Deviation Procedure example wanted

[Ka Pilo]

The title says all I am asking.

When I say deviation procedure, I mean a pre-determined and documented set of corrective actions which are implemented when a deviation occurs.

 

[Pancho]

Re: Seeking an example of a Deviation Procedure

Hi Ka Pilo,

I'm a bit confused by your question.

What is a "deviation" deviating from? Is this another name for a non-conformity or a defect?

Also it appears to me that "a predetermined ... set of corrective actions" is contradictory. A corrective action is an action to eliminate a root-cause. How could such action be "predetermined"?

Are you seeking a sample procedure to handle non-conformities, as required by ISO 9001 sec. 8.3, or something else?

Pancho

 

[Ka Pilo]

Re: Seeking an example of a Deviation Procedure

Hi Pancho,

I am seeking a sample procedure to handle non-conformities, as required by ISO 22000.

If you are a bit confused by my question, I apologize because I am confused about the requirement. How do you interpret the following?

7.6.5 Actions when monitoring results exceed critical limits Planned corrections and corrective actions to be taken when critical limits are exceeded shall be specified in the HACCP plan.

It's clear that it includes the planning of how the corrections and corrective actions should be taken.

Some of my questions -
Can you plan a corrective action?
Can you identify the root cause of future problems?
What should be included in the Deviation Procedure?

EDIT: Deviation - Failure to meet required critical limits for a critical control point.

 

[qusys]

Re: Seeking an example of a Deviation Procedure

Hi Pancho,

I am seeking a sample procedure to handle non-conformities, as required by ISO 22000.

If you are a bit confused by my question, I apologize because I am confused about the requirement. How do you interpret the following?

It's clear that it includes the planning of how the corrections and corrective actions should be taken.

Some of my questions -
Can you plan a corrective action?
Can you identify the root cause of future problems?
What should be included in the Deviation Procedure?

EDIT: Deviation - Failure to meet required critical limits for a critical control point.

Hi Ka Pilo,
I am not an expert of ISO 22000, but I would like to contribute based upon ISO 9001/ISO TS experience, trying to make a comparison between requirements of the prior standards.
For first question, I would say yes, because you could implment a so called " reaction mechanism" when you have a out of specification point in your production control system. Based upon the several process steps of your product realization, you could document how operator and tech shall behaviour when there is an "unexpected" event that could jeopardize the quality of your product. I imagime you could have a series of these procedure, that can be linked in HACCP plan. This could be similar to the Control Plan that is commonly used in automotive industries.
In these procedure you should report how to react in case of a problem ( I mean process, equipment, material, human etc...) and what you do on the processed material ( rework, scrap, on hold waiting of other control and so on ) as well as how you track suspected material that have been produced in the meantime, when you had out of spec.
These procedures shall have authority, responsiblity of the involved staff.
As to corretctive action procedure is a procedure of higher level, that include corrective action in case of problem from incoming to shipping.
The procedures of reaction mechanism are more orientied to be on the floor issues.
Hope this helps

 

[somashekar]

Re: Seeking an example of a Deviation Procedure

7.6.5 Actions when monitoring results exceed critical limits Planned corrections and corrective actions to be taken when critical limits are exceeded shall be specified in the HACCP plan.

Can you plan a corrective action?
Yes. You must have a procedure that will let you take systamatic action involving concerned people when critical limits exceeds. This lets you to take appropriate action and helps avoid panic.
Can you identify the root cause of future problems?
This is not expected, but your procedure must be robust enough to dwell into rootcause for a limit exceeded situation as well as help take quick containment action.
What should be included in the Deviation Procedure?
Everything of a PDCA for your various defined processes, including who are the responsible managers who have to take actions and decisions, when a critical limit is found exceeded.