Internal Audit of Product Quality Complaint System (21 CFR Part 820)

Q

Quengineer

#1
Hi all, could anyone help me in doing na internal audit of product quality complaint system complaiant to 21 CFR Part 820. i am going to do the internal audit of my company's product quality complaint system next month and i need some material or maybe a checklist or a list of questions that can help me out in doing the audit in an optimum way. Any kind of correspondence will be much appreciated. Thank You
 
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J

JoShmo

#2
If it's an INTERNAL Audit your doing, then make your own checklist - it's more effective that way and you get to study the process and the regs so you know what to ask about. Using someones checklist isn't going to help. Put in the work to study the assignment and you:
Will have a much more effective audit
Will know more about what your asking
Won't look stupid asking questions that are wrong
Will build your credibility as an auditor
Will be welcomed back for the next audit.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
Hi all, could anyone help me in doing na internal audit of product quality complaint system compliant to 21 CFR Part 820. i am going to do the internal audit of my company's product quality complaint system next month and i need some material or maybe a checklist or a list of questions that can help me out in doing the audit in an optimum way. Any kind of correspondence will be much appreciated. Thank You
I would take the part of 21 CFR Part 820 which addresses complaints and draw questions from it if you are doing a compliance audit.

Do you currently have a documented complaint process/system?
 
Q

Quengineer

#4
Yes, we do have and currently we are trimming the process according to FDA's audit suggestion we had last year. We have standard operating procedures for complaint handling. i wanted what area should i focus on in relation to prioritization. Like CAPA handling, complaint investigation, trend analysis which area are highly significant areas to FDA's current thinking.
 
Q

Quengineer

#5
If it's an INTERNAL Audit your doing, then make your own checklist - it's more effective that way and you get to study the process and the regs so you know what to ask about. Using someones checklist isn't going to help. Put in the work to study the assignment and you:
Will have a much more effective audit
Will know more about what your asking
Won't look stupid asking questions that are wrong
Will build your credibility as an auditor
Will be welcomed back for the next audit.
thanks for your prompt reply. Yes that's my plan but what i wanted is have some guidance on the way how i should the internal audit and areas where i should focus more. Basically, my background is in Design Control and i did one audit of the Design History File Maintenance of company that went very well and my manager appreciated me for it. Now he wants me to do the audit of complaint system as he predicted i have good sense of asking right questions. I wonder if there is any guidance that i can get online to get myself better prepared for the making of my own checklist or a sample checklist of complaint audit which i can trim to my thinking.
 
J

JoShmo

#6
I wonder if there is any guidance that i can get online to get myself better prepared for the making of my own checklist or a sample checklist of complaint audit which i can trim to my thinking.
Nope - just sit down and study the process and requirements. Think it through as you would have someone do a show an tell. Don't over think it. If you do the study upfront you be better able to deal with the answers you get.
 
Q

Quengineer

#8
Marc, we have process in place. I would like your experienced thoughts on the way i should handle this audit. just a small summary i would like to get from you that concluded the from where i should start and where i should end the audit. i have done detailed research and have gather a good data but just wanted to get your feedback too to feel more confident. thanks
 
J

JoShmo

#9
Marc, we have process in place. I would like your experienced thoughts on the way i should handle this audit. just a small summary i would like to get from you that concluded the from where i should start and where i should end the audit. i have done detailed research and have gather a good data but just wanted to get your feedback too to feel more confident. thanks
Do it as a process. Take a sample of compliants as inputs and follow them through the process to conclusion (or not)
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Yes, we do have and currently we are trimming the process according to FDA's audit suggestion we had last year. We have standard operating procedures for complaint handling.
1. Study any complaint-handling-related issues identified by the FDA during their last audit, and any requirements for improvement made. Sort out what your org has committed to doing about them, and check whether it was done and whether the issues were fixed.

2. Study 21 CFR 820.198 - Complaint Files. Check whether your org's SOPs satisfy the applicable requirements in that section.

3. Once item 2 above is positive, take a random, diverse sample of complaints received during the last 12 months and step through the record trail (complaint initiation to closure) to ascertain that all your org's related SOPs were followed correctly.

That should be enough for a first go.

Cheers,
Ronen.
 
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