New Quality Manager Role

K

Krazykev32

#1
Hi everyone. I am new to this forum so apologies if this is in the wrong section.

Background:

My background is Medical devices so I am used to working in a highly regulated environment with a robust quality system. And a high level of focus towards quality as an ideal rather than a piece of paper to hang on the wall.

Problem:

I am a month into a new role and I have noticed some role as quality manager for a company that makes a piece of lab equipment. It has had no quality manager for 18 months. What little of a quality system they have has completely collapsed (It's like the wild west).

What do I do first:
We need some platform to host the quality system to the employees.
We need a doc control process
We need to train people how to use the QMS and integrate with other training packages across site.
We need a calibration system
I need to convince senior management to buy in properly and not play at quality.

My plan:

I have kick started a small calibration project, updated equipment list and outsourced calibration.

I am working on gaining senior manager buy in showing them waste in the system. Linking recurring NCR's to customer complaints

I am working on a doc control hosting package

I want to process map everything to define the inputs processes and outputs and decide what records to keep and their lifecycle etc. Aim is to create a DHR type document.

At some point I will need to train all this out.

Problems:

Its just me on my own in quality
People seem to view me as the saviour and keep sending me info to host somewhere in quality.


What would you guys do?

:whip
 
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Mikishots

Trusted Information Resource
#5
Hi everyone. I am new to this forum so apologies if this is in the wrong section.

Background:

My background is Medical devices so I am used to working in a highly regulated environment with a robust quality system. And a high level of focus towards quality as an ideal rather than a piece of paper to hang on the wall.

Problem:

I am a month into a new role and I have noticed some role as quality manager for a company that makes a piece of lab equipment. It has had no quality manager for 18 months. What little of a quality system they have has completely collapsed (It's like the wild west).

What do I do first:
We need some platform to host the quality system to the employees.
We need a doc control process
We need to train people how to use the QMS and integrate with other training packages across site.
We need a calibration system
I need to convince senior management to buy in properly and not play at quality.

My plan:

I have kick started a small calibration project, updated equipment list and outsourced calibration.

I am working on gaining senior manager buy in showing them waste in the system. Linking recurring NCR's to customer complaints

I am working on a doc control hosting package

I want to process map everything to define the inputs processes and outputs and decide what records to keep and their lifecycle etc. Aim is to create a DHR type document.

At some point I will need to train all this out.

Problems:

Its just me on my own in quality
People seem to view me as the saviour and keep sending me info to host somewhere in quality.


What would you guys do?

:whip
My take:

1. Get management buy-in. It has to be 100% or you're wasting your time.
2. Once you have the buy-in, plan the process flow of the QMS. Map it out using a flowchart or any other means that you prefer.
3. Create your required procedures and work instructions. An important note at this point:
Nobody will reject something that they own, their group own or have contributed in one way or another to it. That's why it is so important to make sure the people involved in a process are consulted, given opportunity to make contributions when coming out with procedures, work instructions or other documents.
4. Get these processes under proper document control.
5. Proceed with training.

The most critical aspect of all this is to get management buy-in, and make sure that the creation of the procedures and work instructions is not done by people who don't actively use that procedure or work instruction.
 
P

PaulJSmith

#6
...It has had no quality manager for 18 months. What little of a quality system they have has completely collapsed (It's like the wild west)...
This doesn't happen simply because of the absence of a Quality Manager. Upper and middle management throughout the system have allowed it to happen. Mikishots is dead-on; you need to ensure that you have buy-in from the entire management staff, but especially those at the top. Without that, any efforts on your part will likely be fruitless.

You said they had something of a system, and they're obviously still in business, so something must be working right. Note whatever that is, and build on that success, regardless of how small. It'll give you a base from which to rebuild their confidence in any system, even their current broken one. They'll be much more likely to help rebuild with you if they see it can work, and they all have a part in it.
 
K

Krazykev32

#7
Cheers for the help guys.
Similar thinking to myself note that the list I had was in no specific order just a brain fart onto the screen.

We are all agreed that senior management buy in is important, so how do we do it. I am currently tracing problem parts through the system to the little bit of customer complaints data that we have.

What it does right: It makes a very high value product with little competition in the market place.

With the procedures that are here I am thinking I separate old system from new system. Create a simple doc control process and then get the procedure owners trained up on doc control. Then process map with them and write some good documents.

Its going to be a long journey I fear. I hope to gain support by picking some low hanging fruit as I go along
 

Wes Bucey

Quite Involved in Discussions
#8
Cheers for the help guys.
Similar thinking to myself note that the list I had was in no specific order just a brain fart onto the screen.

We are all agreed that senior management buy in is important, so how do we do it. I am currently tracing problem parts through the system to the little bit of customer complaints data that we have.

What it does right: It makes a very high value product with little competition in the market place.

With the procedures that are here I am thinking I separate old system from new system. Create a simple doc control process and then get the procedure owners trained up on doc control. Then process map with them and write some good documents.

Its going to be a long journey I fear. I hope to gain support by picking some low hanging fruit as I go along
As an outside consultant, I have a long conversation with the top folks about clarifying what they see as their "challenges" for which they [may] want my help in formulating plans for solutions. The culmination of this conversation is an understanding and agreement of the "deliverables."

In my practice, I usually am called in for the challenges listed below. They are not the only challenges I encounter, but they are the most frequent:

  • seeking registration to a Standard due to outside pressure
  • "re-engineering" an organization which needs major Kaizen events to become competitive in its market
  • "assimilating" a recent takeover of an organization with a different culture
  • "fairness opinions" when selling an organization or creating an Employee Stock Ownership Plan (ESOP) or Initial Public Offering (IPO)
  • Complying with Sarbannes-Oxley Act for public corporations
  • new product introduction (production and marketing)
  • achieving government certification in a regulated industry
  • negotiating with aggressive customers
  • negotiating with banks, financiers, equity investors
  • adopting and assimilating new technologies (such as Electronic Document Management or Customer Relationship Management)
In my opinion, you should consider having a similar conversation/discussion with the top bosses. The goal of that conversation should be to establish a list of deliverables and mutually agreed priorities and target dates for accomplishing them. You may be excellent in the things you do, but those things may be extraneous to what the guys who sign your checks require or want.
 
Q

QA Bee

#10
I am in the same situation and I have been trying extermely hard for management's buy in. I am the one person QA Manager here too and its been long 7 months but Management won't budge:(

Their only goal is to ship the product out the door, no matter what! And, I have tried all different appoaches by saying that we might not be able to reach higher standards (We are targeting to apply for ISO 13485 in future) but no luck so far.

What do you do in this situation?
 
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