I am looking for a typical format to log in and maintain for any complaints which meets the requirements stated in FDA 820.198...
:thanx:

Do you have an ERP system?
I ask, because many companies already have the tools, but do not always know about them.

I am looking for a typical format to log in and maintain for any complaints which meets the requirements stated in FDA 820.198...
:thanx:

As per GHTF - Guidance On Quality Systems For The Design And Manufacture Of Medical Devices (http://www.ghtf.org/documents/sg3/sg3-n99-8.doc), that is quite similar to FDA, it states clearly the sections required in the format -

The documentation of complaint investigations should contain enough information to show that the complaint was properly reviewed. For example: a determination of whether there was an actual product failure to perform per specifications; whether the product was being used to treat or diagnose a patient; whether a death, injury or serious illness was involved; the relationship, if any, to the reported incident or adverse event. An investigation record would typically include:

1. the name of the product;

2. the date the complaint was received;

3. any control number used;

4. the name and address of the complainant;

5. the nature of the complaint;

6. The results of the investigation, including:

- the corrective action taken

- the justification, if no action is taken

- the dates of the investigation

- the name of the investigator

- the reply (if any) to the complainant.

Where the technical staff who are responsible for an investigation are located at a site other than the place of manufacture of the medical device, the supplier should copy the records of the complaint and the investigation to the manufacturing plant, so that the staff at that plant can be fully informed of the events.

Give you some sample questions in your customers complaint form for your reference. You can add check-box to determine each question.

If this complaint is related to the medical device, then please answer the following questions:
1) Does the information reasonably suggest that the device caused or contributed to a death?
2) Does the information reasonably suggest that the device caused or contributed to a life
threatening injury to the patient, or resulted in a permanent loss of, or loss of use of any
sense, organ, limb, or member?
3) Does the information reasonably suggest that a device malfunction occurred?
4) If the malfunction were to recur and continue, would it be likely to contribute to a death or
serious injury?
5) If any answers are YES, immediately notify the Head of Quality Assurance.

While I agree with the responses provided by ajith,luloo117117;

the following reference should give you detailed insights into FDA requirements.

www.fda.gov/cdrh/qsr/15compl.html (http://www.fda.gov/cdrh/qsr/15compl.html)


Hope this helps.

Thanks.

valiveti.

Thanks all for the input and references. We do not operate an ERP to this extent and have to demonstrate a good system in line with this requirement.
Regards...

As manager for QA and Service , I have prepared for my company the document you need. I prepared the procedure and also the form you are looking for. Both forms passed the FDA audit successfully.
Tell me how do you want me to send it to you.

v0raz

As manager for QA and Service , I have prepared for my company the document you need. I prepared the procedure and also the form you are looking for. Both forms passed the FDA audit successfully.
Tell me how do you want me to send it to you.

v0razCould you please attach it here using the attach file option.
http://elsmar.com/Forums/attachment.php?attachmentid=10262&d=1237305665