7 replies to this topic

[Jay T]

is anyone familiar with positive release program? Can you please help?

Edited by Jay T, 08 April 2009 - 05:43 PM.

[Simon]

Hi Jay,

What industry are you in, what products and processes?

Regards,
Simon

[Jay T]

Human and pet food

Edited by Jay T, 08 April 2009 - 07:56 PM.

[Simon]

Human and pet food

Do you have specifications for your end products?

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?

[Jay T]

we do. However, I am interested in positive release program.

Any example?

[Charles.C]

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

[Simon]

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.

[Jay T]

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

Edited by Jay T, 09 April 2009 - 08:49 PM.