Regulatory Open Forum

 View Only

  • 1.  DHF and Design outputs

    This message was posted by a user wishing to remain anonymous
    Posted 28-Mar-2019 09:58
    This message was posted by a user wishing to remain anonymous

    Hi everyone,

    Are Design Outputs part of the DMR?  If not, where do they live in the DHF?  I understand they are drawing, production protocols etc. To me, they are part of the DMR, not part of the design process. If so, why does DHF specifically call out Design Outputs? Is this a document that records the list of design outputs?  

    Thanks!


  • 2.  RE: DHF and Design outputs

    Posted 28-Mar-2019 12:04
    Edited by Kevin Randall 28-Mar-2019 12:04
    ​

    Remember that for FDA-regulated firms, design output is formally defined in 21 CFR 820.3(g) as, "…the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record…" [Emphasis added by ComplianceAcuity].  This definition is also compatible with the corresponding requirements in ISO 13485:2016 clause 7.3.4.

     
    Here are some pointers to help derive, manage, and maintain design outputs relative to the DMR and DHF:

     
    A. The realization of design outputs is an iterative effort done as follows:
     

    1. Translate design inputs into final engineering specifications and solutions comprehensively meeting all of the targeted parameters and characteristics itemized in the design inputs.
    2. Define and document design output in objective terms allowing an adequate evaluation of conformance to design input requirements. Do this by defining design outputs in objective, tangible terms, and by using a trace matrix (see step B. below).
    3. Make reference to acceptance criteria. (Note: The acceptance criteria and test methods for the final design output are ultimately established and vetted during design verification and thereafter translated into the final Device Master Record in the form of final product, labeling, packaging, and process specifications.)
    4. Identify and distinguish the design outputs that are essential for the proper functioning of the device (i.e., those that will ultimately make up the Device Master Record, as well as those derived from the risk-control design inputs conceived via risk analysis to mitigate unacceptable risk).
    5. Document and approve probationary design output as needed (prior to final verification/validation) via AR (Advance Release) numeric revisions.
    6. Initiate trial builds as necessary to adjust the product or process design, test equipment, facilities, etc., as needed to meet design input requirements.
    7. Progressively update AR versions of design outputs as the design evolves toward the final design alpha-rev outputs and final/release.

    B. Ultimately, ensure that design outputs in all cases include backward traceability to the originating design inputs, and forward to corresponding verification and validation. Accomplish this by recording the design outputs in the 'Output' column of a trace matrix.

    C. Finally, be sure to include or reference the design outputs in the DHF by way of the trace matrix and also the DHF indexes created per your DHF procedures.
     

     

    Hope this helps,

     



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    © Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 3.  RE: DHF and Design outputs

    Posted 29-Mar-2019 08:22
    Actually the Device Master Record (DMR) is an output of the design control process.  The DMR should live "on its own" as part of the quality management system.  The drawings, component specifications, instruction, QC test procedures that are established out of the design control process become the DMR.  Inputs into the DMR are the outputs of the design process.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: DHF and Design outputs

    This message was posted by a user wishing to remain anonymous
    Posted 29-Mar-2019 10:32
    This message was posted by a user wishing to remain anonymous

    Thanks so much.
    Original Message


  • 5.  RE: DHF and Design outputs

    Posted 01-Apr-2019 14:24
    Edited by Kevin Randall 01-Apr-2019 14:34
    ​

    Remember that the DMR is intrinsically linked to the design control process. The DMR is by formal definition a design output (see my preceding comment).  It unequivocally lives and breathes in direct relationship to the design control process.  A properly-maintained DMR never becomes decoupled from the design control process.  Indeed, decoupling the DMR and the design control process is a certain recipe for an FDA 483.

     

    As the product life-cycle evolves and DMR changes are needed, they by regulation are not allowed to happen apart from the design change requirements of the design control process. Even more eye-opening is that, if there is ever a change to design outputs (and thus the DMR), then it must always be paired with corresponding design verification and perhaps also design validation.  Oftentimes, this in addition means there was a change in the underlying design inputs.

     

    Another way to say all this is that if there is ever a change to the DMR, then it inherently means there was a "design change".  That is the reason FDA doesn't permit us to maintain the DMR independent of the design control process.  The associated use of a general (e.g., 21 CFR 820.40) document control process may create the impression that this is independent of 820.30 design controls; however, that is not the intent of the design control and DMR regulations.

     

    For example, FDA has stated that "…Post-production design changes [which would include DMR changes] require the firm to loop back into the design controls of Section 820.30 of the regulation…[Emphasis added by ComplianceAcuity].  Similarly, FDA has also clarified that, "…The design change control section is linked to and is redundant with Section 820.70(b) Production and process changes of the regulation…" [though this particular citation focuses solely on the manufacturing section(s) of the DMR].  For additional insights about design changes and thus how the DMR must be maintained in direct correlation with design controls, visit the prior Forum discussion here:

     

    https://connect.raps.org/communities/community-home/digestviewer/viewthread?GroupId=97&MessageKey=f35899b1-b1ef-4655-bbf3-75281029e8f9&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer&SuccessMsg=Thank you for submitting your message.#bmf35899b1-b1ef-4655-bbf3-75281029e8f9

     

    If you are careful to assure that your DMRs don't wander away from the design control mechanism, then you'll more easily avoid consequent DMR nonconformities and regulatory citations.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    © Copyright 2019 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


Related Content