What would the FDA expect to see when they ask for our QSR?

J

Jimmy the Brit

#11
Yes essentially, making sure to cover other relevant regs like ISO13485 and or 9001 in the same matrix and listing any exclusions/exemptions you have with the associated justification.

It is imporatnt that it has sufficient granularity to be useful and is frequently revisited/revised to reflect current QMS status. A living document rather than a one-off list of procedures.
 
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T

Tim Penrose

#13
Yes essentially, making sure to cover other relevant regs like ISO13485 and or 9001 in the same matrix and listing any exclusions/exemptions you have with the associated justification.

It is imporatnt that it has sufficient granularity to be useful and is frequently revisited/revised to reflect current QMS status. A living document rather than a one-off list of procedures.
So a 'living' document with issue numbers updated as and when they chage?
 
J

Jimmy the Brit

#15
So a 'living' document with issue numbers updated as and when they chage?
That's what we do - I realise that is a lot of work but we were having problems with keeping people in step with updates so we required the local doc controllers to update the quality plans at any rev. change as part of the change control process. If you have your revision control under control that that may be a step too far - we just lack that connectivity between sites and our electronic document system is deeply flawed.
 

Doug Tropf

Quite Involved in Discussions
#16
Thanks for your comment so far but

QSR 820.186 Quality System Record says:

Each manufacturer shall maintain a quality system record (QSR)

Then the text in my original post with a final sentance:

Each manufacturer shall ensure that the QSR is prepared and approved in accordance with 820.40 (Document control)


Now a 'record' to me means a completed form used to record that an activity has been performed by someone at a particular time.

So from that I'm assuming a QSR is a controlled document that includes details of/reference to all documents held within the Quality System that are NOT product specific, and going by past experience is more than a list of document numbers and titles

Any further comments/advice?


Thanks in advance
This is from the ASQ Biomedical Quality Auditor Handbook:

"The QSR comprises general procedures and documentation of activities not directly related to a product or process. For many manufacturers, the QSR comprises the quality manual, lower-level SOPs, and the records documenting those activities".
 
J

jscholen

#17
We have a principal document that we call, "Quality Manual"...it states at a high level how we intend to be compliant to QMS...here's the table of contents of our QM (our QM is 29 pages long)


SECTION 4.0 Quality Management System

4.1 General Requirements
4.2 Documentation Requirements

SECTION 5.0 Management Responsibility

5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility, Authority and Communication
Organizational Chart
Business Process Map
5.6 Management Review

SECTION 6.0 Resource Management
6.1 Provision of Resources
6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment

SECTION 7.0 Product Realization
7.1 Planning of Product Realization
7.2 Customer-related Processes
7.3 Design and Development
7.4 Purchasing
7.5 Production and Service Provision
7.6 Control of Monitoring and Measuring Devices

SECTION 8.0 Measurement, Analysis and Improvement
8.1 General
8.2 Monitoring and Measurement
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement

Appendix 1 Correlation Matrix for FDA QSR and Company procedures
Appendix 2 Correlation Matrix for ISO 13485:2003 and Company Procedures
Appendix 3 Quality Management System Planning Chart
Appendix 4 Product Realization Planning
Appendix 5 Design and Development Planning
Appendix 6 Measuring and Monitoring Planning

Revision History


Hope this helps
 
T

Tim Penrose

#18
Thanks to all

We have a quality Manual too but it's geared around ISO 9001:1994. We took a concious decision not to rewrite it when the 2000 version came out and we only have certification to ISO 13485:2003 so in a way it's a bit out of date though it does reference the 21 CFR part 820 clauses


Once again, thanks to you all


:thanx:
 

Weiner Dog

Med Device Consultant
#19
Kim Trautman's ASQ book "The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices" is a good resource. Additionally, you can also refer to FDA's QSIT Manual http://www.fda.gov/cdrh/comp/gmp.html The QSIT manual "Preannounced Inspections" and "Management Controls" sections cite the typical documents FDA investigators ask to examine prior to and during the audit visit.
 
W

Watchwait

#20
Its very easy to confuse "Quality System Regulation" with the "Quality System Record". The latter is a subset of the former. 21 CFR 820.186 spells out the requirement for the Quality System Record.

FYI...here's an example of our Quality System Record procedure - and the QSR itself. My only advice is NOT to list the revision levels of the documents referenced in the procedure. Otherwise this would require constant maintenance. This way, it only needs to be revised it we create a new - or eliminate an existing procedure.

If you're like me - an example/template is worth a thousand words...
 

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