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How to implement 820.20 (d) “ Quality planning“?

Discussion in 'Medical Devices (21 CFR Part 820)' started by Daliane, Feb 8, 2016.

  1. Daliane

    Daliane Member

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    Hello everyone,

    21 CFR 820.20 (d) "Quality planning" requires a quality plan to ensure quality requirements.

    Since we (a German OEM) follow ISO 9001 and ISO 13485 we have already established a quality manual which includes also quality policy, responsibility of management representative etc.

    The quality policy descibes (in 1-2 sentences) how the quality aim is going to be achived.

    Is this enough to meet requirements with 820.20 (d) or does the quality plan have to be customized to every product?

    Would appreciate some information how other companies implement a quality plan to meet this requirements

    Thanks
     
  2. Ronen E

    Ronen E Well-Known Member

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    Hi,

    21 CFR 820.20(d):

    "Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met."


    The QSR (part 820) doesn't have a "Quality Manual" in its terminology. The "Quality Plan", however, is similar in contents and intent. The quality manual, as well as the FDA's quality plan, is supposed to encompass your entire QMS; since it's less practical to include everything in a single document, most do it via references from the manual. The components integrated in the quality manual (e.g. Quality policy, quality objectives etc.) are important, but in the current context the references to documents that cover practices, resources, activities and all the other "how-to" (e.g. SOPs etc.) are even more important. Provided that your quality manual is indeed structured this way, it can serve as the FDA-required quality plan, too. You may even spell it out in the manual, to avoid any confusion.

    The preamble for the 1996 (initial) publication of the QSR read:

    "54. Some comments suggested that the requirements in § 820.186(a) and (d) be moved to § 820.20 for clarity and to better align with the structure of ISO 9001:1994 and ISO/CD 13485. FDA agrees and has moved the specific requirements from § 820.186 and rewritten them into new § 820.20 (d) and (e) for clarity, better organization, and closer harmonization. Therefore, § 820.20(d) is consistent with ISO 9001:1994, section 4.2.3, "Quality planning", and § 820.20(e) is consistent with ISO 9001:1994, sections 4.2.1, "General", and 4.2.2, "Quality-system procedures". Section 820.20(e) discusses "[a]n outline of the structure of the documentation used in the quality system". FDA believes that outlining the structure of the documentation is beneficial and, at times, may be critical to the effective operation of the quality system. FDA recognizes, however, that it may not be necessary to create an outline in all cases. For example, it may not be necessary for smaller manufacturers and manufacturers of less complicated devices. Thus, the outline is only required where appropriate."

    The above indicates that section 820.20(d) was initially created to facilitate closer harmonisation with ISO ISO 13485 (the then-current revision), among other reasons. This was suggested, at the time, by GHTF (IMDRF predecessor). In my opinion, if you meet ISO 13485:2003 you are likely to be just fine in regard to 820.20(d).

    Cheers,
    Ronen.
     
    esalsan likes this.
  3. Daliane

    Daliane Member

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    Thank you, Ronen!
     

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