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product audits

Discussion in 'IATF 16949:2016 - Automotive Quality Systems' started by bkirch, Oct 22, 2019.

  1. bkirch

    bkirch Member

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    Depending on who I talk to, there seems to be different opinions on what would be classified as a product audit. Some people say that your normal checks per your manufacturing control plan are a product audit. Some will say that a product audit would be in addition to your normal checks per the manufacturing control plan. In other words it would be an audit to verify that the normal checks per the manufacturing control plan are being done correctly. I would be interested on hearing some more opinions on what would be classified as a product audit.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Whomever told you that first item is smoking some baaaad stuff.

    An audit is an audit - independent and done to give assurance that the processes are working as planned. A product audit - depending on where it is performed in the process(es) often checks not just the conformity of the product, but a number of other things. The closer it gets to being packaged and shipped, the more comprehensive the audit becomes. At shipment, you might be doing a fully functional test of the product, color, labeling, checking packaging materials, quantity and labeling to spec, contract/PO requirements, user handbooks - all kinds of things. In process, earlier on it might be handling, labeling, material traceability and so on to the various specification.

    Doing an audit to check the items in the Control plan are just that - a control plan audit. Aka a IATF Manufacturing Process Audit. A PRODUCT audit is just that - auditing PRODUCT, not the process(es) which caused it.
     
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  3. John C. Abnet

    John C. Abnet Well-Known Member

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    I've come across the same question @bkirch

    As you mentioned, the control plan states what product characteristic verification is performed and at what frequency (and sometimes, by whom). These are usually performed by the operator performing or responsible for the related manufacturing process.

    As @Andy Nichols pointed out, the key word is "independent" . While the standard does not use the term "independent", it does use the word "audit", where ISO 9000:2015 (3.13.1) defines an Audit as"...independent"..."

    So, an auditor may give you a hard time about the operator not being "independent". That is likely the source of the comments you received " ...a product audit would be in addition to your normal checks... "

    Summary:
    I council my customers to utilize existing methods and not add new or additional methods unless the current methods aren't effective. If the operator can provide objective observation during his/her control plan scheduled verification ("audit"), then I recommend standing firmly on that.

    This is a good question...great discussion point. I 'd be curious to see what others have to say about it.

    Hope this helps.
    Be well.
     
    Last edited: Oct 24, 2019
  4. John C. Abnet

    John C. Abnet Well-Known Member

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    Help me understand @Andy Nichols .
    I have read your comments again and want to make sure I understand your position on this.

    If I understand you correctly, you are saying that to meet the requirements of Product Audit, means that an independent resource (not the "operator"), must audit the product in addition to any Product Characteristics verification and frequency stated on the control plan? Is that what you are indicating Andy?

    Thanks in advance
     
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  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes! I'm not certain that it'll be in the CP, since audit shouldn't be part of any PFMEA as a detection etc.
     
  6. John C. Abnet

    John C. Abnet Well-Known Member

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    Interesting. Thanks for your feedback. All of the OEM and control plan I have worked with to date have the product characteristic , specification, verification, and frequency included. Considering the potential for a small organization, wherein, there may not be the luxury of an "independent" auditor (and my own experience that the operator is capable of objective verification), I have not promoted an additional product audit. Are we fighting ?!o_O

    (I actually see this through the same lens I use for internal audits, wherein, the requirement is for "objective and impartial", which does not necessarily equate to someone outside the area of the process)
     
    Last edited: Oct 24, 2019
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  7. tony s

    tony s Well-Known Member

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    Auditing using the control plan as the reference or audit criteria is not product audit. It falls under the scope of a manufacturing process audit. Manufacturing process audit is intended to determine effectiveness (i.e. planned activities realized and planned results achieved). See clause 9.2.2.3. Looking at the control plan, an auditor would need to evaluate whether the "planned activities are realized" by examining the control plan columns on Process Name, Process Characteristics, Process Specifications, Measurement Technique, Control Methods and the Reaction Plan. The "planned results" are then assessed by looking at the control plan columns on Product Characteristics and Product Specifications/Tolerance. That is why it is a requirement that manufacturing process auditors must be technically knowledgeable on control plan (see clause 7.2.3).

    On the other hand, product auditors must have competence in understanding product requirements and use of measuring/test equipment to verify product conformity. The intention of product audit is to determine conformity to product specifications. So if we have to analyze the statement from the standard:
    • The organization shall audit products using customer-specific required approaches... (so focus on evaluating the product using the prescribed inspection, measuring and test equipment/approaches);
    • at appropriate stages of production and delivery... (monitor the product as it progresses from the first production process up to delivery);
    • to verify conformity to specified requirements... (use the specifications as reference for establishing the audit criteria).
     
  8. John C. Abnet

    John C. Abnet Well-Known Member

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    It depends @tony s
    IF the control plan specifies that the PRODUCT characteristics are verified at a specific frequency to a specific requirement using a specific method, then it can indeed be considered as "product audit". The product audit per 9.2.2.4 states, "...at appropriate stages of production..."

    The original poster is not stating the use of simply a "control plan audit" (i.e. process audit verifying PROCESS characteristics). The OP is asking if PRODUCT characteristics verified as prescribed on the control plan, constitutes part (or all) of PRODUCT audit.

    If the control plan states that PRODUCT characteristics are indeed verified at "...appropriate stages of production...", then someone needs to help me understand WHY that can not be considered part of PRODUCT AUDIT per 9.2.2.4.
     
  9. tony s

    tony s Well-Known Member

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    Are you auditing:
    1. to determine whether the product characteristics are verified at appropriate stages of production? OR
    2. to determine whether the characteristics of the product conform to specified requirements at appropriate stages of production?
    Which of the two above is a manufacturing process audit and which is a product audit?
     

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