QMS Overload

Hello all,
I am a new Quality Manager for a company. This is my first job "quality" job, my other experience is as a manufacturing engineer. I was a trained AS9100 internal auditor for my past job and was often tasked with reviewing and revising many process documents, so I am familiar with reviewing QMSs.
My situation is this: My new company is not ISO certified nor do they have what I would define as a Quality Management System. The owner has expressed a desire to be certified but has also shown it not to be a top priority since our customers have not requested it of us. I want to help this company to succeed, but this task is currently too daunting for me to decide where to step first. I've found un-released procedures that attempted to align with ISO9001:2008, but they were never implemented.
My boss is hoping to see results in the form of reduction of non-conformances. My brain is telling me to start with a receiving inspection procedure, but there are a lot of holes in the process before we've ever received these parts, both in-house and out-sourced machined parts.
My question is, where do I even start with this project? I know the best way to eat an elephant is 1 bite at a time, but would you start at the snout or the tail?

Reminds me of a story....

• Miyagi: Now, ready?
• Daniel: Yeah, I guess so.
• Miyagi: [sighs] Daniel-san, must talk.
• [they both kneel]
• Miyagi: Walk on road, hm? Walk right side, safe. Walk left side, safe. Walk middle, sooner or later
• [makes squish gesture]
• Miyagi: get the squish just like grape. Here, karate, same thing. Either you karate do "yes" or karate do "no." You karate do "guess so,"
• [makes squish gesture]
• Miyagi: just like grape. Understand?
• Daniel: Yeah, I understand.
• Miyagi: Now, ready?
• Daniel: Yeah, I'm ready.

Your boss is expecting results while planning for failure.

DesantisJ said:

Hello all,
I am a new Quality Manager for a company. This is my first job "quality" job, my other experience is as a manufacturing engineer. I was a trained AS9100 internal auditor for my past job and was often tasked with reviewing and revising many process documents, so I am familiar with reviewing QMSs.
My situation is this: My new company is not ISO certified nor do they have what I would define as a Quality Management System. The owner has expressed a desire to be certified but has also shown it not to be a top priority since our customers have not requested it of us. I want to help this company to succeed, but this task is currently too daunting for me to decide where to step first. I've found un-released procedures that attempted to align with ISO9001:2008, but they were never implemented.
My boss is hoping to see results in the form of reduction of non-conformances. My brain is telling me to start with a receiving inspection procedure, but there are a lot of holes in the process before we've ever received these parts, both in-house and out-sourced machined parts.
My question is, where do I even start with this project? I know the best way to eat an elephant is 1 bite at a time, but would you start at the snout or the tail?

Click to expand...

First. Take the un-released procedures and pitch them. Second, you have something -- every business has a QMS. Some are better than others, but we all have them. Start documenting what you already do -- make simple flow chart procedures. If you have an idea, or a gut feeling, where the majority of your issues lie, start there -- i.e.; manufacturing, purchasing, order entry, etc. (And start a pareto chart so you can see where the big issues are). Don't worry about ISO9001. Just look at what you're currently doing and see if there are any holes from plain old common business sense. Close those holes first. Get managers and other people to help explain what they do -- and under no circumstances mention ISO or QMS.

For example, you mention receiving. Question 1 would be are we even checking what we received against what we ordered? Those types of things.

Work on a section at a time. Get everything outlined. Revising as necessary to make them better -- not just more work, and absolutely not "just to comply with ISO." Once you have everything outlined, and have started making improvements, then you can start an ISO gap analysis. Depending on company size and how much time you dedicate to this, you could be several months to a year or more out. Good luck.

Find out what the people there are actually working to (e.g. documents however sketchy that they refer to, to get work done) and make these "official procedures". Find out where the problems (rework/re-doing a task) are and tackle them. It's a bit like a Pareto analysis of the business focussing on where "unplanned extra work" is being done. Your boss will see the results in an improved bottom line and you will be off to a good start

As Golfman25 noted find out and document what people are doing. People do get stress out in this activity. I often let them know if they win the lottery and quit, the company will be without the knowledge they have, I I want to capture their experience. I also find it helpful to create process flow charts. These may be high level, or combined into sops. As ChrisM said find out where the problems are, data gathering, and place the data in a format you boss will understand. Preset the data to your boss and discuss where your resources would be the most effective for the company. Getting to the non-conformities - depends on the data - is there a solid nonconforming procedure, or a CAPA procedure, or are the non-conformances coming from customers - how about a complaint procedure. These procedures would address how to resolve, prevent, and track the non-conformances.

DesantisJ said:

My boss is hoping to see results in the form of reduction of non-conformances.

Click to expand...

DesantisJ said:

My question is, where do I even start with this project?

Click to expand...

You have a clue right there. Go to the manufacturing area and/or the "inspection" area and find out about these non-conformances. Pareto them, formally or informally. Pick the biggest, or one of the biggest, issues that looks like it is solvable in the short-to mid term. Work with the team to fix the issue. Show some early success, then rinse and repeat.

by non-conformance’s do you mean defects?

Start with a gap analysis table; for each clause in the ISO standard, write down the current practices and gaps in the process.

IF the nonconformances that the OP is referencing (that his boss wants to see a reduction in non-conformances) then no amount of paper, documents, gap analyses, audits or certification will help. IF the real problem here is that there are too many defects then the OPs references to documents and QMS things is probably just his only point of reference - given that he said that his past role was in documentation. IF so, that is all just a bunch of red herrings. We should hear from the OP on what the real problem is.

Me personally, I wouldn’t even think about ISO9001 until I had started to get my house in order.

Find out what’s going wrong with what’s coming in and going out and address the things that are causing you and your customers the most pain.

This will have the greatest impact in the shortest amount of time and almost certainly highlight areas within your business and supply chain that need addressing first.

Once you have done with the initial firefighting you will have a better understanding of what you actually do and where you need better structure/control, you will also have time (now you are not firefighting) to align ISO9001 with what you do as a business.

Please feel free to shoot me down in flames if you disagree.