Institution
Laboratory name
Location
Head/Responsible person / Standard Operating Procedure (SOP)
Document Control / Code:
Version: no.
Date: of release
Page: 1of 7

1. Document Control

2. Objectives and scope

The objective of this SOP is to describe how SOPs, forms, attachments and other documentation are modified and managed. Uniformity ensures standardization, clarity and readability.

This SOP describes:

6.1 Lay-out

6.2 Types of SOPs

6.3 Codes and version numbers

6.4 Designing an SOP

6.5 Review

6.6 Approval and implementation

6.7 Changes

6.8 Revising SOPs

6.9 Document control (paper and electronic archives)

This SOP is applicable to all technical employees of the laboratory.

3. Abbreviations, definitions and terms

•NTPNational Tuberculosis Programme

•N.A.Not applicable

•QMQuality Manual

•QO Quality Officer

•SOP Standard Operating Procedure

4. Tasks, responsibilities and accountabilities

Task / Responsible / Accountable
Dedicate a SOP code and version number / QO / Lab Manager
Arrange reviewing / QO / Director
Arrange quality meeting / QO / Lab manager
Review SOP / Appointed senior staff / QO
Approval of SOPs / Lab manager/director / QO
Implementation / QO / Lab manager
Document control / QO / QO

5. Safety and environment

N.A.

6. Procedure

6.1 Lay-out

  • Front page

Author

Reviewers: One with technical knowledge (for technical SOPs) or managerial knowledge (for managerial SOPs) and one with knowledge of the ISO 15189:2007 standard (usually the QO).

Authorizer: Director or lab manager

Date of Retirement

Approved modifications

Modifications compared to the previous version

  • Header

Ministry of Health logo/laboratory logo/National Tuberculosis Programme logo.

Name of the laboratory

SOP title

SOP code, version number, effective date, initials authorizer

  • Footer

SOP code, version number, effective date and Page X of Y

  • Page for reading and understanding the SOP

All relevant staff (according to job description) signs after reading and understanding the page for reading and understanding the SOP.

  • Font, font size, margins, spacing

Font:Times New Roman

Font size:12

Margins:Left and right 2.54 cm

Top 2.95 cm

Bottom 2.54 cm

Spacing: Between text and next chapter 2.0

Between text and paragraph 1.5

Between paragraph title and sentence 1.0

Between sentence and sentence 1.0

6.2 Types of SOPs

There are three types of SOP:

- Analysis SOPs

- Equipment SOPs

- Procedure SOPs

Each type has its own format (see annexes format for Analysis SOP, format for Equipment SOP and format for Procedure SOP).
Each SOP and QM chapter has a front page.

SOPs have a page for reading and understanding the SOP that needs to be signed by the relevant staff (according to job description).

Attachments and forms are part of the SOP and thus share the same SOP code and version number.

6.3 Codes and version numbers

  • SOP codes:

Each SOP and QM chapter have a unique code, e.g. for analysis SOPs A#, for equipment SOPs E# and for procedure SOPs P# and for quality manual chapters QM#.

  • Version numbers:

A version number is required to be assured of the valid SOPs at the workstation.

Final, implemented versions end with “#.0”, e.g. v1.0, v2.0, vx.0

Draft versions never end with “#.0”, e.g. v0.1, v0.2, v0.x

As soon as any modifications on the current version is needed, the QO changes the current valid version to x.1, distributes it to the author, so that the SOP can be revised. E.g. any modifications on SOP A01 “ZN microscopy” version 1.0 will lead to the modified SOP A01 “ZN microscopy” version 1.1.

After discussing the SOP, the author applies the agreed comment in the SOP, which is now version number 1.2.

If a next meeting/discussion is needed, more modifications will be made, which lead to version 1.3 etc.

The final version will be 2.0.

6.4 Designing a SOP

  1. The lab manager appoints one of the staff to write a SOP and at least two persons to review the SOP: one person with knowledge of the content of the SOP (e.g. a senior technologist) and one with knowledge of the ISO 15189:2007 standard (e.g. the QO).
  2. The lab manager decides on the title of the SOP.
  3. The QO provides the instructions how to write an SOP, including the appropriate SOP format (e.g. format for Analytical SOPs, format for Equipment SOPs or format for Procedure SOPs).
  4. The QO dedicates an SOP number and updates the sheet “SOP overview” in the document control log (see below).
  5. When the author finalizes writing the SOP, the author gives the SOP to the reviewers and the QO arranges a meeting to discuss the draft SOP.

6.5 Review

  1. One of the reviewers should be the quality officer, to guarantee that the quality standards are met. This is not possible when the QO is the author (it is not possible to review your own text)! In this case another member of the QA team shall review the SOP.
  2. Another reviewer should be someone who is competent in performing the work written in the procedure; e.g. principal or senior staff.
  3. Discuss the content of the SOP in a quality meeting:
  • To agree on the content.
  • To clarify any obscurities.
  • To guarantee that the whole work procedure is covered.
  • To assure that the handling procedure is written in the correct order.
  • To agree on the number of photocopies and where these photocopies should be placed (except for the paper version in the quality archive).
  1. The author will adjust the SOP according to meetings discussion and agreements
  2. The author sends the SOP to the reviewers for the final review.

NOTE: When many modifications are made, discussing the SOP in a second meeting can be useful.

6.6 Approval and implementation

  1. Set a date for discussing the final approved SOP in a Monday morning meeting.
  2. Put the new/revised SOP on the agenda.
  3. Discuss the content of the SOP to ensure that all the staff has read and understood the SOP.
  4. Explain that the SOP is binding and that everybody needs to work according to the SOP to gain good quality performance.
  5. The lab manager should stress that it is compulsory to work according the agreed procedure.

The QO gives the final version of the SOP an x.0 number.Agree on a date when the SOPs will be approved, so that the effective date can be filled out and the SOP can be printed. The effective date in the header and footer of the SOP should be the same date as the date of signing by the authorizer.The author and reviewers sign the final version on the front page.Approval is done by the authorized person, most of the time this is the lab manager.

The authorizer approves the SOP, by dating and signing the first page, and putting initials on every following page to indicate that this is the original approved version of the SOP.

6.7 Changes

1.As soon as any modifications on the current version is needed, the QO changes the current valid version to x.1, distributes it to the author, so that the SOP can be revised. E.g. any modifications on SOP A01 “ZN microscopy” version 1.0 will lead to the modified SOP A01 “ZN microscopy” version 1.1.

2.The SOP will be discussed in a meeting, so that any other alterations can be included when revising the SOP and to emphasize the need of the change and to update all the staff of the modification in the work procedure.

3.Requested modifications need to be approved by the authorizer, before they can be documented in a new version of the SOP. When agreed on, and approved by the authorizer, the SOP can be changed by the author. Therefore lab personnel are prohibited from writing on SOPs (original of copy).

4.After discussing the SOP in a meeting, the author applies the agreed comment in the SOP, which is now version number 1.2.

5.If a next meeting/discussion is needed, more modifications will be made, which will lead to version 1.3 etc.

6.The QO gives the final version of the SOP an x.0 number.

7.Approval is done by the authorized person, most of the time the lab manager or the laboratory director. Agree on a date when the SOPs will be approved, so that the effective date can be filled out and the SOP can be printed.

8.The authorizer approves the SOP, by dating and signing the first page, and putting initials on every following page to indicate that this is the original approved version of the SOP.

Until the new version of the SOP is implemented, alterations in SOPs should be written on the front page under “Approved modifications”, signed and dated for approval by the authorized person; when a staff member did not attend the meeting, this person will be updated by the alteration described on the front page of the SOP in the section dedicated to this.

6.8 Revising SOPs

Every year a SOP needs to be reviewed by the reviewers. The QO changes the current valid version to x.1, distributes it to the author and reviewers, so that the SOP can be reviewed.

Agree on a date for a quality meeting to review the SOP.Discuss the suggestions for modification in a quality meeting with the author, reviewers and authorizer. See for changes “6.7 Changes”.

6.9 Document control (paper and electronic archives)

  1. Place the signed original SOP in the quality archive.
  2. Place a photocopy of the original copy with a signature of the authorizer on the front page at the workstation. The photocopied initials on every page indicate that the copy is photocopy of the original document. ONLY the original SOP may be photocopied.
  3. Update the document control log.

Revised versions:

Only one version of an SOP can be valid. As soon as the new version is valid, it needs to replace the old version at the workstations:

  1. Paper archive: write the date of retirement on the front page of the old version.
  2. Electronic archive: type date of retirement on the front page of the old version.
  3. All old original versions will be saved indefinitely.
  4. Remove and destroy old version at workstations immediately after placing a new version of the SOP.

Paper archive:

The paper archive contains:

  • All original valid copies signed by the reviewers and authorized person (blue pen).
  • Previous versions, also the original copies, indicating when this version was retired.

Accessibility: archived SOPs will be stored behind lock and key in a cabinet which is accessible by the QA who will keep the keys.

Document control log

The copies should be listed in a document control log, to track all the documents and replace them when needed. Three sheets are used in the document control log:

  1. SOP overview contains a table with: SOP code, title, current version, effective date, review date, distributed copies, author, reviewer, and authorization, and previous version, valid till, copies removed from. This file is used, to have a complete overview of new SOPs. In a meeting a deadline is agreed as well as the deadline for the review. Once an SOP has a code, it will stick to that code!
  • Code SOP: Unique number of SOP, in this cases an Analysis SOP, because it starts with an “A”.

Example:

  • Title of this SOP A01 is called ZN microscopy; A02 is called Culture reading. This title and coding are fixed and may not be changed anymore.
  • Current valid version. The current valid version of A01 is 2.0, which means that version 1.0 is not valid anymore. The current valid version of A03 is 1.0, meaning that this is the first version implemented.
  • Valid per: The date of the implementation: all the copies are signed (with a blue pen) by the reviewers and authorized person. This date should be the same as the date the previous version of an SOP is not valid anymore and removed from the lab.
  • Review date: the date the SOP should be reviewed (periodically)
  • Distributed copies: always one in the archive (locked) and at least one at the workstation. The copy at the workstation may be a photocopy of the original one, but it needs to be signed on the front page (blue pen). In the document log the place of all the copies should be mentioned.
  • Author and reviewers should be appointed by the authorizer of the SOP.
  • Reviewer: this should be the quality officer (for checking the SOP with the ISO 15189 standard) and one of the authorized technical staff who frequently does the analysis described.
  • Authorization is done by the person who approves the SOP
  1. Requested changes contain a table with: SOP code, SOP version, date requested, approved by, date approved, who will change, deadline change implemented, date new version implemented. If some changes need to be made in an SOP it is written on the front page and approved by the authorized person by signing and dating (blue pen).
  • Nr of requested change (record number)
  • SOP code of the SOP in which a change should be made
  • Date when the change was requested
  • The version of the SOP in which the change should be made
  • Authorized person who approved the requested change
  • Date when the change was approved by the authorize person
  • Person who is going to change the SOP
  • Deadline when the change should be implemented
  • Date of the implementation of the new SOP
  1. Author’s overview of new SOPs contains a table with: SOP code, title of SOP, name of the author, deadline draft, and deadline review. This file is used to have a complete overview of new SOPs. The author needs to be appointed by the authorized person. In a meeting a deadline is agreed as well as the deadline for the review. Once an SOP has a code, it will stick to that code!
  • Unique number of SOP
  • Title of SOP, in this case an analysis SOP
  • Who is the author
  • When should the first draft be ready so that the SOP can be discussed during a meeting
  • When should the final draft be ready and been reviewed

Electronic archive

The final valid versions need to be read-only documents, to prevent unauthorized modifications.After every modification a back up will be made on the server.

The previous versions in the electronic archive system will NOT be destroyed! On the front page of the retired SOP the date of retirement will be written and the SOP will be archived for an agreed period of time.When a version is retired, the QO types the date of retirement on the front page (same as paper copy).

The QO, lab manager and lab director will have access to the retired SOPs which will also be password protected.

The electronic archive contains:

  • All draft versions until they are valid versions
  • All valid copies, read only.
  • Previous versions, indicating when this version was withdrawn.

7. Related documents

Quality Manual, chapter QM 12

Document control log (Excel file): sheets “SOP overview”, “Requested changes” and “Authors overview of new SOPs”.

8. Related forms

N.A.

9. References

ISO 15189:2007 standard

10. Attachments / Annexes

Source: GLI Stepwise Process towards TB Laboratory Accreditation