FDA Quality Plan - Document Management Responsibility, section 820.20 d

W

Watchwait

#11
Thanks Al! That's helpful. So does that mean you do not need a seperate document entitled "Quality Plan"? Or do you just mention this structure in the Quality System SOP, e.g. "The Quality Plan at XYZ Corp consists of the Quality Manual, the associated SOPs and Work Instructions"? Has anyone tried this route and has it passed muster??:agree1:
 
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W

Watchwait

#13
Thanks Al. This was actually the reference I was coming from. Still, I'd just love to see how others have "packaged" this requirement. The verbiage is such that the "evidence" of having met the Quality Plan requirement could be nearly anything relating to the appropriate elements. Thanks again.:thanx:
 
G

giz1007

#14
Thanks Al. This was actually the reference I was coming from. Still, I'd just love to see how others have "packaged" this requirement. The verbiage is such that the "evidence" of having met the Quality Plan requirement could be nearly anything relating to the appropriate elements. Thanks again.:thanx:
Hi Watchwait,

The Quality plan is different for each organisation. One Idea which I have shown to auditors in the past is to have a proposed plan of improvements with owners and time lines. The List of (QA system improvement) projects which will be conducted over the next 12 months that the company will supply resources too to develop and improve the quality system.

That clearly will satisfy the plan. Just make sure that updates and progress are clearly documented in the minutes / output from management review....
 
A

AZ Texas

#15
........Also look at ISO 90001:2000/ISO 13485:2003 7.1 Planning of product realization, note 1. The quality plan they are looking for is product specific, while your QA manual is general. Therefore, you would have a different plan for different products or product families.
All,
I would like to see a template of a "Product Spefic FDA approved Quality Plan"
Can someone share a blank Template? Thank you.
 
M

MIREGMGR

#16
I assume that you're starting from position zero in regard to both knowledge and systems-in-place. Thus I reckon this must seem to you like a simple, straightforward question. It sure looks complicated to me, though.

This FDA page provides a guideline for businesses needing info on what all they need to do to be compliant. Maybe that will be helpful.
 
M

maxenix

#17
Bridget:

Do you have documentation that describes product specific manufacturing processes, inspections and tests that are performed including the order and references to the procedures and instructions? If the answer is yes, then this is a quality plan. Also look at ISO 90001:2000/ISO 13485:2003 7.1 Planning of product realization, note 1. The quality plan they are looking for is product specific, while your QA manual is general. Therefore, you would have a different plan for different products or product families.
I agree. GMP do not require you must have a quality manual, but instead requires for quality plan, so quality plan have more interpretations than it in ISO13485 and ISO 9001, document defines the quality practices, resources,and activities relevant to general and specific device that are designed and manufactured can be referred as quality plan, so there your quality manual is general device quality plan, and if you have specific device that do not follow the quality manual, you must establish another one.

ISO13485 and ISO 9001 require you establish quality manual for general device, and not referred quality manual as quality plan, but interpreted quality plan as : a document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract. so if you have a specific device that not follow the quality manual, and you establish a document defines the quality practices, resources,and activities relevant to this specific device that are designed and manufactured ,this document can be called as quality plan in ISO13485 and ISO 9001.
 
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