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Peter Armstrong is a community pharmacist from Worksop,
Nottinghamshire
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During the past year, I have spent an inordinate amount of time on the irksome task of writing standard
operating procedures. This has been a singularly disheartening experience. The idea that a set of written instructions documenting, in great detail, a routine or repetitive activity will in some way guarantee the quality of the end-result is, to put it mildly, fanciful.
The thinking, and I use the word advisedly, behind this notion is that
having formulated a set of instructions that describe the process, it
is used as a template against which the operation is made to conform.
In other words, the basic procedure should be carried out in exactly
the same way and in exactly the same order as laid down in the SOP. This
will purportedly, among other things, confer accuracy and consistency
upon the operation and hence provide quality assurance. This would all
be very well if these claims were true. However, the truth is that the
hypothesis is seriously flawed. It may lend itself to a simple linear
process constituting what might be described as a “closed system”,
namely, one that is isolated from any input, from whatever origin, that
could in any way alter the process. Under any other circumstances, the
concept is intellectually untenable and, in practical terms, unworkable.
The dispensing process cannot, by any stretch of the imagination, be
considered to be a “closed system”. It is not an isolated
process because it takes place within the context of a community pharmacy
and is subject to the demands therein. It is carried out and controlled
entirely by human beings, working together as a tight-knit team, communicating
with each other, monitoring and evaluating each other’s work and
responding to information, whatever its source and whenever it arises.
Complexity
Dispensing is an information-based activity that is dependent on a
high level of technical and empirical knowledge. It also requires extensive
data sources relating to patient medication records, drugs and medicine.
It may appear a simple linear process, but it belies a potential complexity
that derives from the disruption of that linearity. The disruptive
influences take the form of organisational and cognitive interactions
that generate a multiplicity of possible branches that deviate from
the preordained path. The original steps may only be regarded as generalisations
whose form and chronology may be altered by the exigencies of the unpredictable.
For example, in the “Assembling and labelling prescriptions” SOP,
operational flexibility dictates that differing numbers of individuals
with varying roles will be involved in the dispensing process. These
options will be determined by the volume of prescriptions presented,
staffing levels and ancillary tasks. Ideally a three-unit team, checking
each other’s work, reduces the chance of error and is highly efficient
but often a lesser number will be required. However, to devise individual
SOPs to describe any or all of these pathways would be impracticable.
Equally, in the “Interventions and problem solving” SOP,
to assume that there is a common pathway by which a problem is solved
would be to assume that all problems are fundamentally the same. Clearly
this is not the case and the procedure can only be regarded as guidance
that requires interpreting in terms of a particular problem. As for dispensing
being a simple process, the quoted examples are just two of five individual
SOPs required to describe the whole procedure. Inflexibility
The hypothesis underlying the use of SOPs betrays a staggering poverty
of intellect. It is simplistic and, by definition, inflexible. This
inflexibility is evident, not only in the rigid framework which defines
the steps that configure the procedure, but also in its prescriptive
application. To base the operation of a complex activity on an inflexible
format is to fly in the face of reason. Moreover, there is no one “correct” format.
Whether it is “correct” or not is immaterial; what is deemed
to be important is conformity of organisational practices. Any shortcomings
in a SOP may be repeated ad infinitum with impunity and with the quality
assurance that the criterion of consistency has been fulfilled.
This formulaic approach may attempt to mimic the linear processing
architecture of the computer but, even here, conditional addressing
gives rise to
immense complexity, although this pales into insignificance in comparison
with the processing power of the human brain and its capacity to analyse
and resolve the most profound problems. Neural computing crudely simulates
the brain’s micro-architecture employing interconnected parallel
processing pathways that have a propensity to learn and evolve. It is
worth remembering that diversity, plurality and contingency are the currency
of evolutionary theory whereas chance and extinction are the market forces.
Unalterable uniformity has no place in this scheme of things: it is at
the mercy of events, it restricts choice and inhibits initiative.
To constrain the analytical and creative powers of the human brain by
the use of such a straitjacket strikes me as the height of folly. People
are not computers. And, to reinforce the point, computers as presently
constructed cannot possibly duplicate the workings of the brain. All
digital computers now operate according to algorithms, rules which the
computer follows step by step. However, there are plenty of things in
mathematics that cannot be calculated algorithmically and even more in
the real world. Control
SOPs would be perfectly acceptable if they were intended purely as
guidance: a checklist to ensure that certain important tasks are carried
out.
But this is not guidance. This is governance — an expression
of control, albeit remote control. For it is one of the features of
a management culture operating on a plane that is far removed from
the reality of the workplace — a culture that is also bureaucratic,
distrustful and dogmatic. Not surprisingly it tends to be ineffectual.
SOPs are an example of one of the many means by which large organisations
seek to exert control. A lot of these bright ideas are the brainchildren
of management gurus cloistered in those groves of academe on the far
side of the Atlantic — the most powerful nation in the world and
yet one that has a particular penchant for the ridiculous. Unfortunately,
many of our bright young things espouse these ideas, as if they were
some form of Holy Writ, with a fervour that borders on zealotry.
From 1 January 2005, SOPs covering dispensing-related activities within
individual pharmacies became a professional requirement, enshrined in
the Royal Pharmaceutical Society’s Code of Ethics, much of which
is another rigid framework that bears little relation, in perception
or expression, to moral philosophy. The stated purpose is to ensure that
systems used within pharmacies are safe. This is seen as an essential
part of risk management and harm minimisation strategies which themselves
are part of the clinical governance requirements of the new NHS contract.
Given that the operation of these SOPs is unworkable, the Code of Ethics,
the risk management strategies, clinical governance and the new contract
will all be undermined and all will be compromised — unless, of
course, we all continue to maintain the pretence that SOPs are working. |
The
Pharmaceutical Journal