Quality Records (QR) Control Codes

[klcuellar]

Hello! Can anybody share his or her idea regarding quality records control codes?

We have audited and the auditor noted that our masterlist of quality records do not have QR control codes which shall be interfaced with documents, procedures, and other records for easy identification/retrieval.

I hope somebody who has an idea or sample could share asap. Thanks!

 

[keres]

By my opinion your auditor is right. This is not mandatory requirement but is logic and good practice.

 

[klcuellar]

By my opinion your auditor is right. This is not mandatory requirement but is logic and good practice.

thanks for the opinion. but do you have any idea on how we could address this? i thought it would be very tedious for us if we will assigned a unique code for each type of record. do you have any sample of Masterlist of Quality Records? template or format?

 

[keres]

thanks for the opinion. but do you have any idea on how we could address this? i thought it would be very tedious for us if we will assigned a unique code for each type of record. do you have any sample of Masterlist of Quality Records? template or format?

I suppose you have templates for mandatory records by your procedures. You may create rules for code identification. For example:
P001 Control of documents procedure
FM-001.001 Request for document change
...
P002 Control of records procedure
FM-002.001 Masterlist of records
...
P003 Human resourses
FM-003.001 Request for training
FM-003.002 Training protocol
In FM-002.001 Masterlist of records you can list all of your templates for the records (FM - form), not Procedures (P) with their numbers, names, revision e.t.c.
It is just a simple table.

 

[QAMTY]

Hi Keres

Please explain, Is not mandatory the identification, 4.2.4 Control of Records?

"The organization shall establish a documented procedure to define the controls needed for the identification,storage, protection, retrieval, retention and disposition of records."

Thanks
​

 

[klcuellar]

I suppose you have templates for mandatory records by your procedures. You may create rules for code identification. For example:
P001 Control of documents procedure
FM-001.001 Request for document change
...
P002 Control of records procedure
FM-002.001 Masterlist of records
...
P003 Human resourses
FM-003.001 Request for training
FM-003.002 Training protocol
In FM-002.001 Masterlist of records you can list all of your templates for the records (FM - form), not Procedures (P) with their numbers, names, revision e.t.c.
It is just a simple table.

Yes actually, we do have a separate Masterlist of Forms where all our templates are indicated. and we have another Masterlist of Records where all of the filled-out forms are indicated. it is in here, in the Masterlist of Records, where our auditor is suggesting to have a different code for each record aside from the code for each forms.

Meaning a form (unaccomplished) has a form code. and once it has been accomplished and become a record, a different code shall be assign. have you encountered something like this? for example, a Document Approval Request Form has a code of FM-CSFP-QMS-01, and once accomplished, a separate code shall be assign. that is, as per the observation of the auditor.

 

[keres]

Hi Keres

Please explain, Is not mandatory the identification, 4.2.4 Control of Records?

"The organization shall establish a documented procedure to define the controls needed for the identification,storage, protection, retrieval, retention and disposition of records."​

Thanks​

I mean it is not mandatory to write masterlist of quality records and have QR control codes interfaced with documents, procedures, and other records in this masterlist.

You are right the identification is requirement. But not mandatory in masterlist of records. There are many ways to do this.

 

[keres]

Yes actually, we do have a separate Masterlist of Forms where all our templates are indicated. and we have another Masterlist of Records where all of the filled-out forms are indicated. it is in here, in the Masterlist of Records, where our auditor is suggesting to have a different code for each record aside from the code for each forms.

Meaning a form (unaccomplished) has a form code. and once it has been accomplished and become a record, a different code shall be assign. have you encountered something like this? for example, a Document Approval Request Form has a code of FM-CSFP-QMS-01, and once accomplished, a separate code shall be assign. that is, as per the observation of the auditor.

Did you mean a separate code for the template and another for filled-out form?

 

[klcuellar]

Did you mean a separate code for the template and another for filled-out form?

yes.. could you help me with this? do you know other companies doing the same thing?

 

[klcuellar]

I mean it is not mandatory to write masterlist of quality records and have QR control codes interfaced with documents, procedures, and other records in this masterlist.

You are right the identification is requirement. But not mandatory in masterlist of records. There are many ways to do this.

Since it is not mandatory to have QR control codes in the masterlist, what other ways can we answer the observation cited by our auditor? like to address his issue on records "identification"?