Control of Records - Process Flow, ideas and examples wanted

B

bbeesley

Gents/Ladies

I'm trying to attach process flow diagrams to each of my documented procedures. I've got rather a nice (if complex) one for document control but I'm struggling to stick together a useful flow for record control. Although not everyone will have the same sort of record control procedure I was wondering if anyone else had mapped their record control process. If you have and wanted to post it on here it would be great, might give my creative process a jolt.
 

Marc

Fully vaccinated are you?
Leader
This is the ISO 9001 requirement:

Records shall be established and maintained to provide evidence of conformity to requirements and the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

Typically different records are processed differently. E.g.:

- Management review records (5.6.1)
- Records of Education, training, skills and experience (6.2.2)
- Records needed to provide evidence that the realization process and resulting product meet requirements (7.1)
- Records related to the review of customer requirements (7.2.2)
- Design and development inputs (7.3.2)
- Design and development review records (7.3.4)
- Design verification records (7.3.5)
- Design validation records (7.3.6)
- Design and development change review records (7.3.7)
- Supplier evaluation records (7.4.1)
- Validation arrangements for processes (7.5.2)
- Product identification records (7.5.3)
- Records related to customer property (7.5.4)
- Calibration and verification records (7.6)
- Internal audit records (8.2.2)
- Product conformity records (8.2.4)
- Records of the nature of nonconformities and any subsequent action taken (8.3)
- Results of Corrective Actions taken (8.5.2)
- Results of Preventative actions taken (8.5.3)

I typically see control of records generated in the procedure for the form which ends up as a record or in the procedure that 'process'.

Are you trying to do a single procedure to cover all your records?
 
B

bbeesley

Sort of, I have a master procedure which sets out the general ethos behind our record keeping strategy. Things such as a requirement to back up electronic copies, maintain hard copies in a legible state, minimum retention time for all documents etc. It also has matrices defining owners for specific record types and their retention times.

I understand that the generation of records is generally covered in other procedures/work instructions etc, however, maintenance, storage and retention has it's own documented procedure. Its only really for the sake of consistency that I want it to have a flow map, as all the other procedures already have them
 

JoCam

Trusted Information Resource
Hi Bbeesley,

Here is my flow chart for control of records. I also add a 'Records' section to each of our quality procedures, indicating where and for how long the documents specified in the procedure are held.

I hope this gives you a few ideas.

Jo
 

Attachments

  • QMS-2002 CONTROL OF RECORDS.doc
    77.5 KB · Views: 2,210
B

bbeesley

Thanks for that Jo. I also have a little records section on the bottom of each procedure and work instruction. Your process flow is rather like my records matrix but it certainly looks better when presented your way. Something to think about.

Bill
 
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