Fillable Printable Standard Operating Procedure - King's College London

Standard Operating Procedure - King's College London

KCL HTA105/SOP Page 1 of 9

Standard Operating Procedure

Title: Production and Control of Standard Operating Procedures

Purpose

The purpose of this SOP is to describe the procedure to be followed to ensure that

SOPs are produced in a consistent format and that they are adequately controlled so

that staff work to the same closely controlled standards.

Scope

The scope of this SOP covers writing, review, approval and release of new

procedures and review and update of existing procedures. This SOP also describes

the procedures to be followed when SOPs are withdrawn from use.

Document Detail

Reference Number

KCL HTA105/SOP

Version

3.0

Effective From

June 2009

Review Date

May 2012

Author

Dr Cheryl Gillett

Approved By

KCL HTA Governance Committee [17/6/2010]

KCL HTA105/SOP Page 2 of 9

Revision status

Each document has an individual record of amendments. The current amendments

are listed below. The amendment history is available from the document control

system

On issue of revised or new pages each controlled document should be updated by

the copyholder.

Amendment

Number: Date

Version no.

Discarded

Insert

Version

Page

Section(s)

involved

Amendment

1. 16/6/09

Change in responsibilities

Change in process

reflecting new

responsibilities

New appendices

2. 17/6/10

2.1

2.3

Biennial Review

Any minor amendment must be handwritten on the SOP without obscuring existing text. An asterisk should be placed

in the adjacent margin to highlight the alteration. Alterations should be signed and dated by either the person

designated or nominated individuals and then forwarded to the document controller. The SOP must be retyped,

authorised and reissued as soon as possible. Amendments requiring immediate action should be dealt with in the

same way but highlighted as high priority. Major changes must result in the immediate review of the procedure

Document amendment does not replace the review process.

KCL HTA105/SOP Page 3 of 9

1 Responsibilities

1.1 KCL HTA Governance Group

1.1.1 The KCL HTA Governance Group will ensure KCL HTA Persons

Designated (PD) and those staff who work under the HTA Licence are

aware of their responsibilities to produce and maintain standard operating

procedures for all HTA – associated activities.

1.1.2 To support PD in their role as Document Recorder

1.1.3 To review and authorise all SOPs for ‘core’ HTA associated activities that

are standardised across the College.

1.2 Person Designated (Document Recorder)

The PD is responsible for:

1.2.1 Maintaining a register of all HTA activity associated SOP’s for the groups

they oversee (appendix 3.1).

1.2.2 Ensure that SOP numbering complies with KCL HTA Governance Group

requirements

1.2.3 Ensure that groups supply all relevant information to allow completion of

the SOP register

1.2.4 Monitor SOP review dates and where appropriate contact the author/

Principle Investigator to request SOP review

1.3 Group Document Controller

The Group document controller is responsible for:

1.3.1 Ensuring SOPs have a standard format and include:

a. Title

b. SOP number

c. Version Number

d. Date created

e. Revision Date

f. Author

g. Reviewer/Authoriser

1.3.2 Supplying SOP templates.

1.3.3 The assignment of SOP numbers, the distribution of uncontrolled copies of

SOPs for review and the co-ordination of the SOPs prior to filing and

release.

1.3.4 Updating all appropriate staff on the release of a new or updated SOP

1.3.5 Keeping a record of all local SOPs in use

1.3.6 The annual review of SOPs and their re-issue if necessary, prior to expiry

date

1.3.7 Informing the PD (Document Recorder) of new, updated or reviewed SOPs

1.3.8 The maintenance of records of archived SOPs

1.4 Author

The author is responsible for the preparation of a clear and concise procedure.

The SOP should fully describe the roles and responsibilities of individuals,

materials and methods to be used and a description of data recording and

KCL HTA105/SOP Page 4 of 9

retention requirements. The SOP should be written in the KCL HTA Licensed

Laboratories format, an example of which is given in appendix 3.2. Additionally

the author should ensure:

1.4.1 The SOP, if necessary, should include procedural checks or quality control

for the activity in question.

1.4.2 The SOP should be of sufficient detail to guide a trained operator to

perform the Procedure defined.

1.4.3 The SOP should include a description of any protective equipment and/or

precautions necessary to allow the Procedure to be performed safely.

1.5 Authoriser/ Reviewer

Reviewers are responsible for checking that the content of the SOP is technically

correct and that the procedure in the SOP is comprehensible.

1.6 Senior Staff

Senior Staff must ensure that;

1.6.1 SOPs are prepared to cover the work, equipment and procedures within

the KCL HTA Licensed Laboratories and that they are adhered to.

1.6.2 The resources are available so that the work outlined in the SOP can be

performed.

2 Procedures

2.1 Document Control

2.1.1 SOPs must all have a standard format. The current SOP template will be

supplied by the Document Controller.

2.1.2 A folder should be maintained with all current SOPs, which is accessible to

appropriate staff on a read only basis via the KCL IT network

2.1.3 Only the Document Controller will have privileges to update, edit or delete

SOPs from the local server/PC

2.1.4 It is the responsibility of the local Document Controller to ensure the

information is disseminated to appropriate staff working under the HTA

licence.

2.1.5 An historical file of all SOPs and revisions will be kept in a secure archive

area.

2.2 New Procedures

2.2.1 SOPs can be written by any member of staff, but can only be approved for

use by management.

2.2.2 Once a new SOP is identified, the title is forwarded to Document Controller

to be numbered and logged. All SOP numbers must begin with the initials

of the Principle Investigator, thereafter a local numbering system can be

used

KCL HTA105/SOP Page 5 of 9

2.2.3 Once the SOP number and version is allocated, the new/revised document

will be returned to the author to finalise the SOP and for it to be authorised.

2.2.4 An author can not also authorise a SOP

2.2.5 The Document Controller will add the new SOP to the folder on the local

server/PC and inform all appropriate staff (by e-mail) that a new SOP has

been added.

2.2.6 The Document Controller will inform the Person Designated when a new

SOP has been added to their local document folder.

2.3 Review and update of existing procedures

2.3.1 SOPs will be reviewed biennially, unless changes are required before this

time has elapsed. The Document Controller will keep a record of review

dates for each SOP.

2.3.2 For SOPs which have reached their natural review date, the document

controller will issue a request to the author to review the document. The

author should update the SOP if appropriate. Changes should be detailed

on the ‘Revision Status’ section of the SOP. If major changes have been

made to an SOP it must again be authorised. The author should return the

updated document to the Document Controller for a new version to be

issued.

2.3.3 If no changes are required the author must notify the document controller

by e-mail that no update is required. The Document Controller will record

that no amendments are required and update this on the ‘Revision status’.

2.3.4 If an SOP needs to be changed prior to the natural review date of the

procedure, the person making the changes should update the SOP, detail

amendments on the ‘Revision status’ and forward the revised SOP to the

document controller.

2.3.5 The amended SOP will be given the next consecutive version number, and

the SOP registers updated.

2.3.6 When an SOP is updated, staff will be requested to destroy all copies of

the previous version of that SOP.

2.4 Withdrawal of SOPs

When an SOP is no longer required the Document Controller and Person

Designated (Document recorder) must be notified, the registers updated

and the SOP removed from the current SOP folder.

KCL HTA105/SOP Page 6 of 9

3 Appendices

3.1 Person Designated/ Document Recorder Register of SOPs

SOP

Number

Title

Version

Number

Date

Created

Review

Date

Author

Reviewer/

Authoriser

KCL HTA105/SOP Page 7 of 9

Standard Operating Procedure

Title:

Purpose

Scope

Document Detail

Reference Number

Version

Effective From

Review Date

Author

Approved By

3.2 SOP Template Page 1

King’s College London

Human Tissue Authority Licensed

Laboratories

KCL HTA105/SOP Page 8 of 9

3.2 SOP Template Page 2

Revision status

Each document has an individual record of amendments. The current amendments are

listed below. The amendment history is available from the document control system

On issue of revised or new pages each controlled document should be updated by the

copyholder.

Amendment

Number:

Date

Version no.

Discarded

Insert

Version

Page

Section(s)

involved

Amendment

Any minor amendment must be handwritten on the SOP without obscuring existing text. An asterisk should be

placed in the adjacent margin to highlight the alteration. Alterations should be signed and dated by either the

person designated or nominated individuals and then forwarded to the document controller. The SOP must be

retyped, authorised and reissued as soon as possible. Amendments requiring immediate action should be dealt

with in the same way but highlighted as high priority. Major changes must result in the immediate review of the

procedure Document amendment does not replace the review process.

KCL HTA105/SOP Page 9 of 9

3.2 SOP Template Page 3

1 Responsibilities

List responsibilities of users, line-managers, administrators and senior staff in

ensuring that activity is carried out in an appropriate manner and in accordance

with documented procedures.

2 Materials

List any equipment, consumables or other materials required to carry out the

procedure

3 Procedures

Provide a clear and concise, step-by-step account of the procedure. This should be

in sufficient detail for a trained operator to carry out the procedure defined. The

section should also include a description of data recording and retention

requirements. If necessary should include procedural checks or quality control for

the activity in question.

4 Health & Safety

Include a description of any protective equipment and/or precautions necessary to

allow the procedure to be carried out safely.

Note: This does not replace a requirement to undertake a formal risk assessment.

5 Cross Reference SOPs

List by number and title and SOP’s, which relate to the activity described.