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.