Clinical Laboratories: Standard Operating Procedures
Clinical Laboratories: Standard Operating Procedures
SOP Roadmap
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP Roadmap
SOP
1 General
2 SOP
3 SOP
4
INTRO FORMAT TYPES PROCESS
1.1 Overview 2.1 Title Page 3.1 Master SOP 4.1 Preparation
1.2 Purpose 2.2 TOC 3.2 Administrative 4.2 Revision and Approval
1.3 Benefits 2.3 Text 3.3 Technical SOPs 4.3 Frequency of Reviewing
1.4 Writing Styles 3.3.1 Procedure 4.4 Checklists
3.3.2 Equipment 4.5 Document Control
3.3.3 Analysis 4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP Roadmap
SOP
1 General
2 SOP
3 SOP
4
INTRO FORMAT TYPES PROCESS
1.1 Overview 2.1 Title Page 3.1 Master SOP 4.1 Preparation
1.2 Purpose 2.2 TOC 3.2 Administrative 4.2 Revision and Approval
1.3 Benefits 2.3 Text 3.3 Technical SOPs 4.3 Frequency of Reviews
1.4 Writing Styles 3.3.1 Procedure 4.4 Checklists
3.3.2 Equipment 4.5 Document Control
3.3.3 Analysis 4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP Roadmap
SOP
1 General
2 SOP
3 SOP
4
INTRO FORMAT TYPES PROCESS
1.1 Overview 2.1 Title Page 3.1 Master SOP 4.1 Preparation
1.2 Purpose 2.2 TOC 3.2 Administrative 4.2 Revision and Approval
1.3 Benefits 2.3 Text 3.3 Technical SOPs 4.3 Frequency of Reviews
1.4 Writing Styles 3.3.1 Procedure 4.4 Checklists
3.3.2 Equipment 4.5 Document Control
3.3.3 Analysis 4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP PROCESS
SOP PROCESS
1st Step
Making a list of all the tests performed in the laboratory
so you know which SOPs you have to write.
Who is responsible for this 1st step :
Quality Project Team
in cooperation with the Laboratory Manager
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
1st Step
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
The experience requirement for performing an activity should be noted in the section on personnel qualifications
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP Roadmap
SOP
1 General
2 SOP
3 SOP
4
INTRO FORMAT TYPES PROCESS
1.1 Overview 2.1 Title Page 3.1 Master SOP 4.1 Preparation
1.2 Purpose 2.2 TOC 3.2 Administrative 4.2 Revision and Approval
1.3 Benefits 2.3 Text 3.3 Technical SOPs 4.3 Frequency of Reviews
1.4 Writing Styles 3.3.1 Procedure 4.4 Checklists
3.3.2 Equipment 4.5 Document Control
3.3.3 Analysis 4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP Roadmap
SOP
1 General
2 SOP
3 SOP
4
INTRO FORMAT TYPES PROCESS
1.1 Overview 2.1 Title Page 3.1 Master SOP 4.1 Preparation
1.2 Purpose 2.2 TOC 3.2 Administrative 4.2 Revision and Approval
1.3 Benefits 2.3 Text 3.3 Technical SOPs 4.3 Frequency of Reviewing
1.4 Writing Styles 3.3.1 Procedure 4.4 Checklists
3.3.2 Equipment 4.5 Document Control
3.3.3 Analysis 4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
Revision +
Who would review and approve the finalized SOPs? Approval
Revision +
Who would review and approve the finalized SOPs? Approval
1 2
Signature approval indicates that an SOP
has been both reviewed and approved by
management.
Unit Director QA Officer
(Immediate Supervisor)
Use of electronic signatures, is an acceptable
substitution for paper, when practical.
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP Roadmap
SOP
1 General
2 SOP
3 SOP
4
INTRO FORMAT TYPES PROCESS
1.1 Overview 2.1 Title Page 3.1 Master SOP 4.1 Preparation
1.2 Purpose 2.2 TOC 3.2 Administrative 4.2 Revision and Approval
1.3 Benefits 2.3 Text 3.3 Technical SOPs 4.3 Frequency of Reviewing
1.4 Writing Styles 3.3.1 Procedure 4.4 Checklists
3.3.2 Equipment 4.5 Document Control
3.3.3 Analysis 4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP Roadmap
SOP
1 General
2 SOP
3 SOP
4
INTRO FORMAT TYPES PROCESS
1.1 Overview 2.1 Title Page 3.1 Master SOP 4.1 Preparation
1.2 Purpose 2.2 TOC 3.2 Administrative 4.2 Revision and Approval
1.3 Benefits 2.3 Text 3.3 Technical SOPs 4.3 Frequency of Reviewing
1.4 Writing Styles 3.3.1 Procedure 4.4 Checklists
3.3.2 Equipment 4.5 Document Control
3.3.3 Analysis 4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP PROCESS
Reviewing
SOPs need to be updated to be useful
The review date should be added to each SOP that has been reviewed
SOP PROCESS
Reviewing
The review process should be simple and not cumbersome
to encourage a timely review
The frequency of review should be indicated by management
in the Laboratory Quality Management Plan
The plan should also indicate the individual(s)
responsible for ensuring that SOPs are current and updated
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP Roadmap
SOP
1 General
2 SOP
3 SOP
4
INTRO FORMAT TYPES PROCESS
1.1 Overview 2.1 Title Page 3.1 Master SOP 4.1 Preparation
1.2 Purpose 2.2 TOC 3.2 Administrative 4.2 Revision and Approval
1.3 Benefits 2.3 Text 3.3 Technical SOPs 4.3 Frequency of Reviewing
1.4 Writing Styles 3.3.1 Procedure 4.4 Checklists
3.3.2 Equipment 4.5 Document Control
3.3.3 Analysis 4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP Roadmap
SOP
1 General
2 SOP
3 SOP
4
INTRO FORMAT TYPES PROCESS
1.1 Overview 2.1 Title Page 3.1 Master SOP 4.1 Preparation
1.2 Purpose 2.2 TOC 3.2 Administrative 4.2 Revision and Approval
1.3 Benefits 2.3 Text 3.3 Technical SOPs 4.3 Frequency of Reviewing
1.4 Writing Styles 3.3.1 Procedure 4.4 Checklists
3.3.2 Equipment 4.5 Document Control
3.3.3 Analysis 4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
In those cases:
• The SOP should describe how the checklist is to be prepared,
or on what it is to be based.
• Copies of specific checklists should be then maintained in the
file with the activity results and/or with the SOP.
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP Roadmap
SOP
1 General
2 SOP
3 SOP
4
INTRO FORMAT TYPES PROCESS
1.1 Overview 2.1 Title Page 3.1 Master SOP 4.1 Preparation
1.2 Purpose 2.2 TOC 3.2 Administrative 4.2 Revision and Approval
1.3 Benefits 2.3 Text 3.3 Technical SOPs 4.3 Frequency of Reviewing
1.4 Writing Styles 3.3.1 Procedure 4.4 Checklists
3.3.2 Equipment 4.5 Document Control
3.3.3 Analysis 4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP Roadmap
SOP
1 General
2 SOP
3 SOP
4
INTRO FORMAT TYPES PROCESS
1.1 Overview 2.1 Title Page 3.1 Master SOP 4.1 Preparation
1.2 Purpose 2.2 TOC 3.2 Administrative 4.2 Revision and Approval
1.3 Benefits 2.3 Text 3.3 Technical SOPs 4.3 Frequency of Reviewing
1.4 Writing Styles 3.3.1 Procedure 4.4 Checklists
3.3.2 Equipment 4.5 Document Control
3.3.3 Analysis 4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP PROCESS
SOP PROCESS
Gram Staining Generally, each page of an SOP
P05v03 should have control documentation notation
Page 3 of 6
SOP PROCESS
Gram Staining The revision number (e.g. v03 in the left example) and date
P05v03
Page 3 of 6 are very useful in:
• Identifying the SOP in use when reviewing historical data.
• Critical when the need for evidentiary records is involved.
• When the activity is being reviewed.
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP Roadmap
SOP
1 General
2 SOP
3 SOP
4
INTRO FORMAT TYPES PROCESS
1.1 Overview 2.1 Title Page 3.1 Master SOP 4.1 Preparation
1.2 Purpose 2.2 TOC 3.2 Administrative 4.2 Revision and Approval
1.3 Benefits 2.3 Text 3.3 Technical SOPs 4.3 Frequency of Reviewing
1.4 Writing Styles 3.3.1 Procedure 4.4 Checklists
3.3.2 Equipment 4.5 Document Control
3.3.3 Analysis 4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP Roadmap
SOP
1 General
2 SOP
3 SOP
4
INTRO FORMAT TYPES PROCESS
1.1 Overview 2.1 Title Page 3.1 Master SOP 4.1 Preparation
1.2 Purpose 2.2 TOC 3.2 Administrative 4.2 Revision and Approval
1.3 Benefits 2.3 Text 3.3 Technical SOPs 4.3 Frequency of Reviewing
1.4 Writing Styles 3.3.1 Procedure 4.4 Checklists
3.3.2 Equipment 4.5 Document Control
3.3.3 Analysis 4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP PROCESS
The quality management plan should also designate SOPs Archiving
where, and how, outdated versions are to be archived
• In a manner to prevent their continued use,
• As well as to be available for historical data review.
SOP PROCESS
The organization should maintain a master list of all SOPs SOPs Archiving
The QA Manager (or designee) is generally the individual responsible for maintaining
a file listing of all current, quality-related SOPs used within the laboratory.
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP Roadmap
SOP
1 General
2 SOP
3 SOP
4
INTRO FORMAT TYPES PROCESS
1.1 Overview 2.1 Title Page 3.1 Master SOP 4.1 Preparation
1.2 Purpose 2.2 TOC 3.2 Administrative 4.2 Revision and Approval
1.3 Benefits 2.3 Text 3.3 Technical SOPs 4.3 Frequency of Reviewing
1.4 Writing Styles 3.3.1 Procedure 4.4 Checklists
3.3.2 Equipment 4.5 Document Control
3.3.3 Analysis 4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
SOP Roadmap
SOP
1 General
2 SOP
3 SOP
4
INTRO FORMAT TYPES PROCESS
1.1 Overview 2.1 Title Page 3.1 Master SOP 4.1 Preparation
1.2 Purpose 2.2 TOC 3.2 Administrative 4.2 Revision and Approval
1.3 Benefits 2.3 Text 3.3 Technical SOPs 4.3 Frequency of Reviewing
1.4 Writing Styles 3.3.1 Procedure 4.4 Checklists
3.3.2 Equipment 4.5 Document Control
3.3.3 Analysis 4.6 Document
Tracking and Archival
4.7 How to Apply a SOP System?
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
Heroes
+
4.7 How to Apply a SOP System? Quality Project Team LM
Start
1 2 3 4 5 6 7 8
Listing
Periodic Reviewing
Understand List
SOPs Reading
SOP Finished
Present SOPs
Archiving
All Choosing
Who will write Assign
Read and
Lab Define When to Revise +
Monitor
Tests the SOPs Them Tasks Finish Approve
SOPs
9
Making a list of all the tests performed in the laboratory in a weekly staff meeting
to all the staff members.
so you know which SOPs you have to write.
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
Heroes
+
4.7 How to Apply a SOP System? Quality Project Team LM
Ready
Start
1 2 3 4 5 6 7 8
SOP
Listing
Periodic Reviewing
Understand List
SOPs Reading
SOP Finished
Present SOPs
Archiving
All Choosing
Who will write Assign
Read and
Lab Define When to Revise +
Monitor
Tests the SOPs Them Tasks Finish Approve
SOPs
9
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
Heroes
+
4.7 How to Apply a SOP System? Quality Project Team LM
Start
Listing
All
Lab
Tests
Heroes
+
4.7 How to Apply a SOP System? Quality Project Team LM
Start
1
Listing
All Choosing
Who will write
Lab
Tests the SOPs
Heroes
+
4.7 How to Apply a SOP System? Quality Project Team LM
Start
1 2
Listing
All Choosing
Who will write Assign
Lab
Tests the SOPs Them
Heroes
+
4.7 How to Apply a SOP System? Quality Project Team LM
Start
1 2
Listing
All Choosing
Who will write Assign
Lab Define
Tests the SOPs Them Tasks
Clearly Define:
• The tasks of the staff member
(Creating the SOP content: writing the procedure and other paragraphs)
• The tasks of the Quality Project Team
(Optimizing the SOP to make it matching with the Master SOP guidelines)
Lab Manager
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
Heroes
+
4.7 How to Apply a SOP System? Quality Project Team LM
Start
1 2
Listing
All Choosing
Who will write Assign
Lab Define When to
Tests the SOPs Them Tasks Finish
Lab Manager
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
Heroes
+
4.7 How to Apply a SOP System? Quality Project Team LM
Start
1 2 3
Listing
All Choosing
Who will write Assign
Lab Define When to Revise +
Tests the SOPs Them Tasks Finish Approve
[ Previously described ]
1 2
Heroes
+
4.7 How to Apply a SOP System? Quality Project Team LM
Start
1 2 3 4
Listing
SOP Finished
All Choosing
Who will write Assign
Lab Define When to Revise +
Tests the SOPs Them Tasks Finish Approve
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
Heroes
+
4.7 How to Apply a SOP System? Quality Project Team LM
Start
1 2 3 4
Listing
SOP Finished
All Choosing
Who will write Assign
Lab Define When to Revise +
Tests the SOPs Them Tasks Finish Approve
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
Heroes
+
4.7 How to Apply a SOP System? Quality Project Team LM
Start
1 2 3 4 5
Listing
SOP Finished
Archiving
All Choosing
Who will write Assign
Lab Define When to Revise +
Tests the SOPs Them Tasks Finish Approve
Heroes
+
4.7 How to Apply a SOP System? Quality Project Team LM
Start
1 2 3 4 5 6
Listing
Understand List
SOP Finished
Archiving
All Choosing
Who will write Assign
Read and
Lab Define When to Revise +
Tests the SOPs Them Tasks Finish Approve
SOPs
Include the SOPs in a Read and Understand List
• Indicate which staff members must read and understand
the SOPs (those for whom the SOPs are relevant).
• A template for a Read and Understand List should be provided.
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
Heroes
+
4.7 How to Apply a SOP System? Quality Project Team LM
Start
1 2 3 4 5 6 7
Listing
Understand List
SOP Finished
Present SOPs
Archiving
All Choosing
Who will write Assign
Read and
Lab Define When to Revise +
Tests the SOPs Them Tasks Finish Approve
SOPs
In a weekly staff meeting to all the staff members,
• Present the SOPs and where to find them
• Explain which staff members have to read the SOPs
• Explain about the Read and Understand List
and that they must sign the list when they have read an SOP.
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
Heroes
+
4.7 How to Apply a SOP System? Quality Project Team LM
Start
1 2 3 4 5 6 7 8
Listing
Understand List
SOPs Reading
SOP Finished
Present SOPs
Archiving
All Choosing
Who will write Assign
Read and
Lab Define When to Revise +
Monitor
Tests the SOPs Them Tasks Finish Approve
SOPs
• Monitor that all the staff members have read the SOPs
assigned to them.
• If not, remind them that they still have to do this.
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
Heroes
+
4.7 How to Apply a SOP System? Quality Project Team LM
Start
1 2 3 4 5 6 7 8
Listing
Periodic Reviewing
Understand List
SOPs Reading
SOP Finished
Present SOPs
Archiving
All Choosing
Who will write Assign
Read and
Lab Define When to Revise +
Monitor
Tests the SOPs Them Tasks Finish Approve
SOPs
9
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman
Many
Thanks