This may sound elementary, as Sherlock Holmes would sometimes say, but having a plan in place with specific and executable processes, and being intentional, is not easily done with most Quality Management Systems and laboratories.
People who know me well know what I mean when I ask, ‘does it meet the triad?’ Let me explain. Whenever I make a significant purchase (other than the normal grocery store purchases) I ask myself if it meets the triad; defined as ‘want, need and practicality.’
Typically, if the answer is ‘no’ then I punt on that purchase or have a family board meeting to discuss further. You may be thinking, what does the triad have to do with having a plan, a process and being intentional? Well, I’m glad you asked.
Conversely, if a quality manager meets the triad for managing their quality manual, they would have a plan with actionable processes in place, and be intentional in carrying out that plan. That said, does your quality manual meet the triad?
This topic really struck a chord with me after attending and sponsoring the recent (virtual) AASHTO re:source technical exchange. They provide excellent guidance when it comes to action items in quality manuals following the guidelines of AASHTO R18. I have written about being intentional (October 23, 2013, wow how time flies!) in a previous blog, please check it out.
Some may think a plan is the mere existence of a QM, and while this is partially true, the full plan is the method in achieving the requirements in specific areas within your QM. Having a plan in place helps you achieve your objectives, stay focused and meet the goals of your QM. I can relate planning and maintaining your QM to an airline filing a flight plan. The flight would be compared to the success of the laboratory’s QM and the lab being compliant with current standards. Would you get on an airplane if the pilot had no (flight) plan? If you were looking for a laboratory to have testing performed and they had no quality plan in place would you hire them?
This is where many laboratories get off track, as they lack processes to maintain the ongoing requirements to properly maintain their QM. A process is a series of actions that are performed to achieve a specific result. Let’s break this down. I’ll use the example of equipment procedures as this is by far the most active part of any QM. If a laboratory has 100 pieces of equipment that requires calibration and maintenance, that would lead to a minimum of 200 procedures needing to be completed. This requires a process throughout the course of the year that may include but not be limited to the following:
1) The action of completing procedures
2) Review of the procedure template
3) Meeting the most current standards
4) Completing and saving the procedure in an accessible location available to management and assessors when it comes time for on-site/remote assessments.
Being intentional is choosing to take decisive action on what is important to you while maintaining a clear purpose from the outset.
Points to ponder:
Q: I have completed several technician evaluations, I’m not seeing them in the Quality Manual (tab) in section 5.5.4, Technician Training Evaluation Report Records, I only see three. Am I missing something here?
A: Great question. When technician evaluations are created and completed under the evaluations tab they will appear in the QM in sections 5.5.4 when you click save and complete. However, if they are incomplete (save progress) or if an evaluation was created for any role other than Primary Lab Manager, Lab Manager, or Technician, they won’t appear in section 5.5.4 of the Quality Manual, however, you can continue where you left off for an incomplete evaluation and once completed, they will appear in the QM under section 5.5.4.
Resources and training opportunities
Once you work through the setup process, the following links can be found in the lower right hand corner of the application;
All travel to industry meetings will be assessed on their scheduled dates, hopefully, we can reset in 2021-22.
The technical exchange for 2021 was a great experience for R18LabQMS not only as a sponsor but for virtual attendees as well. Everyone at AASHTO re:source did a fantastic job at presenting, it was worth every penny if you’re involved in all things laboratory accreditation. Next year hopefully we will be meeting in person in Minneapolis.
For all questions regarding your Quality Management System, whether your lab is accredited or not, please contact us and learn how R18LabQMS can add value to your company.
– Gary Irvine
R18LabQMS Program Manager