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Change Control System in QMS

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by TomJones, Dec 26, 2020.

  1. TomJones

    TomJones New Member

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    I'm fairly new in ceating a QMS and I have been tasked to improved our change control system. I have used QCBD software in the past and have had no issues opening a change order, determining the risk level from FMEA's, knowing what documents needing changes, if a validation is required, implementing tasks, uploading redlines and sending out the approvals through document control.

    I used the design risk assessment for critical changes under 510 (k) 2017 and presented this checklist but the TEAM felt it was good for design changes only for new products. Our system is all paper based until the final version of a document is loaded in Master Control and group training is signed off.

    The issue at hand is changes are being requested all the time, change order request forms are being filled out and process change order numbers are being given out on the PCR form with missing tasks for the implementation plan. Forms aren't being fully filled out and activities are begining.

    I'm responsible to get the change control process under control and was asked to create a decision tree that is super high level where the employee won't misinterpret the questions to go to the yes/no section of the decision tree and they will know if an SOP is required, a document needs updating, a validation is required and I need to set up whether it is a minor, major or critical risk. Currently we don't have FMEA's so I'll take any advice please. The decision tree is the largest task at hand per bosses request. Thanks!
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Can I check that your organization's QMS is ISO 9001:2015 compliant and not ISO 13485 (since you mentioned 510K)?
     
  3. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Hello TomJones, welcome to QFO!

    Do I correctly understand you are making medical devices? If so, I did not see what type(s) of device(s) you produce. The FDA has published guidance that I hope will help: Is a new 510(k) required for a modification to the device?

    There are also a number of risk assessment matrixes that address likelihood and consequence while a decision tree addresses is/is not. In my view the risk matrix will likely serve you for risk evaluation better than the decision tree.

    There may not be a clear requirement to use FMEA (unless your customer says you must - is that the case?), but I wonder how you otherwise identify, evaluate, prioritize, make plans to address then assess the results of post-action risks in product design?

    Are you selling in the European Union? If so, EU MDR requirements apply and could guide you in what's needed to control changes. It is absolutely important to control design changes.

    I will leave you with these points for now. I hope this helps!

    I have no affiliation with Wipro or Oriel.
     
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  4. TomJones

    TomJones New Member

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    We are a tissue bank where tissue products are classified as Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/Ps), which are regulated solely under Section 361 of the Public Health Service (PHS) Act. FDA's regulations, 21 C.F.R. Part 1271, set out the criteria that a tissue product must meet in order to be marketed without prior approval or clearance from FDA. We also follow the American Association of Tissue Banks Standards for Tissue Banking (14th Ed.) that includes subsystems for each mandatory core element. We have critical design control taken care of treated as a critical change. I'm trying to make a yes/no decision tree for the employees that drives no misinterpretation before for the change review board meetings. I've been asked to come up with a decision tree that would point to using a document change request (minor change) vs a change order (major change) listing an implementation plan vs. a (critical design change) 510 (k) 2017. I have no choice and have to create a yes/no decision tree. We have a very good QMS system, we want to add to it a yes/no decision tree as a job aid with very high level questions for example, is it a material change (yes/no) or is it a design change (yes/no), is it a change to the equipment (yes/no), is it a change to the process (yes/no), is it a change to a test method (yes/no), is it a change to a work instruction (yes/no) and from these high level questions they will drill down deeper until it points you to a document change which will still need a change order with no implementation plan, a change order with an implementation plan or a change order listed as critical with an implementation plan with project review meetings.
     

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