I Can Evaluate Your QMS With Just One Question

By: Steve Gompertz, QRx Partner

I have lost count of the number of Quality Management Systems (QMSs) I have audited, observed, refined, or repaired over 30+ years in the MedTech industry. Over time, certain patterns emerge. One of the most reliable indicators of the health of a QMS is the relationship between the company's Quality Manual and the way the system actually operates.

So here is the question: How many pages is your Quality Manual?

1 - 5 Pages

Lean.

Quality understands the purpose of the Quality Manual. The QMS is likely suitable, adequate, and substantially effective. It is probably more efficient than most systems.

The focus is on continual improvement, or better yet, continual optimization.

SOPs are also likely lean. Less text, more visual. Written for the people doing the work rather than for the auditors. Engagement tends to be higher because employees understand the why, not just the what and how.

Process metrics are robust and established for at least the critical processes, and often for all processes. Reviews occur frequently at multiple organizational levels. Process owners present their own metrics and discussions lead to real actions.

6 - 10 Pages

Not bad.

Assuming the extra pages are used to illustrate the Process Approach or explain the company’s interpretation of applicable standards and regulations rather than simply repeating them.

The QMS is still likely suitable, adequate, and mostly effective.

SOPs tend to be more traditional. Some visual elements may exist, but the writing is often aimed more at demonstrating compliance than driving engagement and performance.

Process monitoring is usually limited to the critical processes. These are typically the ones discussed during Management Review. Some process owners present, and some discussions occur.

11 - 20 Pages

At this point, it is unlikely that anyone in the company has actually read the Quality Manual.

Much of the content is usually copied or paraphrased from standards and regulations, perhaps with a small amount of company-specific interpretation.

The QMS may still technically be suitable and adequate, but mostly in a generic sense. Effectiveness tends to be inconsistent and sometimes dependent on luck.

Metrics are often driven by pain points or by what management assumes Quality should focus on. Cycle time and cost typically dominate.

Management Review usually occurs annually and is presented entirely by Quality. Discussion is minimal. Any resulting actions tend to be assigned right back to Quality.

20+ Pages

At this point the Quality Manual is largely non-value added.

The QMS has become a facade designed primarily to satisfy auditors.

SOPs are enormous text-heavy documents that grow larger with every CAPA or audit finding. The system becomes increasingly generic and disconnected from how the organization actually operates.

Effectiveness relies heavily on the diligence and reactive effort of the Quality organization.

Management sees the QMS as a necessary burden and resents the cost for what appears to be little return.

The company becomes very good at firefighting or playing Whack-A-Mole.

Preventive action? Rare.

Management Review? That annual meeting where Quality talks for an hour about how the sky is falling. Little discussion. No questions. Quality assigns itself actions.

Bottom Line

Like judging someone within the first ten seconds of meeting them, the Quality Manual is intended to tell you everything you need to know about the QMS.

In reality, the document only needs to accomplish a few things. Under ISO 13485 there are essentially four:

1. Define the scope of the QMS; what is applicable and what is not

2. Identify the procedures that make up the QMS

3. Describe how those processes interact, i.e. - the Process Approach

4. Describe the structure of the QMS documentation

That’s it. Everything else belongs somewhere else.

If your Quality Manual needs twenty pages to say this, the problem probably is not the manual; it’s the system behind it.

And if the system only works when it is explained in twenty pages, it probably does not work very well at all.

So, how many pages is your Quality Manual?