Hi friends!!!

Today we are going to
discuss about complaint handling
procedure specified in ISO 13485:2016.

CLAUSE 5.6.2 suggest complaints to be one of the
mandatory inputs in management review.

CLAUSE 8.2.2 gives procedural requirements of
complaint handling.

ISO involves complaints in risk management.

Therefore, it is important for every medical device
regulatory professional to know in detail about complaint handling procedure.

Let’s get into the topic.

ELEMENTS OF
COMPLAINT HANDLING PROCEDURE

The complaint
handling procedure has 10 steps as following.

APPLICABLE TO
REGULATORY REQUIREMENTS

The customer
complaint handling procedure should be compliant with applicable regulatory
requirements.

RECEIVING AND
RECORDING INFORMATION

Receiving and
recording information procedure should address how all received complaints are
routed within organization, recorded and saved in complaint log or complaint
management system (in the scope of enterprise resource planning ERP system).

COMPLAINT
EVALUATION

The complaints
handling procedure should check whether the complaint is valid or not. If not,
no further proceedings are made. Justification records are maintained for non-valid
complaints.

REPORT TO
REGULATORY AUTHORITY

1. Important aspect
of complaint handling procedure is that serious complaints having adverse
impact on patient’s health must be routed to regulatory authorities.

2. Authority can stop
the sales of that product for a period of investigation and corrective action.

3. In some cases, a
particular device should have to be recalled from the market.

4. Complaints has to
be resolved and closed by regulatory authorities.

5. All records of
reporting to regulatory authority have to be maintained by company itself.

COMPLAINT
INVESTIGATION

Identification of
root cause, so that subsequent actions can be identified.

HANDLING OF
COMPLAINT ABOUT RELATED PRODUCT

In complaints
handling all returned products by customers are properly tagged and identified.
All returns are reworked and shipped again or these returns are discarded and
replacements issued to the customers. The customer complaint handling procedure
should address all these queries so as to minimize the risk of returned product
being mixed with inventory of production.

CORRECTION
AND CORRECTIVE ACTION

1. Take actions to
address the root cause.

2. May be rework or
offer replacement.

3. Records for
corrections and corrective actions must be maintained.

THIRD PARTY
INVOLVEMENT

1. Sometimes
complaint is a result of third-party services in manufacturing or delivery of
medical device. Example: Shipping services.

2. The complaint
handling procedure should address the mode of communication with external service
providers.

3. The investigation
findings that highlight their contribution or any corrective action on their
part must be shared with proper documented records.

REVIEW OF
SERVICING RECORDS

1. Servicing records
are details of activities taken under scheduled or breakdown maintenance.

2. If records
identify the issue of complaint, the whole complaint handling procedure has to
be initiated.

 

Now I hope you have acquired some
knowledge about complaint
handling procedure of ISO 13485:2016. We will see a different topic
related to healthcare in our next blog.

NOTE:
Dear friends!!! …Please do comment a topic related to Biomedical, so that we
can discuss it in future blogs.

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