What kind of quality plan is required for FDA QSR?

820.20(d) Quality Planning - Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevent to devices that are designed and manufactured. The manfucturer shall establish how the requirements for quality will be met.

I have a book that states that the Quality Planning document is a general, high level document that desribes the manufacturer's plans for implementing its quality system in general, including a description of the plans to meet cGMP req's, structure and interrelationships among personnel, responsibilities, long and short term objectives. That sounds like our quality manual!

Can our Quality Manual satisfy the FDA Quality Planning Document? :cfingers:

Thanks for any light shed on this!

Seek and ye shall find! I think I just found the answer to my own question from the QSIT guide:

Quality Plans
The firm must have a written quality plan that defines the
quality practices, resources and activities relevant to the
devices that are being designed and manufactured at that
facility. The manufacturer needs to have written procedures
that describe how they intend to meet their quality requirements.

For firms that manufacture devices as well as other products,
there must be a quality plan that is specifically relevant
to devices. Much of what is required to be part of the
plan may be found in the firm's quality system documentation,
such as, the Quality Manual, Device Master Record(s),
production procedures, etc. Therefore, the plan itself may
be a roadmap of the firm's quality system. The plan in this
case would need to include reference to applicable quality
system documents and how those documents apply to the
device(s) that is the subject of the plan.

Quality plans may be specific to one device or be generic
to all devices manufactured at the firm. Quality plans can
also be specific to processes or overall systems.
http://www.fda.gov/ora/inspect_ref/igs/qsit/QSITGUIDE.PDF

Does anyone having anything else to add?

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