Re: Management Representative
I audit for BSI to ISO 13485 (medical QMS) & 9001 (QMS). The intent of the 9001 Standard was always to have the MR be part of management, but some companies did not interpret the Standards in this way. With the 2008 revision of 9001, the possibility of misinterpretting the meaning is much less likely.
Sorin was on the right track when it was suggested to have "training" as the CA.
The first step is to identify a suitable root cause for your response. You have a couple of choices:
1) Management Oversight is a common response.
2) Insufficient training on the 9001:2008 Standard is another possible choice.
3) Misunderstanding how to effectively identify responsibility and authority is a third possible choice.
For #1, your CA could involve development of a systematic checklist for regulatory requirements in the Standard...your own internal desktop audit to be performed by a person trained as an internal auditor, but someone that did not write the Quality Manual.
For #2, there are several course available and webinars. I teach a one-day course on this. BSI offers a 2-day course. The webinars are cheapest. If you choose to be "self-taught" you still need to document training and develop some way to evaluate effectiveness of training.
For #3, best practices are to identify the MR in the org chart and in a job description. The title will need to include the title "Manager". If the person is a Quality Engineer, change the title to Quality Engineering Manager. The differentiation between this person's job description and other QE's could be as simple as having the MR responsibilities added.
The definition of "Management" is typically the stumbling block. Most people think of managers requiring that they have other people reporting to them. This is not an absolute. The MR should report directly to a top manager such as the President or CEO to prevent conflicts of interest. As a manager, they should not require a lot of direct supervision and the President or CEO should not be overly burdened by adding one person to their list of direct reports. Some auditors like to see a "deputy MR" identified. My advice is to have the CEO or President sufficiently trained that they can be the "back-up" when the MR is on vacation. Every manager should know enough about their subordinates job duties that they can "fill in." MR's should be involved in senior staff meetings too, but not necessarily at the same frequency as every other senior staff manager. Typically operations and sales have the most frequent meetings with the CEO--often weekly. Finance is typically monthly. HR and the MR might be bi-monthly or Quarterly. Communication of the status of Quality Objectives should be regular reports to all senior staff, but you don't have to have a Management Review to communicate the status. If the company is small enough to have only one QA person, there probably isn't a need for more than one or two management review meetings per year.
Before you submit your revised CA plan, think about how you are going to evaluate effectiveness of the corrective action. Internal Audits and monitoring quality metrics are the most common methods for performing an effectiveness check. If you settle on #3 as the CA, you might give the senior staff a quiz on management responsibilities to evaluate the effectiveness of training. A 15 minute multiple choice quiz is short and objective.
Good luck.
If you are still having trouble, it might help to know what reason the auditor is giving for rejecting your plan.
ikon put at the beginning of the subject line in post # 111 ~~~
