Record Control - Who are the Record Custodian and Retention Times - ISO9001 - 7.5.3

[juliov]

Hello to all the Quality partners out there in cyber space.
Hey, who is listed under process owners and how is retention time defined in a "Master list of records??" how do you comply with this req in order to show the auditor compliance,

Thanks,

 

[Jim Wynne]

Re: ISO 9k2k req 7.5.3 record control, who are the record custodian and retention times

Hello to all the Quality partners out there in cyber space.
Hey, who is listed under process owners and how is retention time defined in a "Master list of records??" how do you comply with this req in order to show the auditor compliance,

Thanks,

7.5.3 is Identification and Traceablility, and there is no requirement for a "master list of records" in 9000:2000. 4.2.4 deals with control of records. So it's not clear what you're trying to find out.

 

[juliov]

Re: ISO 9k2k req 7.5.3 record control, who are the record custodian and retention times

Thanks for the reply,
what I meant is that 7.5.3 is one of the records required to be in the master list of records. How is compliance ensured??

 

[Coury Ferguson]

Re: ISO 9k2k req 7.5.3 record control, who are the record custodian and retention times

Thanks for the reply,
what I meant is that 7.5.3 is one of the records required to be in the master list of records. How is compliance ensured??

There is no specific record required unless specified by the customer via the Contract/Drawing. For example: Serialization is required via the drawing or contract. You must maintain those records and they must have a unique identifier.

Basically, in my opinion, if the contract/drawing specifies that traceability is required you must be able to show objective evidence via records.

As for being identified in your in your master list...if it is required by your customer then it should be reflected in your list.

But lets see how someone from a Registrar would address this issue, like Randy and even Hjillings.

 

[juliov]

Re: ISO 9k2k req 7.5.3 record control, who are the record custodian and retention times

Thanks Coury, also note that it is mandatory to include in the Master list of records compliance to 7.5.3 which means that some records must be entered, however there are various process owners in the chain and my question was who is/are the process owners and retention times

 

[Jim Wynne]

Re: ISO 9k2k req 7.5.3 record control, who are the record custodian and retention times

Thanks Coury, also note that it is mandatory to include in the Master list of records compliance to 7.5.3 which means that some records must be entered, however there are various process owners in the chain and my question was who is/are the process owners and retention times

juliov,

I'm still confused. There is nothing in the standard that requires a "master list of records," as I said earlier. Are you referring to records of traceability (lot control) requirements? If so, and in view of the fact that no master list is required, could you restate your question?

 

[atitheya]

Control of records is subclause 4.2.4 of ISO 9001:2000 and not 7.5.3

A process owner can be the person responsible for the operation and control of the process. e.g. HR Manager for Recruitment pocesses, MR for Internal quality audit, Sales manager for sales process and so on. HOD may be defined as the process owner of processes in his departments.

If you are maintaining a masterlist of records, the retention time can be specified right in front of the respective record in another column titled as 'Retention Time'.

Else if retention times do not differ largely, you may include it in the documented procedure only or use any other method to specify the same.

Regards,

Parag,
Management Consultant

 

[shunter - 2009]

Re: Record Control- documented procedure

How is everyone meeting the requirement in TS16949 " A documented procedure shall be established to define the controls needed for protection". We have all sorts of records kept by all departments and I am confused on how to protect all of them. Our auditor talked about either keeping them electronically or in fire proof boxes. Most of our records are not electronic and fire proof boxes for 4 facilities would be too expensive.

 

[juliov]

Relax there Shunter,
True, there has to be a record control procedure and you have that, now with reference to storage: let your company select the method of storage either electronic or in a "designated" area, no, you do not need fire proof boxes, if you want use cardboard boxes, however just make sure that the designated location is reasonably safe from damage such as fire, water, etc. it could be an empty room in your company, a closet space, an attic, you pick them. Remember, it is how your organization chooses to run its process and procedures that counts. Make sure the records are retrievable and easy to find when needed.

 

[potdar]

Re: ISO 9k2k req 7.5.3 record control, who are the record custodian and retention times

Thanks Coury, also note that it is mandatory to include in the Master list of records compliance to 7.5.3 which means that some records must be entered, however there are various process owners in the chain and my question was who is/are the process owners and retention times

I take it that you are using a "Master list" for control of records. I also take it that you are talking about the identification record where traceability is a requirement.

There is no simple answer to your question. It will all depend on your process. Your record may stay in the stores in custody of the storekeeper. Or it may move alongwith the material. It could be a batch identification that needs to stay alive after despatch for warranty or even statutory reasons. So, if we know the details, further discussions can be made. The owner varies.

Same is true for retention time. You may only note now that it is not necessary that the retention period should be defined in absolute terms. It can be defined as "Till product is in process", "Two years after despatch", "Till issued".... Just as a training record may be maintained "Till in service".

I hope this helps you in your query.