Standard Operating Procedures 101
Written and updated SOPs provide reliability, consistency, and reduced risk to any manufacturing environment. This week’s blog will introduce common types of SOPs while highlighting their value using a case study that examines the dangers of not following SOPs.
What is a Standard Operating Procedure?
A Standard Operating Procedure (SOP) is a protocol unique to the processes within a company, outlining a set of written instructions to complete tasks in compliance with industry regulations and specific business standards. SOPs are control documents that can be used by companies to substantiate the validity and safety of their products and services during any inspection, whether it is conducted by a consumer, a firm performing due diligence for a potential purchase or a regulatory authority conducting an audit.
Value of SOP’s
SOPs have countless benefits to the organization utilizing them. The following list illustrates these benefits.
Business Continuity – SOPs facilitate the training and delegation of tasks to new or designate employees in the absence of key staff members responsible for such tasks; this prevents any delays that may occur. Furthermore, multi-site companies can share the most up-to-date standards between sites with ease; this ensures the same work is being done from site-to-site.
Regulatory Compliance – SOPs will ensure that all trained individuals are conducting processes in a compliant manner as per specified regulations.
Consistency and Reliability – SOPs establish consistent and reliable production by defining planned procedures in industries where quality standards exist.
Reduced Learning Curve and Increased Productivity – SOPs are a living document and are subject to change overtime. SOPs serve as a reference tool for companies, as the written operational practices are recurrently modified to reflect resolutions to issues that have previously occurred. Establishing streamlined processes will save time and resources required to perform tasks, as the SOPs will outline precisely how to execute the task without any uncertainty or delays. This increases productivity, reduces the risk of errors, and reduces onboarding time for new employees.
Secure Workplace – SOPs help maintain a safe work environment. If employees are not properly trained, they may conduct tasks in an unsafe or inconsistent manner; SOPs are put in place to outline set procedures, avoid the risks involved and eliminate possible liabilities for a company.
Evidence of a compliant Quality Management System (QMS) – when producing a product that adheres to a standard, SOPs are the building block of the QMS that organizations employ to ensure that they are producing a quality product every time.
ALPS’ Compliance Specialist, Ashton Sturm, recalls a system failure that occurred as a result of an SOP not being followed:
“The SOP for drying Cannabis flower states that flower is to be dried until it reaches 18-21% moisture content. During a particularly large production batch run, there was a shortage of available space on the drying racks and as a result drying sheets were loaded with more than the normal amount of product. This caused uneven drying of the product and resulted in a discrepancy in the moisture content of the finished product. This discrepancy and excess of the allowable limit for total moisture resulted in mold formation of the finished product. All product contaminated with mold had to be destroyed and millions of dollars of revenue was lost.”