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Relationship Between Preventive Measures and Quality Audit

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Viewing 9 posts - 1 through 9 (of 9 total)
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  • #55079

    uv104
    Participant

    Hi All, the discussion I would like to start is on how quality audit as a process is related to preventive measure. I understand that the feedback from quality audit irrespective of the methods of audit at the transaction level(live, post delivery, post production etc) is an input to preventive measures for that production process. At a transaction level the audit might not prevent the defects, especially if the method is post delivery audit however, the feedback serves as an input for preventive measures to be taken. A preventive measure can be arrived through, historical experience, audit feedback or predicting expected failures or in combination of all. The audit feedback also acts as an input to the preventive measure. Could we share if there are other views?

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    #198563

    Mike Carnell
    Participant

    @umav104 I normally avoid answering certain types of questions and this is one of them. Auditing has become big business and that pretty much says it all. I am not a fan of QMS audits. Two issues. First there is an expectation that normally takes the form of a spec of some sort. These specs are written by people who at some point made a decision they knew enough about every industry that they could write a universal spec. The next spec that gets written is because someone decided they knew more.

    The second issue is that these specs (opinions) are interpreted by auditors who were trained/certified by another person who also interpreted the spec. You now have a opinion (spec) interpreted and another opinion (trainer) and another interpretation and another opinion (auditor) looking at a process/business they may or may not understand and passing judgment. I learned early in my career to say “show me where it says.” I have also learned when you do that with an auditor it begins to take longer and becomes more petty.

    Basic audit theory says you look for two things 1. adequacy 2. compliance. Most audits are about compliance. Very infrequently it addresses adequacy. Even worse is when a bunch of people get together and write a spec and there is no real adequacy check there either.

    Basically auditors walk through the door with their idea of what compliance looks like and very infrequently are willing to sit back and say “I have never seen it done like that. I accomplishes what the spec asks for i.e. adequacy and you follow your own process i.e. compliance.” Any discussion that is something other than “Thank you sir I’ll have another.” is considered argumentative even when you have an auditor who looks at an attribute control chart and says he doesn’t understand how they work because control charts are based on the normal distribution.

    Certification becomes a business and getting paid to do the audit. It is about predicable revenue.

    A more direct response to your question is you are trying to use audit as a measurement device that becomes an input to your process. Like every measurement device it should have a Measurement System Analysis attached to it. If you can quantify the error of the measurement system then it is a complete crap shoot on the data it produces. If that is how you want to run your process that is your call.

    Just my opinion.

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    #198566

    Shelby Jarvis
    Participant

    I think I am in Mike’s camp. Quality audits are better than a poke in the eye. I prefer process design to incorporate error proofing in the eyes of the customer to prevent defects or at a minimum self identify when a failure occurs.

    At one time in my career I was a certified quality auditor. I share Mike’s frustration concerning compliance over adequacy and sometimes compliance in the auditor’s eyes may not reflect the same as the customer. Audits can be effective, so those are my thoughts based upon experience.

    The other issue is cost (Customer Satisfaction, Time, and Money). Below is a rough list in order of most cost (time, money, and customer satisfaction) with first is worst and progressively get better.

    * Customer finds the mistake: Worst Case Scenario
    * 2nd/3rd Party Audit finds mistake
    * Internal Audit finds mistake
    * Internal Data (defect rates) identifies the problem
    * Error Proofing identifies the problem
    * SPC on process output (product)
    * SPC on process inputs (pressure, temp, flow, etc)
    * Error proofing prevents the error which causes the problem

    The order and completeness of list are debatable but this is directionally correct.

    Keep in mind the audits I am speaking to are quality related. Legal compliance audits although may feel the same as this discussion may be driven for regulatory reasons which trumps my argument.

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    #198568

    Amit Kumar Ojha
    Participant

    Perfectly elaborated by Mike and Shelby!!!

    In Software Industry, Internal Quality Audits (Functional Testing done by BA Team, Performance and Security Testing done by concerned teams) during testing phase can be valuable if those are done with the focus on customer requirements. In this aspect Audits do add value on unveiling lot of defects which could lead to bigger problems had they been gone into production.
    However, the external audits (Final Inspection in software industry) done by third party who have limited knowledge about the particular domain or process may not be useful in providing quality product to the end customer.

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    #198569

    JB
    Participant

    I do think QMS audits can be a good input to helping define in-process controls and measurements, and risks. However, I think it’s best to use a tool like pFMEA to address and identify much of these before audits are conducted. There is some great info on auditing in Juran’s Quality Handbook that describes the purpose and benefits of auditing (and downfalls). But, the issue is it’s reactive rather than pro-active approach to improvement.

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    #198708

    uv104
    Participant

    Dear All,

    Thank you for taking time and participating. I understand the current misunderstood and misinterpreted usage of quality audits. However considering the correct way it should be used will a quality audit’s (especially the internal delivery audits) feedback help to come up with preventive measures?

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    #198710

    Strayer
    Participant

    Audits, whether internal or external, do no more than identify noncompliance with standards. The standards are assumed to be effective and therefore bringing processes into compliance will prevent defects. The truth is that although audits have value the defects they find are defects in compliance and preventive actions resulting from audits focus on ensuring compliance with the assumption that improved quality will result. Actual improvement might not happen.

    Quality assurance, as a form of internal delivery audit, can help you to come up with effective preventive measures. After many years as a QA leader I learned that the real value of QA is not enforcing compliance. It is collecting and analyzing data about noncompliance and nonconformance with specifications to gain insight into WHY this is happening. Using common tools such as Pareto to find the biggest problems and root cause analysis you can then focus on preventive measures.

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    #198712

    JB
    Participant

    @Straydog,

    Overall, I agree with your post but, if the defects in non-compliance to the QA Standards do not result in product or service failures or defects then we probably have the wrong standards/control/audit points. There should be a direct correlation to process failures (or at least significant risk of failure), and non-compliance with audited standards.

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    #198759

    MBBinWI
    Participant

    @umav104 – You’ve received good advice here, especially from my friend @mike-carnell, but I’d like to go back to your original question. An audit is merely to check that other checks are being done, and as Mike states – they should also verify that those checks are adequate for the item being checked. Thus they should not only check that the measurement is being made, but that the tool/method for making that measurement is adequate/sufficient for the task. Rarely is that done. The audit should also verify the veracity of the data – I remember one time looking at the data recorded that was perfect out to 3 decimal places for hundreds of measurements. It clearly was being “pencil whipped” as there is no way that these values could have no variation from the spec’d value when the amount was being created manually and measured on a floor scale. These measurements were “audited” but clearly the auditors were only concerned that values were entered, not that those values represented actual readings, nor that those readings were satisfactory to the task at hand.

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