QA Manager's Responsibility at a Work Place

What is a QA manager's responsibility at a work place?
Does QA manager have anything to do with Regulatory Affairs?

Thank you

Re: QA manager's Responsibility

vinqua said:

What is a QA manager's responsibility at a work place?
Does QA manager have anything to do with Regulatory Affairs?

Thank you

Click to expand...

Somewhere, there should be a clear definition of "Responsibility and Authority" within your management system. The organization; typically Top Management, in cooperation with Human Resources develop the job descriptions. Although not specifically required, job descriptions are very common in American industry.

Bottom line: Responsibilities are determined by Top Management and Regulatory Affairs can be part of them.

Stijloor.

Re: QA manager's Responsibility

vinqua said:

What is a QA manager's responsibility at a work place?
Does QA manager have anything to do with Regulatory Affairs?

Thank you

Click to expand...

I have moved this post to this forum, since it specifically asking for duties and responsibilities of the QA Manager.


The responsibilities of a QA Manager is based upon the Company's definition and responsibilities. I have heard that Regulatory and Quality fall hand in hand for title and responsibilities.

Here at the company I am currently working identified the QA Manager (I am the QA Director which he reports to) as someone that is responsible for all machining, and inspection from the Quality aspect.

As I said, it can vary from company to company.

Re: QA manager's Responsibility

Hello!!

The responsibility of a QA manager can be extremely narrow to quite vast. The exact responsibilities will vary from organization to organization, and even within departments in the same organization.

And yes, that may even include regulatory affairs, depending on the size and structure of the organization.

Do you mind too much if I ask what is the nature of your question?

Re: QA manager's Responsibility

The QA manager can be responsible for anything his employer wants him to be responsible for including quality. It really doesn't matter it's just a job title that every employer has the right to define as they see fit..

Re: QA manager's Responsibility

vinqua said:

What is a QA manager's responsibility at a work place?
Does QA manager have anything to do with Regulatory Affairs?

Thank you

Click to expand...

Brad asks "what is the nature . . . ?"

My guess, since your Profile says you are 28, is that you are probably NOT asking to gather information for establishing policy and job criteria at an organization where you are a top manager, but maybe . . .

my opinion:
In days gone by, having the word "quality" attached to a job title essentially relegated someone to the task of "detecting nonconforming parts AFTER they had been made."

In modern times, more and more organizations are coming to have a much wider and proactive view of "quality" similar to my own philosophy which has been in my ASQ Profile for more than 15 years:

I believe an effective Quality Management System (QMS) is a profit center, NOT a "cost item."

My entire career has been centered on the concept "Quality should be involved in every aspect of a company - including executive planning, administration, marketing, purchasing, design, production, shipping, and service."

This concept holds true whether the company is a manufacturer or service company (banking, insurance, communications, transportation, construction, janitorial, etc.) The major emphasis is on pleasing or delighting the customer while maintaining or increasing organizational profitability. (In the case of non-profits, does the organization's performance delight both recipients and the contributors? If so, the organization will continue to thrive.)

I put more emphasis on "big picture" and "company culture" than on metrics. If all the members of the organization are indeed working together, metrics are a natural function of identifying areas to improve. If the organization is NOT working together, the imposition of metrics can be draconian and serve to divide the culture even more.

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Accordingly, I think the Quality Manager or Quality Director (or any other title an organization choses to confer) has a duty/goal/function of helping the individual members of the organization understand the "big picture" of the organization and how their individual roles (when performed properly) help the organization achieve and maintain that "big picture."

Part of that function is helping to create and maintain the system of checks and balances of the various sub-processes within the organization to comply with that plan. If the organization must comply with governmental regulations, then that, too, falls within the scope of the quality manager's attention.

Depending on the size of the organization, the organization may require a hierarchy of quality folks to deal with different aspects, coordinated and overseen by the chief quality director or manager. Thus, it would not be unusual for a fairly large organization in a pharmaceutical industry to have

• product quality
• supplier quality
• regulatory affairs
• customer quality liaison

handled by different folks reporting to a quality manager or quality director. Whereas a much smaller company might have ALL those function performed by one person.