot write the non-conformance. The answer: 4.9c) states "compliance with reference codes/standards". It really wasn't intended to be a catch all for health and safety. Taken in context, the sub-clause is referring to product and process specifications. However, it could be used in the manner the auditor envisioned. In this case, the auditor replied, that if the auditee could get the Fire Marshall to okay the blocked door, the nonconformance would be repealed. The doorway was cleared. |
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The Back Page:
The official rollout of ISO/TS 16949:2000 is over. The taskforce gave a pretty good presentation. The only real surprise was the admission that the effectiveness of QS 9000 was less than spectacular. Although they placed most of the blame on the registrars, they too have to share some of the blame. The OEMs have personnel that still do not understand the rules of QS, based on some of the horror stories. They tightened the rules to ISO/TS 16949. Part of the tightening is limiting how many companies will require 16949. It looks like 16949 will be applicable for Tier 1 and some Tier 2, but not too much beyond that. In order to achieve ISO/TS 16949 you must first have a customer that subscribes to the Technical Specification. If you wish to achieve it in order to do business, you must secure some applicable business by the first surveillance audit, or registration will be revoked. ISO/TS 16949 registrations will also accompany ISO 9001:2000 registrations, like QS 9000 does currently. Also, There are no plans for a TE supplement to ISO/TS 16949. Tooling and Equipment companies will have to register to ISO 9001:2000. Because QS 9000 and the Tooling and Equipment Supplement are not set to expire until 12/15/06, it might be in TE companies best interest to hold off on any transition in case the rules changes later on. But seeing as though 16949 uses ISO 9001:2000 as the base document, transitioning should not be an issue. Dave ...Good auditing!
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Copyright notice: internal-auditor.com is
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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 |
