Quality Progress - November 2014 - (Page 64)
ONE GOOD IDEA
BY MARCIA M. WEEDEN
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
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
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
analysis, as well as process and product validations.
SOPs are invaluable when dealing with quality costs.
Reviews and comments
When customer complaints or regulatory investigations
occur, SOPs are the go-to documents to determine what
happened. SOPs, along with their supporting records, make
Draft stage for
response times to complaints, which, in turn, conveys that the
and point to effective preventive actions.
Readily available information contained in SOPs shortens
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
an SOP is worth nurturing because in the end, an SOP may be
Regulatory changes and
Customer and user
Internal and external
changes, upgrades and
© Quality Excellence Services
64 QP * www.qualityprogress.com
Internal and external
problems and issues
SOP is obsolete.
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
Table of Contents for the Digital Edition of Quality Progress - November 2014
Mr. Pareto Head
Bank on It
The System Is the Solution
Quality in the First Person
One Good Idea
Quality Progress - November 2014