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Process performance and conformity of products and services ISO&IATF

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by luis hernandez, Feb 7, 2020.

  1. luis hernandez

    luis hernandez New Member

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    Hi all, I'm working on IATF implementation, and during the MR presentation or report, I had some doubts about the "Process performance and conformity of products and services" how can I demonstrate this?
    I understand that we need to demonstrate the conformity of our processes like how can probe or analyze that our products reach the customer satisfaction and their field performance.
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @luis hernandez and welcome to the site.

    Two observations...
    1- You mention "...THE management review presentation...". I am hoping when you state it this way, that you are not indicating that management review is a
    single- once a year- dark room- stale doughnut- single meeting. This is (sadly) a typical approach which rarely benefits the company (once a year is "too late" to make adjustments and remedy any situations/misses that need addressed throughout the year).

    2- In regards to "process performance and conformity of products"....
    A- Process performance...
    What processes does your organization measure? (i.e. what does your organization care about?). For example, if your organization monitors on-time delivery ,then how is that reported daily, weekly etc...? Is there evidence this is being reviewed? Is there a goal established? Is the process meeting the established goal? If the process is not meeting the established goal, is there a decision being made whether any changes/adjustments/corrections need made/are made to the process? If there is a decision/need to make adjustments to the process is there a plan?

    B- Product conformity

    i. Is product conformity measured during stages within your organization? (i.e. IPPM, etc..?) Is there evidence this is being reviewed? Is there a goal established? Is the the established goal being met? If not meeting the established goal, is there a decision being made whether any changes/adjustments/corrections need made? If there is a decision/need to make changes, is there a plan?

    ii. Are product conformity requirements be met according to the customer's expectation? Is there evidence this is being reviewed? If the customer's perception is that product requirements are NOT being met, is corrective action being taken? If yes, what are the corrective actions and were they effective?

    These are typical questions/expectations that will benefit the organization (which is more important than satisfying an auditor).

    Hope this helps.

    Be well.
     
  3. luis hernandez

    luis hernandez New Member

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    Thanks for the answer! We have the management review almost twice a year.

    A- Process performance...

    We measure our five processes (production, purchasing, sales, management, and design) i.e for production, we have the DPM's metric, but this information is only posted in our informative whiteboard, we don't have a meeting or some review of this. Do we need to start to review this? And is the same thing with the other processes, we have the metrics but are only informative.

    B- Product conformity

    i. I am some confused on this point, we have metrics on line production but these metrics are just for produced pieces, non-confirming pieces / produced pieces. Can you recommend some metric additional or how can I work with these metrics?

    ii. We don't measure the customer's experience during the aftersale event, just sent a survey once a year. or in some cases, if we receive a customer complaint or during the inspection, we found a non-conformity just we make non-conformity report. I think that I need to do more actions but I don't know to do this, or how can I work with the information that currently I have.

    thank you!
     
  4. tony s

    tony s Well-Known Member

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    Process performance:
    If performance is defined by ISO 9000:2015 as "measurable result", then include in your review of QMS the "processes' measurable results". These can include performance indicators (see 4.4.1c) you have established for the QMS processes. The requirements of ISO 9001 are interrelated. Thus 9.3.2c.3 interrelates with 9.1.1 which interrelates with 4.4.1c. So, what does your organization need to monitor about your processes to "ensure effective operation and control"? If these are reported to the top management for their review, then you have fulfilled 9.3.2c.3.​

    Product conformity:
    Does your top management get to know the "fulfillment of requirements" relevant to your organization's product? This doesn't need to be very detailed. Summarized information, such as reports, on product conformity can be presented to top management for their review. Determination of product conformity is a requirement under 8.6. So, information obtained from the results of verification of product conformity e.g. acceptance rate at outgoing inspection or at customer's incoming inspection, should be reviewed by your top management to initiate decisions and actions for improvement.​
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    What is it that your organization makes.

    @John C. Abnet is very helpful with his comments. What is the Process Measurement for each process? DPM metric?

    I'm a little concerned that it's YOU who is doing this. Don't you have "Process Owners"? For IATF you are supposed to assign them AND they should be clear how their processes are measured, against established objectives etc...
     
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  6. John C. Abnet

    John C. Abnet Well-Known Member

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    Sounds to me like you ARE indeed measuring and monitoring process performance and product conformity @luis hernandez .

    For you example...
    A- You mention data is "only" posted on the whiteboard. When you ask "...Do we need to start to review this? ", I wonder...and assume it is on the whiteboard so individuals (including management) can REVIEW it and be familiar with it. (specific to your management review reference, the auditor will expect members of Top Management to describe WHAT is was being measured and expect them to be able to describe/explain it as well as if/when actions are taken).

    B- You mention "...but these metrics are just for produced pieces, non-confirming pieces / produced pieces..." Again, it appears to me your organization IS measuring product conformity. It concerns me when you ask...."can you recommend some metric additional or how can I work with these metrics?" If the CURRENT metrics provide information needed to understand the situation and drive action when needed, then why add additional work or metrics?
    Specific to your management review reference, I would again ...expect members of Top Management to describe WHAT is was being measured and expect them to be able to describe/explain it to me as well as if/when actions are taken and have record(s) showing evidence of a "management review", regardless of how that review is performed.


    Don't overthink this stuff @luis hernandez . I want to be careful that I don't diminish the requirements. As you know there are indeed specific inputs and outputs required for "management review". Specific to your management review reference, Top Management is expected to review (understand/explain), and (when necessary) take planned actions to cause any necessary adjustments/corrections, AND and have record(s) showing evidence of a "management review", regardless of how that review is performed. And, as @Andy Nichols states, it is important to ensure TOP MANAGEMENT owns this as required by the standard.

    Hope this helps...be well.
     
    Last edited: Feb 10, 2020
  7. leyladonmez

    leyladonmez Member

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    Hello,

    In IATF standard 8.5.1.3 item there is "first-off/last-off part validation" definition. Does it mean "first-off and last-off parts" or does it mean "first-off or last-off parts"?
    In our process we do first-off part validation is it enough or not?
    ...where applicable, ...where appropriate definitions confuse the meaning.
     
  8. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @leyladonmez
    The key word is "...as applicable..."

    Your organization will need to determine if applicable or not.

    Remember, more important than the requirement of the standard is the protection of your organization. Your organization will likely wish to establish verification points that limit exposure if a nonconforming product is manufactured. Without last piece verification, how will your organization be aware if something went awry with the manufacturing process at some point after the first piece verification? Without the last piece verification, you may have no way of knowing and won't be able to be proactive in responding to the problem.

    Hope this helps.
    Be well.
     
  9. tony s

    tony s Well-Known Member

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    When I have to sign a pile of documents (e.g. training certificates), I usually compare the first one that I signed with the last one. I just want to find out whether my signatures were consistently penned. Performing first-off/last-off, or "middle-off" is intended to address variation. So, as @John C. Abnet pointed out, it's the organization's discretion to perform both or not.

    Whenever discretionary phrases such as as applicable, as necessary, where appropriate are specified in any management system standard, it's left to the organization to determine "applicability", "necessity", and "appropriateness". The organization should ask "Would the absence of the “as necessary, as applicable or as appropriate” put the organization at risk of not meeting the customer or applicable statutory and regulatory requirements"? A “YES” answer supported with objective evidence/s will establish the “applicability”, “necessity” and “appropriateness”.
     
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  10. leyladonmez

    leyladonmez Member

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    Thank you veryansın much for your answer. İ think so that must be the organisation decision. But auditor insist that fırst and and last parti have to be checked. So i need to ask it to you.
     

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