I just wrote him out of the system.
While 4.1.3 requires “management with executive responsibility…” it does not require
ALL “management with executive responsibility…” and ISO 900x does not require management commitment, although it
greatly influences success. The word ‘commitment’ can be found only at 4.1.1 which requires:
…supplier’s management with executive responsibility shall define and document its policy for quality, including objectives for quality and its commitment to quality.
A registrar may be able to stretch this to a noncompliance, but I doubt it.
I have had to do a similar situation here, but not for the reasons cited above. The President of my firm is physically located in the corporate office, approximately 800 miles from the manufacturing facility. The corporate office is outside the scope of this registration. He visits manufacturing approximately six hours a month, mainly to discuss business operations. His commitment to the system is high and he demonstrates it each time he visits, but this condition did create a management review problem.
While this situation is tricky, it can be done. The procedures for Management Review were written such that the President is involved in management review but does not have to attend review meetings (Besides, review ‘meetings’ are not even
required). He provides input through advanced notice of meetings, an agenda and a request to reply by return his inputs. If none, he states “none” and the meeting is conducted between myself and the VP’s. If he has inputs, there are discussed at the meeting, with myself as the President’s liaison. Afterwards, he is provided minutes of the meeting stating his involvement as outlined above, and signed acceptance of the minutes is requested by return, which he does faithfully. While 4.1.3 does not REQUIRE procedures, the above is very well documented in them, probably to the overkill point, but I wanted my FDA bases covered.
Besides, when it comes to our ISO and FDA system, I have the last and final word, not the President and the employees (including the VP’s) know this.
Perhaps a variation on the above may be useful in Michael’s situation. I would recommend not ‘writing him out,’ but rather include him indirectly through procedures.
As to Kevin’s comments regarding the negative impact of dad’s behavior, I would tend to agree in part, but I will withhold judgement without knowing dad’s involvement in operations and how seriously employees regard dad, as Tom correctly pointed out. If they know he is a ‘loose cannon’ and the son really runs the show, that should be considered as well. This was exactly the case at one company I worked for. Dad owned the company, but did not run it. His only involvement in day-to-day operations was to arrive when he wanted, smoke cigars, read the paper, sign checks and then leave when he wanted. The employees knew who ran the show (Executive VP-his son) and there was virtually no trickle down effect from dad’s behavior (other than the cigar smell from his office).
I think to assume that the registration is "smoke and mirror" is too harsh a conclusion.
I agree within the confines of the concerns and comments stated in my previous paragraph.
Regards,
Don