R
ritammy
First let me say how wonderful this site is. I find it very useful and thank everyone for their inputs.
We are a medical device Contract Manufacturer that is ISO 13485 certified. During a recent BSI audit it was observed that on our Rework Form there was no reference that risk was assessed prior to approving to rework. I modified our form to include a statement that reads: "By approval below the rework to be completed below has been evaluated and determined to not pose any adverse effect to form, fit or function of the device". Is it acceptable to simply do a letter to file that details that the risk was addressed. It seems crazy to do a full blown FMEA or PFMEA for this.
Additionally, what do other Contract Manufacturers do for Risk Management. Are we supposed to have a PFMEA for every process? I would like to develop a simple step by step, idiot proof form that addresses handling risks that are non design control related. Any thoughts.
I am aware of ISO 14971 and have reviewed it thoroughly and have a very comprehensive procedure based on it. However I am stuck on how to implement it and actually start using it. A lot of the procedure is for a manufacturer with design controls.
Thanks!
Tammy
We are a medical device Contract Manufacturer that is ISO 13485 certified. During a recent BSI audit it was observed that on our Rework Form there was no reference that risk was assessed prior to approving to rework. I modified our form to include a statement that reads: "By approval below the rework to be completed below has been evaluated and determined to not pose any adverse effect to form, fit or function of the device". Is it acceptable to simply do a letter to file that details that the risk was addressed. It seems crazy to do a full blown FMEA or PFMEA for this.
Additionally, what do other Contract Manufacturers do for Risk Management. Are we supposed to have a PFMEA for every process? I would like to develop a simple step by step, idiot proof form that addresses handling risks that are non design control related. Any thoughts.
I am aware of ISO 14971 and have reviewed it thoroughly and have a very comprehensive procedure based on it. However I am stuck on how to implement it and actually start using it. A lot of the procedure is for a manufacturer with design controls.
Thanks!
Tammy