Written procedures used by trained staff are the basis for all quality systems but there are many ways of writing a procedure. Are you getting it write?
A basic tenet of any quality system, be it ISO 9001, ISO 17025, GMP (Good Manufacturing Practice) or GLP (Good Laboratory Practice), is that we have trained and qualified analysts and chromatographers with the appropriate combination of education, experience and training. Furthermore, they need to follow written procedures in their work, for example, analytical methods, preparation of mobile phases, weighing of reference and analytical standards and sampling.
It is important to understand that there is no explicit statement in any quality system that mentions the quality of the output of the analytical laboratory. However, the principle employed is that if qualified staff follow written procedures then the analytical work and results should be better and more consistent that if there were nothing in place. For example, samples should be prepared the same way each time a specific analysis is performed; a mobile phase should be prepared consistently to eliminate run to run variation; samples presented to a sample probe should be consistently measured and correction factors should be appropriately and consistently applied to calculated data. This is a good way to avoid out of specification (OOS) results.The consistent element that runs through this whole stream is the written procedure. This document can be called a procedure, standard operating procedure (SOP), technical operating instruction (TOP), work instruction (WI) or anything else that somebody thinks up. Regardless of the name, the written procedure is the key element that ensures that each analytical scientist is able to produce consistent work for the same process.
The problem is that there are many ways of writing a documented procedure: some are good, a few are very good and some bad. The purpose of this article is to look at the ways that procedures are written and how they could be improved the next time you are involved in reviewing them.
A Little Written Problem?
As an auditor I get to see some really amazing things in laboratories, but let us focus on the subject of this article. During an audit I asked to see the procedure for a topic and was proudly presented with a pile of paper 117 pages long. You expect that there will be various document controls that take up some pages such as front pages with sign off signatures, table of contents, document history, but even allowing for three to five pages what remained was an awful lot of procedure. Looking through the document I noticed that there were no figures, no tables, just text. Lots of text. In fact, lots and lots of text. More text on the subject than you could find in some textbooks. Certainly more text than I really want to find in any procedure.
Early Christmas for the Auditor!
Auditing is not known for its excitement or entertainment value, either for the auditor or auditees. However, there are times when the afternoon's entertainment is assured — for the auditor — and this time it has arrived in the form of a 117-page SOP. The only problem is that the auditor has to remember to keep a straight face.
Just think this through next time you consider writing a mega procedure. When presented with a procedure of this length, consider the following questions:
I would go as far as saying that reading this SOP is highly unlikely to make anybody's bucket list.
So the prologue of this entertainment can begin with the auditor asking to see the training records for the mega SOP. Presented with the training records you could expect to see some substantial training material for this procedure plus a demonstration of understanding or competence. Read and understand this procedure? Don't even think about this option — you'll need extensive training. Then you pick a lucky individual — better known to the auditor as the stooge — to bring in and begin Act 1.
The (un)lucky individual arrives. Fortunately the auditor does not need to bring a selection of medieval torture instruments such as a rack or thumb screws as the laboratory has already provided one with the SOP. With a copy of the SOP on one side and the documented evidence of the output mandated by the procedure on the other, you ask the individual where in the procedure it states that a particular output must be produced. Just stay quiet and watch the entertainment unfold. Act 2 is simply Act 1 in reverse; here's what it says in the procedure, show me the evidence that this was followed. Everyone's a winner! If the auditor uses the power of silence effectively, the squirm factor index can rise substantially throughout this process.
Of course, the laboratory could have made your job even easier by updating the procedure the week before you have arrived. In which case the prologue becomes Act 1, as you'll be very interested to see how effective training has been undertaken in such a short period of time.