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mind over matter

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Posted 10 January 2011 - 07:39 AM

I know that a document is any item that captures and communicates information. But in the context of ISO 22000, what kind of document each of the following? A procedure? Instruction? Forms? Or what?



1) Identification and Control of Outsourced Processes

2) Documents that specify how prerequisite programme activities are managed

3) Information required to conduct the hazard analysis

4) Descriptions of raw materials to the extent needed to conduct the hazard analysis

5) Descriptions of Ingredients to the extent needed to conduct the hazard analysis

6) Descriptions of product-contact materials to the extent needed to conduct the hazard analysis

7) The characteristics of end products

8) Descriptions of the intended use to the extent needed to conduct the hazard analysis

9) Descriptions of the reasonably expected handling of the end product to the extent needed to conduct the hazard analysis

10) Descriptions of any possible unintended but reasonably expected mishandling and misuse of the end product to the extent needed to conduct the hazard analysis

11) Descriptions of the methodology and parameters used for the categorization of control measures as belonging to the HACCP plan or Operational prerequisite programmes

12) The food safety hazard or hazards to be controlled by each operational prerequisite programme

13) The food safety hazard or hazards to be controlled by each operational prerequisite programme

14) The control measures used by each operational prerequisite programme

15) The corrections and corrective actions for each operational prerequisite programme

16) The responsibilities and authorities for each operational prerequisite programme

17) The HACCP plan and identified critical control points (CCPs)

18) The food safety hazards to be controlled at each critical control point

19) External documents relevant for the food safety activities including statutory, regulatory and customer requirements

20) The critical limits applied at each critical control point

21)The rationale for the chosen critical limits

22) The corrections and corrective action to be taken if critical limits are exceeded for each critical control point

23) The responsibilities and authorities for each aspect of the critical control point

24) The control measures used at each critical control point



tsmith7858

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Posted 11 January 2011 - 09:10 PM

I know that a document is any item that captures and communicates information. But in the context of ISO 22000, what kind of document each of the following? A procedure? Instruction? Forms? Or what?



1) Identification and Control of Outsourced Processes

2) Documents that specify how prerequisite programme activities are managed

3) Information required to conduct the hazard analysis

4) Descriptions of raw materials to the extent needed to conduct the hazard analysis

5) Descriptions of Ingredients to the extent needed to conduct the hazard analysis

6) Descriptions of product-contact materials to the extent needed to conduct the hazard analysis

7) The characteristics of end products

8) Descriptions of the intended use to the extent needed to conduct the hazard analysis

9) Descriptions of the reasonably expected handling of the end product to the extent needed to conduct the hazard analysis

10) Descriptions of any possible unintended but reasonably expected mishandling and misuse of the end product to the extent needed to conduct the hazard analysis

11) Descriptions of the methodology and parameters used for the categorization of control measures as belonging to the HACCP plan or Operational prerequisite programmes

12) The food safety hazard or hazards to be controlled by each operational prerequisite programme

13) The food safety hazard or hazards to be controlled by each operational prerequisite programme

14) The control measures used by each operational prerequisite programme

15) The corrections and corrective actions for each operational prerequisite programme

16) The responsibilities and authorities for each operational prerequisite programme

17) The HACCP plan and identified critical control points (CCPs)

18) The food safety hazards to be controlled at each critical control point

19) External documents relevant for the food safety activities including statutory, regulatory and customer requirements

20) The critical limits applied at each critical control point

21)The rationale for the chosen critical limits

22) The corrections and corrective action to be taken if critical limits are exceeded for each critical control point

23) The responsibilities and authorities for each aspect of the critical control point

24) The control measures used at each critical control point



By the context of ISO, you can call them whatever you like! ISO used to get caught up in Standard Operating Procedure or Work Instruction or many other terms for documents but now you can use whatever term you want.

Most auditors will want some sort of consistency so they can understand what you have but I have seen people define documents as Level 1, Level 2, Level 3, etc. with Level 1 being the high level overview like a manual or policy and each level getting to more detail down to basic forms.

I call a HACCP plan, well, a HACCP plan. Why give it another title? I do call a PRP (Pre requisite program) an SOP (Standard Operating Procedure) because it fits better with the rest of my system (integrated ISO 22000 and 9001) and reduces the terminology.

Do what works for you!


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Zeeshan

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Posted 12 January 2011 - 07:14 AM

I know that a document is any item that captures and communicates information. But in the context of ISO 22000, what kind of document each of the following? A procedure? Instruction? Forms? Or what?



1) Identification and Control of Outsourced Processes

2) Documents that specify how prerequisite programme activities are managed

3) Information required to conduct the hazard analysis

4) Descriptions of raw materials to the extent needed to conduct the hazard analysis

5) Descriptions of Ingredients to the extent needed to conduct the hazard analysis

6) Descriptions of product-contact materials to the extent needed to conduct the hazard analysis

7) The characteristics of end products

8) Descriptions of the intended use to the extent needed to conduct the hazard analysis

9) Descriptions of the reasonably expected handling of the end product to the extent needed to conduct the hazard analysis

10) Descriptions of any possible unintended but reasonably expected mishandling and misuse of the end product to the extent needed to conduct the hazard analysis

11) Descriptions of the methodology and parameters used for the categorization of control measures as belonging to the HACCP plan or Operational prerequisite programmes

12) The food safety hazard or hazards to be controlled by each operational prerequisite programme

13) The food safety hazard or hazards to be controlled by each operational prerequisite programme

14) The control measures used by each operational prerequisite programme

15) The corrections and corrective actions for each operational prerequisite programme

16) The responsibilities and authorities for each operational prerequisite programme

17) The HACCP plan and identified critical control points (CCPs)

18) The food safety hazards to be controlled at each critical control point

19) External documents relevant for the food safety activities including statutory, regulatory and customer requirements

20) The critical limits applied at each critical control point

21)The rationale for the chosen critical limits

22) The corrections and corrective action to be taken if critical limits are exceeded for each critical control point

23) The responsibilities and authorities for each aspect of the critical control point

24) The control measures used at each critical control point



We are using following types of documents.

Manual
Document containing the structure and policies of system including description and interaction of processes.
Procedure
Document containing a brief step-by-step way to perform a group of activities related to a specific area such as production, maintenance etc.
Diagram
Examples are organization chart, functional chart, process flow diagrams etc.
Specifications
Document containing technical details related to a system, process, material, machine, product etc. Such as plans, product characteristics, raw material specification etc.
Work Instructions
Document containing detailed instructions specific to a process or an operation.
Form Formats
Document used to record data and information to provide evidence of activities performed.
External Documents
Documents of external origin. External origin may be customers, suppliers or any other external organization.
Annexures
A document which is a sample or guideline that can be used to generate actual document. For example sample recall record, sample audit checklist etc. Annexures could be associated with a manual or a procedure.

Any type of documentation requirement is fulfilled by preparing either a manual, procedure, diagram, specification, work instruction, form format or annexure or controlling a document as external document. For example, we have separately controlled our quality and food safety policy as Annexure of Manual. Whenever it requires to be reviewed and updated, new issue of that Annex is released.

Taking one to two examples from your list, I would suggest following type of documents:

1) Identification and Control of Outsourced Processes.............Identification could be documented in Diagram (Process Flow Diagram) andControl could be documented in separate or existing procedure or manual.

2) Documents that specify how prerequisite programme activities are managed..............We have documented our PRP's as separate procedure. You can documents them as PRP plan also in which you can specify which PRP is managed by whom with what frequency and what monitorin records are mainained. One suggestion is to make a PRP plan with important information for stakeholders and put a references there to detailed procedure.

I strongly agree with tsmith. Just amend his comments "Do what works BETTER for you! I have seen people are confused with terminologies of documentation. Some are confused among SOP's, procedure and work instructions, some are stucked up in defining process charts and specifications. IMHO, we should titled our documents as simple and generic as possible whcih any body could understand, use or refer.

Hope it helps!


M.Zeeshan.


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