Complaint Investigation: When You Don’t Have to Investigate Every Complaint

Q: Does every complaint require some kind of complaint investigation?

A: Yes, but with some qualifications.

For each complaint you receive, you should determine the extent of the problem, its impact (risk) to the user, patient or by-stander, and its validity. Why validity? If it isn’t your product, then for you it isn’t a valid complaint. Or, if you are 100% certain your product could not or did not do what was claimed, then the complaint may not be valid.

Based on what you learn, you need to determine whether any additional complaint investigation is required. If the complaint is related to an on-going investigation you have initiated, you can close the complaint to that particular investigation.

If the complaint is related to a product made prior to an already implemented corrective action — and if you can establish the complaint is related to that corrective action — you may close the complaint to the previously implemented action.

If the complaint, event, or failure mode is occurring within an expected frequency and severity, and the reason for its occurrence is well understood (meaning, it’s not unexpected), then you may choose to not investigate further.

You should always track and trend each complaint in case additional data shows the problem is occurring beyond expected frequencies or severities.

You should always track and trend each complaint in case additional data shows the problem is occurring beyond expected frequencies or severities.

The person making the decision to not further perform a complaint investigation should date and sign his/her decision and document the reason why no further investigation or action was taken.

By the way, for products produced in lots, your frequency/severity assessments should be determined within individual lots as well as across all lots.

For serial-numbered products, your frequency and severity data should include not only complaints but also service data, including routine service where a non-routine problem may have been discovered.

Answered by Denise Dion, Vice President of Regulatory and Quality Services for EduQuest, who served 18 years at the U.S. FDA as an expert field investigator and who contributed to the development of FDA’s Quality System Inspection Technique (QSIT). Denise is the lead instructor for EduQuest’s 12-hour training class, The CAPA Compliance Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management.

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