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Episode 3 – ISO 9001 Implementation

ISO 9001 Implementation

In this week’s podcast, Bruce Newman, Lead Consultant at Core Business Solutions, will be discussing the essential aspects of ISO 9001 implementation and the importance of maintaining control over documentation. Bruce will guide listeners through measurement planning, and highlight the necessary role that management plays in the success of a QMS implementation, and the importance of the QMS to employees. This podcast is an excellent opportunity to gain valuable knowledge that can help improve your business operations.

Core Business Solutions publishes ISO Certification podcast episodes weekly. You can find more episodes here.


Episode 3 Key Content

Hello, everyone, and thanks for listening to the Quality Hub chatting with ISO experts. I’m your host, Xavier Francis, and I’m here with Bruce Newman, Lead consultant and one of our longer-tenured consultants here at Core Business Solutions. So glad you could be with us today, Bruce.

Yeah, I’m happy to be here with you. I hope. I hope I can enlighten our listeners on some of the aspects of the implementation of different systems.

Yes. Thank you. That’s exactly today’s title. Today’s show is entitled From Planning to Implementation. How to Get From Planning Your QMS to Implementing One. Now, if you’ve listened to the Quality Hub before, you know that we’ve been interviewing our guests with a focus on starting your quality management system. We’re going to be continuing that journey here today with Bruce.

Bruce Yeah, well, I go way back. I started in quality before ISO had even been launched. I’m working with automotive companies. I’ve worked with yacht companies, Medical Devices, you name it. What I have found is that if you’ve got good quality skills, it’s easy to learn different products and processes and apply those skills. So it’s not a bad field to be in as far as versatility and job security.

Okay. And how long would you say you’ve been here? I mean, you’re doing this.

I’ve been with Core for six years. Okay. And then about 45 years before that. Managing different quality systems.

So last week’s podcast, we started planning our quality management system. Now we want to focus on implementation this week. Can you tell us what the three main thrusts might be at this stage?

Okay. The idea here is that we want to put into action the different things that we’ve put down on paper, I guess you could say.


So, one thing I need to have is a good relationship with the client. I want them to understand that we’re not about changing things you do. We’re about taking advantage of the things you do well, which if you’re a solid business, there are a lot of good things you’re doing.

Yeah. I think one of the things that we talked about with some other people was, you know, you start with what you have now.

Exactly. So once that documentation is complete to me, that is part of the groundwork that you complete during planning and all that’s designed to make the process of registration go simply. So now all we need to do is get you comfortable with that documentation and with using the tools that we’ve put down on paper.

So you want to get those controls, those processes, and things like that in place, that’s going to keep your QMS moving forward.

Right. So we’ve identified the key processes that impact the quality of your product or service. So what we want to do is put together some signals that tell us when things are going well and when they’re not going so well. And, when we notice that things are going not so well, we want to fix that.


Right. The opposite of that now is something that a lot of people neglect when things go unexpectedly great. That’s cause for an investigation as well because maybe there is something that we’ve done a little differently that improved the process that we want to institutionalize and maybe document and continue.

Yeah, maybe implement it in other parts of the company.


All right. Well, that’s great. You just mentioned documentation. I know we spoke in the past podcast about why it’s so important and why it’s part of the quality management system if you’re looking at 9001. So now, why is controlling that documentation so important?

Well, the importance, there are a few things. One, we want people who are subject matter experts in charge of their documentation. We want them to be the ones that generate it and revise it to approve any revisions.


Now, the other thing is that we don’t want anybody using out-of-date documents. So that’s the whole point behind maintaining the revision levels. Let’s say, for example, we’ve got a final inspection process that is a checklist of items to inspect and maybe we’ve got a design change that takes place with one of our products. So we need to change the specifications or even add an inspection point if we’ve got people out there inspecting using the old document, there’s a good chance we’ll ship nonconforming products because they don’t have the latest and greatest.


Right. So you need to control these documents. So one point would be so you have the right revision when you’re doing some work based on it if it’s work instructions.


And then what if it’s another type of documentation? What’s the importance of controlling it that way?

Well, like, for example, a procedure or the quality manual, if we make any changes to instructional or procedural type documents. Again, we don’t want people following the wrong procedures.

Correct. You want them to use the most up-to-date ones.

Primarily these documents. Once somebody knows their job, they’re not referring to documents like this day in, day out. But the secret is that they’re good for training. So when we bring new employees in, we don’t want to be training them to out-of-date processes or methods of doing things. We want them trained in the latest and most current versions of those documents.

Right. And a lot of times you are saying the subject matter experts, you know, or what we call SMEs. They might be the people doing the job. So they might say, Hey, I’m going to revise this. You know, management’s like, yep, go right ahead. It’s revised.

So they don’t need to necessarily be trained on it or told about it, but the person is coming on as a new person or maybe a switch from another position in the actual company. They’re going to need to know what to do.

Well, that’s true. And there are cases in a lot of businesses, people are versatile and they work in different areas of the shop or the warehouse or whatever. And it may be that you’re working at a workstation for some time, and then move on to somewhere else where the company needs you. Right, Right, right. When you come back, there may be changes to the process.

So it’s another it’s probably a good practice to review. Any document changes with personnel as they move to a new workstation.

You want to control, which is what we were talking about. We want to control those documents to keep them to the latest and greatest, the most current version for a myriad of reasons. Now, when we’re talking about management planning, can you give us a little bit of details about what that is and why it’s so important to a quality management system?

Failure to plan is a plan to fail.


So part of the ISO journey is developing a disciplined structure for managing your business, and part of that discipline is planning. You know, you wouldn’t bring in a $100,000 new piece of equipment without planning about where am I going to put it? What do we need to set it on? Does it need to have some sort of vibration cancellation technology or foundation?

Yeah. How are we going to power it, especially if it’s a pretty large piece of equipment?

Right, exactly. We even have the amps to run the thing. Plus, who.? Who’s. who’s going to operate the machine? Right. We’ve got personnel training. The changes in manufacturing, you know, what are we going to run there? How are we going to? You know, what product lines are we going to move on to this thing?

All that discipline should be applied across the board. Part of the planning involves measuring our process performance because how do we know how well we’re doing if we’re not measuring?

Right, Right.

A lot of people kind of go by gut feelings, but Deming, who is probably the premier expert on quality, once said that I trust in God. All others bring data.

Yeah. One of our previous guests said, you know, if you’re not measuring it, you’re not able to look at it and to have, you know, a metric to base any kind of decisions on. And if you’re talking about performance, you want to have a baseline……..

Right. And that’s again, you know, you just want to get that measurement in place to maybe differentiate what you’re talking about. Hey, we’re going to count all of this, put this in this bin, because that setup scrap, once we get rolling, everything else goes in this bin. So we can say, okay, this is how much percentage we used for setup, This is how much we did when the manufacturing started. Okay, we’ve got those baselines. How can we improve it? Do we need to get another machine, something that sets up faster?

One good example of a robust quality system. I worked with a company that made body armor. The material used to make body armor is extremely expensive. It’s about eight feet across and a three-foot length section of it can cost upwards of $300 – $400.


So every inch of that material that you can save is incredibly valuable. We were spending upwards of, well, we were losing $1,000,000 a year in scrap.


We got the quality team together and did some. First, we collected information about where the scrap was coming from, how it was being generated, the measurements we were using to lay the material out for cutting into the panels, and such. And we found some slop in the setup. So we concentrated on the setup. We worked with training the team. We worked with putting some measurement devices on the long tables where we pulled this material out to measure it. We worked on things like pulling out the wrinkles, just simple things like that. So we put the project in we implemented some changes to the process, and about four months later, a manufacturing engineer came to me and said something screwy with our data. It’s got to be wrong. We’re using this much less material than we were using last quarter.


So I asked to look it over, and what I found out was that our process, our simple process of revising measurements, but more attention to setup and just the simple things that we implemented wound up saving the company $500,000 a year in setup scrap on very expensive material.

Wow! $500,000 is half a mill just from one aspect of a quality management system being used in place. And just for scrap.

And it was all about measurement.

Yep. Wow.

Knowing. Knowing what to expect and then how to improve it and being able to objectively attach, you know, attach a value to what we were doing.

That’s amazing. That’s amazing. It does show the absolute value of a quality management system. Well, Bruce, I appreciate you taking the time today to do this podcast with us. This has been helpful. This has been informative.