Quality Progress - January 2016 - (Page 21)

BACK TO BASICS Best of DECEM B 2013 ER BY MARCIA M. WEEDEN Pyramid Scheme A framework for stronger standard operating procedures AN IMPORTANT element in the quality SOP ownership ensures proper oversight them. Include how to manage unusual or professional's quest for compliance and and approval, and provides users with a re- unplanned situations. Details are not neces- excellence is the standard operating pro- source when questions or problems arise. sary; simply point the reader in the right cedure (SOP). Often regarded simply as a Include the SOP's revision history to show direction. document with a set of work instructions, how methods evolved and when decisions SOPs can provide much more. A well- were made. This knowledge is valuable process flows and decision rules. They written SOP eliminates confusion and dis- when performing a gap analysis. permit quick visuals when fast answers are putes, ensures repeatability, and provides Because employees can sometimes for- Second-tier flowcharts show high-level being sought. a means for continuous improvement. get their manager and facility are governed The bottom tier provides details for car- Breaking the SOP into three tiers of by organization and external requirements, rying out required activities. Consequently, information elevates an SOP to a precision referencing customer, organization, indus- it is the largest and most detailed tier. quality tool. A pyramid is a helpful model try, and regulatory standards and policies to use to structure and communicate help employees understand and comply associated tasks and step-by-step instruc- information because its tiered composi- with SOPs. List records associated with the tions. Illustrations and screenshots are tion allows for varying levels of detail and SOP so it is easy to locate records that can often helpful aids. Flowcharts provide a complexity (Figure 1). demonstrate compliance with procedures visual representation of the process and if a liability issue occurs. decision points. The top tier contains high-level information-the SOP's purpose, objectives and The SOP's middle tier provides a basic For each process stage, specify the Address records by indicating the tasks scope, who uses the SOP, as well as train- understanding of the main processes. Keep to be documented, who performed them, ing and qualifications that are all critical it brief. The person reading the SOP, such and where to file or forward them. Make for correct execution. Because strong dif- as a customer or auditor, may not require sure records contain the who, what, when, ferences of opinion can arise, be objective specifics. Managers typically refer to this where and why for compliance and trace- from the start and define responsibilities section for quick insights. ability. The "how" is detailed in the SOP. by department or job function. Indicating Define the words, terms or acronyms used in the SOP if there is Tiered structure of a standard operating procedure / FIGURE 1 Overview Purpose Scope Requirements related to: * Training * Responsibilities * References * Governance * Records * History Definitions Policies High-level processes Flowcharts for: * Complicated processes * Approvals * High-level decision making Detailed information How-to steps for carrying out specific tasks Checklists Final steps and records any chance someone may complete. Checklists constructed in progressive be unfamiliar with them or work order are optional but helpful tools if the possibility of multiple to manage complicated or critical activi- meanings exists. ties, and workflow interruptions. They People feel most comfortable doing something when serve as reminders and records. Well-written SOPs are a mainstay for they know why it must be reducing costs and ensuring customer done. Detailing policies satisfaction. When it comes to policies, specific to the SOP resolves regulatory directives and liability risks, disputes and instills worker SOPs are excellent insurance for achieving confidence. compliance. QP Processes provide an overview of the stages the Flowcharts for: * Complicated tasks * Decision making * Start-to-end activities Providing these details ensures records are main activities go through. Briefly describe what initiates the processes, the steps to carry out and what concludes 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. Source: Quality Excellence Services © 2013 January 2016 * QP 21

Table of Contents for the Digital Edition of Quality Progress - January 2016

According to Plan
Solid Proof
Use Your Head
Stakeholder Management 101
Customer Delight
All About Data
Eight Simple Steps
Minimizing Chaos
Take Note
Pyramid Scheme
Assessing Failure
Which Six Sigma Metric Should I Use?
Turning ‘Who’ Into ‘How’
In the Beginning
Outputs and Outcomes
That’s So Random—Or Is It?
Understanding Variation
Improving a System
Putting It All on the Table
Know the Drill
It’s Fun To Work With an F-M-E-A
Solve Problems With Open Communication
Tell Me About It
Separate the Vital Few From the Trivial Many
To DMAIC or Not to DMAIC?
Breaking It Down
Smart Charting
1 + 1 = Zero Defects
QFD Explained
Curve Your Enthusiasm
Make a Choice
What Is a Fault Tree Analysis?
Successful Relationship Diagrams
The Benefits of PDCA
Creative Combination
Return on Investment
The Art of Root Cause Analysis
Why Ask Why?
Get to the Root of It
Checks and Balances
Calculated Risk
Sufficient Evidence
Sample Wise
Clearing SPC Hurdles
Supplier Selection and Maintenance
Team Advantage
Building a Quality Team
Plan Experiments to Prevent Problems
Substantiation Test
Training Day

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