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Does a process under Statistical Process Control need to be a CCP?


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#1 micampelos


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Posted 15 October 2013 - 03:31 PM



My company has a product that is filled into a pouch - we control the weight of components that goes into the pouch.


The pouch is then sealed.


Then the pouch passes through a checkweigher.


Later the product undergoes a thermal process.


All 4 steps are currently considered CCP's- the component weight and the total weight- because the thermal process is validated for a worst case scenario of excess weight.


1) If the SPC shows that filling of component weight and the total weight are well within the accepted limits, can I consider the likelihood of ccurrence as low and the hazard non significant?


2) What statistics should I calculate to prove that the process is under statiscal control? Std deviation? Should the Std deviation always be under 1 std? 2x std? 3x Std?


2) For what period of time should I look into to accept that the SPC proves that the process is under control?


Is there any document that you can advise over this?


Thank you for all your inputs.

#2 Charles.C


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Posted 15 October 2013 - 07:07 PM

Dear micampelos,


Seems to be a combination post, haccp and SPC. I presume this is a sterilization process.


i have a few comments on the haccp aspect.


Retorted pouches not my area of expertise but this hazard analysis seems rather unusual.


I do not see any mention in the OP but, IMO, any significant (safety) hazard is likely to be microbiological in nature. C.botulinum ?


I would hv thought any validation would involve primarily factors like the external dimensional parameters of the pouch / the coldest location within the pouch / product matrix.? Seems improbable but perhaps these have all been combined / correlated to the gross weight  ?


Subsequent control of the safety of the process would then require specification of Critical Limits, or rather Limit in this case, the value being derived from the validation procedure. usual procedure is to set an "Operational Limit"  of more conservative value than the Critical value so as to avoid triggering a detailed corrective action. Similar concept to the warning level in SPC  but tends to be more empirical in haccp.


For canning processes, i believe the CCPs are often legislatorily defined. Pouches, no idea.


Rgds / Charles.C

Kind Regards,



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