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Customers' Feedbacks and Complaints

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Guest user Created:   Nov 06, 2020 Last commented:   Nov 10, 2020

Customers' Feedbacks and Complaints

Firstly, I hope you and your family are safe during this challenging time. 
I would like to thank you for your webinars. They are extremely helpful.

I am relatively new in this industry and I am struggling with a few quality related issues and I was hoping that maybe you could kindly have a minute to give me your expert opinion about the following:

1.) Would it be compliant that a medium size company (70  employees) to have separate procedures for Feedback and Complaint, Non-Conforming Product, Non-conformance and CAPA but the following logs: Feedback Log, Employee Suggestion Log (for employee feedback data gathering), CAPA log and just one log for both Complaints and Non-conformances.

2.) If there were 2 logs, one for complaints and one for non-conformances and a complaint is received that is investigated and considered a non-conformance, shall that complaint appear in both complaint log and non-conformance log? 
    Similarly, if a hypothetically a complaint is received and it is incident related, would it be registered in all logs applicable (complaint log, then incident log, then non-conformance log if it is due to a non-conformance, then in CAPA log when corrective action is required?) or can some of them be skipped (such as recording the incident straight into incident log rather than complaint log and in CAPA log to carry out relevant action plans?)

3) Is it  considered as being a complaint an instance when a customer is dissatisfied because his expectations are not met, but for meeting their expectations the regulatory requirements shall be broken?

I believe registering every issue that is detected in all the logs relevant is so confusing and time consuming.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Nov 10, 2020

1. Would it be compliant that a medium size company (70 employees) to have separate procedures for Feedback and Complaint, Non-Conforming Product, Non-conformance and CAPA but the following logs: Feedback Log, Employee Suggestion Log (for employee feedback data gathering), CAPA log and just one log for both Complaints and Non-conformances.

Yes, it would be compliant for a company this size to have separate procedures for defined requirements. How you divide the registration logs, it seems OK.

2. If there were 2 logs, one for complaints and one for non-conformances and a complaint is received that is investigated and considered a non-conformance, shall that complaint appear in both complaint log and non-conformance log?
Similarly, if a hypothetically a complaint is received and it is incident related, would it be registered in all logs applicable (complaint log, then incident log, then non-conformance log if it is due to a non-conformance, then in CAPA log when corrective action is required?) or can some of them be skipped (such as recording the incident straight into incident log rather than complaint log and in CAPA log to carry out relevant action plans?)

In my opinion, it is OK to have one log for complaints and non.conformances to skip repeating the information. If that is not the case, then you need to register a complaint in one log, and then connect that complaint with the non-conformance log. The best way to do it is that in the complaint log you have one column where you will, after the investigation of the complaint, put the number of the non-conformance that you will raise to solve this complaint.

3. Is it considered as being a complaint an instance when a customer is dissatisfied because his expectations are not met, but for meeting their expectations the regulatory requirements shall be broken?

Here, the only question is - has customer expectation been written somewhere (in contract, on the invoice, or similar). If there is no record of the customer expectation and even if it will mean that regulatory requirements shall be broken, in my opinion, it isn't a complaint. In requirement 7.2.2 Review of requirements related to the product is stated product requirements must be defined and documented, and the organization must review the requirements related to the product. Records of the results of the review must be maintained.;

4. I believe registering every issue that is detected in all the logs relevant is so confusing and time consuming.

I agree with you. So try to make this as simple as possible. From my experiecne as auditor, some clients has only customer complaint log and all other elements are in one log: CAPA, non-conforming products, even findings from internal audit.  It is very easy to manage this logs when using advance excell.

Following articels can be helpful:

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