How much do you love your SOPs? Introduction
By Dee Carri
Over the years, organisations have spent vast sums of money developing, documenting, implementing and managing Standard Operating Procedures (SOPs) (See Q.20).The theory is that with SOPs in place people performing tasks are provided with clear instructions, making them more productive and making tasks repeatable with consistent outcomes. Management know that staff follow the clear instructions so it frees up management for higher value work and inspectors, auditors and regulators can trace a regulation through to an SOP or SOPs will prove that the regulation is implemented correctly.
Wouldn’t you think, then, that everyone would love their SOPs?
Sadly, the opposite is true. Mention of the words “SOP” or “SOPs” generally invokes a litany of woe; they don’t work, they don’t reflect reality, they are wrong, they can’t be found, they can’t be understood, they take too long to develop, they take too long to approve, it is a pain to change them, it takes too long to train on them, they are a good example of rampant bureaucracy.
The reality is that there is a major performance gap between what we expect from SOPs and what we actually get from SOPS.
Some time back, we began to reflect on our many years of SOP experience: as users and managers of SOPs, and the many conversations we’ve had with management, staff, and independent observers and auditors. This set us on a “5-Whys” (See Q.21) journey to explore and gain a better understanding of SOP problems.
In this series of blogs we will share some of the findings and the insights we have gained from our analysis that will cover a range of SOP problems, including:
Firstly, however, it is necessary to explain the underlying context for SOPS.
Why does management develop SOPs?
Today, compliance – driven by regulation, is the single biggest driver of SOP development. The reasons for regulation are simple: consumers and the public in general are more risk aware, more knowledgeable and more demanding of high standards from business; government wants a greater degree of visibility and control of business, in the belief that more control will prevent a repeat of the ethical, product and financial scandals that have dogged economies over the last decade. Given these drivers, the compliance agenda is growing and becoming more complex.
For those charged with the management of business, this has resulted in a complex web of compliance activities covering all the main operational areas of a business: Financial; Product / Manufacturing; Environmental; Health and Safety; Privacy. On top of the compliance agenda, many organisations opt to overlay a quality agenda to demonstrate it has achieved a quality accreditation e.g. ISO, OHSAS, CE standards, and others.
To meet each of these individual compliance and quality agendas, documented policies and procedures need to be implemented and maintained, together with evidence to “prove” that quality and compliance are satisfactory for inspectors, external partners, auditors and regulators, placing a considerable burden and cost on the business. Today, all businesses are subject to some regulation, as diverse as anti-money laundering or environmental, making the compliance burden universally applicable.
Certain sectors, such as Life Sciences and Aviation, are subject to more regulation than others. Consider, for example, a Life Sciences company to understand what the compliance and quality burden means in practice. A UK pharma plant, employing 500 employees, must satisfy EU and US good manufacturing practices. It is also subject to the Sarbannes Oxley Act and has implemented ISO 140001:2004 to help manage its environmental requirements. It has 900+ SOPs in place for manufacturing operations, approximately 200 Work Instructions (more explicit “how-to” instructions for certain types of tasks) and approximately 350 other procedures – all subject to formal management and regulatory control. It takes quite an effort and cost to create and govern this body of documentation! Various governance committees and independent quality assurance / audit functions are required to provide independent oversight, IT infrastructure and systems are needed to provide secure content management and control of documentation, and of course, all affected parties are required to develop and implement their procedures.
This is the context in which organisations develop and deploy SOPs.
In the next blog in our SOP series, we'll focus on the topic of “duplication”. In the meantime, we invite you to provide feedback, comments and your experience in the comments section below.