Hi All,
Looking for some guidance on the requirement for independence within clause 5.5.1
Previously I've worked at large companies that have had dedicated quality control departments, completely independent of production, product goes into QC - gets tested by the QC op - gets signed off by the QC supervisor - goes back out and gets packed - goes back in to QC - gets inspected by the QC op - gets signed off by the supervisor - goes out the door.
The documented interrelation and independence of the personnel in those situations is very clear, they report to individual managers who have distinct roles and each shows the QC supervisor/manager has the authority to perform his/her duty with regards to quality of the product.
I've found myself working with a very small company (fewer than 10) where it's not possible to have separate people performing each of these functions, in some cases it is possible for a single person to take a product from incoming component inspection through to final device packing and release which to me does not seem quite right.
I'm looking for some help in acceptable solutions to this, whether change is required or whether I'm coming from "big company mindset".
I appreciate the requirement isn't asking for absolute independence, as stated by MIREMGR in a previous thread (Quality Staff - Independence (ISO 13485 Clause 5.5.1) ), but I'm not sure what is required minimally where the company is so small.
Is it acceptable to have a single individual performing both assembly and test/inspection so long as within the documented roles and responsibilities within the business , quality and release are to a different member of management than the production management?
Once release testing has been performed does it need secondary approval from another individual reviewing documentation?
Thanks in advance.
Looking for some guidance on the requirement for independence within clause 5.5.1
Top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks.
Previously I've worked at large companies that have had dedicated quality control departments, completely independent of production, product goes into QC - gets tested by the QC op - gets signed off by the QC supervisor - goes back out and gets packed - goes back in to QC - gets inspected by the QC op - gets signed off by the supervisor - goes out the door.
The documented interrelation and independence of the personnel in those situations is very clear, they report to individual managers who have distinct roles and each shows the QC supervisor/manager has the authority to perform his/her duty with regards to quality of the product.
I've found myself working with a very small company (fewer than 10) where it's not possible to have separate people performing each of these functions, in some cases it is possible for a single person to take a product from incoming component inspection through to final device packing and release which to me does not seem quite right.
I'm looking for some help in acceptable solutions to this, whether change is required or whether I'm coming from "big company mindset".
I appreciate the requirement isn't asking for absolute independence, as stated by MIREMGR in a previous thread (Quality Staff - Independence (ISO 13485 Clause 5.5.1) ), but I'm not sure what is required minimally where the company is so small.
Is it acceptable to have a single individual performing both assembly and test/inspection so long as within the documented roles and responsibilities within the business , quality and release are to a different member of management than the production management?
Once release testing has been performed does it need secondary approval from another individual reviewing documentation?
Thanks in advance.