Do standard operating procedures (SOPs) ensure quality or stifle innovation?
Gary Collins
Multidisciplinary Quality Manager - NHS Ayrshire & Arran
As we all know, SOPs are a mandatory requirement of accreditation and regulatory standards. Without a doubt, the transition to ISO15189 has resulted in
the review of the majority, if not all, SOPS that a department holds. The number has also increased.
I believe that during this time there has been a certain degree of “stifling” of innovation. Bridging the gap in the documentation requirements has dictated the workload and the focus of laboratory services.
Speaking from a personal perspective and probably for a lot of laboratories, this has been a difficult process and has required a lot of input and commitment from staff. Quality Management resource has been a limiting factor.
However, post-transition is the time to focus on adding value through innovation and continual improvement. As scientists, we are trained to question and re-evaluate why we do things a certain way. Is there a better way we can do this? Too often SOPs are reviewed with no change. SOPs should be regarded as dynamic documents; the review process should be innovative, incorporating staff ideas and new methods or approaches with the expectation of meeting the needs of service users Innovation can be accompanied with a certain degree of risk taking and, therefore, there has to be this approach of integrating or linking of compliance and innovation, ultimately driving change to improve the patient pathway while maintaining safety.
Alison Adkins
Biomedical Scientist and Training Officer - University of Birmingham
SOPs have become an integral part of the daily laboratory experience. Broadly, an SOP exists to instruct how a task will be performed and will deliver a safe, secure process for the operator and environment that conforms to legal obligations and professional standards by efficient use of resources.
SOPs are fundamental components of Quality Management, provided that they are “fit for purpose”, well written, clear, concise and regularly updated.
However, they should be more than simple mechanistic instructions providing boundaries for behaviour. SOPs should offer background information regarding associated documentation, sample preparation, IQC, EQA, reporting and other criteria detailed in ISO15189.
Critical examination of SOPs may stimulate rather than stifle innovation, resulting in modifications and providing evidence-based quality improvements, which may be incorporated into future updated versions.
Innovations may be as a direct result of staff suggestions, new methodologies or original research rectifying flaws in current practice or identifying new aspects that may be validated and verified resulting in change control to include in an updated version of an SOP.
Key to this is evidence and regular review, combined with compatibility and a will to amend SOPs as necessary, not purely when review is mandatory. This requires team commitment to contribute and adopt new processes, techniques and technologies.
Nymeth Ali
Senior Healthcare Scientist - Imperial College Healthcare NHS Trust
A lay definition of SOP is a step-by-step set of instructions for a procedure, from simple tasks to the more complex ones. Its aim is to ensure that any person reading it is able to repeat the same task efficiently and uniformly. My view is that SOPs ensure a high-quality level as they are set based on past experience and recently validated methods to ensure excellence at work; these also means that new scientific updates should inform SOP reviews and promote, rather than hinder, innovation.