How do I make the Corporate QMS work in the manufacturing setting?

[desireecharm]

Hi everyone. Long time listener, first time caller.

I work for a large quasi-governmental organization (approximately 20k employees). I'm a process engineer in an overhaul facility, which is not the company's main line of work/service, but we directly support it. The corporate quality department did an internal audit recently and we failed, mainly because we don't have any type of quality system in place in our location.

The gentleman running the Corporate Quality show sounded incredibly surprised that we weren't all using the corporate QMS. I'd never seen it, to be honest. Now that I have, I see that it's a flight of fancy, especially the parts where it states that we're ISO 9001:2008 compliant, etc, etc.

In the past, I studied to be a CQA, and was one of the internal ISO auditors for my company. That was 9001:2000, which isn't a whole lot different, from what I can see.

Here's the question: I have a corporate QMS document that's fairly inadequate at describing what we do and how we ensure a quality product, how all the departments fit together, etc. It's pretty generic and fits the letter of ISO requirements, not really the spirit. We need something for our location that's relevant, describes our processes, identifies our document control methods, shows local management involvement, engineering support, materials support, etc. What would this document be? Is it a "Springfield, USA Overhaul Facility Quality Manual" (i.e. lower level QMS)? Is this an addendum to the corporate QMS? Is this a Quality Plan for performing captial projects and component repair (our two main business lines on site)? Something else entirely?

We are not pursuing ISO certification, but in order to be competitive, we need to be more efficient, and getting a handle on quality will help. Part of that is getting everyone here at the facility on the same page. Any advice you can offer would be very greatly appreciated.

Thanks in advance,

Marisol

 

[Sidney Vianna]

What I have seen used very effectively is the approach of having "supplemental" documents describing the processes at each site, location, etc... High level corporate QMS policies lack granularity and are too generic to be effective, especially for organizations with very diversified product and services portfolios.

Having a site specific QMS supplementation (supporting and not conflicting) with the corporate QMS has always been the most effective way to handle the challenge, in my experience.

And welcome to The Cove as a first time poster. Hope it is not your last one and many more follow.

 

[PaulJSmith]

We are not pursuing ISO certification, but in order to be competitive, we need to be more efficient, and getting a handle on quality will help. Part of that is getting everyone here at the facility on the same page.

Hi, Marisol.
Judging from this statement, you seem to already be on the right path to success. You're pursuing this for the "right" reasons.

Sidney's advice is solid ... as it usually is.

Good luck.

 

[desireecharm]

Thanks to you both for your insight.

Sidney, when you talk about a supplement, what would that look like? In the past, I've seen the local manual pick up at section 4.2.3 or 5.1-5.2 (saying to reference the corporate policy on everything before that), and as it goes forward, it skips the sections that don't require supplementing. Does that sound right, or am I leaving something out?

Also, would that be titled "<local facility> Quality Manual"?

Thanks,
Marisol

 

[JaneB]

I think the structure, title etc depends on you, or a negotiated outcome between what you want & whatever the corporate wants, as well as how their manual is structured.

Also sounds as though you have a reasonable handle on what is needed.

 

[DRAMMAN]

I would view the Corporate QMS Manual as the high level governing document. Then document what you do at your site through procedures, WI's, etc. It would not be required, but you could also write a facility specific quality manual. This would be the typical approach I have seen at multi-facility companies from large to massive.

 

[RoxaneB]

I've worked for a large multi-national corporation that was going down the road of having a large, all-encompassing QMS for all sites. Thankfully, it was generic enough to apply to all...and unfortunately, it was generic enough to apply to all.

What we had to do was walk that fine line between ensuring we developed a system that was valued-added for us without violating what the company said was going.

This resulted in frequent reaching out to our other sites to see what they were up. You could try doing the same. No point in re-inventing the wheel if you don't need to.

 

[desireecharm]

for example corp's guidance states in very high level overarching words, 'we believe in the concepts of a quality program...blah...blah...blah'.

Sector's guidance states our technical teams follow 'AS or ISO or standards...blah blah blah' 'and as such will have QMS, metrics, customer, ad nausm'

the project level QMS is where the knife hits the steak...'our QMS does this by doing that, etc., etc.,

each entity assesses the next lower group to assure there is a quality within the system.

The corporate QMS manual is a combination of the first two you described, with a lot more of the 'we believe in the concepts of quality' than I am comfortable with at the facility level. That's why I'm leaning towards a site specific document, but only addressing those sections which are different, and for anything that can be said generically enough, just have it reference the Corporate QMS (since that's how we'll be operating).

One more thing (and this is almost a separate question): Has anyone run into the situation where the company QMS document had sections where the author basically regurgitated the ISO 9001 element? I want very much to follow this document, but in several places it paraphrases the elements in the affirmative.

For example:

Element 5.4.2 Quality Management System Planning states

Top management shall ensure that:

a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and

b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented

Corporate wrote:

This QMS has been carried out to meet requirements identified in 4.1 as well as the quality policy. Integrity of this system is maintained when changes arise through planning, implementation and review.

Is this sufficient for a company that is using ISO format but isn't pursuing certification? If not, what should it include, or is this something that needs clarifying at the facility level?

for your patience, everyone. I know I'm throwing a lot of questions out here.

Marisol

 

[JaneB]

One more thing (and this is almost a separate question): Has anyone run into the situation where the company QMS document had sections where the author basically regurgitated the ISO 9001 element? I want very much to follow this document, but in several places it paraphrases the elements in the affirmative....

Unfortunately, yes. Many, many times. As have many other forum regulars.
Indeed, many people still mistakenly believe that this is what a 'quality manual' should be. And others still sell copies of the things as a 'canned' quality manual template - indeed, your corporate chappie may well have bought one of those horrible things. Sigh. Complete waste of time and words.

 

[DRAMMAN]

Yes. If you are ever in a position where you audit many companies you see this frequently. In my case it was auditing supplier quality systems. This was especially prevalent when standards such as ISO, QS, TS etc first started appearhing and large companies started requiring certification from smaller suppleirs. The companies that simply got certified to meet the customer requirements did this frequently.