BACK TO BASICS
A framework for stronger standard operating procedures
by Marcia M. Weeden
An important element in the quality professional’s quest for compliance and excellence is the standard operating procedure (SOP). Often regarded simply as a document with a set of work instructions, SOPs can provide much more. A well-written SOP eliminates confusion and disputes, ensures repeatability, and provides a means for continuous improvement.
Breaking the SOP into three tiers of information elevates an SOP to a precision quality tool. A pyramid is a helpful model to use to structure and communicate information because its tiered composition allows for varying levels of detail and complexity (Figure 1).
The top tier contains high-level information—the SOP’s purpose, objectives and scope, who uses the SOP, as well as training and qualifications that are all critical for correct execution. Because strong differences of opinion can arise, be objective from the start and define responsibilities by department or job function. Indicating SOP ownership ensures proper oversight and approval, and provides users with a resource when questions or problems arise. Include the SOP’s revision history to show how methods evolved and when decisions were made. This knowledge is valuable when performing a gap analysis.
Because employees can sometimes forget their manager and facility are governed by organization and external requirements, referencing customer, organization, industry, and regulatory standards and policies help employees understand and comply with SOPs. List records associated with the SOP so it is easy to locate records that can demonstrate compliance with procedures if a liability issue occurs.
The SOP’s middle tier provides a basic understanding of the main processes. Keep it brief. The person reading the SOP, such as a customer or auditor, may not require specifics. Managers typically refer to this section for quick insights.
Define the words, terms or acronyms used in the SOP if there is any chance someone may be unfamiliar with them or if the possibility of multiple meanings exists.
People feel most comfortable doing something when they know why it must be done. Detailing policies specific to the SOP resolves disputes and instills worker confidence.
Processes provide an overview of the stages the main activities go through. Briefly describe what initiates the processes, the steps to carry out and what concludes them. Include how to manage unusual or unplanned situations. Details are not necessary; simply point the reader in the right direction.
Second-tier flowcharts show high-level process flows and decision rules. They permit quick visuals when fast answers are being sought.
The bottom tier provides details for carrying out required activities. Consequently, it is the largest and most detailed tier.
For each process stage, specify the associated tasks and step-by-step instructions. Illustrations and screenshots are often helpful aids. Flowcharts provide a visual representation of the process and decision points.
Address records by indicating the tasks to be documented, who performed them, and where to file or forward them. Make sure records contain the who, what, when, where and why for compliance and traceability. The "how" is detailed in the SOP. Providing these details ensures records are complete.
Checklists constructed in progressive work order are optional but helpful tools to manage complicated or critical activities, and workflow interruptions. They serve as reminders and records.
Well-written SOPs are a mainstay for reducing costs and ensuring customer satisfaction. When it comes to policies, regulatory directives and liability risks, SOPs are excellent insurance for achieving compliance.
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.