Tuesday, June 30, 2020

ISO 13485:2016 COMPLAINT HANDLING PROCEDURE

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.


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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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