Implementing ISO 13485:2003 - 8.5.1 - Advisory Notices - Recall Procedure

Hello,
I was wondering if I could get some ideas from anyone who has already or is soon to be implementing ISO 13485:2003 in regards to Advisory Notices. I may not be looking into it far enough, but in 8.5.1 states the requirement for a procedure(s) for the issue and implementation of advisory notices. Following the definition of Advisory Notice, would it be wise to add an additional process in the Recall Procedure, where it would document the notification to customer(s) as an Advisory Notice (use of, modification of, return of, or destruction of) in regards to the medical device? I was thinking of also adding a "yes/no", in the Engineering Change approval process to ensure if an Advisory Notice is needed.

Let me know your thoughts.

Thanks,

Dan

[Al Rosen]

I added the issuance of advisory notices to our recall procedure. I did not, however, revise our EC approval process. What % of Engineering Changes require an Advisory Notice?

In Reply to Parent Post by Al Rosen

I added the issuance of advisory notices to our recall procedure. I did not, however, revise our EC approval process. What % of Engineering Changes require an Advisory Notice?

Thanks Al, you are right, it would be a very low %, and usually that would result from a Customer Complaint which is linked to the recall process.

[Chan J]

Hi, just would like to know, that do we need to send an advisory notice to our suppliers as well should a product recall happen? Since we control our supplier, should they have a vigilence system? Who actuallly are the stakeholders should we issue an advisory notice? Sorry for the many questions.Thanks

[Al Rosen]

In Reply to Parent Post by Chan J

Hi, just would like to know, that do we need to send an advisory notice to our suppliers as well should a product recall happen?

It would seem to me that your supplier should be involved long before an advisory notice is sent.

In Reply to Parent Post by Chan J

Since we control our supplier, should they have a vigilence system?

I think not.

Guidance Document MEDDEV 2.12-1 describes the Vigilence System.

In Reply to Parent Post by Chan J

Who actuallly are the stakeholders should we issue an advisory notice?

This is also addressed in MEDDEV 2.12-1.

[Roland Cooke]

For companies that are unlikely to experience much need for advisory notices, performing a dummy recall exercise is never a bad thing.

It means that should a problem arise at some point in the future, your company is not testing its system, out for the first time in the midst of what might well be a crisis situation.

Traceability and supplier/distributor communication lines can often be significantly strengthened as a result of this exercise, and if nothing else it helps spread a sense of confidence and competence in the system.

[Miragesy]

Hi,
I'm new in Elsmar Cove. I find the site very outstanding.
I also have trouble with advisory notice procedure. Should there be a seperate procedure for advisory notices or are recall, customer complaint, post production surveillance, etc. procedures enough?
Where can I find a sample for advisory notice procedure if these are not enough?
Thank you in advance.
Serap

[Roland Cooke]

In Reply to Parent Post by Miragesy

Hi,
I'm new in Elsmar Cove. I find the site very outstanding.
I also have trouble with advisory notice procedure. Should there be a seperate procedure for advisory notices or are recall, customer complaint, post production surveillance, etc. procedures enough?
Where can I find a sample for advisory notice procedure if these are not enough?
Thank you in advance.
Serap

(In European terminology) a recall is one type of advisory notice, specifically demanding the product be returned/destroyed.

AFAIK, in the US, a recall is any type of regulatory/complaint communication.



In your QMS, you should have a cascading system:


1. Risk Management - problem prevention

2. Post Market Surveillance (not just complaints!!!!!!!)

3. Complaints Handling (sorting price complaints from safety complaints)

4. Vigilance Complaints Handling (confirmation, determination of seriousness, communication with regulators)

5. Advisory Notices (issued by manufacturer to users, advising them of product issues. Often the product does NOT need to be returned/destroyed. Usually would be copied to regulators.)

6. Recall Process (a specific advisory notice, which requires the product to be returned/destroyed. Mandatory to involve regulators when a recall occurs. An established procedure to ensure that the recall will be effective, however running dummy recalls is recommended to validate the system especially wrt communication and traceability.).

7. Risk Management - incorporating lessons learned.


There is no requirement to have more than one procedure covering these different processes. I would however strongly recommend it!