21 CFR 820.20(d) says: Each manufacturer shall establish a Quality Plan

shimonv

shimonv

Trusted Information Resource
Hi everyone,

21 CFR 820.20(d) says:

(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 pharse "quality plan" is somewhat vague. Can you share from your experiences examples of what might constitute a quality plan in a mature company? and how to make sure businesses don't use it as a 'cover up' for a CAPA..

Thanks,
Shimon
 
shimonv

shimonv

Trusted Information Resource
Re: Quality plannning

Thanks Marcelo,
Can you give an examples for a quality plan? will you use this tool for process improvement or to address backlogs of sorts?

Shimon
 
Kronos147

Kronos147

Trusted Information Resource
Re: Quality plannning

Quality Plan:
Contract Review as per AS9100 8.2.2, 8.2.3
Production Planning as per AS9100 8.5
Inspection as per as per AS9100 9.1.1
Packing, preservation, and shipping as per AS9100 8.5.4


Add more detail (reference you procedures and processes) and that is a quality plan, in my book.
 
A

Access2hc

It's very similar to a business plan
just that it focuses on your quality objectives (hope you have them) instead of business objectives

hence you can have quality planning for the year, for 3 years, for 5 years, as appropriate to your organisation

it must have goals that are SMART, and hold individuals responsible and accountable (these could be quality or non-quality department people)

and reviewed as part of management review, how-ever frequent you define that

hope it helps.

Cheers,
Ee Bin
Access2hc
 
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