Full Circle

Systematically review and revise your SOPs

by Marcia M. Weeden

Standard operating procedures (SOP) are snapshots of an organization’s vitality.

SOPs undergo birth, maturity and death. The obvious phases of an SOP’s life cycle are draft, review, comment and revise, approval, publication and use. As Figure 1 indicates, an SOP’s life cycle is more intricate than often assumed.

Figure 1

Because SOPs explain so much, an initial question for any organization seeking answers should be, "What does the SOP say?" Unfortunately, some organizations regard documenting SOPs as a one-time event. Typically, they generate SOPs in response to external requirements. Despite the development costs and time invested, SOPs may sit unused.

Well-written and properly used SOPs are essential to the smooth operation of a business. They are testaments to regulatory compliance and can serve as comprehensive training tools. They define terms that provide common understanding and eliminate ambiguity. SOPs may contain specifications and help users determine which inspection or test methods to use, or indicate where to find them.

SOPs explain what to do in cases of an exception, noncompliance or failure. Flowcharts visually explain SOPs’ processes and decisions, and provide quick reminders. SOPs answer urgent questions at 2 a.m. when no one else is available to make a decision.

SOPs instill confidence in customers that their concerns and needs have been addressed. SOPs provide baselines and benchmarks for continuous improvement, complaint resolution and innovation.

Display the value of SOPs with the demonstration of support via a management launch, particularly in cases of a new program. To ensure understanding and compliance, deploy a full-fledged and formal training program. If a strong document control or configuration management system exists, review SOPs at least once a year and determine whether employees are performing tasks as stated.

The reviewer may casually ask SOP users whether anything has changed. But a formal, internal audit is a better approach. Audit findings may uncover confusion, process drift, changes or obsolete methods. Audits may highlight risk areas that must be addressed.

Shifts in job functions or department responsibilities may indicate SOPs require tweaking or that users need retraining. New equipment, facilities, materials, methods or customers also can necessitate updates, revisions or obsolescence. SOPs can support design or process failure mode and effects analysis, as well as process and product validations.

SOPs are invaluable when dealing with quality costs. When customer complaints or regulatory investigations occur, SOPs are the go-to documents to determine what happened. SOPs, along with their supporting records, make root cause determinations and corrective actions easier, and point to effective preventive actions.

Readily available information contained in SOPs shortens response times to complaints, which, in turn, conveys that the organization is vigilant. If a lawsuit occurs, well-documented SOPs and their accompanying records are among the best tools in an organization’s arsenal of defense. The life cycle of an SOP is worth nurturing because in the end, an SOP may be what saves an organization’s life.

Marcia M. Weeden is the owner of Quality Excellence Services in Barrington, RI. An ASQ member, she holds a master’s degree in textiles, clothing and related art with specializations in quality assurance and adult education from the University of Rhode Island in Kingston. An ASQ-certified quality engineer and technician, Weeden is a frequent dinner speaker at ASQ section meetings.

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