Help Determining QA Documents

Hello all

For the moment, I am trying to control all the documents in my factory. Also their archiving, retention, retrieval and use. I have some quesionts for which I do not have any answers...hoping I will get help from this forum like before.

1. What kind of documents needs to be controlled?

2. What kind of documents does the QA needs to control?

3. What is the procedure for changes or updates in any kind of SOP's? Is it necessary for the QA dept. to approve any changes in all kinds of docs?

Any other information relating to this topic is welcomed. Please help me.

Thanks,

Regards,
Rajini

DEAR RAjini..

Answer for question no 1 and 2 :
As ISO 22000 state, specifically documen that have to controll. They are :
1. the documented procedures for the control of documents,
2. Control records,
3. Emergency preparedness and response,
4. Internal audits,
5. corrections, corrective actions and withdrawl.
6. Documented statement of food safety policy and related objectives
7. Documents needen by the organization to ensure the effective development, implementation and updating of food safety management systems


for no 3 :
my answer (no.1) include procedure how to change the document (SOP'S, WI'S etc).. and IMEX for approval document can be done by Responsible people in the dapartment (such as Production departmen) plus Management Representative.. If the QA as MR.. so Approval document should be done by QA...


hope can help you to solve the problems


rgds

AS Nur

1. What kind of documents needs to be controlled?
2. What kind of documents does the QA needs to control?

The simple rule for above is "Focus on your management system requirements". If you have QMS then control only those documents that are related (directly or indirectly) to quality of product or process. If you have FSMS then control those documents that are related to food safety. If have integrated QMS+FSMS then control combined documentation. Do not control irrelevant documents at least at first stage of management system development until and unless your management system become mature (maintained). Even carefully judge those documents that are seem to be relevant w.r.t. quality or food safety before controlling them. The reason is that extensive documentation leads to deviation from focal points (quality and food safety).

3. What is the procedure for changes or updates in any kind of SOP's? Is it necessary for the QA dept. to approve any changes in all kinds of docs?

If a controlled SOP needed to be changed, it must be reviewed and re-approved by a competent authority before re-issuance or re-distribution.

IMEX approving authority may be different for different type of docs. Such as a work instruction to operate a machine may be approved by authority related to operations or production.

Regards:
Zeeshan

Dear All,

Sorry if I missed it in the original post but is the query addressed to a particular audit standard or what ?? And what kind of a process ?

A fundamental question IMO is "how many people to assist" and what equipment etc to do the slog? If you work for NASA, you can look up their beautiful on-line computerised systems but .......

I guess the iso 9000 standards contain the basic requirements of many other iso documents (eg 17025 perhaps) but certainly won't match the BRC expectations for sure (in a good way from the BRC users point of view ).

IMEX, this topic is one of the easiest subjects to spend hours worrying oneself over without proper reason. It is just too easy to find oneself going round in hypothetical circles. Mind you, if you are in the automobile industry, there may be some audit justification.

Rgds / Charles.C

If you are talking about ISO 22000:2005 / FSMS and are related to limited and few of them already mentioned above by Nur, Zeeshan & Charles.

1. What kind of documents needs to be controlled?

Documented procedures and policies what ever made internally.

2. What kind of documents does the QA needs to control?

Control of non conforming products
Corrective actions
Withdrawals
Internal audit
Records of management review
Verification of CCP’s & PRP
Traceability
Calibration
Testing/Analysis of product
System updating activities
Control of RM, PM, FG specifications
Flow diagrams
Records and results of hazard analysis
HACCP plan


3. What is the procedure for changes or updates in any kind of SOP's? Is it necessary for the QA dept. to approve any changes in all kinds of docs?
If you are acting as FSMS Team leader or MR you are allowed to do any desirable changes, you need to maintain control of documents and control of records.