I am in the process of training new personnel on the FDA basics and would like to know if anyone is willing to share how they document Management Responsibility, section 820.20 d (quality planning). Some of them are stating that is what the quality manual is for but I never thought of it that way.

Thanks,
Bridget :tg:

I am in the process of training new personnel on the FDA basics and would like to know if anyone is willing to share how they document Management Responsibility, section 820.20 d (quality planning). Some of them are stating that is what the quality manual is for but I never thought of it that way.

Thanks,
Bridget :tg:


Most people do this as part of a regular management review after going over complaints, CAPA's, audit findings. The notes become the record of the review and everyone has a good idea as to where improvement is needed. I'm sure this has already been talked to death, so search the threads for further information.

:confused: Why are you worried about how to tell new employees about FDA basics of management review. Don't you already have a system in place for management review? Tell the people what you do.



L

I guess I did not ask my question correctly ( that happens once in a while)
Section 820.20d refers to quality planning and how do we have this "established" and "defined". My coworkers want to know how others define this. Is it shown through audits, mgmt review, car's to show compliance, is the best place in the quality manual or does it take separate procedure? Before I answer them I wanted to get feedback as to how others do it so I we can discuss it at our next meeting. There are others in the Cove that may interpet this differently than I have.
Bridget

I guess I did not ask my question correctly ( that happens once in a while)
Section 820.20d refers to quality planning and how do we have this "established" and "defined". My coworkers want to know how others define this. Is it shown through audits, mgmt review, car's to show compliance, is the best place in the quality manual or does it take separate procedure? Before I answer them I wanted to get feedback as to how others do it so I we can discuss it at our next meeting. There are others in the Cove that may interpet this differently than I have.
Bridget 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.

Al:
We are in transition to ISO13485 and I will be the first to admit it will be difficult for me, the second is top management who at first reading were totally at loss. I may have more questions on Monday, Have a great weekend

Thanks for the answer.
Bridget

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.In a regular manufacturing environment, organizations have used the term "Control Plan" to describe the process of assuring the finished product meets requirements. In the early years, folks sought "control" of quality through "detection" [of defects.] Gradually, folks came to understand the concept of "prevention" [of defects.]

Today, we speak in terms of "quality processes" and "quality plans" and the word "control" is rarely used outside the rarified air of Quality statisticians.

Ultimately, your Quality Plan should include all the "failsafe" things you do to ensure no faulty product reaches a consumer. The key is how you convince yourself and others the "failsafe" processes are effective.

This section (as do others in the QSR) use the word "establish". This means that there has to be an implemented written procedure, this procedure is followed, and that you document that you did what was contained in this procedure.

Additionally, for quality plans, they can be globally (i.e. one plan that is generic to all products manufactured) or specific to each product (i.e. individual plans).

What is contained in a quality plan (i.e. a roadmap of your quality system) is actually found in a company's quality system records.

Ways to show quality plans hav been established include approved quality plans, documented staff training (which include that they have read the plans and know that the plans exist), signs/cards noting the quality plans, adherence to the quality system, etc.

This section (as do others in the QSR) use the word "establish". This means that there has to be an implemented written procedure, this procedure is followed, and that you document that you did what was contained in this procedure.

Additionally, for quality plans, they can be globally (i.e. one plan that is generic to all products manufactured) or specific to each product (i.e. individual plans).

What is contained in a quality plan (i.e. a roadmap of your quality system) is actually found in a company's quality system records.

Ways to show quality plans hav been established include approved quality plans, documented staff training (which include that they have read the plans and know that the plans exist), signs/cards noting the quality plans, adherence to the quality system, etc.

Hi geochaz,

There is lot of enthusiasm on the "Quality Plans" as noted in 820.20.

Do you have an example that is acceptable by FDA ?

A quality plan can be your Quality Manual, product traveler/router and all procedures.

Great information - but still no example of an FDA "Quality Plan". Since FDA requires it, I assume every device manufacturer has one (we are just becoming one, so this is new to us). Would anyone be willing to share what they have actually in place to meet this requirement (redacted, of course)?:yes:

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:

Look at what the FDA QSIT Guide (http://elsmar.com/Forums/attachment.php?attachmentid=2418&d=1090851152) says about Quality Plans on page 22.

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:

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....