cubix rube
Involved In Discussions
1. In more than one recent audit, we were issued nonconformances for not conducting process validations. In reading both ISO 13485, as well as 21 CFR 820, it says validation must be performed n "special processes", whose output cannot be verified through subsequent monitoring and measuring", e.g. sterilization, heat treating, etc. We are a die cutting facility, and we do not have any special processes, whose output cannot be verified by subsequent monitoring and measuring. Even though we've explained this, they still include it as a nonconformance.
2. Our change control procedure indicates that customers will be notified if a change affects cost or delivery of their product. We were issued a nonconformance on a recent audit because our procedure does not specifically state that we would notify our customer of a change that does not affect cost or delivery. For instance, a material callout that says, "black EPDM rubber sheet 40 durometer shore A". If I switch from one supplier to another, supplying identical material that indeed meets the same spec., where does the standard state that I must notify my customer?
I have looked extensively through the aforementioned standards, and have found no specific requirement for either of these. For the record, we do notify customers prior to making any changes that would affect their parts, such as materials, or such, and I understand why a customer would want such notification, but isn't that usually addressed in Terms and Conditions, or stated on a PO issued by the customer? These are QMS audits, and our QMS was developed to meet 13485, which it does.
Can somebody please direct me to the clause/paragraph/etc. where these requirements are specifically stated, i.e. process validation for a process whose output CAN be verified, and notification to a customer prior to making a change?
Thank you!
2. Our change control procedure indicates that customers will be notified if a change affects cost or delivery of their product. We were issued a nonconformance on a recent audit because our procedure does not specifically state that we would notify our customer of a change that does not affect cost or delivery. For instance, a material callout that says, "black EPDM rubber sheet 40 durometer shore A". If I switch from one supplier to another, supplying identical material that indeed meets the same spec., where does the standard state that I must notify my customer?
I have looked extensively through the aforementioned standards, and have found no specific requirement for either of these. For the record, we do notify customers prior to making any changes that would affect their parts, such as materials, or such, and I understand why a customer would want such notification, but isn't that usually addressed in Terms and Conditions, or stated on a PO issued by the customer? These are QMS audits, and our QMS was developed to meet 13485, which it does.
Can somebody please direct me to the clause/paragraph/etc. where these requirements are specifically stated, i.e. process validation for a process whose output CAN be verified, and notification to a customer prior to making a change?
Thank you!