7 replies to this topic

[lavalienteQA]

Hi ALL! 

 

Reviewing my current facilities plans against the code (food manufacturing) for internal audits.

 

 

 

2.3.1.5 The process flows for all new and existing manufacturing processes shall be designed to ensure that product is manufactured according to approved product formulations and to prevent cross-contamination. 

 

I am creating a product formulation SOP for new and existing processes that will include product develop and end with label review.

 

Would this satisfy this section since I will be detailing each process within the flow from beginning to end?

 

Thanks! 

[Scampi]

Have you created an actual flow diagram?  That is what this is asking for

[olenazh]

On your flow diagram, don't forget to indicate process parameters (e.g. time, temperature, pressure, etc.), CCPs, if any, quality checks, and other important information.

[Rick Reyes]

Good morning lavalienteQA, one suggestion when doing your process flow chart, don't forget to include ingredient receiving and at that point mention your approved supplier program. Olenazh is correct, any time you list a oPRP or CCP you should list the parameters for that process step (5.0 NonFE, 5.0 FE, 7.0 SS eg.).

[Scampi]

Remember, no one section of the food safety/haccp plan is/should be independent of another

 

your process flow diagram should be numbered, and those numbered steps have detailed control measures in place on your hazard analysis, and then the floor plan shows where any cross contamination may occur

 

you should have forms 1 through 10 (if applicable) https://inspection.c...4/1480440822085

 

https://www.fda.gov/...tion-guidelines

[lavalienteQA]

sorry, all. I should explain, we have HACCP/FSMS in place which shows our flow chart- that would suffice in this section? Since our HACCP outlines the shelf life- etc.

[olenazh]

sorry, all. I should explain, we have HACCP/FSMS in place which shows our flow chart- that would suffice in this section? Since our HACCP outlines the shelf life- etc.

Not sure what you mean by "we have HACCP/FSMS in place which shows our flow chart" - what does your flow chart show?

[Scampi]

Yes, it should suffice

 

IF you had a cross contamination issue, it should/would show on the process flow chart with overlapping lines----if there aren't any then there are no issues

 

Use the process flow to walk the line---document on your internal record that that is what you did-any issues should appear when you do this----things you may not have thought of, but will become glaringly apparent when you walk the process