C
craig-c
Hello Everyone,
We are working towards ISO 9001-2000 certification and have run into a bit of a problem with two different consultants pointing us down different paths with respect to Corrective Action / Preventive Action / and continuous improvement changes to our products. One path requires that all changes be tracked as either a Corrective or Preventive Action while the other path requires a new set of actions/documents/reviewers for any action deemed by our Quality Dept. to be a Preventive or Corrective Action.
I am seeking additional input.
Current Change Processes
1. Non Conformance -> Corrective Action -> RFC (Request for Change) -> Review -> ECO (Engineering Change Order) -> Approval of new docs -> Implementation
2. Process change (maybe the assemblers would like to change the assembly steps, documentation change) that is not tied to a Non Conformance: RFC (Request for Change) -> Review -> ECO (Engineering Change Order) -> Approval of new docs -> Implementation
3. Feature addition (adding a mounting hole in a bracket): RFC (Request for Change) -> Review -> ECO (Engineering Change Order) -> Approval of new docs -> Implementation
4. Preventive Action (documentation changed to prevent incorrect building of parts): RFC (Request for Change) -> Review -> ECO (Engineering Change Order) -> Approval of new docs -> Implementation
It has been proposed that any change made to a item or document be labeled as a corrective or preventive action and then documented as such. For a lot of the changes that are made that aren't tied to a non-conformance or to prevent a non-conformance, this seems to be an undue burden.
How do other companies handle changes that do not stem from non-conformances or are to prevent nonconformities? The RFC->ECO process has served us well for 25+ years and the proposed additional paperwork seems to be just an additional burden.
Thanks for your help.
We are working towards ISO 9001-2000 certification and have run into a bit of a problem with two different consultants pointing us down different paths with respect to Corrective Action / Preventive Action / and continuous improvement changes to our products. One path requires that all changes be tracked as either a Corrective or Preventive Action while the other path requires a new set of actions/documents/reviewers for any action deemed by our Quality Dept. to be a Preventive or Corrective Action.
I am seeking additional input.
Current Change Processes
1. Non Conformance -> Corrective Action -> RFC (Request for Change) -> Review -> ECO (Engineering Change Order) -> Approval of new docs -> Implementation
2. Process change (maybe the assemblers would like to change the assembly steps, documentation change) that is not tied to a Non Conformance: RFC (Request for Change) -> Review -> ECO (Engineering Change Order) -> Approval of new docs -> Implementation
3. Feature addition (adding a mounting hole in a bracket): RFC (Request for Change) -> Review -> ECO (Engineering Change Order) -> Approval of new docs -> Implementation
4. Preventive Action (documentation changed to prevent incorrect building of parts): RFC (Request for Change) -> Review -> ECO (Engineering Change Order) -> Approval of new docs -> Implementation
It has been proposed that any change made to a item or document be labeled as a corrective or preventive action and then documented as such. For a lot of the changes that are made that aren't tied to a non-conformance or to prevent a non-conformance, this seems to be an undue burden.
How do other companies handle changes that do not stem from non-conformances or are to prevent nonconformities? The RFC->ECO process has served us well for 25+ years and the proposed additional paperwork seems to be just an additional burden.
Thanks for your help.