Developing an Effective Quality Management System (QMS)

 Let’s start by breaking down and defining what a Quality Management System (QMS) is in its simplest form:

–          Quality (Q) – Effectively and efficiently giving the customer what they are expecting and paying you for.

–          Management (M) – is the most effective and efficient use of resources (people, equipment, processes, etc…)

–          System (S) – is a stable, repeatable way of meeting some goal/ objective by effectively managing the processes making up the system.

If we put this together we see that a QMS is the repeatable method of managing all of the processes that form the system by which you provide a customer (internal or external) for something that they find value in.

In the not so distant past developing a QMS meant nothing more than writing a quality manual, procedures and work instructions to meet the requirements of some standard (such as ISO 9001).

More recent approaches are looking at the entire system and the QMS (business) processes that make it up, the objectives and measures of success (goals) of these processes and then the documentation aspect of it. The “bottom line” is that you can have the most perfectly written procedures in the world that are followed to the letter of the law, but if they are not adding value by meeting the “real” goals of the processes they mean nothing.

QMS processes are meant to add value, be measured, require the use of resources and data and be managed to fulfill the stated objectives.

Developing a QMS can be difficult if it is done correctly. Now there are those that buy a pre-packaged documentation package or have a Consultant write the entire system for them.

Many companies and quality professionals find the biggest hurdle to be resistance to change. In developing a QMS, one has to try to minimize this resistance where possible. A few strategies that I personally find helpful to minimizing this resistance are to:

• Involve and empower the workforce that will be working in the processes.
• Find out which of the current practices, processes, procedures, etc… are working well and try to use them and only changing/ adding/ revising those aspects that need to be changed, initially.
• Get Senior Management buy in and support right at the outset. If this is lacking you are almost always doomed to failure. This helps in obtaining the resources for the project, and getting the process owners to take ownership of the processes that they were tasked to manage.

Here is a brief path that I find useful in developing a QMS (note – this is not claimed to be the only path as there are many).

1)      Establish a steering committee/ team to guide the process and an overall champion

2)      Determine the overall project required completion and work backwards on the pieces that make up the project.

3)      Determine the QMS process and objectives. These may not formally exist yet, but you can sometimes determine them by talking to those involved in the processes of the QMS. These should also drive your quality policy and quality objectives.

4)      Perform a baseline audit to the required QMS standard or other requirements.

5)      Based on the audit, determine the “gaps” and put a priority on them based on those that impact the customer, effect the company bottom line or the order needed to build a basic quality management system if one does not exist. More on this later.

6)      Develop your Quality Policy Manual/ Documentation. (Sometimes called Level 1 documentation)

7)      Develop your QMS procedures (Who is responsible for what) in the determined format (process maps, text based, pictures, etc…). (Sometimes called Level 2 documentation)

8)      Where deemed necessary develop any needed work instructions (The How To) documentation of your system. (Sometimes called Level 3 documentation)

9)      Train your entire team on the required new or revised QMS documentation and verify the effectiveness. This is a chance to give the changes a “dry run”.

10)  Gather and analyze data on the QMS process metrics/ measures/ etc…

11)  Make sure that the QMS process measures have been given careful planning. Mainly what is being measured, who will produce the data, who will gather it, how, how often, who will analyze it and who will take action on it?

12)  Perform another QMS system audit and address any “gaps” with your corrective action process.

Developing a QMS can be intimidating but if you keep a cool head and focus on the important things first as discussed above you will be fine with some simple project management. Keep in mind that you still have a business to run and you need to keep the customer serviced and satisfied.

Good luck.

Mark