Quality Progress - November 2014 - (Page 64)

ONE GOOD IDEA BY MARCIA M. WEEDEN Full Circle Systematically review and revise your SOPs STANDARD OPERATING procedures (SOP) are snapshots of an test methods to use, or indicate where to find them. SOPs explain what to do in cases of an exception, noncompliance organization's vitality. or failure. Flowcharts visually explain SOPs' processes and decisions, SOPs undergo birth, maturity and death. The obvious phases of an SOP's life cycle are draft, review, comment and revise, approval, and provide quick reminders. SOPs answer urgent questions at 2 a.m. publication and use. As Figure 1 indicates, an SOP's life cycle is when no one else is available to make a decision. SOPs instill confidence in customers that their concerns and needs more intricate than often assumed. have been addressed. SOPs provide baselines and benchmarks for Because SOPs explain so much, an initial question for any continuous improvement, complaint resolution and innovation. organization seeking answers should be, "What does the SOP say?" Display the value of SOPs with the demonstration of support via Unfortunately, some organizations regard documenting SOPs as a one-time event. Typically, they generate SOPs in response to exter- a management launch, particularly in cases of a new program. To nal requirements. Despite the development costs and time invested, ensure understanding and compliance, deploy a full-fledged and for- SOPs may sit unused. mal training program. If a strong document control or configuration management system exists, review SOPs at least once a year and Well-written and properly used SOPs are essential to the smooth operation of a business. They are testaments to regulatory compliance determine whether employees are performing tasks as stated. The reviewer may casually ask SOP users whether anything has and can serve as comprehensive training tools. They define terms that provide common understanding and eliminate ambiguity. SOPs may changed. But a formal, internal audit is a better approach. Audit find- contain specifications and help users determine which inspection or ings may uncover confusion, process drift, changes or obsolete meth- SOP life cycle ods. Audits may highlight risk areas that must be addressed. Shifts in job functions or department responsibilities may / FIGURE 1 SOP is needed indicate SOPs require tweaking or that users need retraining. New equipment, facilities, materials, methods or custom- SOP = standard operating procedure MGMT = management ers also can necessitate updates, revisions or obsolescence. SOPs can support design or process failure mode and effects Process is roughed out analysis, as well as process and product validations. SOPs are invaluable when dealing with quality costs. Reviews and comments Revise according to feedback Yes Draft stage Is MGMT support needed? Document approval When customer complaints or regulatory investigations Make announcement or conduct kick-off meeting No occur, SOPs are the go-to documents to determine what happened. SOPs, along with their supporting records, make Is training required? Yes Conduct training Draft stage for SOP revisions response times to complaints, which, in turn, conveys that the Release and distribute Reviews and comments and point to effective preventive actions. Readily available information contained in SOPs shortens No Updates and modifications root cause determinations and corrective actions easier, 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 Use an SOP is worth nurturing because in the end, an SOP may be Regulatory changes and noncompliances Yes No Scheduled reviews Customer and user complaints Continued suitablilty Internal and external changes, upgrades and innovations Are revisions needed? © Quality Excellence Services 64 QP * www.qualityprogress.com Yes Scheduled audits Internal and external problems and issues Is SOP still current? No SOP is obsolete. Archive SOP. what saves an organization's life. QP 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. http://www.qualityprogress.com

Table of Contents for the Digital Edition of Quality Progress - November 2014

Up Front
LogOn
Expert Answers
Keeping Current
Mr. Pareto Head
Finding Harmony
Multipronged Approach
Bank on It
The System Is the Solution
Innovation Imperative
Quality in the First Person
Career Corner
Statistics Roundtable
Standards Outlook
QP Toolbox
QP Reviews
One Good Idea

Quality Progress - November 2014

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