Question about FDA 21 CFR Part 820.90 Nonconforming Product

A

andy.yuan

#1
Dear friends,
I'm very puzzled about the setcion 820.90 of FDA 21CFR QSR820, Do you have a full understading about this section that could share with me?
I have several questions as below:
1: "The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented"
Question: for the lot rejected or high reejct rate, we should evaluate and then investigate, however, tf there is only 1-2 PCS rejected products from production line or parts from receiving inspection, shall we evluate and have of the need for an investigation and then keep the evaluate record as the documented? this is impractical, we don't have the evaluation record for these 1-2PCS , how do I understand this section and how to do?
2: (b) Nonconformity review and disposition.Disposition of nonconforming product shall be documented
Question: disposition for Each Nonconformity product or part should be documented? How do I document the 1-2 PCS and other scattered rejects ( such as 1-2 PCS rejects but the whole lot accepted by AQL in receiving inspection?
3: The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance.
Question: how to understand this sentence? Does it mean we should review the nonconformance first and then decide whether we need to the corrective action as CAPA?
I really apprecite your help and explanation in advance!
Thanks a lot
Andy
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
Dear friends,
I'm very puzzled about the setcion 820.90 of FDA 21CFR QSR820, Do you have a full understading about this section that could share with me?
I have several questions as below:
1: "The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented"
Question: for the lot rejected or high reejct rate, we should evaluate and then investigate, however, tf there is only 1-2 PCS rejected products from production line or parts from receiving inspection, shall we evluate and have of the need for an investigation and then keep the evaluate record as the documented? this is impractical, we don't have the evaluation record for these 1-2PCS , how do I understand this section and how to do?
2: (b) Nonconformity review and disposition.Disposition of nonconforming product shall be documented
Question: disposition for Each Nonconformity product or part should be documented? How do I document the 1-2 PCS and other scattered rejects ( such as 1-2 PCS rejects but the whole lot accepted by AQL in receiving inspection?
3: The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance.
Question: how to understand this sentence? Does it mean we should review the nonconformance first and then decide whether we need to the corrective action as CAPA?
I really apprecite your help and explanation in advance!
Thanks a lot
Andy
§ 820.90 Nonconforming product.
(a) Control of nonconforming product.
Each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented.
(b) Nonconformity review and disposition.
(1) Each manufacturer shall establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product. The procedures shall set forth the review and disposition process. Disposition of nonconforming product shall be documented. Documentation shall include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use.
(2) Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR.
The preamble to the 1996 initial publication of part 820 in the federal register includes the following:
I. Nonconforming Product (Subpart I)
(...)
155. ... Several written comments ... stated that § 820.90(a) should be written so that it is not interpreted to require investigations for every nonconformance. ... One comment stated that the requirement that persons responsible for nonconforming product be ‘‘notified’’ should be deleted because it is overly burdensome and not needed in all cases. ... FDA has also added the requirement that the procedures provide for the ‘‘evaluation’’ of nonconforming product because evaluation is key to protecting against recurring nonconformance. ... Second, the procedures shall ‘‘address the identification, documentation, evaluation, segregation, and disposition of nonconforming product,’’ which gives the manufacturers the flexibility to define how they are going to ‘‘control’’ products that are nonconforming. Third, the evaluation process addressed in the procedure ‘‘shall include a determination of the need for an investigation.’’ Therefore, the procedures will need to set forth the manufacturer’s SOP on when investigations will take place and provisions for trending and/or monitoring the situation in the future. Fourth, FDA added ‘‘The evaluation and any investigation shall be documented,’’ which would include the explanations for not performing investigations and how nonconformances will be trended and/or monitored. ... FDA disagrees that the notification requirement should be deleted. Where some person or organization is responsible for nonconformances, they must be notified to ensure that future nonconformances are prevented. ...
More guidance on nonconforming product can be found at:

http :// www .fda. gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122653.htm#nonconformaing product - DEAD (404) LINK DELINKED
 
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Ronen E

Problem Solver
Staff member
Moderator
#4
To further address your questions --

Question: for the lot rejected or high reejct rate, we should evaluate and then investigate, however, tf there is only 1-2 PCS rejected products from production line or parts from receiving inspection, shall we evluate and have of the need for an investigation and then keep the evaluate record as the documented?
You should have documented evidence of an evaluation process, compliant with your established procedures, that took place, with a possible determination that no further investigation is required.

Question: disposition for Each Nonconformity product or part should be documented? How do I document the 1-2 PCS and other scattered rejects ( such as 1-2 PCS rejects but the whole lot accepted by AQL in receiving inspection?
These are 2 separate issues. You should be documenting any units actually found to be nonconforming (regardless of number), and the justified disposition of such units. If you decide to pass/fail a whole lot based on statistical considerations (sampling, AQL etc.) that is a separate issue; such approach a-priori accepts the possibility that some non-conforming units will be released to the market, with the general justification that under a certain percentage (AQL) this would still be acceptable.

Question: how to understand this sentence? Does it mean we should review the nonconformance first and then decide whether we need to the corrective action as CAPA?
It means that first you evaluate and decide whether further investigation and/or notification is required; then you document your evaluation; then you investigate and/or notify (or none at all), according to the documented evaluation results.
 
A

andy.yuan

#5
Hi Ronen
Thanks a lot ! I really appreciate your reply for my answer, I have more questions in Blue

To further address your questions --


You should have documented evidence of an evaluation process, compliant with your established procedures, that took place, with a possible determination that no further investigation is required.
Andy: How I document the evidence 1-2 PCS and other scatter nonconforming parts/products? for example, if there is 1 or 5 PCS rejects found by operator, and IPQC will double check and then stick a reject lable on it , it will be scraped or reworked directly, where I can write down this evaluation/judgement process as the documented evidence? what's the meaning of documented evidence? is it the evluation or judgement record?

These are 2 separate issues. You should be documenting any units actually found to be nonconforming (regardless of number), and the justified disposition of such units. If you decide to pass/fail a whole lot based on statistical considerations (sampling, AQL etc.) that is a separate issue; such approach a-priori accepts the possibility that some non-conforming units will be released to the market, with the general justification that under a certain percentage (AQL) this would still be acceptable.
Andy: Do you mean I should have the record for each nonconforming product/part and disposition record for each one? Usually we have the record if there is the high reject rate or the lot is rejected in IQC or OQC, but we don't have the evaluation record for some scatter nonconforming products/parts, I don't how to doument each nonconroming, could you explain more details to me?

It means that first you evaluate and decide whether further investigation and/or notification is required; then you document your evaluation; then you investigate and/or notify (or none at all), according to the documented evaluation results.
Andy: Do you mean I must have the record for the evaluation/judgement and this is also investigation and notification conclusion on the evaluation record for each nonconforming? I'm not very clear about the meaning of "evaluation" if the evaluation/judgement and investigation and notification conclusion record is needed, there will need a form, but I don't know how to desin the form, it seems very complex for daily operation, do you have an example form or procedure?

Besides, I want to know do we need the review such as MRB review for each nonconforming even there is only 1 or 5PCS? but QSR required the review for the nonconforming prouct, does it mean for each nonconforming or just for the decison of use the nonconforming product? how do we understand the meaning of "review"
Usually the scatter nonconforming is judged by IPQC or IQC inspector, they evaluate the defect and give the decision for disposition (rework, scrape,etc.) exclude the concession approval for nonconforming, it's complex if we use the MRB to reveiw each nonconforming.

I'm sorry to take your time for so many questions, thanks again.
Regards,
Andy
 
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Ronen E

Problem Solver
Staff member
Moderator
#6
Hi,

It's a bit difficult to give spot-on answers with knowing so little about your product and operations. Obviously I can only provide broad-brush answers that may fit many cases, but not all. Only someone on-site, with intimate acquaintance, can tailor procedures that are regulation compliant, practical and economically appropriate. I recommend getting an outside expert help on-site, if knowledge is lacking in the organization.

From your "music" I get that you are dealing with mass production, low-value units, production around the clock and relatively-low-competence operators attending the line. Is that so? I'll try to further answer your questions assuming it is the case. If otherwise, my answers may be N/A.

Andy: Do you mean I must have the record for the evaluation/judgement and this is also investigation and notification conclusion on the evaluation record for each nonconforming? I'm not very clear about the meaning of "evaluation" if the evaluation/judgement and investigation and notification conclusion record is needed, there will need a form, but I don't know how to desin the form, it seems very complex for daily operation, do you have an example form or procedure?
Yes, you will need a record. You don't necessarily need a separate form for each nonconforming unit; you can design a form that can accommodate multiple items (e.g. one form per lot etc.). If filling a form is too complex for line-attending personnel, you could hold the nonconforming items in quarantine, and periodically have some higher level personnel fill the form at regular intervals (say, shift end etc.). In this case you would need to make sure all essential details are captured in real time and the units are properly identified and segregated, to allow off-line documentation. For designing the form (and more important, the segregation and evaluation process) maybe look for some external help. I don't have a particular form to provide, but there may be some suitable one on the Elsmar free resources depot, or elsewhere on the web.

The term "judgement" does not appear in the regulation. "Evaluation" does include a judgement component, because someone would have to make a call on whether or not an investigation and/or notification is required. It doesn't mean this would be purely subjective; your SOP could (and probably should) provide guidelines on how / by what to make such calls.

Besides, I want to know do we need the review such as MRB review for each nonconforming even there is only 1 or 5PCS? but QSR required the review for the nonconforming prouct, does it mean for each nonconforming or just for the decison of use the nonconforming product? how do we understand the meaning of "review".
My interpretation of this "review" requirement is the consideration of all available relevant information -- such as non-conformance details, any subsequent investigation results, trending analysis results, commercial and operational considerations, any risk evaluation taken etc. -- for the purpose of making an informed and responsible disposition decision.

Such review (e.g. by MRB) could, and probably should, take place off-line by qualified personnel, when enough information and analysis is available. It could be done on a lot basis rather than for each and every single item, with consideration of the various types of non-conformities, their relative frequencies and other info specific for each failure mode. The only evaluation and decision that would need to take place rather quickly (though not necessarily on-line) is the one concerning the need for further investigation and notification. Final disposition could come as a separate, later stage.

Usually the scatter nonconforming is judged by IPQC or IQC inspector, they evaluate the defect and give the decision for disposition (rework, scrape,etc.) exclude the concession approval for nonconforming, it's complex if we use the MRB to reveiw each nonconforming.
The regulation does not call for a "MRB". A qualified inspector could be all you need (only you know), nevertheless, the documentation requirements would apply nonetheless: "Disposition of nonconforming product shall be documented. Documentation shall include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use."
 
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A

andy.yuan

#7
Hi Ronen,
Thanks very much for your reply, I'm working for a US. medical device OEM company and responsible for the quality system, we provide some injection parts, cables or assemble some devices to our customers, for some injection parts, they are mass production, but for device assembly, the production volume is too much.( 50-200 units/month)
I found we have some problems for the nonconforming control and management, I want to improve this so that I have so many questions.
I have uploaded Nonconforming Product Disposition Report in attached which we are using currently, the process is as below:
Step 1: IQC, IPQC or production people, if any of them find the Nonconforming products/parts/material, they fill this report immeidately, in regardless of the number of Nonconformity
Step 2: Purchasing, production, engineering, and quality to review the Nonconforming, and give their disposition and corrective suggestions.
Step 3: Our deputy general manger to make the final decision, he choose the dispostion option for the nonconformity.
Step 4: This report will be copied to related department and implement as the final dispostion decision on this report.
It seems this process is profect, but there are several problems:
1: Every time, when IPQC finds the high rejects in process inspection, he reports the nonconformity by this report, but usually, there is only disposition of " rework" or " Concession release/acceptance", there is no corretive action, nobody to investigate the root cause and improve, this is very bad.
2: Usually, this report is submited for some nonconforming products but not for all, that means we don't have the record for some scatter nonconforming products/parts, they are identified, reworked or scraped without any record, if each nonconforming product need a record for evaluation and disposition, this report is not suitable because it just can record one kind of products or parts each time ( there is the part number)
That's why I really want to how do document/record the evaluation and dispositon for each nonconforming product even 1PCS.
3: The reveiw process is long, it needs the comments for 4 departments and also the deputy general manger's decision, it's too long which wastes a lot of time.
4: Based on my experience, if IPQC or production people they found the high rejects and confirmed, they should send out a corrective&Preventive action report immediately, and quality or engineeing dept. should give containment action subsequently, and then the responbile dept. should give the corrective and preventive action, but we are very different, IPQC found the nonconformity, we spend a lot of time to reveiw the nonconformity and dispostion actions, but no corrective&preventive action, even it needs corrective&preventive actions, the IPQC should re-write a new report (CAPA) and repeat to write the nonconforming information, this is also not reasonable.
I think there is a big problem for the process and this report, so I asked so many questions, do you have more suggestions for our process and report? I need a process that doesn't only meet the FDA QSR requirements but also adapts to our company.
I really appreciate your help.
Thanks again.
Regards,
Andy
 

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