By Karen Welch
Eventually, a entire strategy audit list has been constructed for use with ISO/TS 16949:2002! This list does what many others don't: it teams the questions through approach instead of through common clauses, hence instantly guiding the auditor to behavior a procedure method audit. This guide was once constructed to help somebody concerned with engaging in or making plans caliber approach audits, together with caliber auditors, caliber managers, caliber procedure coordinators, administration representatives, and caliber engineers. moreover, power auditees in any functionality or place may still locate the questions precious in getting ready for an audit. The guide comprises: a short evaluate of the method method; dialogue of troublesome areas frequently came upon via 3rd get together auditors; the method audit record; and varieties for use along with the method audit record to extend audit effectiveness. As a 3rd occasion auditor, the writer has noticeable the constraints in inner caliber audit methods because of green inner auditors, as many simply usually are not convinced what inquiries to ask simply because they just audit a few times a yr. using this list takes the guesswork out of the interior audit technique. merits: Questions written and grouped via a 3rd celebration expert auditor. The instruments had to behavior a profitable audit from begin to end using a real strategy procedure. by utilizing the record and its appendices, your inner auditors may be required to audit by way of technique and practice follow-up in linked components to maximise advantages. An audit that prepares all degrees and capabilities within the association for a profitable 3rd get together technique audit. some great benefits of a strategy established audit with out hiring a qualified! the method audit record is incorporated on an accompanying CD-ROM in Microsoft notice structure
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Extra resources for TS 16949 : insights from a third party auditor with a process approach audit checklist
Sometimes, the organization argues that the customer has never asked for the requirements stated in the manual. However, as an auditor, my approach must be that the customer believes the organization is meeting its requirements whether or not the organization specifically asks for each requirement. The exception here would be if the organization obtained a very clear waiver from the customer. If the organization should pursue a waiver, it is strongly recommended that the organization put the request in writing and ask the customer to sign it.
Also, all shifts must have persons who are responsible for product quality and thus have the authority to stop production. This is often not clearly defined in organizations. It is not uncommon for production operators to tell me they are responsible for quality; however, when asked who can stop production, they many times refer to their supervisor. qxd 28 4/4/05 11:36 AM Page 28 Chapter Two called at home. These people should understand that this makes them responsible for quality on that shift.
27 VALIDATION OF PROCESSES NOT DEFINED One of the most common nonconformities during an ISO/TS 16949:2002 audit involves validation of processes. More often than not, organizations believe that if they have no “special” processes, this does not apply to them. This is a mistake. An addition in ISO/TS 16949:2002 that we did not see in QS-9000 requires validation to apply to every process. So, whether you have special processes or not, you must validate and revalidate each process. Be certain to define your process and identify the records.