HI,
Has any one heard of backwards traceability for dietary suppluments? The company I work for is looking into implemnting a computer system for this function and now that the cost is being looked at they want to see justification for implementing such a costly project.
I thank any one that can shead some light on this.:thanx:

In my industry backwards traceability refers to being able to trace a single device and each of it's subcomponents back through all manufacturing processes including manufacturing / test / inspection records back to raw material lots.

Conversely, forward traceability refers to starting with a raw material lot (or sub component lot) and tracing every device that contains that raw material.

My experience with traceability in automotive is the same.

It is hard for many people to understand, but you can have perfect traceability in one direction and it will break down in the opposite direction.

Both are important. If you have a field issue, you need to trace backwards to the component or material that caused the issue. If you then need to recall product, you need to trace forward to all product built using this component or material.

The point about "traceability" is always COST
(forward - if something screws up and you have to notify buyers to fix or recall products because they pose life, injury, safety hazards.)
(backward - to eliminate the component or material which may have caused the glitch to avoid continuing the error (all errors have forward consequences, compounding the cost in spoilage because of added materials and labor cost which are lost) - remember the ditty which goes "for the want of a nail, the shoe was lost, for the want of a shoe, the horse was lost, for the want of a horse, the rider was lost, for the want of a rider, the battle was lost."

Therefore, the risk analysis for the organization implementing traceabilty is always balancing the "what if" cost of potential recall of ALL products against the prevention cost (allowing recall to to be limited to certain lots, etc.) and being able to trace and correct a gitch in the backward traceability with little fuss and muss.

Good point Wes, but sometimes traceability is a regulatory requirement. Dietary supplements may be covered by the FDA, which probably requires traceability.

Good point Wes, but sometimes traceability is a regulatory requirement. Dietary supplements may be covered by the FDA, which probably requires traceability.
Right! My post gave a COST reason for ANY manager in ANY business to consider - if it is a regulation, there is simply no option for the manager, except fraud!

In the same parlance, Bidirectional traceability is a term that indicates the ability to trace both forward and backward

I worked in automotive in various 'critical systems' such as airbags and braking systems where bidirectional traceability was required as is the case in drugs and such. One had to be able to trace an assembly within a car back to the OEM within 24 hours and to each component manufacturer within another 24 hours. Then you had to be able to trace to every car that component or assembly went into. Finding every car a component or assembly went into was another story.

These are a great responces and I Thank You all. What I'm now concerned with is I've heard but can't substansheate is "Is there a Need" to have back ward traceability for the Dietary Supplaments manufactor.
Someone told me that in the next year the FDA was going to mandate it but they never said if it is a requirment as of now or not. I've looked on the FDAa' web site but can't find anything. I'm new (fresh out of school) and have been hired to be a QA manager for this company and they now want me to "help" them become complient with regulations (something I've told them I know little about) I'm more veresed in ISO. I want to have a computer tracking system for various reasons and one BIG one is for inventory control and the back wards thing. I jsut need varification that we NEED it.
Any help would be Very Welcomed.
Thank you in advance~Dawn:thanx:

Hi pettie,

FDA has already one Draft Guideline which requires you to have both forward and backward traceability - refer INGREDIENT IDENTITY TESTING RECORDS AND RETENTION (http://www.cfsan.fda.gov/~dms/facgmp.html)

These are a great responces and I Thank You all. What I'm now concerned with is I've heard but can't substansheate is "Is there a Need" to have back ward traceability for the Dietary Supplaments manufactor.
Someone told me that in the next year the FDA was going to mandate it but they never said if it is a requirment as of now or not.

Some form of traceability is necessary for an effective corrective action system anyway (looking at external rejects). It may well be worth getting ahead of the game though before traceability is mandated.