SOP Review

Question 1

What should be included in an SOP? (Bioinformatics specific)

Answer 1

Step-by-step list of instructions
Glossary/fully written explanation of abbreviations
Hyperlinks to software/repositories
Passwords (IF appropriate, if account shared)
All command-line commands
Screenshots
Unique reference number that does not change (only version changes)

Question 2

What makes a good SOP?

Answer 2

Conforms to ISO 15189:2012 standards
Legible, readable, comprehensible
Version-controlled, up-to-date with schedule for review
Reviewers/approvers assigned to each SOP (these should not be the same individuals)
System for recording and enabling distribution, implementation and archiving
Used as basis for staff competency

Question 3

Why are SOPs useful?

Answer 3

Ensure consistency, accuracy and quality of data
Improve user compliance to standardised procedure
Reduce user error
Improve repeatability

Question 4

What are the sections needed in an SOP?

Answer 4

1. Author, title, version, approver, date, review date, SOP number
2. Sections: Background, Purpose, Summary, Scope, Requirements, Definitions & Abbreviations, Responsibilities, Health & Safety, Risk Assessments, Reference to other associated documents
3. Procedure: Step by step , plain English, not overly technical, screenshots, references. Forms/Templates. Quality QC + QM + UOM, Link to validation doc,
4. Type of sample, type of container, equip + reagents, environmental and safety controls, calibration procedures, cross reactivity, UOM, References to Clinical Utility

Question 5

How often should an SOP be reviewed?

Answer 5

Every 2 years

Question 6

If the procedure alters from the SOP, what should be raised?

Answer 6

A change request