Releasing Product Prior to Positive Release Being Completed for Customer

We are a comanufacturing site for ice cream and I have written a positive release program which complies with SQF and FDA.

A brand we produce for needs the product ASAP and wants it sent to them prior to it being positive released.

My management has told me that we can do it as long as we get a waiver signed that releases our site from all liability.

I have worked at 2 very large manufacturers and have never heard of this before, so I am hesitant on allowing a waiver to be signed that bypasses our program.

Any insight on this would be helpful. Thank you!

I would consider circumventing a positive release program for sales reasons to be a bad call. Regardless of liability concerns, it goes against any commitments your company has towards public safety. We're all aware that "Food Safety Commitment" has had increased focus in GFSI in recent years. I think that focus is precisely for these situations. The purpose of your management team being committed to food safety is not to limit your company's liability, but to reduce the risk of foodborne illness in our world's food supply.

I agree with Brothbro here.  This is essentially moving a goal post and if you allow this to happen once, it will be requested again, Its a slippery slope.  Positive release is there for a reason and all need to stand by it and back that up.  

The customer signing a liability release for you does nothing to prevent the tarnished image your company faces from a recall due to errors or contamination present when you ship prior to your release criteria.

You've established the criteria for release.  As QA, the only choices you have are to evaluate release and determine if any steps can be speed up, then modify the program.

But when these situations come up, the root cause is usually a scheduling, production, or sales issue that they'll then attempt to blame QA for causing delays.  But ultimately the product run should be scheduled in such a manner to meet the date, or your company needs to tell the customer what realistic shipping expectations look like.

But when these situations come up, the root cause is usually a scheduling, production, or sales issue that they'll then attempt to blame QA for causing delays.

This is exactly it, if your business is suddenly unable to meet orders you need to re-evaluate your sales projections, production scheduling, and purchasing habits, not your release protocol.

It's a sacred no go.

As an Auditor I've seen companies think it was ok to issue a waiver but I never saw a waiver that didn't have at least a fail on it.

So, don't do it.

Hi rwilliams,

Since Ice Cream has a relatively long life, this appears to be an order/planning issue.

Why should your food safety systems be compromised because other departments cannot get their act together?

Have a word with the relevant people !  :bop:

Kind regards,

Tony

A waiver does not remove the legal responsibility of the manufacturer in the event that test results indicate a product is compromised (microbiologically or chemically).  If product has shipped and it is unsafe it is an automatic recall.  The cost of being late with an order to a customer is miniscule in comparison to the cost of lost business and bad publicity due to a recall.  Ice cream is considered an RTE item and anything that falls into that category must always be held to a higher standard.  So never compromise your Hold/Test procedure.

When our QA Manager is asked to "bend" the rules, he creates a short document that places full responsibility on the owner (or whomever is asking for the concession). Something like "I (owner's name here) accept all responsibility for any issues arising from the early release of this product and understand that I have been told by (the QA Manager's name here) it is in direct violation our release policy." This is given to the owner and usually he hands it back unsigned and goes and talks to sales and tells them the customer will have to wait. Until you force them to understand the potential danger of their request you'll continue getting the requests. As was stated before, you made those rules for very specific, good reasons, why would you violate them any time for any reason?

Read the story about Blue Bell. Ice cream is a high risk product. 

If a recall occurs - the FDA won't care about liability. They will be looking at your facility and your policies. They will do a swab-a-thon. The owner signed the Food Safety Plan, they will be ultimately responsible in the FDA's eyes. Then it will fall on QC. 

They'll also look at the other products you make. So while the other company may cover your costs, ultimately that is nothing compared to the headache you would be going through with the FDA and auditors. 

The waiver is really only "good for" your liability to the direct customer, not the consumer who is ultimately being protected by that positive release system.  The regulatory and certifying bodies are still holding you responsible for what you manufacture.