QA's Role in the Overall Picture of the Organization and in Day to Day Activities

[DesiQE]

Hi All,

This is something that I am currently experiencing at my present company. I am trying to prepare a presentation that will help the people understand what QA is all about and how helping QA is helping themselves in the end; what is QA's role in the overall picture of the organization and in day to day activities. Any pointers, jokes, presentations you have would be most welcome. I am going down to the one-on-one type of level here, because I am seeing a LOT of resistance to the improvements being suggested by my QA team. The resistors are not just the shop floor guys, but also their immediate management. They have all come from a tool shop kind of factory and are still unable to grasp the concept of medical device industry and how critical the QMS is to overall quality of the organization and the product. My team and I feel very which is leading to a lot of with the people. They are just hellbent on resisting anything suggested by us.

Any help would be highly welcome and appreciated greatly!



Merry Christmas and a Happy New Year!

 

[sagai]

Hi,
it is difficult, however recently I am lucky to be in my company aware enough, not having such fundamental problem.
One way may go on the way of knowledge sharing. You can educate them about the different aspect of the QMS as well as you can arrange open q&a session on their daily problems. It gives an opportunity for them to recognize by themself sooner or later the need of your work.
Other way may go on the benefit they can gain from process improvement, in case your management can support such activities, sooner or later they will see, the value of your work.
And yes, you can sit and wait, regulatory body will remind them about the essence of the QM in medical industry.

wishes also for you, br
Sz.

 

[Duke Okes]

I would ensure that people understand what it is like in a high-risk, highly regulated industry. How different it is from "other" businesses. What the role is of QA in protecting patients/users as well as the company, and the impact of failures in product and regulatory requirements.

 

[Chennaiite]

You may have to figure out whether it is the question of understanding or of attitude. If it has something to do with attitude, presentation/explanation/education would never work. Your team probably has to render more of helping hands to other functions, involve them in improvement activities and do away with policing. Not as easy as it sounds and inevitably requires support from the boss of all bosses. But certainly you can make life little easy with this approach.

Merry Christmas & Happy New Year.

 

[DesiQE]

Thanks for the quick responses! Yes, its more of an attitude problem than anything else. The 'operators' are at the very least 'bachelor' degree holders. It is more that they have not had a decent QA department before, and now with the QA stepping into any and all activities, they feel they are being told that they are 'WRONG'.

 

[arrabellaangel]

maybe you can educate/expose them with medical requirement from time to time such medical industries article,standard,regulation..u can start with mail these article or paste on board somewhere that can be seen by other worker..involve in their production so that u will have more knowledge about process compare to them.

 

[Jen Kirley]

QA people have grappled with our evolutionary process for some years now. It's said we are becoming infused throughout the organization, but I have seen a mix of that and simply reducing the ranks.

QA is being taught in higher education now, but that is usually done as a subject, like a class in ethics, and not built into the entire curricula. As a result, many otherwise brilliant, highly educated people are emerging into leadership and management positions without the "big picture" viewpoints and systems thinking that QA people can provide from day to day. As a result, QA people are still often regarded as some sort of exotic breed, nice to have around but not to be used everyday.

You can often influence that kind of thinking, but it takes time to build credibility. You can try doing so by taking it upon yourself to translate the consequences of "getting it wrong" to the language of money. Accounting systems are seldom set up to do that, so you will probably need to do it on an example-by-example basis. Use cost accounting methods and COPQ information we have here in the Cove.

In the end, unless we have authority we can only provide sound data for management to use to make good decisions. It took years, but my people are now starting to ask me questions about this in that in regards to compliance to the standards I audit to. I dare to hope you will also eventually enjoy increased credibility and trust. Be patient. Changing people's minds takes time or a calamity. I hope a calamity won't be needed for your people to come around.

 

[DesiQE]

Thank you for the thoughts...I am trying my luck by talking with the whole bunch of manufacturing people a couple of days from now...Am trying to find some jokes/cartoons about how it always is joked that Manufacturing and Quality are always at loggerheads....please share some of the best ones that you like...

Happy Holidays!

 

[Chance]

Thank you for the thoughts...I am trying my luck by talking with the whole bunch of manufacturing people a couple of days from now...Am trying to find some jokes/cartoons about how it always is joked that Manufacturing and Quality are always at loggerheads....please share some of the best ones that you like...

Happy Holidays!

Hey this might be useful to you.
Cartoons for presentations

Good luck.

 

[sulkinsf]

Hi All,

Regarding your comment, "I am seeing a LOT of resistance to the improvements being suggested by my QA team. The resistors are not just the shop floor guys, but also their immediate management."

Sometimes resistance comes from misunderstanding, sometimes from defensiveness to outside critique, and sometimes they are just plain right – it’s a lousy suggestion. You will hear this a lot on the cove...involve the shop floor operators in local improvements that have an immediate positive effect in their work areas. Demonstrate how your techniques work to make their life easier. It’s more fun to create a suggestion together than to be handed one down by another department.

What is the suggestion coming from QA? We can give you more specifics on how to tear down the resistance.

Regards,

Steve