Is anyone familiar with positive release program?
Started by Jay T, Apr 08 2009 04:32 PM
is anyone familiar with positive release program? Can you please help?
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Hi Jay,
What industry are you in, what products and processes?
Regards,
Simon
What industry are you in, what products and processes?
Regards,
Simon
Human and pet food
Do you have specifications for your end products?Human and pet food
Do you have a HACCP system?
Do you have any Critical Control Points?
Do you have any in process / end of line quality and safety checks of the products?
we do. However, I am interested in positive release program.
Any example?
Any example?
Dear Jay T,
The essential operational steps IMO are twofold – (a) Have the relevant results for every product lot to show compliance to specification and (b) be able to demonstrate that every lot is individually and specifically cleared for release(= use) before shipment, for example by notification from QA to the shipment controller, eg by a chronological form which can be validated. (Basically, no official listing as "approved" = no permission to ship).
Since you posted in the HACCP section, the requirements for (a) will directly relate to Simon’s questions.
Some previous, more general, threads here -
http://www.ifsqn.com...?showtopic=9519
http://www.ifsqn.com...p?showtopic=321
Obviously this topic overlaps traceability and can get quite complicated where there is a problem . (segregation etc)
Rgds / Charles.C
The essential operational steps IMO are twofold – (a) Have the relevant results for every product lot to show compliance to specification and (b) be able to demonstrate that every lot is individually and specifically cleared for release(= use) before shipment, for example by notification from QA to the shipment controller, eg by a chronological form which can be validated. (Basically, no official listing as "approved" = no permission to ship).
Since you posted in the HACCP section, the requirements for (a) will directly relate to Simon’s questions.
Some previous, more general, threads here -
http://www.ifsqn.com...?showtopic=9519
http://www.ifsqn.com...p?showtopic=321
Obviously this topic overlaps traceability and can get quite complicated where there is a problem
Rgds / Charles.C
1 Thank
Thanks Charles, that's where I was trying to lead Jay without spelling it out.
If all process steps and product checks are verified as completed as planned and as per the parametres of the specification and this has been documented and checked by a competent person then the product is good to go. Positive Release.
If all process steps and product checks are verified as completed as planned and as per the parametres of the specification and this has been documented and checked by a competent person then the product is good to go. Positive Release.
Thanks guys. Very informative.
Additional questions
Is there regulation coming up about positive release from FDA? if so, does it pertain to every lot test for salmonella or all quality checks?
Jay
Additional questions
Is there regulation coming up about positive release from FDA? if so, does it pertain to every lot test for salmonella or all quality checks?
Jay
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