JoshuaFroud
Involved In Discussions
Good Morning
I'm currently in the middle of a very difficult situation I would greatly appreciate some guidance on.
I work for a small but growing Medical Device company, we hold both 9001 and 13485 certifications. I started here December last year and have been updating their quality systems since.
The situation I am currently in is as follows;
About 3 years ago the company implemented a very low-level electronic document management system. At this time they re-wrote the change request procedure to exclude all Quality Documentation held within it, stating that the software handled this. The software allows any management level user to edit a document without prior request and only requires approval. There is a way to request a change but it can only go to the document owner. This, however, is not used. I did not agree with this but let it lie until I had cause to edit the document.
I was re-writing the change request procedure recently for a different unrelated reason and at this time amended the procedure to require the Change Request form be used for change approval for the Quality documents. Once the change was approved the form is filed and the electronic workflow takes over. This was approved and has gone live.
The problem I have encountered is one fairly senior member of staff is outright refusing to comply with the procedure saying it is a huge step backwards and has asked to be written out of the quality system as they are unwilling to follow the new procedure.
I have spoken to senior management about this and was told along the lines of "you need to work it out with them, if not we can discuss this further at management review and Top Management will make a ruling". Being the Senior Quality Representative for the organisation it has somewhat grated that my point of view may be overruled by length of service.
I would greatly appreciate is some guidance and references to applicable standards to back the procedure I have written (or someone on here with great knowledge than myself telling me I'm wrong). I'd be happy with either.
I'm currently in the middle of a very difficult situation I would greatly appreciate some guidance on.
I work for a small but growing Medical Device company, we hold both 9001 and 13485 certifications. I started here December last year and have been updating their quality systems since.
The situation I am currently in is as follows;
About 3 years ago the company implemented a very low-level electronic document management system. At this time they re-wrote the change request procedure to exclude all Quality Documentation held within it, stating that the software handled this. The software allows any management level user to edit a document without prior request and only requires approval. There is a way to request a change but it can only go to the document owner. This, however, is not used. I did not agree with this but let it lie until I had cause to edit the document.
I was re-writing the change request procedure recently for a different unrelated reason and at this time amended the procedure to require the Change Request form be used for change approval for the Quality documents. Once the change was approved the form is filed and the electronic workflow takes over. This was approved and has gone live.
The problem I have encountered is one fairly senior member of staff is outright refusing to comply with the procedure saying it is a huge step backwards and has asked to be written out of the quality system as they are unwilling to follow the new procedure.
I have spoken to senior management about this and was told along the lines of "you need to work it out with them, if not we can discuss this further at management review and Top Management will make a ruling". Being the Senior Quality Representative for the organisation it has somewhat grated that my point of view may be overruled by length of service.
I would greatly appreciate is some guidance and references to applicable standards to back the procedure I have written (or someone on here with great knowledge than myself telling me I'm wrong). I'd be happy with either.