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How to Set Up a Great Factory Quality Management System (QMS)

June 28, 2020

 by Renaud Anjoran

If you have been in business for a few years, chances are that you already have a Quality Management System (QMS) but it might be informal, inconsistent, or incomplete. If you want to develop it, there are no shortcuts.

Fortunately, there is an approach to setting up a quality management system that has proven its effectiveness, in China as in other countries!

What is a Quality Management System?

team putting colorful puzzle pieces together

Simply put, a QMS is the way a company ensures it delivers what it promises. It is not just a set of documents, or a state of mind. It requires many elements that pull the organization in the same direction and helps different parts support each other.

Here are the main elements of a quality management system:

  1. A few high-level goals (e.g. customer satisfaction).
  2. Some measurable and specific objectives that support the higher-level goals (e.g. ensuring at least 90% of customers rate the company’s offer at least 3 stars out of 5)
  3. A certain way of working, and associated training and coaching programs to achieve the objectives (e.g. standard operating procedures, an employee onboarding program, certification).

They don’t necessarily all have to be documented. The excessive focus on having all documents in order comes from common auditing practices, not from the needs of the quality management system itself.

When you see someone say “Oh, our QMS? Let me show you” and they open a drawer, you know they are probably not doing a great job. The more it is visual and shared with the teams, the more effective it probably is. 

Which brings me to an important point... If the company culture is "just do your job" and "one mistake and you are fired", you will probably struggle in getting people's attention and energy. However, if they want to make improvements, try new things, and then stick to what has shown to work well, you are already very, very far ahead.

 

3 Steps for Setting Up an Effective Factory Quality Management System

Step 1: Map out your processes, and think of your controls

This aspect is often forgotten, and yet it is one of the few essential steps in setting up a quality management system.

Draw a map of all the process steps. It will help you notice inefficiencies and to propose changes. For example, certain steps might be combined, semi-automated, and/or simply eliminated. Usually, the fewer steps the better, since hand-offs from one team or department to another tend to generate mistakes and delays.

Here is a simple example of a process map:

quality process map example

Source: North Carolina Center for Public Health Quality

Once you have listed your processes this way, you need to determine those that are ‘critical to quality’, those that are also important to control but as a second priority, and finally those that don’t need to be controlled formally.

The next step, setting controls in place, is often based on the production team's experience. Sometimes it is easy – to control an injection molding process, one has to control the pressure, the temperature, the cycle time, the air humidity, and certain properties of the polymer.

The more complex the process, the harder these decisions become. You might need to run experiments 'several factors at a time', which can involve heavy statistics.

In each case, the key is to select the few variables that have a dominant effect on the end result of the process.

Once the process is stable (based on at least 20 observations), the hard work of process improvement (which may include changes in maintenance, testing procedures...) can start. This is an integral part of your QMS – not just making sure things don’t get worse, but also improving processes to make the organization stronger over time.

4 Templates for Planning Factory Management Improvements

Step 2: Create documentation for your procedures & protocols

Certain documents are obvious – for example, work instructions and product specification sheets for the production and the quality staff. You can’t skip on that. And don’t hesitate to try new things – videos are usually much better than black-and-white sheets of paper full of text.

You will need a document control procedure. Without it, employees might use the wrong version of a document – for example an out-of-date drawing from a customer. If you develop new product, this should be tied closely to your engineering change request procedure.

I won’t go into the details of writing documents. Just make sure you make it easy to the staff to access the information they need, and easy to keep the documents up to date. And color illustrations are always better. (Yes, all this is much harder than it sounds!)

The key is to agree on a standard “best current way of doing things”. As Masaaki Imai, who did a great job analyzing exceptional companies such as Toyota, wrote:

Where there is no standard, there can be no improvement. For these reasons, standards are the basis for both maintenance and improvement.

One last piece of advice: Focus on the 20% of operations that might cause 80% of the damage. Taxi drivers have memorized a basic procedure to respect (the rules that apply to every driver). A jet pilot has much more detailed procedures, as well as a number of checklists to fill out for each and every flight!

Step 3: Continuously refine your manufacturing operations and procedures

engineers looking at factory documentation

ISO 9001 contains several clauses about staff competency, so quality managers know training is important. However, some essential steps in setting up a quality management system are overlooked by 99% of Chinese factories.

What about maintenance? Making sure your equipment is up and running in good conditions has a strong positive impact both on quality and costs. If a tool gets used up, it might damage parts that might have to be scrapped later on. And yet, preventive and predictive maintenance are often a blind spot. 

Regularly reviewing testing procedures is also often overlooked. People use procedures written 5 years ago and never wondered if they are still adequate. Very often we find a few testing protocols that make no sense.

If you keep developing products, develop a new product introduction process that makes sense in your situation. If it is done well, all the engineering for smooth purchasing & production will be done before things can go wrong.

Finally, some basic tools, such as FMEA and control plans, can bring a lot of benefits to a factory. And yet, since they are not part of ISO 9001, they are left aside. This is a big mistake if you run production batches in the tens of thousands or higher – in that case you need to do FMEA (risk analyses) on each product and its corresponding processes.

Final Words

A quality management system helps you cut costs. It is not just about pleasing customers. Most Chinese manufacturers miss that. It is NOT primarily about documentation, but about process control and risk reduction. And, when done well, about process improvement.

What about you? Have you got experiences to share about setting up a quality management system for your company, or your suppliers? Any positive points? Please leave a comment below and we will respond.


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Topics: Management/Turnaround, Quality, Quality Management System

Renaud Anjoran

Renaud Anjoran

10 years experience in China.
President, China Manufacturing Consultants.
Audited and/or consulted for hundreds of factories in China.
Author of well-read blog, Quality Inspection Tips.

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