HACCP Document Control vs. ISO 9001 Document Control Requirements

[Ka Pilo]

2)There are many companies that are HACCP but not ISO 9001. Have you looked at ISO 22000? The ISO 22000 standard deals specifically with HACCP. ISO 9001 is mainly a Quality Standard.

I haven't looked at ISO 22000, but we will ultimately be targeting it. To our management, it is just as easier to do GMP and HACCP then ISO 22000 than to do ISO 22000 without making GMP and HACCP as foundation.

Can you think of some consequences for organization (practicing GMP and HACCP) without adopting all ISO 9001 requirements?

 

[Ajit Basrur]

I haven't looked at ISO 22000, but we will ultimately be targeting it. To our management, it is just as easier to do GMP and HACCP then ISO 22000 than to do ISO 22000 without making GMP and HACCP as foundation.

Can you think of some consequences for organization (practicing GMP and HACCP) without adopting all ISO 9001 requirements?

When you say GMP, you are probably referring to the FDA requirements like 21 CFR Part 210, 211 or 820, right ?

If you have the US FDA requirements for GMP and HACCP in place, getting ISO 22000 would be much easier.

 

[Ka Pilo]

When you say GMP, you are probably referring to the FDA requirements like 21 CFR Part 210, 211 or 820, right ?

I haven't looked at FDA requirements like 21 CFR Part 210, 211 or 820, therefore I can't really say at the moment if that's what I was referring to. Is it the same as Codex Alimentarius?

 

[Bilijaf]

In Fact the prerequisites program is based on GMP (Good Manufacturing Practices) which were developed from codex Alimentarius. I do not think there is intersection between GMP and ISO 9001 except the control of documents and records 4.2.3 and 4.2.4 since GMP should be supported by both documents and records.

 

[Ka Pilo]

In Fact the prerequisites program is based on GMP (Good Manufacturing Practices) which were developed from codex Alimentarius. I do not think there is intersection between GMP and ISO 9001 except the control of documents and records 4.2.3 and 4.2.4 since GMP should be supported by both documents and records.

What about the corrective and preventive actions? What is the difference between HACCP corrective/preventive actions and ISO 9001 corrective/preventive actions?

Is it more difficult to implement HACCP corrective and preventive actions than ISO 9001 corrective and preventive actions? If not, why not? If yes, in what way more difficult?

 

[Ka Pilo]

If you have the US FDA requirements for GMP and HACCP in place, getting ISO 22000 would be much easier.

Please discuss ISO 22000 as flowing from the GMP and HACCP systems. Can you enumerate other requirements of ISO 22000 which GMP and HACCP didn't address?

 

[Bilijaf]

The concept of corrective & preventive actions is the same for any management system. But again remember that HACCP is a program and not a standard, it would be better to take a look into the 7 principles of HACCP to understand more the requirements.

 

[tsmith7858]

The concept of corrective & preventive actions is the same for any management system. But again remember that HACCP is a program and not a standard, it would be better to take a look into the 7 principles of HACCP to understand more the requirements.

I would agree that the concepts are the same but the use of corrective actions as defined by HACCP and ISO 22000 are different than ISO 9000.

HACCP (and Section 7 of ISO 22000 which deals with HACCP) require "predetermined" corrections any time a Critical Limit is violated. An example would be the use of Metal Detection as a Critical Control Point. Say the critical limit is set at 2 mm and the detector is set to reject product with metal larger than 2 mm. A predetermined plan or "Corrective Action" must be established for what to do if the detector goes off. Do you shut down all processes, do you put everything on hold that has been run, do you look at the product that was rejected and determine where it came from, do you do a combination of these. Some people will not stop the process for one failure, particularly if they know the detector is working and will continue to reject bad product. However, most of them will have a limit that says, if there are multiple hits in a certain time frame then there is a risk of things being missed so the previous questions apply.

In the end there is corrective action (from the ISO 9001 viewpoint) taken to stop the issue from recurring and possibly preventive action in other areas but the initial corrective action for HACCP is not the same.

To the initial question on document control, the basic guidelines are the same for ISO 9001 and ISO 22000. We have both and use the same basic SOPs for each. HACCP does not state anything specific on document control but if you are looking at being HACCP certified or going to ISO 22000 you will need to show control of documents so the basic ISO principles on document control are a good base.

As mentioned, consult regulatory and customer guidelines for records retention but the shelf life plus one year that was mentioned is a good starting point. I disagree with the "10 year" statement unless your product has long enough of a shelf life to warrant it.

 

[Bilijaf]

I would agree that the concepts are the same but the use of corrective actions as defined by HACCP and ISO 22000 are different than ISO 9000.

HACCP (and Section 7 of ISO 22000 which deals with HACCP) require "predetermined" corrections any time a Critical Limit is violated. An example would be the use of Metal Detection as a Critical Control Point. Say the critical limit is set at 2 mm and the detector is set to reject product with metal larger than 2 mm. A predetermined plan or "Corrective Action" must be established for what to do if the detector goes off. Do you shut down all processes, do you put everything on hold that has been run, do you look at the product that was rejected and determine where it came from, do you do a combination of these. Some people will not stop the process for one failure, particularly if they know the detector is working and will continue to reject bad product. However, most of them will have a limit that says, if there are multiple hits in a certain time frame then there is a risk of things being missed so the previous questions apply.

In the end there is corrective action (from the ISO 9001 viewpoint) taken to stop the issue from recurring and possibly preventive action in other areas but the initial corrective action for HACCP is not the same.

To the initial question on document control, the basic guidelines are the same for ISO 9001 and ISO 22000. We have both and use the same basic SOPs for each. HACCP does not state anything specific on document control but if you are looking at being HACCP certified or going to ISO 22000 you will need to show control of documents so the basic ISO principles on document control are a good base.

As mentioned, consult regulatory and customer guidelines for records retention but the shelf life plus one year that was mentioned is a good starting point. I disagree with the "10 year" statement unless your product has long enough of a shelf life to warrant it.

Hi Tsmith
Thank you for your informative detailed reply.
Regarding predetermined correction in ISO 22000 or HACCP, it should be clarified and stated when determining the critical points and answering questions like (When, who, what) if a CCCP is out of the limit.
We need to distinguish between Corrections and corrective actions, as illustrated in 3.13 and 3.14 in ISO 22000. In case of corrective actions, root causes are to be investigated (which is not necessarely the case of correction) for preventing the reccurance of the problem.
Returning back to the example of metal detector, when metals larger than 2 mm are not rejected, than the CCP is out of the limits, and a predetermined correction should be taken (as stated in HACCP discussion).
If corrective action is to be taken then an investigation is to be done for finding the root causes (like saying device was out of calibration or positioning of metal detector is not correct).

 

[Ka Pilo]

Thank you for the incredible replies.

I would greatly appreciate if someone could share a sample HACCP control of document procedure.