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SOP:11:QA:103:03:NIBT PAGE 1 of 13

Document Details

Document Number: SOP:11:QA:103:03:NIBT No. of Appendices: 2

Supersedes Number: SOP:11:QA:103:02:NIBT

Document Title: PREPARATION AND CONTROL OF POLICY DOCUMENTS Prepared By: Angela Macauley Job Title: Regulatory Affairs &

Compliance Manager Department: REGULATORY AFFAIRS & COMPLIANCE

Document Authorisation/ Issue & Implementation

Prepared By: A Macauley _________________________ Date: _________________ Approved By: Dr K Morris ________________________ Date: _________________ Chief Executive Officer ISSUE DATE: 28 June 2013 EFFECTIVE DATE: 08 July 2013

CROSS REFERENCES

This SOP refers to the following documents:

Doc. Type

Doc. No.

Title

POL PP:032 Equality Screening Policy

SOP QS:026 Reviewing A Controlled Document Using Q Pulse

SOP QS:029 Acknowledging Receipt Of A Controlled Document Using Q Pulse.

SOP QS:009 Approval/ Rejection Of A Draft Controlled Document.

SOP QS:004 Preparing A Controlled Document For Revision (Movement to Draft Register)

FORM DD:971 Equality Screening Template

FORM DD:1286 Equality and Human Rights Screening Written Assurance

FORM DD:229 Policy Document Training Record

FORM DD:1233 Controlled Document Distribution/Distribution Review Form

FORM DD:961 Controlled Document Issue Notice

FORM DD:962 Controlled Document Recall Notice

FORM DD:960 Control Master Copy – Review and Distribution History

Appendix 1 GMP Policy List

Appendix 2 Blank Policy Template

Northern Ireland Blood Transfusion Service STANDARD OPERATING PROCEDURE

(Operational Copy)


Key Change From Previous Revision: Update throughout to reflect move to use of Q Pulse 5 Documents module. Removal of requirement to complete hard copy review record FORM:DD:960.

1 RESPONSIBILITY

1.1 Author of the policy document is responsible for ensuring the document is prepared taking into account all appropriate legislation and guidelines including the statutory requirement for the policy to be screened for equality implications.

1.2 The author of the policy is responsible for completion of the equality screening

process for the policy and provision of the relevant documentation to the Document Control Officer for storage and a copy to the HR & Corporate Service Department.

1.3 The appropriate senior manager is responsible for countersigning policy

documents. 1.4 The author is responsible for ensuring the Quality Manager and/or Regulatory

Affairs & Compliance Manager must be consulted regarding the content of any policies relevant to GMP as appropriate.

1.5 Document author and/or Senior Manager is responsible for providing guidance

on the training requirements associated with the policy. 1.6 The Departmental Manager/Section Head is responsible for ensuring that all

appropriate staff in their area read and understand relevant NIBTS policies. 1.7 Senior Managers must ensure all Policies in their area are controlled via this

procedure. 1.8 Document Control Officer responsible for allocating policy reference codes,

provision of templates on request and storage of the equality screening documentation provided.

1.9 Document Control Officer responsible for issue and withdrawal of Policies and

maintaining current documentation including distribution lists. 1.10 Document Control Officer is responsible for securing stocks of ‘watermarked

controlled document’ paper.


2 INTRODUCTION

2.1 GENERAL

2.1.1 Policy documentation forms a key element in the organizational process

of NIBTS. To be effective, adequate control of their preparation, issue, amendment and withdrawal must be in place. This document addresses this need.

Policy documents are split into two categories based on their relevance to Good Manufacturing Practice (GMP). Appendix 1 details which policies are relevant to GMP or otherwise. Where possible policy documents should be prepared using the headings listed in section 6 however NIBTS recognises that some policies notably those where the format of the policy stems from a regional agreement which NIBTS must follow or those personnel policies written in accordance with best practice in that field will not be formatted in this manner. Q PULSE ‘Documents’ module will be used to record the management of policies.

2.2 CLINICAL RELEVANCE/ PURPOSE OF EXAMINATION

Not Applicable.

2.3 PRINCIPLE OF EXAMINATION

Not Applicable.

3 HAZARD AND SAFETY PRECAUTIONS

Not Applicable.

4 MATERIALS

4.1 EQUIPMENT AND SPECIAL SUPPLIES 4.1.1 Controlled paper (watermarked) for policy documents. 4.2 SPECIMEN REQUIREMENTS AND MEANS OF IDENTIFICATION Not Applicable. 4.3 REAGENTS, STANDARDS OR CALIBRANTS AND INTERNAL CONTROL MATERIALS Not Applicable.


5 CALIBRATION Not Applicable.

6 PROCEDURE

6.1 Preparation and Format of Policies

Policies must be prepared taking into account all appropriate legislation and guidelines

6.1.1 Cover Page

Document Details section :

This section is completed by the Document Control Officer or Deputy.

Document Number: this is the Policy number allocated to the

document.

The document number will be assigned by the Document Control Officer using the following format

POL 08 QP 093 01 NIBT

Document Year Document Policy Version NIBTS Identifier Code Code Number

Supersedes Number: the number of the Policy which is being superseded / replaced should be recorded here. If there is not an old version, i.e. this is a new Policy, then record N/A in this section. Document Title: the document title should be recorded here in ‘Capital and Bold letters. No. of Appendices: records any appendices. If there aren’t any record N/A in this section. The Document Control Officer will liaise with the author and approver to agree the issue and effective dates, these sections will be completed by the document control officer. Issue Date: this is the date the Policy is to be issued. The relevant Departmental Manager/Section Head must agree the distribution list with the Document Control Officer. Effective Date: this should normally be one month after the issue date. All training and related competency assessment must be completed during this period.


Document Authorisation Section:

Prepared by: The author should sign and date this section.

Authorised By: The person/s authorising the policy should sign and date this section.

6.1.2 In general these documents should be formatted using the following

headings however, it is recognized that in some cases policy documents may vary in style.

6.1.2.1 Statement

Under this heading the author should outline the aim/purpose of the policy.

This portion of the policy should be printed on a separate page and framed in a box.

6.1.2.2 Overview

Under this heading the author should outline the background information relevant to the policy and the intent of NIBTS with regard to the policy subject

6.1.2.3 Responsibility

This section should be used to outline the main responsibilities of staff associated with the implementation of the policy

6.1.2.4 Policy

Under this heading the author should describe the content of the policy and how it is to be delivered/monitored/audited etc

6.1.2.5 Equality Screening Outcomes

6.1.2.5.1 All policies must be equality screened as per

POL:PP:032. Equality Screening Policy FORM:DD:971 Equality Screening Template OR FORM:DD:1286 Equality and Human Rights Screening Written Assurance is used to document this process.

6.1.2.5.2 On completion of screening, and prior to

activation/issue of the policy, the following statement should be inserted in this section:

‘This policy has been drawn up and reviewed in light of the statutory obligations contained within Section 75 of the Northern Ireland Act (1998). In line with the statutory duty of equality this policy has been screened against particular criteria. If at any stage of the life of the policy there are any issues within the policy which are perceived by any party as creating adverse impacts on any of the groups under Section 75 that party should bring these to the attention of the Head of HR& Corporate Services.’


6.1.2.5.3 A copy of the documentation related to the equality

screening process must be provided to the HR& Corporate Service Department to facilitate publication on the BSO Website. The original copy of the screening documentation should be forwarded to the Document Control Officer for storage with the master copy of the policy.

6.1.2.5.4 The Document Control Officer will not activate the

policy until a copy of the screening documentation has been received.

6.1.2.6 Training Requirements

6.1.2.6.1 Under this heading the author in consultation with the

relevant senior managers should outline the training expectations associated with the policy e.g. All staff must read and understand the policy, Line Managers must read and understand policy etc.

6.1.2.7 The Document Control Officer will place a blank template containing

the above headings into the draft register of Q PULSE on request and allocate the appropriate reference number to the policy. See Appendix 2.

6.2 APPROVAL AND AUTHORISATION

6.2.1 All policy documents must be authorised by the Chief Executive Officer and

where appropriate the NIBTS Board Chairperson. In some instances approval by the Board may be by reference to minutes of Board meeting.

6.2.2 All policy documents must be countersigned by the appropriate senior

manager.

6.2.3 On completion of the final draft of the policy on Q PULSE the author and approver/s are required to approve the document on Q PULSE as per SOP:QS:009 ‘Approval/ Rejection Of A Draft Controlled Document’.

6.2.4 On receipt of all Q PULSE approvals the Document Control Officer will issue

a hard copy of the policy document for approval/authorisation signatures.

6.3 ISSUE

6.3.1 In general hard copies of policy documents shall be issued to the Senior Management Team member for each section by the Document Control Officer. Any variation from this requirement should be specified by the author. Only controlled copies printed on controlled paper showing ‘Policy’ as a watermark or, in those policies issued prior to Jan 2011, the NIBTS stamp in RED INK are valid.

6.3.2 The Department Manager/Section Head must instruct the Document Control

Officer as to the required distribution of the Policy (i.e. electronic copy or hard


copy) by completing FORM:DD:1233 - Controlled Document Distribution/Distribution Review Form at the time of signature.

6.3.3 Equality screen documentation must be returned to the Document Control

Officer and a copy forwarded to the HR& Corporate Service Department at the time of signature.

6.3.4 A policy will not be issued unless both FORM:DD:1233 and the equality

screening documentation has been returned with the signed copy to the Document Control Officer.

6.3.5 Electronic notification of the issue of a new/revised policy document will be

undertaken by the Document Control Officer to all relevant Departmental Manager/Section Heads as identified by the document author.

6.3.6 Any other copies must be stamped “Uncontrolled Copy”. Where such copies

are made/used the responsibility of ensuring that the policy is current rests with the user.

6.3.7 Receipt of the hard copy document must be acknowledged by completing

Controlled Document Issue Notice (FORM:DD:961) and returning to the Document Control Officer. Electronic acknowledgement of receipt via Q PULSE is also required as described in SOP QS:029 ‘Acknowledging Receipt of a Controlled Document Using Q Pulse’.

6.3.8 For policy copies that are controlled electronically acknowledgement via a

PIN Number controlled entry in Q PULSE is required as described in SOP QS:029 ‘Acknowledging Receipt of a Controlled Document Using Q

Pulse’. 6.3.9 A record of all controlled issues must be recorded on form Control Master

Copy – Review and Distribution History (FORM:DD:960) and this kept with the master copy retained by the Quality Department.

6.4 COMMUNICATION

6.4.1 It is the responsibility of each Departmental Manager/Section Head to ensure that all appropriate staff read and understand relevant NIBTS policies. This must be recorded on the Policy Document Training Record (FORM:DD:229) which should be retained with the section’s copy of policy document.

6.4.2 Training records (FORM:DD:229) for superceded policy documents should

be returned with the superceded document when recalled and will be stored with the archived master copy of the document.

6.5 REVIEW

6.5.1 NIBTS aim to review all policy documents every two years, with the exception of HTA policies which must be reviewed annually. GMP related policies must be reviewed at a maximum two-year interval. Policy author must advise the Document Control Officer regarding the review interval to be set.


6.5.2 The senior manager who writes/authorises a policy responsible for ensuring the review process occurs.

6.5.3 If on review no changes are required then the individual reviewing the policy

document must record this on Q PULSE . See SOP:QS:026 ‘Reviewing a Controlled Document Using Q Pulse’.

6.5.4 If on review changes the individual reviewing the policy document must

record this on Q PULSE . See SOP:QS:026 ‘Reviewing a Controlled Document Using Q Pulse’. The Document Control Officer will move a copy of the document into draft as per SOP QS:004 ‘Preparing a Controlled Document For Revision (Movement to Draft Register)' are required the Document Control Officer must be informed and requested to move a copy of the document into draft. See SOP:QS:014 ‘Process for Responding to an SOP, DD Form or Policy Document if Changes are Required’. A copy of the document will be moved to draft.

6.5.6 Where a new version of a policy document is issued the index will be

reissued to indicate the current version of that policy document.

6.6 AMENDMENTS

6.6.1 The Senior Management Team member for the section writing or amending a policy must consider the impact of the changes to other areas and circulate the proposed amendments to other SMT members for comment as appropriate. The Quality Manager and/or Regulatory Affairs & Compliance Manager must be consulted regarding any changes to be made to policies which are relevant to GMP.

6.7 WITHDRAWAL

6.7.1 Where a document is withdrawn for any reason ALL COPIES issued must be taken out of circulation. The Document Control Officer will issue recall documentation, Controlled Document Recall Notice FORM:DD:962, to each Senior Management Team Member as appropriate. This must be completed and returned along with the superceded copy of the document.

6.7.2 The Document Control Officer will ensure all issued copies of the

withdrawn/superceded policy are accounted for and will destroy the returned copies.

6.7.3 The Document Control Officer will archive the master copy of the document

along with the returned document recall notices, distribution documentation and any relevant review records.

6.8 POLICY TO BE POSTED ON NIBTS INTRANET OR INTERNET SITE.

6.8.1 Where Policy Documents are to be posted electronically on the NIBTS

Intranet or Internet sites the author must advise the Document Control Officer.

6.8.2 Copies of such documents will be issued to the person responsible for

posting on the appropriate site as per section 6.3. The issue


documentation will indicate the location of the document.

6.8.3 Where such copies are superceded they will be recalled as per section 6.7. Completion of the recall documentation will confirm policy has been removed from intranet/internet site.

6.9 ADDITIONAL COPIES OF SECTIONS OF POLICY FOR DISPLAY

6.9.1 Occasionally departments may wish to make additional permanent hard

copies of sections of the Policy for various reasons such as display purposes. It is important that such copies are known to the Document Control System to ensure these documents are captured in the withdrawal process for superceded documents.

6.9.2 Where such copies are required the Author or the Head of the Department

requiring the copy of the Policy must advise the Document Control Officer. The Document Control Officer will produce the number of copies required and issue as per section 6.3.

6.9.3 Where such copies are superceded due to revision of corresponding

Policy they will be recalled as per section 6.7. 6.10 LIMITATIONS OF THE EXAMINATION Not Applicable.

7 RESULTS

Not Applicable.


APPENDIX 1

POLICY DOCUMENT CATEGORY

GMP RELEVANT NON GMP RELEVANT

AP - ADMINISTRATIVE AP:025 ALL OTHER

EP - EMERGENCY PLANNING

ALL N/A

FP - FINANCIAL FP:005 ALL OTHER

HP - HEALTH & SAFETY HP:006, HP:010, HP:012, HP:014, HP:015, HP:016

ALL OTHER

IP - IM & T ALL N/A

IGP - INFORMATION GOVERNANCE

ALL N/A

LP - LABORATORY ALL N/A

MP - MEDICAL ALL N/A

PP - PERSONNEL PP:031, PP:034 ALL OTHER

QP - QUALITY ALL N/A

RGP - RESEARCH GOVERNANCE

ALL N/A

RP - RISK MANAGEMENT

ALL N/A

TP - TRANSPORT ALL N/A

UP - CORD BLOOD ALL N/A

VP - VALIDATION ALL N/A

ZP - ENVIRONMENTAL N/A N/A Page 1 of 1

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