Definition Quality Records - 4.16 - Definitions for "identification, collecting, indexing....."

D

dbzman

#1
I have had auditors come into my facility and look at Section 4.16 "Control of Quality Records" and ask for evidence of the following for quality record(s):

Identification
Collection
Indexing
Access
Filing
Storage
Maintenance
Disposition

I believe that I have addressed each of these in practice but can anyone give me some examples/definitions for them so that I could verify my practice?

Thanks

Signed:

:bonk:
 
Elsmar Forum Sponsor
A

Al Dyer

#2
You must have a good system if they are trying to hone in on records. I guess it depends on what your stated retention times and execution are in your procedure. Otherwise I would give him/her a big kiss and try to prove it!!!!!!!!!!!!!1
 
D

D.Scott

#3
Dbzman

Best way I found to address these is to develop a matrix for your controlled documents. It gives the auditor something to hold and gives a picture of how your documents are handled.

I am attaching a copy of our old matrix just to give you some ideas.

Dave
 

Attachments

JodiB

Still plugging along
#4
Definitions and examples? I'll give it a shot...

1) Identification - how do people know that this form or piece of data is supposed to be kept as a record, and how do you distinguish one record from another? ex. they are listed in the applicable procedures and/or there is a master list. Records are uniquely identified with a number or other ID (like CAR #s)...

2) Collection - are the records actually collected as they are supposed to be? ex. weekly reports that are supposed to be submitted

3) Indexing - this sounds alot like filing to me...sort of like how do you compile your records so that they are distinguishable, available, and readily available

4) Access - If you have to get your hands on a particular record, can you do it? Where do you keep them

5) Filing - I don't know. Sounds the same as indexing to me.

6) Storage - do you remove records from a particular location after a period of time (but before disposal time) and where do you put them to keep them safe, identified, etc. Ex. the file cabinet fills up after one year but they must be kept for 3 years so they are boxed up and kept on a shelf in the warehouse

7) Maintenance - keeping them safe, clean, legible, making sure they are filed/indexed as appropriate

8) Disposition - after you no longer need them, what do you do with them? Are there any confidentiality issues regarding disposal methods, how does everyone know when and how to dispose of records, etc.

I'm not sure that I've pegged everything because I'm new at this, so this question is still very much open to all the experienced knowledgable folks here.

I agree with Dave that defining these points in a matrix is the easiest way to answer these questions for the auditor.
 
Thread starter Similar threads Forum Replies Date
U Manufacturing solutions and keeping records on quality Content CE Marking (Conformité Européene) / CB Scheme 3
I Date of Quality Management System - Training Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Q Do hard copies of quality records have to be retained? ISO 13485:2016 - Medical Device Quality Management Systems 2
R Custom Records and Quality Systems - Products that change frequently Other US Medical Device Regulations 3
B Quality Records - Should any record be signed? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Records Records and Data - Quality, Legal and Other Evidence 10
R 21 CFR Part 820.186 - Types of Quality System Records Document Control Systems, Procedures, Forms and Templates 1
S Retention time requirement for various for quality records Records and Data - Quality, Legal and Other Evidence 1
S Atlassian and Plugins for Quality System/Records? Quality Assurance and Compliance Software Tools and Solutions 1
C Incremental revisions to Quality Manual, and Training Records Document Control Systems, Procedures, Forms and Templates 2
M Contractors with poor Quality Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
K Integrating acquired existing product into Quality Management System Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Are all In-Process Quality Records required in final QA Batch Record Review. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
K Quality Records (QR) Control Codes Records and Data - Quality, Legal and Other Evidence 13
J Quality Records Register Requirements - ISO 9001:2008 Records and Data - Quality, Legal and Other Evidence 31
H Must I mention "records kept" in the Quality Manual itself ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L Storage Cabinets for Quality Documentation (Procedures and Records) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
P NQA-1 Requirement 17 Quality Records - Facility Types and Temporary Storage Various Other Specifications, Standards, and related Requirements 5
M Suggestions for Handling Quality Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M What to do about missing Quality Records? Records and Data - Quality, Legal and Other Evidence 11
M Quality Records Matrix Content and Revision Records and Data - Quality, Legal and Other Evidence 6
N Quality Records - Password and Anti-virus Protection Records and Data - Quality, Legal and Other Evidence 3
H Review and Approval in Quality Records? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G Creating a "Records Policy" - Control of Quality Records Records and Data - Quality, Legal and Other Evidence 13
P Obsolete Quality Records - Approval Prior to Disposal Records and Data - Quality, Legal and Other Evidence 15
I Do ALL Quality Records Require Approval? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
P Quality formats - ISO 13485 Design and development related records and formats ISO 13485:2016 - Medical Device Quality Management Systems 7
S Retention Periods of Quality Records Records and Data - Quality, Legal and Other Evidence 1
A Examples of Quality Records Master List ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Corrective Action for lost project quality records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Are environmental compliance documentation quality records? Document Control Systems, Procedures, Forms and Templates 5
J ISO 9001:2000 4.2.3- Quality Records, Production Travelers Records and Data - Quality, Legal and Other Evidence 9
S Retention time of quality records for parts with Critical (safety) Characteristics? Document Control Systems, Procedures, Forms and Templates 2
C Need a procedure or outline on Good Practices for Completing Quality Records/Document Document Control Systems, Procedures, Forms and Templates 2
Q Signature on Management Review Minutes - Quality Records ISO 13485:2016 - Medical Device Quality Management Systems 5
T Sample Retention Requirements - Quality Records procedure - ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 8
A Action on Quality Records - Approve, Update and Carry Out Revision Control Records and Data - Quality, Legal and Other Evidence 10
T Is there a minimum retention time for any of the Quality Records? ISO9001 Records and Data - Quality, Legal and Other Evidence 8
K Records - Are weekly purchasing reports, backlog reports, etc., Quality Records? Records and Data - Quality, Legal and Other Evidence 4
R Procedure does not adequately identify quality records - Audit Minor NC - Why? General Auditing Discussions 8
H Formats for Master List of Quality Records (MQR) & Document Change Request Form (DCR) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Quality records kept "off site", is it ok or not? Records and Data - Quality, Legal and Other Evidence 19
Q Minimum Quality records required by ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
C How often will I update the quality records list? We have about 189 quality records Document Control Systems, Procedures, Forms and Templates 6
M Defined retention time of quality records - ISO 9001:2000 Paragraph 4.2.4 Records and Data - Quality, Legal and Other Evidence 10
N What are the minimum quality records required by QS-9000? Records and Data - Quality, Legal and Other Evidence 1
G Trigger Point - Determining When We Can Dispose of Quality Records Records and Data - Quality, Legal and Other Evidence 11
L Good Documentation (Quality Records) Practices - Dittos? Arrows? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R Identification of Quality Records (ISO9001 - 4.2.4) - How? Records and Data - Quality, Legal and Other Evidence 32
C New company - How much quality records history required? Records and Data - Quality, Legal and Other Evidence 3

Similar threads

Top Bottom