C
Ran into an interesting one recently.
A customer audited and was concerned because we completed a melt flow test on every 5th lot of resin. They felt we did not have a satisfactory raw materials verification procedure.
They will probably really be upset now because since then, I have completely eliminated melt folw testing for the following reasons:
1. We have never received a melt flow outside the stated range and hence, have never rejected a lot of resin for melt flow.
2. Melt flow for different resins can be within the same range, so what is it telling you?
3. We use major resin suppliers which provide resin certs and state the resin, lot number and melt flow.
So my question is, what would the FDA think? AND how do others verify that what is in the box is the same as what is stated on the incoming cert. because melt flow is definitely not conclusive.
Carl-
A customer audited and was concerned because we completed a melt flow test on every 5th lot of resin. They felt we did not have a satisfactory raw materials verification procedure.
They will probably really be upset now because since then, I have completely eliminated melt folw testing for the following reasons:
1. We have never received a melt flow outside the stated range and hence, have never rejected a lot of resin for melt flow.
2. Melt flow for different resins can be within the same range, so what is it telling you?
3. We use major resin suppliers which provide resin certs and state the resin, lot number and melt flow.
So my question is, what would the FDA think? AND how do others verify that what is in the box is the same as what is stated on the incoming cert. because melt flow is definitely not conclusive.
Carl-