Significant Organizational Changes - Documented Responsibilities

[cathysueb]

We are an ISO 13485:2016/MDSAP company. The company just went through a fairly significant organizational change which including changing names of departments and functions within the departments as well as moving various employees from one department to another. This is all shown on our Organizational Chart.

All of our procedures and work instructions has responsibilities set out in them.

My question is whether or not there is a "gap" (for lack of a better term) document that can be used to cover this and the actual procedures/work instructions be changed as revisions occur for other reasons.

Thank you.

 

[Ninja]

FWIW, my old system used to have an "QSI" option (Quality System Improvement)...like a waiver, but for a self-caught "oops".

I would put one of those in place to fend off the auditors with a due date of a year (or two, or three) to update the docs and complete the useless NVA stuff.

When updating the docs, I would take some time to determine how I could word them so that a future org change wouldn't make me have to do it over again...
The words "or equivalent" come immediately to mind...

"Production manager and/or subordinates (or equivalent) are authorized and responsible to..."
"Personnel trained to this document are authorized and responsible to..."

HTH

 

[regork]

cathysueb,
Yes, you can establish a roles, responsibilities, and authorities matrix that links the new departments to the old departments and the old role names to the new role names. Next you can define specific personnel roles, responsibilities, and authorities required to carryout the activities within your QMS.

The change you described has a significant impact on the company's QMS and you should create a quality plan that fully addresses the activities required to implement this change within your QMS. The plan would identify the possible matrix is a temporary method to identify the R,R&A and the actual update of the procedures would be the permanent solution.

Good Luck,
Steve.

 

[cathysueb]

Thanks for the great input and ideas. I agree it does have a significant impact on the Quality System and of course needs to be addressed. You both have given me some ideas to think about to have the changes addressed in an organized, swift as can be manner. Thanks!

 

[AUDITGIRL]

Hi Cathysueb,
I suggest finding a way to document the gap & plan such as discussing at management review. If that is not possible have a discussion about it during say an internal audit to document in internal audit results. You could also just have a plan together with milestones showing evidence of this pending change. If your document control process has a review time frame requirement (which it should - I have seen it as often as every six months and as far out as 3 years) and state as these documents are due for review they will be updated, as necessary.
Your plan must take into consideration the resources that you have to ensure success. I agree with Ninja. find a way to genericize titles to try to avoid this in the future. i.e. the head of quality, operators, engineering, etc. be careful if you use words such as equivalent because you may be challenged to prove equivalence; I would instead suggest or designee. Have a plan for how designee's are determined (or equivalence) so that you can answer the questions if and when it arises.
good luck.