Standard Operating Procedures 101

Standard Operating Procedures 101

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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 optimizing 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.

 

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Value of Standard operating procedures

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.

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Case Study: Sharing is Caring

Ervins Akrong, Compliance Specialist at LGC, recalls an instance where SOPs were not shared across an organization with multiple food manufacturing facility locations:

“A Foreign Material Incident occurred at a food manufacturing facility, resulting in a distribution centre level recall for product made within the suspected time frame of the incident.  This incident had resulted in the revision of the facility’s Foreign Material SOP, with the inclusion of new areas to be checked / washed out, specifically 90° piping, to ensure that the system has been cleaned of any potential contamination.  A few years later, a sister facility had a similar Foreign Material Incident, which they had resolved using their own Foreign Material SOP.  The learnings from the previous incident were not shared between the facilities, resulting in the 90° piping not being taken apart during the second incident.  At the end of that production week, more metal was found in the system, resulting in production from that entire week being placed on hold.  This had resulted in a costly rework project, where all the product suspected to be contaminated had to be sorted through an X-Ray and re-packaged.  This cost could have been avoided, had the SOP that was revised from the first incident been shared across the organization. 

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