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Analytically Speaking25 Sep 2024

Variability & data quality

Why Procedures Don’t Matter

By Michael Leal · Analytically Speaking · first published on LinkedIn, 25 Sep 2024 · 4 min read

In my last article “Why the Laboratory Matters”, I got some very good feedback, I also had someone mention to me that I may want to rethink some of my phrasing, that although they knew exactly what I was talking about, and agreed with me, they thought some of my language might be viewed as inflammatory, mainly because I said the quiet part out loud. I really respect this person’s opinion and appreciate their input, so I will add this disclaimer:

If you find the truth to be offensive, you may not want to read my articles. I have no intention to offend, my goal is to make things better, and we can’t make things better if we can’t talk about the subjects that make things worse. Read at your own risk.

Procedures, every lab has a book of procedures, or a network folder, SharePoint, etc. filled with procedures that must be reviewed at some interval of time. Many are way past their review date, obsolete and/or poorly written. I once worked in a lab where procedures hadn’t been updated in a decade, and yet technicians came and went, and data was still being produced. A multi refinery committee had been commissioned by corporate to ensure that all procedures were reviewed and updated to get everyone on the same page. They met at least once a month, likely more frequently than that, and after a couple of years, exactly zero procedures had been updated.

But data was still being generated.

Eventually, a manager came along and decided on making it a priority to update every procedure we had. All hands on deck, a contract chemist was added to help with the efforts. The outcome was every procedure was updated, they were beautifully written, with information similar to ASTM. I had never seen such a thing in a laboratory, mostly due to the efforts of the contract chemist, as their ability to research and write technically was extraordinary.

I had the opportunity to work in a new laboratory at a plant that had not started up yet, we had no samples, but we had instruments and technicians. I decided to take the approach that the technicians help write the procedures. I had done this previously on a smaller scale, I needed to commission a new instrument and method, I picked one of my technicians handed her the method and asked her to read it, and then come to me with any questions. Once she read it, and I asked a few questions to ascertain her level of comprehension, I brought her to the instrument. I told her, here are the reagents and glassware you need to make the standards, make the standards and calibrate the instrument. To her surprise she was able to do it with little guidance from me.

I have had to commission many instruments nearly simultaneously. Once the instrument is calibrated, next is to write a procedure, and then you must train the technicians. I can tell you that my first procedure is less formal, but always very detailed with screenshots of the software. Every click is documented in order, with notes as to why you are clicking and how to avoid mistakes. If you follow every step of this procedure, you will do it correctly. Once I distribute this procedure, I personally talk to every technician and walk them through every step, explaining where they will make mistakes and how they can avoid them. I ask if there are any questions, and every time there are none. Before I walk away, I ask, “are you comfortable with this procedure?” and they all nod their heads affirmatively.

I walk away knowing they didn’t get it. I make it a point to be available to my technicians at all hours. This is not ideal, I would like to not spend so many hours at work, however, my area is my responsibility. If the technicians fail, I fail, and I refuse to fail.

So of course, at 1:18 AM, I get a call. The technician has a problem, and the problem is that very thing I told them in person was going to be a problem, the very same thing that I detailed in the procedure and explained how to avoid, yes that thing. So, with my eyes closed, still half asleep, I explain, go to this menu, select that, in the window scroll down, select this, do that and you're done. Then I go back to sleep.

How did I know? Well, I did not have the opportunity to go straight to a 4 year degree after High School, I got an AAS in Chemical Engineering Technology, and got a job right away. I started as a Lab Analyst and worked my way up. I know how technicians think, so I can see a procedure and quickly identify where there will be a problem for the technician. I also am a bit of a perfectionist, I want my instruments to be precisely accurate, so I identify all of the things that can create erroneous data, and I mitigate or eliminate them.

So why procedures don’t matter? Well, because nobody reads them, of course. Ok maybe some of you do, but you are probably an auditor, and you probably skim for that step that will most likely be missed and ask about it. So other than the person who wrote the procedure, and the person that is responsible for reviewing it, the procedure likely will not be read, of course people will sign off that they read it, but they likely did not.

Why not?

Because humans don’t learn by reading, they learn by doing, hand a baby a book and what do they do, they try to eat it. Hand a person a build your own whatever kit, what’s the first thing they do, toss the directions.

Procedures don’t matter but investing the time to help someone develop skills does. I will do whatever it takes to help someone gain a new skill, assuming they want to learn, because these people will eventually become great allies and collaborators one day.