an orientation to the development of standard operating ... · development of standard operating...
TRANSCRIPT
An Orientation to the Development of Standard
Operating Procedures (SOPs)
SCORE Half-day Seminar
June 7, 2016
Presenter
Sharyl Zaccaglino
Director, Research Quality and Compliance
University of Rochester Medical Center
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Describe the pros and cons of adopting standardized SOPs
Discuss the essential components of SOPs
Describe the process of planning, developing, implementing,
and maintaining SOPs
Regulations and Standards
GMP (Good Manufacturing Practices)
GLP (Good Laboratory Practices)
GCP (Good Clinical Practices)
ISO (International Standards Organization)
ICH (International Conference on Harmonization)
What is called for more than 20 times in the GMPs?
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Defining SOPs
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In clinical research, the International Conference on
Harmonisation (ICH) defines SOPs as "detailed, written
instructions to achieve uniformity of the performance of a
specific function“
Clearly written description of how a particular task is to be
performed
What They Do for Us
More Control
Consistent Quality (across all studies)
Reduction in Errors
Better Data Reproducibility
Safer Operations
Improved Likelihood of Meeting Needs
Increased effectiveness
Greater Compliance
Smoother Training
Ongoing improvement
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Standardization
Possible Drawbacks
Upfront work
Wording agreement
Perceived lack of flexibility
Periodic reviews
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Let’s see how this works in ‘real life’
When attempting a
task, most of us need
some sort of
instructions or other
documentation
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Activity
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Timer
Your Steps
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Plan
Develop
Implement
Maintain
Start with a Framework
Policies
Processes
Procedures
Work Instructions
Forms
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Document Types
Policies
Goals
Department Operation
Regulations
Procedures
Obtaining Informed Consent
Reviewing Protocols
Handling Case Report Forms
Monitoring Studies
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Document Types (cont.)
Forms
Follow instructions of SOP
Blank spaces for consistent data entry
Example: training form
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Your Steps: Plan
Determine what processes you
want/need to standardize
Create a Master Document List
Prioritize
Assign responsibility for authorship
Subject Matter Expert (SME)
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Document Lifecycle
Generation Review Approval Training Distribution
For Use
Retention, Destruction
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Your Steps: Develop
Company/Group name
Title
Effective Date
Document number
Revision number
Purpose
Scope/areas involved
References (optional)
Table of contents (optional)
Definitions (optional)
Equipment/resources needed
Responsibility
Procedure steps
Revision history
Approvals
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Content and Format
“W” Questions to Ask (and don’t forget the “H”)
What – the task, steps, sub-steps
How – details of performing the actions
When – sequence, cues
Who – responsibility for steps
Where – location of action
Why – rationale for doing the action; if applicable and useful
for training
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Authoring Tips
Active verbs
observe, collect, inject, transfer
Abbreviations, acronyms
Numbered steps vs bulleted list
Units of measure
e.g., temperature, time
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Your Steps: Develop
Review and Approval
Stakeholder Review
Users of the process
Responsible for the department or group
Responsible for ensuring regulations are followed
Approvals
Author
Technical/Content SME
Area Supervisor/Manager
Quality Assurance 21
What’s Next?
Effective Date
The date that users must begin following the procedure
~1 week between time of last approval to document
becoming effective
Training
A user must have documented training on the procedure
before he/she can perform that activity
Distribution for Use
Master Document
Official Copies
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Your Steps: Implement
Deliver Training
Who needs to know the contents of each
SOP (training plan)
How will each person be trained
Group setting
Individually
What level of training is needed
Read for Awareness
OR
Effectivity Check Required
Distribute Official Copies 23
Your Steps: Maintain Ensure a secure repository for the
Master Documents
Revise as needed to keep documents
accurate
Redline
Archive superseded Master Document revision
Destroy superseded distributed copies
Distribute new version
Periodic review
Every 2 years 24
The Big Picture – in summary
Document Structure – policies, procedures, forms
Consistent Format - template
Content – SME
Organization Acceptance – review and approval
Notification - training
Maintenance – assess & revise
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Sharyl Zaccaglino
Director, Research Quality and Compliance
University of Rochester Medical Center
265 Crittenden Blvd
Office 1.211, Box # CU 420708
Rochester, NY 14642-0708
(585) 275-8803