Putting “Quality” Back into Your QMS

Contributor: Jon Wetzel
Posted:  09/01/2011  12:00:00 AM EDT
Rate this Column: (4.3 Stars | 18 Votes)
Tags: Jon Wetzel | Quality Management System | QMS | quality management | SOPs | SOP review process

From a high level perspective a Quality Management System (QMS) is great but to the lab workers it’s more like a pile of “red tape” that stops them from doing or improving their work.  Here’s what you can do to put the “Quality” back into your QMS. 

"Something is wrong if workers do not look around each day, find things that are tedious or boring, and then rewrite the procedures.  Even last month’s manual should be out of date.”

                        -Taiichi Ohno, former Toyota Executive Vice President

Forget the “suggestion” box and give them an “implementation” process.

Great ideas are left on the lab floor because the workers are only told to make suggestions about improving the process but not given the empowerment to implement the ideas themselves.

Much of a QMS is about control.  This control should rest in the hands of the people on the bench actually doing the work.  They are your experts and have firsthand knowledge of how best to improve their work stations.

Give them a process by which they can get approval to test and implement solutions on their own.  Remember:  Workers manage the process….Managers manage the people.

Streamline the approval process for implementing new SOPs.

There is nothing more demoralising then to take someone’s passion and hard work and give them the response “Thank you, we’ll put it on the agenda for the quarterly QA meeting.”

Would you wait 3 months to implement a process that would make your job easier?  I wouldn’t, you wouldn’t and neither do most other employees.

This is why most company SOPs don’t actually match up with what is physically being done in the lab.  Workers will normally just implement new improvements without tracking them.

You should have a target of 24-48 hr turnaround on signing off new SOPs.  If that’s not possible then you need to do some Value Stream Mapping on your SOP review process and discover what to change to meet or exceed that target.

Employees are also the VOC (Voice of the Customer) for any QMS

“Build it and they will come” works for Kevin Costner in “Field of Dreams” but it’s not going to work for your QMS.

For  your companies QMS to function it needs to fulfill 3 main requirements:

  1. Satisfy compliance with: ISO, TQM, Baldridge, EFQM, GXP, FDA, CAP, CLIA, AATB or any other certification or affiliation you’re working with.
  2. Adheres to your customers expectations in how you operate your business.
  3. Is simple enough to allow your workers to get their work done while wanting to improve their processes.

Ready to take the temperature of your QMS?

Here’s a simple test to see where your QMS really stands. 

  1. Go thru your active SOPs and find any that are older than 1 year.
  2. Take the SOP to the work area and watch the process. (Going to the Gemba)
  3. See how close the SOP is to the actual work being done.

Are you running a high QMS out of tolerance fever?

  • Don’t freak out.
  • Don’t point fingers or play the blame game.
  • Ask the workers what the best way is to get everything back up to speed.
  • Empower them to get everything back on target.

When you pay your staff to do a job with their hands you also pay them for their experience and intelligence.  It’s your job as a company to find a way to harness that.  That’s what it takes to be “Best in Class”.

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Contributor:   Jon Wetzel

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