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Module 10
Standard Operating
Procedures (SOPs)
1
A Systems Approach to Laboratory Quality
Stock Data
Quality Control
Management Management
SOP,
Occurrence
Documents & Assessment
Management
Records
Safety &
Process Specimen
Waste
Improvement Management
Management 2
A Systems Approach to Laboratory Quality
Stock Data
Quality Control
Management Management
SOP,
Occurrence
Documents & Assessment
Management
Records
Safety &
Process Specimen
Waste
Improvement Management
Management 3
Topics
4
Objectives
5
processes and procedures
What is a process?
What is a procedure?
Why do we need to document both?
6
Path of Workflow
Sample
collection
Personnel
Reporting competency
testing
Genotype
QA and QC
testing 7
Each Process Has Procedures
Sample
collection
Personnel
Reporting competency
testing
More
Start Step 1 Step 2 Finish
steps…
• Data and Lab
Management
• Safety
Record keeping • Customer Service Sample receipt
and data and
management accessioning
Genotype
QA and QC
testing 8
Procedures Must Be Documented—in SOPs
Sample
collection
More
Start Step 1 Step 2 Finish
steps…
Standard
Operating
Procedures
(SOPs) 9
Process and Procedure
Process documents:
– Show how everything fits together
– Flow of work
– Across procedures
– Across time
Procedure documents:
– Directions on how to perform a task
– One task
– Clear and accurate
– What the operator needs to do and how
10
Why Processes and Procedures are Needed
11
Standard Operating Procedures
12
Discussion
What is a process?
What is a procedure?
Why do we need to document both?
13
documenting processes and
procedures
What should a process document include?
What types of SOPs are there?
What SOPs does a genotyping lab need?
How can each lab write SOPs that work for it?
14
Essential Process Documents
for HIV DR Labs
15
Template for Process Documents
Title
– Clearly states the intent of the document
– Include the word “process”
Purpose
– State purpose of document (optional: rationale,
theory, or historical background)
Process: Flowchart or Table
– Main part of document
– Shows/describes sequence of activities and
outcome
Supporting Documents
– Related procedures (SOPs)
16
Procedures (SOPs)
Process
Procedure
Procedure Procedure
Procedure
Purpose Purpose
Equipment Equipment
& Supplies & Supplies
Safety Safety
Precautions Precautions
Step-by- Step-by-
step step
instructions instructions
Other Other 17
information information
Pretesting Phase
Sample
collection
Personnel
Reporting competency
testing
Genotype
QA and QC
testing 18
Pretesting Procedures
Sample
collection
Personnel
Reporting competency
testing
Genotype
QA and QC
testing 20
Testing Procedures
21
Post-testing Phase
Sample
collection
Personnel
Reporting competency
testing
Genotype
QA and QC
testing 22
Post-testing Procedures
23
Post-testing Procedures
25
Template for Procedures
Title Procedure
Purpose Troubleshooting
Equipment Calculations
Supplies Interpretation/ Results
Sample (for testing References
procedures only) Related Documents
Special Safety Appendices
Precautions
Standard
Operating
Procedures
(SOPs) 26
Discussion
27
forms, manuals, and job aids
28
Form Documents
30
Procedure Manuals
31
Job Aids
Examples:
– Instruction sheets
– Wall charts
– Instructions posted on equipment
Qualities of good job aids:
– 3 C’s: Current, complete, and correct
– Traceable to the “parent” document
– Effective date is listed.
If some of the above qualities are missing, start
the document change process.
32
Discussion
33
managing documents
34
Document Management
35
Document Management System: Purpose
36
Document Identification (example)
38
Archiving, Storage, and Retention of
Documents
Master file:
– Stored by the Quality Assurance Manager
– Electronic
– Current version
– All previous versions , clearly identified
• RETIRED in bold on the upper right hand corner of the
header OR
• Watermarked diagonally across the page in order
Hard copy
– Stored by the Quality Assurance Manager
– In Master File Hard Copy Binder
39
Discussion
40
Reflection
41
Summary
42
Practice: Create an SOP for Making Coffee
43
Summary
44