Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Responsibilities under ISO 9001

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Matt B, Apr 8, 2019.

  1. Matt B

    Matt B New Member

    Joined:
    Apr 7, 2019
    Messages:
    3
    Likes Received:
    1
    Trophy Points:
    2
    Guys, I am not fluent in ISO 9001, I am hoping someone here can point me in the right direction.

    Please consider this scenario: an organization that has ISO 9001 certification, but who does not adhere to the most basic requirements of the design and development process (somehow, it passes the external audit every year, but that is not the issue at hand). In the latest development, the company has re-written the matrix of responsibilities. In this new format, the "ownership" of the design and development process was taken from the R&D manager and given to one of the project managers working on new product developments. If you were to believe the guy, this was only done only to pass the responsibility for a dysfunctional process to someone else.

    My questions are these: does ISO 9001 allow assigning responsibilities to someone without the authority to influence the process? (what would stop someone to pass responsibility to the new summer student?)

    When all said and done, shouldn't the accountability for process compliance still be borne by someone in the management team? (R&D manager or Quality manager?)

    Any suggestions of what is the best way for this guy to protect himself from being the scapegoat should something hit the fan?

    On a somewhat related topic, how could ISO 9001 prevent instances when the process is changed very often (yearly), just to claim that any non-conformity found is due to the "new" process being implemented?

    I'd appreciate any relevant advice you could provide.

    Regards,
    Matt
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    2,760
    Likes Received:
    1,420
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    Sorry to learn of this dilemma, Matt. Sad to say, ISO 9001 doesn't care - except to say that whatever happens must be effective. It may take time, but the ineffectiveness of this reassignment may work out to be obvious to everyone. Fire your CB, in the meantime!
     
  3. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    906
    Likes Received:
    681
    Trophy Points:
    92
    Location:
    Laguna Philippines
    The standard doesn't prohibit. The person with the assigned responsibilities may not have the authority, but the one who appointed him/her has. I have a client before with a very young QMR but he's the COO (child of the owner).:)
    In ISO concepts, the authorities and responsibilities can be delegated but the accountability remains with the top management.
     
  4. John C. Abnet

    John C. Abnet Well-Known Member

    Joined:
    May 23, 2017
    Messages:
    258
    Likes Received:
    150
    Trophy Points:
    42
    Good day @Matt B and welcome to the QFO family.

    Your last comment is the one that raises the greatest concern with me. How/why is the ability to claim "...due to the new process being implemented" helpful?

    I infer from your statement that someone in your organization or the CB themselves, accepts nonconformances as long as this is the excuse. Am I understanding this correctly?

    Preventing change from causing a nonconformity is actually a quintessential example of the benefits of having a properly functioning QMS. Change is assumed. Change will always be. This is why the standard specifically has requirements such as 7.5 Documented Information" and 8.5.6 Control of Changes, etc..etc..etc..etc...

    Most of my experience has been in the world of automotive manufacturing. A frequently corrective action that the OEM's would regularly "dismember" should a supplier be foolish enough to submit it, was "the process failed because we had a new associate in the position" (change). Many of the OEM manufacturing facilities employ upwards of 3000 associates. Obviously at that level a "new associate" (change) is not only common, it is the norm. Rarely a day goes by when those OEM do not have a "'new associate" (change) . Obviously their intent is to make those changes seamless with no negative impact and they expect the same from their supply chain.

    A proper QMS is all about sustainability. Sustaining the corporate intent long after the associates that are in place today are replaced by the associates of tomorrow (change). Long after the processes of today are replaced by the processes of tomorrow (change).

    Change is inevitable. Control those changes to ensure that the changes are tracked and have no negative impact on the outputs. Using " change" as an excuse for a nonconformity is simply self deprecating...i.e. "we can not properly control changes".

    Something to consider.

    Be well.
     
  5. Matt B

    Matt B New Member

    Joined:
    Apr 7, 2019
    Messages:
    3
    Likes Received:
    1
    Trophy Points:
    2
    Thank you all for the feedback.
    Tony, any chance you could point me to a specific paragraph in ISO that discusses this requirement?

    John, it is a bit more elaborate than that, but you got the gist of it. You still take the hit if the auditor picks up on a non-conformance. But now you have a root cause - new process, have a corrective action - give someone the responsibility moving forward, and you have so many days to show evidence that the corrective measure has been implemented. All this instead of saying "we don't give two cents about the process". If I sound a little jaded, it's because I am.

    Thanks again for your support.

    Best,
    Matt
     
    John C. Abnet likes this.
  6. Richard Billings

    Richard Billings Active Member

    Joined:
    Apr 4, 2019
    Messages:
    59
    Likes Received:
    7
    Trophy Points:
    7
    If you have an organization chart whomever is designated as the senior manager for Design is accountable for the process - usually a Director or Senior Project Manager.
     
  7. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    906
    Likes Received:
    681
    Trophy Points:
    92
    Location:
    Laguna Philippines
    Statements on ISO standards with clarification on the concept re: accountability:
    ISO/TS 9002:2016 clause 5.1.1a - "top management making it clear that they understand and are accountable for the effectiveness of the quality management system by taking responsibility for its activities and by being able to explain the results that are achieved; although certain authorities and responsibilities (see ISO 9001:2015[28], 5.3) can be delegated, the accountability remains with top management"
    ISO 14001:2015 Annex A.3 - "The word “ensure” means the responsibility can be delegated, but not the accountability"
    ISO 45001:2018 Annex A.3e - "The word “ensure” means the responsibility can be delegated, but not the accountability to make sure that it is performed".​

    Not to mention the requirement in ISO 9001 clause 5.1.1a, which specifies "Top management shall demonstrate leadership and commitment with respect to the quality management system by... taking accountability for the effectiveness of the quality management system".
     
  8. tony s

    tony s Well-Known Member

    Joined:
    Sep 10, 2015
    Messages:
    906
    Likes Received:
    681
    Trophy Points:
    92
    Location:
    Laguna Philippines
    I don't think ISO 9001 can prevent any nonconformities against its requirements. If an organization keep on attributing the nonconformities with the "new" processes, CB auditors might slap a major nonconformity against 10.2 and/or 6.3.
     
    John C. Abnet likes this.
  9. Matt B

    Matt B New Member

    Joined:
    Apr 7, 2019
    Messages:
    3
    Likes Received:
    1
    Trophy Points:
    2
    This is gold, Tony. Thanks!
     

Share This Page