Hello... I'm a QA Manager in a med size company. My department has been it's own department until recently. We've been put under the umbrella with the Development Team. I have a real concern about this since I feel that QA should be a stand alone department because we drive "quality" for all aspect of and for the company, not just one specific area. I would like to hear back from others on your opinion regarding this subject and provide feedback on why you feel it's important that QA is an independent department, or why you feel it should NOT be.

Thank you,
QA Manager

Hello... I'm a QA Manager in a med size company. My department has been it's own department until recently. We've been put under the umbrella with the Development Team. I have a real concern about this since I feel that QA should be a stand alone department because we drive "quality" for all aspect of and for the company, not just one specific area. I would like to hear back from others on your opinion regarding this subject and provide feedback on why you feel it's important that QA is an independent department, or why you feel it should NOT be.

Thank you,
QA Manager
I have always visualized each department as a quality department and believe that if this is achieved, the purpose is served. Your whole efforts should be in developing the quality and process approach concept and make everyone in the organization think feel and say that they belong to the QUALITY <whatever> department. Could you do that ? ....... wish you well.

Hello... I'm a QA Manager in a med size company. My department has been it's own department until recently. We've been put under the umbrella with the Development Team. I have a real concern about this since I feel that QA should be a stand alone department because we drive "quality" for all aspect of and for the company, not just one specific area. I would like to hear back from others on your opinion regarding this subject and provide feedback on why you feel it's important that QA is an independent department, or why you feel it should NOT be.

Thank you,
QA Manager

It all depends on the culture. In an ideal world, there would be no quality department, or dedicated inspectors, or quality managers. In some companies the quality manager is a police chief, and in others he/she directs improvement activities and manages the quality system. If, as you say, the quality department is expected to "...drive 'quality' for all aspect of the company..." there's probably something wrong somewhere. Top management should be responsible for "driving" quality, and if that responsibility is thoughtlessly delegated, the need for a quality department will perpetuate itself.

Added in edit: Welcome to the Cove! :D

Thanks for your response.. However, the reason why I love my job, is because I have the opportunity to provide support, and suggestions on process improvements, to drive consistancy, and maintain "quality" throughout a company task, ot a project life-cycle. I would agree that Top Management should be there to help "drive" this, but it should be the responsibility of the QA Manager to implement and maintain the "quality flow" through-out the organization.

Quality should be working with all departments. It should not matter whose “umbrella” you are under as long as you do have the independence you are required to have. I would think of it as a plus that you and the Development Team work together at the beginning to help with requirement standardization, and understating the customer’s goals. This should help make everything work better in the long run for the company as a whole.
:2cents:

Thank you for your reply.. I would agree that for each department there is a level of quality that is focused on, but within each department, that "quality" is only focused on "their" department, where a QA Manager looks "outside" the box and makes sure "quality" covers the whole organization.

...it should be the responsibility of the QA Manager to implement and maintain the "quality flow" through-out the organization.
Why? Why shouldn't each department manager be responsible for that? If a process approach is used (and "process approach" is given something more than lip service) managers need to collaborate across department lines, and department circumscriptions need to fade. The fact that a quality department is expected to be a police force or some sort of evangelical organization is evidence that management hasn't established what Deming referred to as "constancy of purpose." IMO, if there's a dedicated quality department, its mission should be to facilitate elimination of itself.

Thank you for your quick response.. I would agree with you when it comes to a "project" standpoint, and our QA department does work with the dev team from the start til the end, however, QA covers just more than the tasks that relate to "development".

Thank you for your reply.. I would agree that for each department there is a level of quality that is focused on, but within each department, that "quality" is only focused on "their" department, where a QA Manager looks "outside" the box and makes sure "quality" covers the whole organization.

This discussion sounds like its more about relative importance and stature than about business outcomes.

It really shouldn't matter who the quality department reports to as long as they have freedom from production pressure (independence) and the ablity to make a positive impact on the organization.

Mark

In the words of AS9100 as long as you and your department "...have the organizational freedom to resolve matters pertaining to quality", then the current reporting structure is fine. If the development team begins to try and "influence" your decision making process then it is time to rethink the reporting structure. You have an opportunity to make a positive impact at the beginning of the manufacturing cycle, design and development. This reporting structure may work to your advantage.

All the Best,
Rob

Thank you for your reply.. I would agree that for each department there is a level of quality that is focused on, but within each department, that "quality" is only focused on "their" department, where a QA Manager looks "outside" the box and makes sure "quality" covers the whole organization.

And that's the exact problem I was referring to. If department managers can't see beyond the boundaries of their own departments, a police force is necessary.

I think that a department's focus is 1st on their department, and how their department impacts the whole organization. Our departments do have a level of quality focus to them, but not at the level that they should be requried to have. Not only that.. I would have to disagree that a QA department is identified as a "police force". That's being way to negative on what QA should really be and be represented as. QA is to oversee that "quality" is driven throughout the whole organization, as a way to improve in areas where needed, and to aid in the sucess of the organization from a QA perspective.

Our departments do have a level of quality focus to them, but not at the level that they should be requried to have.
Can you require them to have it? I doubt it--that's the responsibility of top management, and you've just stated explicitly that top management has failed in this regard. The need for an independent quality department emanates feom failures of management. Always.

Not only that.. I would have to disagree that a QA department is identified as a "police force". That's being way to negative on what QA should really be and be represented as.
If top management has abdicated its responsibility for making everyone understand their own responsibilities for the Big Picture, and thinks that a QA department is responsible for quality, then the quality department will inevitably become a law enforcement function.

"It should not matter whose “umbrella” you are under as long as you do have the independence you are required to have"
It should not ....but we are living in a real world. If the QA manager reports to another manager whose activity is audited by the QA department how can he be independent?

I certainly think quality has to have some independence from other departments otherwise it will not be able to function with any impartiality!

However in the cold light of day, the Company has to be making money so there will usually be some sort of deal going on!

<snip>In the words of AS9100 as long as you and your department "...have the organizational freedom to resolve matters pertaining to quality", then the current reporting structure is fine.

All the Best,
Rob

I know this post is old, but I don't think AS9100 states anything about the department having the organizational freedom, it is the Management Representative that applies to, not individual or QA Department(s).

I have moved this post to this forum, because it better fits the OP question.

Hello,

I am of the opinion that QA should have its own independent existence in the company. In no case QA head should report to production head. QA head should be at par with Production head in status.

Some people might have some other opinion.

Thanks

A client, who is a very very small medical device company, was just audited by a consultant engaged by a vendor. Among the many recommendations was to "establish an active and effective QA department."

The client's staff is geared to sales and marketing. They do test devices and the associated interfaces and software they ship. The president, vp, office manager, test tech, and tech service specialist all engage in the necessary QA activities related to CAPA and product complaints and service.

I, as the QA and compliance consultant, help them with their QA and QMS activities.

For this small company, what would the minimum requirements be for an active and effective QA department; this company can NOT afford to hire additional staff.

Many thanks in advance for your help.

Mark

Mark,

this sounds as though the recommendation is being accepted as correct and adopted as it stands... is that the case?

If you focus less on the 'department' word and more on the function or activity instead - what's the situation?

Is there any real evidence that active and effective QA is / is not being done? If so, what is it? Who does what now?

You say the "president, vp, office manager, test tech, and tech service specialist all engage in the necessary QA activities"... that sounds like one heck of a lot of people involved. How is responsibility separated? Or is it? Is there, for example, any kind of independent cross-check? After all, that's most often a sound function that 'QA' performs.

Eg, if Person 1 , say, assembles something, then have Person 2 (independent) do the QA check & sign off. If Person 3 picks stuff for the order, have Person 4 (or 1 or 2!) cross-check it for accuracy. That's often how a small business does it effectively.

Thanks for your input, Jane

>>this sounds as though the recommendation is being accepted as correct and adopted as it stands... is that the case?

No this is not the case.

>>If you focus less on the 'department' word and more on the function or activity instead - what's the situation?

The client focuses on the activity, whereas the auditor recommends a QA group.

>Is there any real evidence that active and effective QA is / is not being done? If so, what is it? Who does what now?

The problem is that documentation is not quite complete. If you had to measure the effectiveness of the QA, the metric would be customer satisfaction in terms of prompt servicing, tech service and support, and order fulfillment. I can tell you that the metric is NOT a grade or score on how well the paperwork is filled out but how well customer needs are being met.

>You say the "president, vp, office manager, test tech, and tech service specialist all engage in the necessary QA activities"... that sounds like one heck of a lot of people involved. How is responsibility separated? Or is it? Is there, for example, any kind of independent cross-check? After all, that's most often a sound function that 'QA' performs.

Eg, if Person 1 , say, assembles something, then have Person 2 (independent) do the QA check & sign off. If Person 3 picks stuff for the order, have Person 4 (or 1 or 2!) cross-check it for accuracy. That's often how a small business does it effectively.[/QUOTE]

You have a point. There is no real separation of responsibility in terms of the on site staff. There is minimal QA; complaint investigation and tracking, CAPA, documentation management and record keeping are all handled in-house. They are periodically audited by vendors (due diligence) and me. I need to find out about the cross checks.

What I'd like to do and need to do to do is set things up so there is an effective and active QA function suitable for this understaffed and overworked company.

Regards,

Mark

>>If you focus less on the 'department' word and more on the function or activity instead - what's the situation?

The client focuses on the activity, whereas the auditor recommends a QA group.
Yes, I understood this from your post. That may reflect the auditor's background/bias/whatever.

I meant (leaving aside the consultant/auditor) - what is the situation in your client organisation?

Is there any real evidence that active and effective QA is / is not being done? If so, what is it? Who does what now?

The problem is that documentation is not quite complete. If you had to measure the effectiveness of the QA, the metric would be customer satisfaction in terms of prompt servicing, tech service and support, and order fulfillment. I can tell you that the metric is NOT a grade or score on how well the paperwork is filled out but how well customer needs are being met.
This doesn't answer my question, I'm afraid.
If doc isn't 'quite complete' there's some kind of weakness there. What kind, I don't know. Any time I find doco that 'isn't quite complete', it lowers my confidence factor that a company is following its own system. Something needs to change: practice or documentation (possibly both) so that the paperwork IS filled in consistently and reliably.

Minimising or discounting this as 'just a problem of not filling in paperwork' is missing the point. And gives any outsider something to worry about. After all, if you're relaxed about doing the paperwork (they reason) what else are you relaxed about? If someone from outside cannot see that you're doing it... why would they be comfortable? I wouldn't.

There is no real separation of responsibility in terms of the on site staff. There is minimal QA; complaint investigation and tracking, CAPA, documentation management and record keeping are all handled in-house. They are periodically audited by vendors (due diligence) and me. I need to find out about the cross checks.
I dont have a problem with things being done 'in house'. But you say there's 'minimal' QA... and presumably of that done, the paperwork isn't fully completed.. Something needs to change.

1. Do you have documentation (process/procedure) defining who does what?
2. Does it spell out the quality controls/checks to be done,w ho by and what records are created?
3. If yes to 1 and 2, is it being done? (sounds like no to me)
4. Why not?

Basic principles: what are the essential checksyou need to do, and the critical records that they have been done, in order to be able to demonstrate to an outside, third party, that a/you do what you say you do and b/you have adequate controls and checks in place?

Understaffed & overworked? Sorry, but this is true in most places. But it cuts no ice with any customer and doesn't absolve anyone from their responsibility, either.

".... They do test devices and the associated interfaces and software they ship. The president, vp, office manager, test tech, and tech service specialist all engage in the necessary QA activities related to CAPA and product complaints and service..."

"....What I'd like to do and need to do to do is set things up so there is an effective and active QA function suitable for this understaffed and overworked company...."




dear mark w,

i guess you have answered your question. you have the guys there already. just provide then some particular guidelines to the work. also, provide some matrix for the workload of the managers that can be delegated to those staff.

we do understand that such "small" companies do have tremendous "multi-tasking" activities, and these are one of them. just make it clear to the org.


hope this helps....:)

Top management sets goals and priorities. It doesn’t matter where the quality function appears on an organization chart or if there is a quality function at all. What matters is the direction given and examples set by top management and how well information and resources are deployed to meet goals. That is top management’s responsibility (see ISO 9001:2008, 5.1).

In the factory, there is pressure to meet cost estimates to achieve profits. I wish it were as simple as implementing a cultural change, but that’s not reality. You must compete. You must find ways to innovate, improve quality and productivity, and reduce costs. Everyone must work hard every day to achieve those improvements and reductions. The modern quality department can be important part of achieving those goals, but all processes must be organized to achieve goals or they will go unfulfilled.

I'm with Jim Wynne on this; I believe the goal of every quality department should be to eliminate itself by convincing top management to enable every manager, worker and officer to achieve 100% customer satisfaction without the need for independent verification of quality requirements. That said, I am still striving for that goal after many years. My sincere congratulations to those who have achieved that goal. My best wishes to those who strive every day to achieve it.

Hello... I'm a QA Manager in a med size company. My department has been it's own department until recently. We've been put under the umbrella with the Development Team. I have a real concern about this since I feel that QA should be a stand alone department because we drive "quality" for all aspect of and for the company, not just one specific area. I would like to hear back from others on your opinion regarding this subject and provide feedback on why you feel it's important that QA is an independent department, or why you feel it should NOT be.

Thank you,
QA Manager

I've worked in both situations, and frankly I don't think it matters either way. I've managed quality functions under Engineering, R&D, Marketing and even Finance. I've also worked at companies where Quality existed as a separate department.

Companies usually move the reporting structure around for just a few reasons. It could even be as simple as the President wants to reduce the number of direct reports to himself. Or, the head of your Development team lobbied for control of the quality function.

I'd be more concerned with my relationship with the head of the Development team than the actual reporting structure. I'd want to be sure that I had open communications with this person, and that I had his/her ear and support on quality concerns.

Then, address any issues if/when they arise. I think an open-minded approach will go a very long way in strengthening your relationship with top management. They may very well suspect that you might have a problem with this - these things are usually discussed. I think this is the time to diffuse a defensive situation to open the communication channels. Approach it with an open mind, ask questions, and be collaborative.

After things settle in, and you've got a grasp of the new structure, you'll be in a much better position to discuss it with senior management, and you'll have actual data and evidence to support your concerns. Where, if you raise this as an issue now, before it's even out of the starting gate, senior management will see you as difficult and uncooperative, and will be less likely to actually listen to your concerns.

Top management sets goals and priorities. It doesn’t matter where the quality function appears on an organization chart or if there is a quality function at all. What matters is the direction given and examples set by top management and how well information and resources are deployed to meet goals. That is top management’s responsibility (see ISO 9001:2008, 5.1).

In the factory, there is pressure to meet cost estimates to achieve profits. I wish it were as simple as implementing a cultural change, but that’s not reality. You must compete. You must find ways to innovate, improve quality and productivity, and reduce costs. Everyone must work hard every day to achieve those improvements and reductions. The modern quality department can be important part of achieving those goals, but all processes must be organized to achieve goals or they will go unfulfilled.

I'm with Jim Wynne on this; I believe the goal of every quality department should be to eliminate itself by convincing top management to enable every manager, worker and officer to achieve 100% customer satisfaction without the need for independent verification of quality requirements. That said, I am still striving for that goal after many years. My sincere congratulations to those who have achieved that goal. My best wishes to those who strive every day to achieve it.

I didn't go through all of the other responses to this thread, but I'm glad this was brought up. I just replied from the reporting structure / conflict of interest perspective, but in a perfect world, we'd see far more companies disbanding quality departments all together.

I'm with Jim Wynne on this; I believe the goal of every quality department should be to eliminate itself by convincing top management to enable every manager, worker and officer to achieve 100% customer satisfaction without the need for independent verification of quality requirements. That said, I am still striving for that goal after many years. My sincere congratulations to those who have achieved that goal. My best wishes to those who strive every day to achieve it.

As long as Murphy (of Murphy's Law) is alive and well this will never happen. I haven't found a company yet in which he doesn't live.

Dear Jane and SpongeMouse,

A belated thanks again to Jane and a current thanks to SpongeMouse.

There is a lot if discussion going on with my client. In addition to the usual "no time and no people and too much work" procedures and processes are indeed being implemented because they need to have them and because they are very slowly learning they need them.

It's a slow learning curve and every now and then a light bulb goes off, "Oh, this makes sense and that's why .."

Again, thanks for your help.

Mark W

Mark,

You're welcome. Glad to hear there's discussion going on. As you say, there's a learning curve there, and in my opinion it's at least as important that people understand the why of what they're doing (re. quality) as that they do it.

And if that means it takes a bit of time to discuss, learn, think, and then discuss some more, then that's what it takes. Just keep moving toward it... step by step.... I think it gets easier once a certain 'critical mass' is achieved, and once there's an episode or two when having quality mechanisms in place will save their bacon. Then you start to get converts - provided one can hold one's tongue and not say 'see why I said that' ;) At least, not too often.

welcome mark!

just have fun on it, and all will be smooth sailing :rolleyes::notme:

I agree with Mark R. It doesn't matter who the quality department reports to as long as responsibility and authority are outlined and supported. I agree with all the "ideal world" scenarios, unfortunately in some companies those things don't happen on a day to day basis. I have never supported QA reporting INTO engineering in the companies that I've worked for, but I am currently heading a QA/RA department, I report to the CEO and Engineering reports to me. I don't see any quality related conflicts of interest with this reporting structure.

Keep in mind we do our best to disolve any conflicts, but in most companies you have 1 CEO, or 1 COO, or 1 Board of Directors, etc. At some point both Quality and Production, and Development report to the same person or group. As long as that person/group supports quality you should be fine.

At a high level we're looking for the balance. Top quality products, delievered in a timely manner, by happy employees that work as a team. That's is the goal in every company. If you think that you're org chart doesn't support that, ask for a change.

If you're seeing quality issues because a schedule has to be met, etc. and there is a direct correlation to the org chart... that's an issue for mangement review, your managment rep, etc. If its escalated to that level and there is no action taken, I'd bail!

Can you require them to have it? I doubt it--that's the responsibility of top management, and you've just stated explicitly that top management has failed in this regard. The need for an independent quality department emanates feom failures of management. Always.


If top management has abdicated its responsibility for making everyone understand their own responsibilities for the Big Picture, and thinks that a QA department is responsible for quality, then the quality department will inevitably become a law enforcement function.


:2cents::2cents:(too much for just 2 cents) EEK! I hate all the talk about QA needing to "police" etc. I totally agree with all the responses to this thread. Unfortunately THIS is the attitude that has given QA/RA professionals such bad reputations. Sounds like this company needs to infuse some new culture and a new attitude!

Food for thought: I only hire QA and RA people that are team minded. That team is NOT the QA or RA team. Its the development and design teams that the QA prefessionals are assigned to. Nothing would inspire me to give somoene the ax like having a QA or RA person with an attitude of, "Nope, you can't do that..." The attitude needs to be "We have a common goal, and here's what I can do to help us achevie that goal in a high quality, compliant manner." PERIOD! If you can't work with that attitude, then you're in the wrong field - go work for the IRS.
I train my team to act as advisors, not enforcers. It takes some effort, but I've acheived an amazing environment here and at other companies... QA/RA is the FIRST place anyone goes when they have an issue or want to do something new. THe company knows get the advice that we need from the get go, and there won't be and road blocks along the way.

QA needing to "police" is ridiculous... that's like employing an attorney for the purpose of GETTING you out of jail.... um, isn't the point to have a staff attorney to advice you so you don't ever get in trouble and GO to jail? QA should be viewed inthe same way.

At some point both Quality and Production, and Development report to the same person or group. As long as that person/group supports quality you should be fine....
If you're seeing quality issues because a schedule has to be met, etc. and there is a direct correlation to the org chart... that's an issue for mangement review, your managment rep, etc. If its escalated to that level and there is no action taken, I'd bail!
Yup, just so. Starts at the top and that's what it all comes down to. If therfe's no commitment there, evidenced by support and action, and it's not happening despite best efforts to effect change, I'd bail too. And have.