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SOP on how to write a Standard Operating Procedure
The Standard Operating Procedure:
An SOP is a set of instructions or steps someone follows to complete a job safely, with no adverse impact on the environment (and which meets compliance standards), and in a way that maximizes operational and production requirements. Write SOPs for any processes an individual or group performs: unloading raw materials, manufacturing products, shutting down an operation, repairing a faulty electrical circuit, working with patients in a hospital, working in food service, performing activities in a firehouse, and thousands of other workplace activities.
Critical SOP Document Specifications:
The page header should include the name of the Organization, address and if possible
the department or group. The header will then include the SOP number, title, Version
number, page number, and effective date. Often, the author's name of the SOP is in the
header. At the end of the SOP, indicate a section for documenting SOP reviews with
space for reviewer's signature and date signed. If the SOP is to be archived or retired,
add a line to document this purpose. The page footer should include the complete
filename and path.
• Document Title • Document Class (Policy, Procedure, Process, Directive, etc.) • Document Number, • Revision Number Version, • Copyright • Division • Location • Department • Area • Effective Date, • Author
SOP Document Outline Structure:
Purpose:
The purpose statement identifies the goal of the SOP. It answers the question of why
the SOP is being written. For example, “The purpose of this Standard Operating
Procedure (SOP) is to specify the processes used to manage SOPs". The Purpose
statement needs to be detailed enough so that the intended user can recognize what
the document covers.
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• Explain the objective the SOP is intended to achieve. • To provide individuals who perform operations with all the safety, health,
environmental and operational information required to perform a job properly • To ensure that operations are done consistently in order to maintain quality
control of processes and products
Scope:
The scope of the SOP identifies who needs to follow the procedure and what the
procedure covers. It should help the reader to identify what is (and what is not) covered
in the procedure.
• Explain the objective the SOP is intended to achieve. • Write a scope for the SOP. To do this, answer these questions: Which specific
operations or tasks within an operation will be covered? Which are not covered? • Who is the SOP written for?
General Requirements: (Overall Task Description)
State the personnel, departments, groups, contractors, and/or subcontractors responsible for both performing and complying with the SOP. State the person or group responsible for assuring the appropriate personnel are trained on the SOP.
• Develop an overall task description. • Include the number of people required for the task, their skill levels, the
equipment and supplies required, any personal protective or safety equipment required, and a description of how the finished product or result should look.
• If you need to give some background information, or list any warnings or precautions before performing a procedure, this section is the place to list them. Warnings and Cautions should be set out from the regular text by using bold, italics, underlining, or color (or combination).
Responsibilities
State the personnel, departments, groups, contractors, and/or subcontractors
responsible for both performing and complying with the SOP. State the person or group
responsible for assuring the appropriate personnel are trained on the SOP.
Definitions
Define terms and acronyms that people reading the SOP would not generally know and
that would require clarification. If a definition is needed, and one exists in the
regulations, use the regulation definition.
• Define terms and concepts when needed. Place health and safety warnings prominently in the SOP.
Materials and Equipment
List all of the materials and equipment needed to complete the procedure. If the
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procedure is written to operate a specific piece of equipment, make sure the user guide
for the machine is listed in the References section, and that users have been trained on
operating the equipment prior to performing the procedure.
Policy/Procedure(s)
Explain the procedure in simple steps. Carefully think about how a procedure is
performed from the very beginning. Draft the SOP in a flow diagram to help visualize the
entire process. Describe specifically what to do, not how to do it. Then state who does
each step and where it is recorded to be certain that whoever is performing the
procedure can prove that they have done it.
Describe each task in detail. In this section include the following:
• Specific order in which activities are done • Timing sequences and times allowed • Materials or tools used and how they are used • Safety or health considerations • References to other associated SOPs
Note: Keep in mind that the average person is uncomfortable following a long list of
steps for the following reasons:
• A long list looks formidable, which makes the task daunting and tedious for many people who then don't want to perform the steps.
• A long list is difficult for your eyes to follow. You forget where you are on the list, which can lead to mistakes.
• A long list scares people and makes them nervous or anxious to "get it over with."
• A long list can hide steps that should be performed with caution. • A long list is difficult for writers to write while ensuring that the sequence is clear.
The solution to SOPs that involve a long list of steps is to break up the steps into logical sections of about 10 steps per section, such as "Getting ready for the process," "Initial steps," "Final steps."
Regulatory Review
State how often the SOP is reviewed, and/or under what circumstances it is to be
revised and indicate who is responsible for reviewing the SOP.
Contingencies (Corrective Actions)
State what happens if the SOP cannot be followed and requires contingencies. Identify
who needs to be notified of contingencies and what documentation is required.
Likewise, state what happens when an SOP is incorrectly followed. Include short term
and long-term corrective action measures and how to document the actions.
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References
List related SOPs, any supporting documentation necessary to understand and correctly
follow the procedure, and any applicable regulations and regulatory guidelines.
Attachments
List applicable forms that are required to be completed in the SOP. Attach any
documents used in support of the SOP, e.g., flowcharts, work instructions, pictures or
diagrams, forms and labels.
Document History Table
A separate document should sufficiently detail changes made to an SOP, what parts
were affected and when the changes become effective. Follow a uniform format for
tracking SOP changes; indicate who made the revision, date of revision and the new
version number. Properly archive an outgoing version and - all existing copies - to avoid
unnecessary confusion.
Additional Information Our end-to-end software suite contains various templates to organize your content for
Standard Operating Procedure, Work Instructions, Processes and Protocols.
The SOP Express Product includes the following Templates:
1- SOP Template 2- Work Instruction Template 3- Equipment Template 4- Product Knowledge Template 5- Trouble Shooting Template 6- Policy Template 7- Training Template 8- On-Boarding Template 9- Manufacturing Template 10-Workshop Template 11- Process Template 12- Standard Protocol Template 13-HACCP Template 14-Software Application Template 15-Technical Operations Template 16-Administrative Directive Template 17-Quality Template 18-Preventive Maintenance Template 19-Instructor-led Training Template
If you are interested in more information about the SOP Express product set, please contact us at: [email protected], or browse our website at www.princetoncenter.com Region Carol Heller
1-917-855-8341, [email protected]
West Coast Region David Armistead 1-520-270-8303, [email protected]
Corporate Headquarters:
Mail: P. O. Box 387, Princeton, NJ 08542
Shipping: 106 Straube Center Blvd, Pennington, NJ, 08534
STANDARD OPERATING PROCEDURE SOFTWARE SYSTEM
Capture » Transform » Publish » Train
Capture » Transform » Publish » Train
End-to-End SOP Software Suite
THE TECHNOLOGY AND RESOURCES YOU NEED FOR THE DEVELOPMENT OF IN-HOUSE STANDARD OPERATING PROCEDURES AND TRAINING.
Capture » Transform » Publish » Train
STANDARD OPERATING PROCEDURES
VISUAL WORK INSTRUCTIONS
CHECKLISTS
TASK QUALIFICATION FORMS
TRAINING MANUAL OR USER GUIDE
OPERATION GUIDES
STANDARD/DETAILED JOB AIDS
VISUAL JOB AIDS
QUICK REFERENCE CARDS
POWERPOINT PRESENTATIONS
LEADER AND PARTICIPANT GUIDES
WEB-BASED TUTORIALS
PRINTED AND ONLINE QUIZZES & TESTS
VOICE OVER SCRIPT
QUICK INDEX FOR DEPLOYMENT
SCORM PACKAGING FOR LMS
ExpressTrain™ instantly generates all
the support material below in multi-
ple formats, at the push of a button.
End-to-End SOP Software Suite
THE TECHNOLOGY RESOURCES YOU NEED FOR THE DEVELOPMENT OF STANDARD OPERATING PROCEDURES AND
Our end-to-end standard operating procedure (SOP) software suite ena-
bles companies to create SOPs, track versions and approval workflow,
generate training and assessments, and track employee training results
enabling companies to get a comprehensive SOP system implemented
quickly and reliably.
Capture » Transform » Publish » Train
SOP EXPRESS™ AND EXPRESSTRAIN™ PROVIDES A TOTAL END TO
END SOLUTION & REDUCES DEVELOPMENT TIME & COST BY 65%
ONE SOLUTION-SINGLE SOURCE– COMPLETE TRAINING FACTORY
ExpressTrain Transformation Suite is an integrated set of powerful tools
that help you accelerate the development and deployment of consistent,
concurrent and compliant training, performance support and verification
materials in a variety of formats for your required standard operating pro-
cesses, protocols and procedures (SOPs). With its proven methodology
you will reduce risk, reduce costs, and save time. Write the core SOP con-
tent and any related training information in one place with our Ex-
pressTrain templates, and let ExpressTrain™ create your desired outputs
in seconds.
Reduce work effort
Reduce Risk with single source SOP and training
Minimize work variation
Maintain compliance with organizational and governmental requirements
Automatically generate personnel training programs
Assure quality through consistent implementation of a process or procedure
From a single Microsoft Office® master document, SOP Express™ auto-matically creates quality documents and performance support materials in a wide array of formats including Corporate Policies, Job Aids, Standard Operating Procedures, Work Instructions, Quick Reference Cards, Check-lists, and Task Qualifications. In addition, the ExpressTrain™ upgrade cre-ates ready to use training material including PowerPoint presentations, SCORM conformant web-based tutorials, and online assessments.
Microsoft Office Integration
Capture »
Capture content in MS Word where it
is automatically structured using built-
in content types and stored in a struc-
tured file. This frees the content from
being embedded in MS Word, allowing
ExpressTrain to create many other val-
ue-added representations of it.
Transform »
Transform captured content into desir-
able SOP support material. With Ex-
pressTrain generate group-based train-
ing, including PowerPoint slides and
leader/participant guides as well as
web-based tutorials (WBT) including
on-line assessments
Train »
Generate MS Word documents includ-
ing SOPs, work instructions, task quali-
fication checklists and job aids. Pack-
age WBT lessons for the SCORM-
conformant Learning Management
System and Publish your SOPs for Re-
view, Approval, and Deployment in
SOPTracks, SharePoint, or any other
Document Management System.
PROVEN SOLUTION AND SERVICE PARTNER.
SOP Express™ and ExpressTrain™ are proven solutions, used in many in-
dustry segments including:
Manufacturing: Clients, including Givaudan Flavors, Furmanos Foods,
Archer Daniels Midland (ADM), and Pacer Technologies (SuperGlue),
have used standard operating procedure templates within our software,
to create SOPs, Work Instructions and Job Aids in high-tech manufactur-
ing and food processing facilities.
Pharmaceuticals and Life Sciences: Clients, such as Merck and Bristol
-Myers Squibb, use ExpressTrain to help meet Quality Compliance for the
FDA. Other companies like Johnson & Johnson use ExpressTrain to sup-
port consumer product development and sales. Johns Hopkins Medical
Institute used ExpressTrain to help secure their CAP Certification for Med-
ical Labs.
Government Agencies: Clients, like the U.S. Small Business Administra-
tion and U.S. Department of Agriculture, have used ExpressTrain to pro-
vide on-demand training for embassy workers to use custom software.
One of the world’s largest Airports uses ExpressTrain for Safety System
documentation and training.
Capture » Transform » Publish » Train
Publish »
TrainTracks is a learning management
system (LMS) for the delivery, tracking,
administration, and reporting of online
training programs. TrainTracks sup-
ports any SCORM conformant lessons
and tracks on-line quizzes and tests.
Our software is designed to parallel best practices in Electronic Perfor-
mance Support Systems. Employing Microsoft Office technology makes it
simpler today to use the ExpressTrain development tool to produce more
“visual” job aids and training materials. These visual job aids and training
materials enable employees to quickly learn to perform the work and
better retain the procedures. For example the following clients use our
software suite for:
Bristol-Myers Squibb: Standard SOP document format (customizable) and Visual Standard
Operating Procedures, Policies & Practices
Merck (antibiotic filling room) : Verification (Task Qualification, Performance Checklists) for
improved auditability
Sandata: for software training and user guides
Loveland Foods : checklists for lock-out-tag-out (LOTO) and Process Hazard Analysis group
based training using PowerPoint
A Major Medical Institute : Lab certification for protocols using Job Aids, Checklists and
Quick References Guides
Johnson & Johnson Consumer Products: Sales/Marketing training using PowerPoint Slides
with User Guides and Job Aids
Furmanos Foods: Web-based Training (Tutorial, Elaboration, Glossary, References, Assess-
ment) with SCORM Compliant Quizzes via TrainTracks
Finning CAT: Improved learning with visual work instructions
Givaudan Flavors: using Work Instructions and converting EH&S PowerPoint to online train-
ing and evaluation. WBT tutorials from WI.
Johnsonville Sausage: using video in Web-Based Tutorials associated with Work Instruc-
tions with on-the-job-training
Ma’aden/Alcoa Aluminum: Create Standard Work Instructions and SOP’s for SharePoint,
create Web-Based Tutorials for their LMS
Capture » Transform » Publish » Train
In an ever-changing technology world, the need for a standardized, syn-
chronized and manageable standard operating procedure /training
platform is more critical than ever. Furthermore, it must be Reliable,
Replicable, Scalable and Affordable,
Our End to End, Microsoft® Office based solution, will empower your
organization to meet all the requirements necessary to maintain a safe
work place, comply with applicable laws, and produce profitable prod-
ucts, all while sustaining the highest quality standards critical to excel in
today's competitive business environment.
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SOP Resource Materials:
Click to Download
SOP MASTER DOCUMENT
SOP EXAMPLE
WORK INSTRUCTION
QUICK REFERENCE CARD
PROCEDURE CHECKLIST
POWERPOINT SLIDES
WEB-BASED TUTORIAL
OTHER ITEMS OF INTEREST
HOW TO WRITE AN SOP
FREE SOP TEMPLATE
Designed for Success
Your investment in SOP Express™ or ExpressTrain™ can be
recovered in the first project, usually in less than 3 months.
When you consider that our write-once use-many solution
will reduce the cost of your development and deployment of
your Standard Operating Procedures, Work Instructions, Vis-
ual Job Aids, Quick reference Guides & Checklists by up to
65%*, it is easy to realize the return on your investment
quickly.
Considering that SOP Express™ and ExpressTrain™ will con-
tinue to save you 65% on development costs and up to 90%
on updates and revisions, it will continue to contribute sav-
ings over time, well beyond the initial cost to license and set
up the software.
* Based on industry standards published by Chapman Alliance
Return on Investment
Princeton Center for Education Services, Inc. P. O. Box 387 Princeton NJ 08542
Capture » Transform » Publish » Train
Eastern Region Carol Heller 1-917-855-8341, [email protected] West Coast Region David Armistead 1-520-270-8303, [email protected]
South West Region Bob Englert 1-214-697-1342 [email protected] Central Region Bob DeCarlo 1-908-725-4667, [email protected]