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Clinical Laboratories: Standard Operating Procedures

This document provides guidance on writing standard operating procedures (SOPs) for clinical laboratories. It discusses SOP formats, types, and processes. The key steps in writing SOPs are preparing by making a list of all tests, assigning writers who are knowledgeable about the procedures, and writing with sufficient detail that an inexperienced person could perform the procedure alone. SOPs should be reviewed regularly to ensure they reflect current best practices. The overall goal is to establish a system of SOPs to standardize operations and ensure quality in clinical laboratories.

Uploaded by

Kirt Anonuevo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
338 views52 pages

Clinical Laboratories: Standard Operating Procedures

This document provides guidance on writing standard operating procedures (SOPs) for clinical laboratories. It discusses SOP formats, types, and processes. The key steps in writing SOPs are preparing by making a list of all tests, assigning writers who are knowledgeable about the procedures, and writing with sufficient detail that an inexperienced person could perform the procedure alone. SOPs should be reviewed regularly to ensure they reflect current best practices. The overall goal is to establish a system of SOPs to standardize operations and ensure quality in clinical laboratories.

Uploaded by

Kirt Anonuevo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 52

Standard

Operating for the Episode


Procedures Clinical Laboratories
Based on WHO Laboratory Quality Stepwise Implementation Tool

‫إجراءات التشغيل القياسية لمعامل التحاليل الطـبية‬


Last Episode

Dr. Tamer Soliman


Lecturer of Clinical Pathology
Sohag University Hospital
EGYPT
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman

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

4. SOP Process 4.1 SOP Preparation


Start

SOP PROCESS

Who are most often perform the test


Who know best all the small details
Who should prepare (write) the SOP : that make the tests perform optimally
and can describe these in the SOPs
Individuals who are knowledgeable with • The SOP activity
• The Laboratory internal structure
A team approach can be followed, especially for multi–tasked processes
where the experiences of a number of individuals are critical.
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman

4. SOP Process 4.1 SOP Preparation


Start

SOP PROCESS

To Whom SOP would be written :

Lab staff who are essentially subject-matter experts


• Who actually perform the work or
• Use the process
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman

4. SOP Process 4.1 SOP Preparation


Start

List 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

4. SOP Process 4.1 SOP Preparation


Start

List SOP PROCESS

1st Step
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman

4. SOP Process 4.1 SOP Preparation


Start

List SOP PROCESS


Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman

4. SOP Process 4.1 SOP Preparation


Start

List SOP PROCESS


HOW SOP should be written?
SOPs should be written with sufficient detail
So that someone • with limited experience
• without knowledge of the procedure
• but with a basic understanding
Can successfully perform the procedure
when unsupervised

The experience requirement for performing an activity should be noted in the section on personnel qualifications
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman

4. SOP Process 4.1 SOP Preparation


Start

List SOP PROCESS


HOW SOP should be written?
Spreading the tasks of writing SOPs over different staff members
• Prevents the overloading of one staff member with a huge amount of work
• Increases the involvement and commitment of all staff members.
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman

4. SOP Process 4.1 SOP Preparation


Start

List SOP PROCESS


HOW SOP should be written?

An example of an Analysis SOP is linked below


This can be used to get an impression of • The writing style
• The level of detail
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

4. SOP Process 4.2 SOP Review and Approval


Start

List SOP PROCESS

Revision +
Who would review and approve the finalized SOPs? Approval

1 2 SOPs should be reviewed (validated) by one or


more individuals with appropriate training and
experience with the process.

Unit Director QA Officer


(Immediate Supervisor) It is helpful if draft SOPs are actually tested by
individuals other than the original writer before
the SOPs are finalized.
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman

4. SOP Process 4.2 SOP Review and Approval


Start

List SOP PROCESS

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

4. SOP Process 4.3 SOP Frequency of Reviewing


Start

SOP PROCESS
Reviewing
SOPs need to be updated to be useful

The review date should be added to each SOP that has been reviewed

If an SOP describes a process that is no longer followed,


it should be withdrawn from the current file and archived
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman

4. SOP Process 4.3 SOP Frequency of Reviewing


Start

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

4. SOP Process 4.4 SOP Checklists


Start Reviewing
SOP PROCESS
Checklists
Many activities use checklists:
• To ensure that steps are followed in order
• To document completed actions.

Any checklists included as part of an activity


• Should be referenced at the points in the procedure
where they are to be used
• Should be attached to the SOP.
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman

4. SOP Process 4.4 SOP Checklists


Start Reviewing
SOP PROCESS
Checklists

In some cases, detailed checklists are prepared


specifically for a given activity.

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

4. SOP Process 4.5 SOP Document Control Document


Start Reviewing Control

SOP PROCESS

Each laboratory should develop a numbering system


to systematically identify and label their SOPs

This document control should be described in its Quality Management Plan


Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman

4. SOP Process 4.5 SOP Document Control Document


Start Reviewing Control

SOP PROCESS
Gram Staining Generally, each page of an SOP
P05v03 should have control documentation notation
Page 3 of 6

Location: in the upper right-hand corner of each document


page following the title page.

When the number of pages is indicated (e.g. 3 of 6),


the user can quickly check if the SOP is complete
A short title and identification (ID) number
can serve as a reference designation
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman

4. SOP Process 4.5 SOP Document Control Document


Start Reviewing Control

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

4. SOP Process 4.6 Document Tracking and Archival


Document
Start Reviewing Control

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.

The plan should refer to the individual(s) responsible for


assuring that only the current version is used
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman

4. SOP Process 4.6 Document Tracking and Archival


Document
Start Reviewing Control

SOP PROCESS
The organization should maintain a master list of all SOPs SOPs Archiving

This file or database should refer to:


• SOP number • Author
• Version number • Status (in-use or out-dated)
• Date of issuance • Lab unit, branch or division
• Title • Any historical information regarding past versions

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

Make a list of all the tests performed in the laboratory


to know which SOPs would be written.
Writing SOPs for Clinical Laboratories – Dr. Tamer Soliman

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

For each of the SOP,


Determine which of staff members are most suitable to write
[ Previously described ]
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
Tests the SOPs Them

Assign the selected staff members to write the SOPs


▪ Explain the procedure of writing SOPs
▪ Tell them to familiarize themselves with the Master SOP
▪ To use the protocol for writing Analysis SOPs in the Master SOP
▪ To Use the template for an Analysis SOP attached to the Master SOP
Lab Manager ▪ If they have questions they can go to a member of the Quality Project Team
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
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

Make SMART appointments with the different staff members


when to finish their tasks to keep this process going

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

Unit Director QA Officer


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
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

When SOPs are ready (i.e. written, reviewed, and authorized)


• Determine at which location copies of the SOPs must be available
• Refer to these locations in the SOP
• Refer the location where to replace old copies when the SOPs are revised
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
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

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