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IATF 16949 Minor nonconformities

Discussion in 'IATF 16949:2016 - Automotive Quality Systems' started by Güven Abi, Sep 24, 2019.

  1. Güven Abi

    Güven Abi New Member

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    Hello everyone,

    We had IATF 16949:2016 certification audit 3 months ago and passed it succesfully but I have to close a few nonconformities by root cause analysis. The following nonconformities,

    1-)IATF 8.7.1.5 Control of repair product : Auditor said that You should perform and document risk analyze for your repaired product.
    2-)IATF 6.1.2.3 Contingency plan : Key equipment failure and utility interruption have not evaluated in your Contingency Plan
    3-)IATF 7.1.4 Environment for the operation of process : Legal control has not been planned for your Air Tank.
    4-)IATF 7.2 Competence : Related training with respect to the process experience has not been planned in Training Plan 2019
    5-)IATF 7.2.2 Competence on the job training : Customer requirements and consequences of nonconformity to customer requirements have not been considered during on the job raining for your new employee.


    I would appreciate it if you could share your help and know-hows because I have some difficulties on root couse analysis (5Why).

    Thanks in advance.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome:

    Are these the actual non-conformity statements? If not, can you give us the exact wording. These look like opinions to me, not actual auditor findings.
     
  3. Güven Abi

    Güven Abi New Member

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    Hi Andy,

    Yes. These are actual statements. Of Course I can give more details.

    1-)IATF 8.7.1.5 Control of repair product / Statement of non-conformance : Control of repair product is not fully effective because Risk analyse has not been performed and documented for your repair operations. This year, it's only one time.

    2-)IATF 6.1.2.3 Contingency plan / Statement of non-conformance : Management of contingency plan is not fully effective because key equipment failure and utility interruption have not been evaluated in your Contingency Plan. We have evaluated as electric shock and had a list of key equipment.

    3-)IATF 7.1.4 Environment for the operation of process / Statement of non-conformance : Management of legal control is not fully effective because Legal control has not been planned for your Air Tank. Only this air tank has not been controlled by expert.

    4-)IATF 7.2 Competence / Statement of non-conformance : Management of competence is not fully effective because competence matrix has been documented. Process Experience has been defined in matrix as 5-planned, 3-actual for your personnel. Related traning has not been planned in Training Plan-2019. Auditor said how will you enhance his competence?

    5-)IATF 7.2.2 Competence on the job training / Statement of non-conformance : On the job training is not fully effective because Customer requirements and consequences of nonconformity to customer requirements have not been considered during on the job raining for your new employee. We have explain it him verbally. Auditor wanted to see its evidence.

    I have shared them from audit report.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Thank you for this. Now, I don't have my copy of IATF in front of me, so let me ask:

    Is a risk analysis required for repaired product? When you say it's "only one time" you only repaired product once?

    This finding sounds reasonable. Electric shock is a safety issue, but it may cause power interruption though unlikely to be necessary for lack of production. A list of key equipment isn't the same as contingency planning for that equipment. Utility disruption is always a consideration.

    This is a non-sense non-conformity. Nothing to do with IATF 16949. Nothing to do with 7.1.4 - more like ISO 14001.

    This is confusing. Where does it say you need any training for people? Did you not determine if everyone was competent and, therefore, some might need training.

    Usually, verbally isn't training. If you don't have records, it didn't happen. How did you test understanding?
     
  5. Güven Abi

    Güven Abi New Member

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    Yes. I only repaired product once. I had obtained approval from our customer for repairing operation.

    Why did not I evaluated them in the Contingency Plan? I have difficulties for root cause analysis. We are a factory producing ball bearing seal with eccentric press. We have a large number of press. How can I explain with root cause for not evaluating utility interruptions like electricity, natural gas etc.?

    I can find nothing about it. It's ambigious.

    b item of clause 7.2 "ensure that these persons are competent on the basis of training, education or experience." Yes, I have a polyvance matrix to follow their competencies. He is the one who doesn't go around on production line a lot.

    This is clearly complicated. I don't know what I need to explain about customer requirements for blue-collar. I can control that how many parts he produces and which of them are bad parts.
     
  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    So the risk analysis should be easy.

    Maybe the root cause is YOU did it instead of the people responsible for maintaining the presses/utilities

    Reject it back to the CB management in that case

    But he still works on the production line? Then you need to determine competencies for him!

    Why is it complicated? Communication is verbal. Training can help make people aware. I don't see why this is so difficult. Do you not know what's important to the customer? Someone does, I guarantee. Maybe they should be doing this...
     
  7. Golfman25

    Golfman25 Well-Known Member

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    Don't overthink it.

    The utility disruption on the contingency plan is just a miss. An oversight if you will. Tap around the root cause analysis somehow as "not interpreted correctly" or something like that. Contingency plans are usually a continual work in progress as life goes on.

    As for you're on the job training, you just need a supervisor to "make a record" of the training. We use a checklist for all new employees. We go over all the details, sign and file the sheet. For your line worker the most important customer requirements are probably on-time and no defects. Hasn't been a problem.

    Good luck.
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That might fool an auditor, but it isn't what the requirement is about. It's supposed to be:

    1) competency requirements > 2) demonstration > 3) training (when 1) cannot be demonstrated)
     
  9. Golfman25

    Golfman25 Well-Known Member

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    Actually the whole thing is about fooling the auditors, so you can move on the bigger and better things. The issue in the OP case wasn't about competency. The employee was probably more than capable of running the equipment he was running. He just couldn't answer what the "customer requirements" are or what are the "consequences of non-conformance." Normal, lunch bucket, people don't talk that way.
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    You know better than that. This forum is about helping people and IATF is about getting good product to customers. Please don't post things which others, who may NOT understand your cynicism, take for accurate guidance on implementing the requirements correctly.
     
  11. Ambrose

    Ambrose Member

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    Hello Everyone,

    We just concluded our IATF 16949:2016 certification audit about 2 weeks ago with resulted to 2 Major and 9 Minor Findings, as follows.

    1. The process to control the distribution of documents is not fully effective. 7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable:
    a) distribution, access, retrieval and use;
    2. The process to assure Internal auditor competence is not fully effective. 7.2.3 Quality management system auditors shall be able to demonstrate the following minimum competencies.
    3. The process to handle goods packed on the uppermost racks is not fully effective. 7.1.3 The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.
    4. The process to receive goods sent for plating (outsourced) is not fully effective. 8.6.4 The organization shall have a process to ensure the quality of externally provided processes, products, and services utilizing one or more of the following methods:
    b) receiving inspection and/or testing, such as sampling based on performance;
    5. The process to assess and document CSR affecting the QMS scope is not fully effective. 4.3.2 Customer-specific requirements shall be evaluated and included in the scope of the organization’s QMS.
    6. The process to perform management review is not effective. 9.3.1 Top management shall review the organization’s QMS, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization. 9.3.2.1 Input to management review shall include: l) summary results of measurements at specified stages during the design and development of products and processes, as applicable.
    7. The process to identify scrap material is not fully effective. 8.7.2 The organization shall retain documented information that: a) describes the nonconformity; b) describes the actions taken;
    8. The process to complete the final inspection prior to despatch for surface treatment is not fully effective. 8.6.1 The organization shall ensure that the planned arrangements to verify that the product and service requirements have been met encompass the control plan and are documented as specified in the control plan (see Annex A).
    10. The process to transfer special characteristic symbols between drawings and process control documents is not effective. 8.3.3.3 a) documentation of special characteristics in the product and/or manufacturing documents drawings (as required), relevant risk analysis (such as Process FMEA), control plans, and standard work / operator instructions; special characteristics are identified with specific markings. The management of replacement spares for machines & tooling is not fully effective. 8.5.1.5 The organization shall develop, implement, and maintain a documented total productive maintenance system. At a minimum, the system shall include the following: b) availability of replacement parts for the equipment identified in item a);
    11. The process to drive improvement is not fully effective. 5.1.1.2 Top management shall review the (SI-12 June 2018) effectiveness and efficiency of the quality management system to evaluate and improve the quality management system.
     
  12. Ambrose

    Ambrose Member

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    Any assistance in this regard will be highly appreciated.
     
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome!

    We can give you some very good advice. Are these the actual texts from the non-conformities? I don't see any reference to evidence the auditor used to demonstrate the non-conformities. Do you have any to share?
     
  14. Ambrose

    Ambrose Member

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    Here are references to evidence as per your request.

    FOR-036 Issued Doc Register has the various documents recorded, however when duplicate copies are necessary (such as for the Quality Policy, WOR-054) the system does not record the number printed and issued. Retrieval will be haphazard with the current system.
    The system to manage Internal Auditor competence does not clearly depict the competence criteria and a road map to ensure competence and continued improvement (Job description 010).
    PE Warehouses - Goods packed on the uppermost racks are removed by persons standing on a pallet on forklift, this poses a safety risk.
    Germiston Warehouses - Goods packed on the higher shelves are removed by persons alighting a moveable step ladder. This poses a safety risk considering box weights.
    1) There is no record of the receiving inspection of plated parts.
    2) QCP-PE RL rev 00 dd 16-01-2020 - The control plan for PE warehouse does not define the processes related to outsourcing (plating of product).
    Isuzu & Tenneco have specific requirements related to manufacturing process design, however this entire clause of IATF has been omitted from the CSR matrix. Isuzu – has documented additional CSR related to 8.3.3.3; 8.3.4.4; 8.3.5.2; 8.3.6.1 of IATF and Tenneco has documented specific (4.2 to 4.3.1) related process design.
    1) Summary of results although discussed is not supported by actual status (summarised project data).
    2) The process to attend to listed improvement actions is not formalised as an agenda item within any of the current meeting routines. (Listed improvement actions for HR - item 2 targeted for completion by 30 Nov has not been addressed).
    Although labelled with red scrap tag, the reason code was not identified on the red tag (tag dated 22/1/2020).
    Refer to Tray / Route card W121587 dated 19/6/2019, the associated Attribute sheets were not fully completed for attributes such as “burrs”, “crack” etc.
    1. Safety critical parts (Inverted Delta characteristics) appears on the drawing, however these symbols are not transferred to PFMEA-05 or QCP-Control plan-05.
    2. SC symbols noted on the PFMEA line item 4, does not appear on the CP line item 4.
    1. The critical spares list for machines shows minimum levels as 0 and the consumption of spares is not recorded to ensure reordering and availability.
    2. Tool T6EG7190H shows 0 stock at present, no evidence of reordering could be demonstrated following the submission of the previous months "Daily tool issue control sheet" where stock level of 1 was reflected.
    "Objectives and Targets scorecard" depicts the organization process performance against targets.
    1) The system does not lend itself to "Trend identification for Key indices".
    2) The system does not always contain the "Process Owners" plans to improve under-performance (RED averages).
     
  15. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Was there any evidence of "haphazard" retrieval? If not, reject the nc.
    Who was unclear? The auditor or your personnel? Do you have competencies defined for internal auditors and the necessary actions necessary to achieve competency? If yes, reject the nc.
    This isn't a safety (ISO 45001) audit! Reject the nc as the auditor may NOT be qualified to comment on "safety".
    Do plated parts have to be inspected? What does the plan say? If they don't have to, reject the nc.

    (Based on the rest I would also add what your internal audit program is looking at. These seem very basic and are the type of nc which could have been identified by internal auditors.)
     
    Last edited: Feb 10, 2020
  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Your original post only has 10 nc statements, and one appears to be missing (#9?)
     
  17. Ambrose

    Ambrose Member

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    Hi
    this is supposed to be no:9 The management of replacement spares for machines & tooling is not fully effective. 8.5.1.5 The organization shall develop, implement, and maintain a documented total productive maintenance system. At a minimum, the system shall include the following: b) availability of replacement parts for the equipment identified in item a);
     
  18. Ambrose

    Ambrose Member

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    What I can say the Auditor wanted evidence that there is continual program to improve internal Auditors competency, We have since introduced Internal Auditors competency matrix and made as input into our training plan,
     
  19. Ambrose

    Ambrose Member

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    On safety I assume he used statutory and regulatory requirements as source of the finding
     
  20. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Which means the auditor is out of scope - those are for PRODUCT...
     

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