FDA Part 820 Clause 820.100 Corrective and Preventive Action

[pangchiaboon]

Dear Sir, i do not understand about FDA Part 820 Clause 820.100 Corrective and Preventive Action:

(1) Analyzing processes, work operations, concessions, quality
audit reports, quality records, service records, complaints,
returned product, and other sources of quality data to identify
existing and potential causes of nonconforming product, or
other quality problems. Appropriate statistical methodology
shall be employed where necessary to detect recurring quality
problems

Can you please give me some example on how to comply with "appropriate statistical methodology shall be employed where necessary to detect recurring quality problems" ? Thank you.

Pang Chia Boon

 

[MIREGMGR]

What USFDA is requiring here is that continuing statistical records be kept so as to create visibility of a repeating problem.

Let's say that you make a product in batches. The current batch has a few out-of-spec parts, but not enough to disqualify the batch, so you pass it.

Then the next batch has a few out-of-spec parts, but not enough to disqualify the batch, so you pass it.

Then the next batch has a few out-of-spec parts, but not enough to disqualify the batch, so you pass it.

What FDA wants is for you to have a system that clearly shows you that you have a continuing problem in your process, or whatever's being tracked. Or, conversely, those same statistics would show you, your management, or an auditor or FDA inspector that a subcritical issue in a particular batch was unique to that batch and not part of a continuing pattern.

Such a tracking system of course also will show when a continuing problem has been fixed, because the %-of-out-of-spec-parts curve will show an improvement at the point in time when the fix was implemented. This is your means of proving that your CAPA system works.

Of course, in a more complex setting, for instance with many factors being tracked, more complex statistical analysis is needed; thus FDA's wording. The basic concept however is the key.

 

[bio_subbu]

Dear Sir, i do not understand about FDA Part 820 Clause 820.100 Corrective and Preventive Action:

(1) Analyzing processes, work operations, concessions, quality
audit reports, quality records, service records, complaints,
returned product, and other sources of quality data to identify
existing and potential causes of nonconforming product, or
other quality problems. Appropriate statistical methodology
shall be employed where necessary to detect recurring quality
problems

Can you please give me some example on how to comply with "appropriate statistical methodology shall be employed where necessary to detect recurring quality problems" ? Thank you.

Pang Chia Boon

Hi Pang Chia Boon

FDA QSR (Quality System Regulation) Subpart J, section 21 CFR 820.100 refers to analysis of data sources to identify existing and potential causes of nonconforming product and other quality problems including customer complaints, returned product, servicing, post market surveillance, medical device reporting, corrections and removals. To detect recurring quality problems, the statistical methods should be used. You may want to use appropriate statistical technique/methods such like statistical process charts, Pareto analysis, design of experiments, histograms, and scatter plots and etc..

 

[MetrologKh]

Hi all!

I am wander if this requirements covers not only product quality but processes quality as well.
My question is - how can I use statistics to track minor process nonconformities? I need some technique to detect trends. And how can I reveal "recurring quality problems" in the mass of minor nonconformities?

I will be appreciate for any advices!