An Organisation Wide Policy for the Development and Management of Procedural Documents
Version: V11
Ratified By: Quality & Safety Committee
Date ratified: 19/12/2019
Job Title of Author: Head of Quality and Safety
Reviewed by Sub Group or Expert Group: Other Expert Group
Equality Impact Assessed by: Head of Quality and Safety
Related Procedural Documents:
QSPOL09: Risk Management Policy
LDPOL02: Management of Local & Corporate Induction Policy
IGPOL35: Records Management Policy
Review Date: December 2022
It is the responsibility of users to ensure that you are using the most up to date document template – i.e. obtained via the intranet
In developing/reviewing this policy Provide Community has had regard to the principles of the NHS Constitution.
Version Control Sheet
Version Date Author Status Comment
V2 Sept 09 Senior Governance Manager Ratified Labelled as V2 before initial ratification
V3 June 2010 Quality & Safety Facilitator To go to June 2010 IGC Minor formatting adjustments
V4 March 2011 Quality & Safety Facilitator For PROVIDE CIC IGC
V5 February 2012 Quality & Safety Facilitator Amendment to retention schedules Chair action 22nd February 2012
V6 August 2014 Deputy Clinical Director Interim – to be reviewed when meta –compliance is fully implemented Full review
V6.1
November 2014 Quality and Safety Facilitator Ratified chair’s action 28/11/2014
Adjustment to table in Appendix B to reflect section 7.2
V7 July 2015 Deputy Clinical Director Ratified Full review
V7.1 October 2016 Deputy Clinical Director Ratified Previously IGPOL1. Appendices changed.
V8 February 2017 Head of Quality & Safety Full Review
V9 December 2017 Head of Quality Assurance Approved Addition following committee decision re time scales for policy review
V10 December 2018 Head of Quality and Safety Ratified Full Review
V11 December 2019 Head of Quality and Safety Addition re policy review tolerance and Provide structure update
1. Introduction
This policy covers the document control of Policies, Guidelines and Standard Operating Procedures (SOPs) for Provide.
High quality organisational documentation is an essential tool of governance which will help the organisation achieve its strategic objectives, as well as facilitating the delivery of a consistently high standard of care to service users.
All documents must undergo a rigorous process of development and be approved and monitored by the appropriate committee and sub group/expert group, who provide assurance to Provide Board.
This policy has been written to give a corporate framework for the creation/revision of all procedural documents within the organisation. It will ensure that procedural documents are comprehensive and standardised where possible. Not all documents will have all the features and therefore some elements have been shown as optional. The Standard Operating Procedure for Formatting Procedural Documents describes the framework for development and formatting of procedural documents to achieve a consistent approach. Procedural documents have a key role within the organisation and are integral to the affairs of Provide. It is vital that all such documents are properly consulted upon, approved at an appropriate level, implemented and regularly reviewed.
2. Purpose
The aim of this policy is to clarify the steps that must be taken to secure approval for all new or reviewed procedural documents to be used within Provide. For ease of reading, this document will refer to all policies, guidelines and SOPs as ‘Procedural Documents’ unless specific terminology is more appropriate.
3. Definitions Policy
A Policy is a set of governing principles, which meets all or most of the following criteria: -
• It is a governing principle that mandates or constrains action;
• It has Provide Group or service wide application;
• It will change infrequently and sets a course for the foreseeable future;
• It helps to ensure compliance with overarching principles, legislation or professional guidance;
• It helps to reduce organisational risk.
Standard Operating Procedure (SOP)
A SOP is a series of step by step instructions to ensure routine processes are completed in accordance with organisational policies. SOPs aim to achieve efficiency, quality output
and uniformity, while reducing miscommunication and failure to comply with organisational policies.
Guideline
A guideline is a set of systematically developed standards or rules, which assist in the decision about how to apply an agreed policy, or may relate to the appropriate management of specific conditions or situations. Guidelines are often used to underpin a policy, and represent good practice.
Guidelines may be adopted from national publications, for example NICE guidance.
Terms and Use of Language
All procedural documents must be clear and legible to their respective audience. To ensure this:
• Unusual terms and descriptions must be described in clear language.
• Acronyms must be explained in full, at least once on the first time of their use
Governing Committee
Provide’s governing committees are sub committees of Provide Board which have delegated responsibility on behalf of the Board to ratify the organisation’s procedural documents. Provide Group has the following governing committees:
• Finance & Risk Committee
• Quality & Safety Committee
Sub Group
The sub groups of Provide’s governing committees are responsible for approving the content and format of procedural documents prior to submission to the governing committee for final ratification. Provide’s sub groups consist of:
• Clinical Excellence Group
• Customer Engagement Group
• Estates Strategy Group
• Infection Prevention Group
• Medicines Governance & Safety Group
• Safety & Resilience Group
• Serious Incident Review Group (as required)
• Risk Management Review Group
• Strategic Safeguarding Group
• Learning & Development Strategy Group
• Technology Programme Board
• Workforce Steering Group
Expert Group
If an appropriate sub group cannot be identified to approve a procedural document, an expert group must be convened to take responsibility for approving the content and format of a procedural document prior to submission to the governing committee for final ratification. The expert group will include appropriate specialists identified by the document
author and the Assistant Director for the service where the document is being developed. The expert group must always include either the Director of Clinical Operations, Director of Nursing and Allied Health Professionals and the relevant Assistant Director
Service User
Newly developed or reviewed procedural documents must refer to Service Users. ‘Service user’ is an umbrella term to incorporate patients, clients, customers or others under the scope of the policy.
Provide Social Care Services and Domiciliary Services may adopt documents that refer to clients or patients, in such cases these should be considered Service Users
4. Responsibilities
Provide Board
The Board is responsible for setting the strategic context in which organisational documents are developed, and for ensuring that the formal review and approval of documents takes place. It ensures that resources are available to effectively discharge policies.
The board are responsible for appointing named leads as required by national direction, including but not limited to:
• Freedom to Speak Guardian
• Caldicott Guardian;
• Director of Infection Prevention & Control
• Senior Information Risk Owner SIRO
The Board has a responsibility to ensure that safe practices exist to protect service users and staff which are achieved through robust processes, thus meeting its legal obligations as well as strategic NHS obligations.
Provide Board is responsible for the overall management of health and safety within the organisation. It is responsible for providing leadership, ensuring all Provide decisions reflect the intentions laid down in this policy and monitoring the implementation of this policy.
Each Executive Director of the Board has responsibilities with regard to implementing this policy in their service area. These responsibilities are listed below. In addition, individual Executive Directors of the Board have strategic health and safety responsibilities, which are also described below.
Chief Executive
The Chief Executive has overall responsibility for the strategic and operational management of Provide which includes ensuring that documents comply with all legal and statutory requirements and ensures that resources are available to effectively discharge policies.
Executive Directors
All Executive Directors are responsible for identifying and ensuring the development of documents relevant to their area of responsibility. The Executive Directors are accountable to the Chief Executive and the Board for ensuring documents are implemented and become active documents within Provide
Executive Directors will ensure that procedural documents are appropriately consulted upon and that all resource implications are highlighted and funding identified. They will ensure that their senior managers are informed of progress.
Assistant Directors
All Assistant Directors are responsible for identifying and ensuring the development of documents relevant to their area of responsibility.
Assistant Directors will ensure that this policy is appropriately consulted upon and that all resource implications are highlighted and funding identified. They will ensure that their senior managers are informed of progress
Assistant Directors will receive monthly updates from the Clinical Quality Team via the Quality and Safety Committee and Finance and Risk Committee Meetings detailing the organisation’s overall position in relation to procedural document review dates.
Heads of Service
Managers are responsible for raising awareness of this policy within their own business units and will highlight changes to their teams at meetings. They must always ensure that the appropriate Sub-Group/Expert Group has signed off a procedural document prior to ratification at the Governing Committee Meeting (i.e. Quality & Safety Committee/Finance & Risk Committee).
Team Managers
Team Managers are responsible for ensuring that their team members are aware of where to access procedural documents and have a mechanism to do so. If staff are unable to routinely access procedural documentsthis issuemust be escalatedto the Head of Service and the Clinical Quality Team.
Team Managers are also responsible for having a mechanism in place to ensure that any staff without routine computer access have knowledge of new and revised procedural documents.
Provide Employees
All staff members are responsible for co-operating with the development and implementation of procedural documents as part of their normal duties and responsibilities and for ensuring that they are familiar with and have access to the relevant procedural documents in their area of operations.
Temporary or Agency Staff, Contractors and Students
All other personnel will be expected to comply with the requirements of all relevant procedural documents applicable to their area of operations. Refer to LDPOL02
Management of Local and Corporate Induction Policy and CCPOL01 Engagement of Temporary Workers Policy.
5. Duties
Document Author
The Document Author must ensure that the appropriate Assistant Director is aware and in agreement with a procedural document being reviewed and must ensure that the document is:
• Developed and reviewed in accordance with this policy
• Peer reviewed as appropriate by relevant staff before submission for approval.
• Submitted for approval to the appropriate sub group/expert group prior to the document review date.
• Following approval, submitted for ratification to the relevant committee in line with the process appended to this document.
Consideration must be given to the need for public involvement in the development of procedural documents.
It is the responsibility of the document author to ensure that a thorough review of the procedural document is carried out prior to the document being submitted for approval Document authors must ensure relevant stakeholders, including service users that could be affected by the document, are included in the review. This must include consultation with relevant sub groups/expert groups prior to submission to the committee responsible for final ratification.
The consultation, which seeks advice or opinion from stakeholders can also include:
• E-consultation (via Internet/Intranet)
• Legal advice (the giving of a formal opinion regarding the substance or procedure of the law by an officer of the court
• Expert Advice (recommendation from a person who has special skills or knowledge in a particular field)
Please refer to Appendix A: Process for Document Ratification.
Audit Committee
The Audit Committee provides an objective review of systems and reports presented by internal and external audit, and provides the Board with an assurance that the organisation’s governance, including financial, clinical and risk management processes are conducted within best practice guidelines.
Quality and Safety Committee (Q&SC)
The Quality and Safety Committee will ensure the organisation has procedural documents in place to support delivery of key clinical governance functions and that the document production and development process is in place to do this.
The Quality and Safety Committee is responsible for the ratification of all clinical and operational procedural documents. Review, approval and agreement is a delegated
function to one of the Q&SC’s sub-groups (see structure chart, Appendix B). Final ratification lies with the Q&SC. In the event of an appropriate sub-group not being identified an expert group must be convened with appropriate specialists to review and scrutinise prior to Q&SC ratification. Members of the expert group should be identified by the document author and should include the Director of Operations and the relevant Assistant Directors.
Finance and Risk Committee (FRC)
The Finance and Risk Committee will ensure the organisation has procedural documents in place to support delivery of key corporate governance functions including finance and corporate risk management. The FRC take responsibility for ratifying all corporate and financial procedural documents. There are identified sub-groups that have delegated responsibility for document approval that report directly to FRC.
There are a number of organisational procedural documents such as the Risk Management policy that require a joint oversight and ratification process from the Q&S and FRC.
The Staff Partnership Group
This group ensures that the views of staff and also unions and professional regulatory bodies are consulted upon in the development of human resource policy documents. This ensures that the organisation has the procedural documents in place to support the human resource management of the tasks and duties of Provide. The group provides advice and guidance to the Quality and Safety Committee and/or the Finance and Risk Committee on its views and the wider views of the staff of Provide when procedural documents are presented for ratification.
Clinical Quality Team
The Clinical Quality Team will maintain an overview of all clinical procedural documents liaising with appropriate managers regarding production and revision deadlines and procedural issues. They will be responsible for ensuring that, following ratification, appropriate arrangements are in place for all procedural documents to be uploaded to MyCompliance and will arrange distribution of mandatory documents via Metacompliance.
The Clinical Quality Team are responsible for the archiving and storage of all procedural documents within the organisation. The Clinical Quality Team will maintain a procedural document inventory including prompting of timely document review. They are responsible for liaison with document authors and notifying of ratification/rejections following committee meetings.
Human Resources (HR) Team
The Human Resources Team will maintain an overview of all HR procedural documents liaising with appropriate managers regarding production and revision deadlines and procedural issues. They will support document authors in identifying and submitting documents for approval by sub-groups/expert groups.
HR will develop procedural documents relating to the terms and conditions of employment in partnership with the Staff Partnership Forum (SPF). Policies and Procedures will be discussed with a sub group of the SPF before being approved for ratification at a SPF meeting.
Learning and Development (L&D) Team
The L&D Team will maintain an overview of all L&D procedural documents liaising with appropriate managers regarding production and revision deadlines and procedural issues. They will support document authors in identifying and submitting documents for approval by sub-groups/expert groups.
Finance and Information Technology (IT) Team
The Finance and IT Team will maintain an overview of all Finance and IT procedural documents liaising with appropriate managers regarding production and revision deadlines and procedural issues. They will support document authors in identifying and submitting documents for approval by sub-groups/expert groups.
Business Strategy and Service Delivery
They will maintain an overview of all commercial procedural documents liaising with appropriate managers regarding production and revision deadlines and procedural issues. They will support document authors in identifying and submitting documents for approval by sub-groups/expert groups.
Essex Sexual Health Service ESHS
ESHS operates a lead provider model and as such the policy documents are developed and ratified collaboratively.
ESHS assign a working group or individual to draft policy document with representation from all partners in ESHS within operational development meeting. This is circulated for review and comment.
Final sign off occurs at the clinical strategy group with representation from all parties. These documents are represented through the organisation Q&S Committee meeting through presentation of the associated meeting minutes.
Information Governance & Technology Projects Manager
The Information Governance & Technology Projects Manager will monitor the organisation’s overall compliance in signing up to mandatory procedural documents.
6. Approval Levels
Category Approval Route
Board approval will be sought when a committee with delegated responsibility for the procedural document approval cannot reach a decision.
Corporate Governance Procedural Documents:
Finance and Risk Committee
Clinical and Operational Procedural Documents:
Quality and Safety Committee
Reporting to the Board
As sub-committees of the Board, the minutes from both the Quality and Safety and Finance and Risk Committees are received by the Board. All procedural documents ratified by these committees are contained within these minutes.
Ratification Process
If document authors are unclear on the ratification process for a particular procedural document advice should be sought from the Clinical Quality Team.
Please refer to Appendix A & B: Process for Document Ratification
7. Document Development
Decision to Develop
Individuals identifying a need for a particular procedural document should first discuss the proposed development with the appropriate Assistant Director/Head of Service or Director within whose remit the subject matter falls and establish if:
• There is an area in which the service’s position is not clear
• Staff are unclear of how to deal with a specific issue
• A new process is to be introduced
• If a similar procedural document exists, enquiries should be made as to why it is no longer applicable e.g. circumstances may have changed to make it obsolete such as new legislation. It is the responsibility of the Assistant Director or appropriate Director to establish whether a new procedural document is required and the pathway for approval in accordance with section 4
Document Content
The content of each procedural document should demonstrably comply with all:
• Relevant legal and statutory requirements, Department of Health Guidance and any procedural document in force at the time of writing or reviewing the document
• Provide Standing Orders, Standing Financial Instructions and Scheme of Delegation
• Provide duties in relation to equality and human rights
The document should also:
• Clearly indicate the responsibility placed on directorates, departments and individuals, and how these should be discharged (governing principles are intended to outline what the organisation’s position is in relation to a particular issue)
• Where specific terms are used these must be accompanied by a definition
• Acronyms must be written in full the first time they appear in the document
• Acknowledge any circumstances, detailed in the document, which may require colleagues to exercise discretion. In such circumstances, the areas of discretion, or freedom to act, must be clear and include any constraints and limitations
• Where it may be appropriate, ensure that staff sign to indicate that they have received and understood a document (e.g. Standing Financial Instructions). If this is the case, provision should be made within the wording of the document
• Include who should be aware of, and understand the document and follow its requirements
• Include who may be affected by the implementation of the document.
It is the responsibility of the document author to ensure they are aware of changes in legislation, practice or other guidance to enable them to ensure the document considers and minimises risk and potential adverse consequences for Provide.
A framework for core document content is detailed in Appendix C, Ci, D, E & F and must be followed for all procedural documents except where the format is prescribed within National Guidance
8. Style and Format of Procedural Documents
All procedural documents should be written in a style which is concise and clear using unambiguous terms and language. Consideration should be given to producing appropriate documents in languages other than English dependent on the population groups served by the organisation.
All procedural documents should be written using the appropriate Provide template which contains the correct Provide Logo, footer and formatting. All procedural documents templates can be located on the Staff Intranet.
A version control sheet must be included in all procedural documents as follows:
Version: V[X]
Ratified By:
Choose an item.
Date Ratified: Click here to enter a date.
Job Title of Author: [job title & dept]
Reviewed by Sub Group or Expert Group:
Choose an item.
Equality Impact Assessed by: [job title & dept]
Related Procedural Documents: [show all related document]
Review Date: [3 years from date of ratification]
• It is the responsibility of users to ensure that you are using the most up to date document by accessing the copy available on MyCompliance
• In developing/reviewing this policy Provide has had regard to the principles of the NHS Constitution
All procedural documents must have page numbers, a table of contents and contain a minimum of the following headings:
• Introduction: the background for the document.
• Purpose: what the procedural document will achieve.
• Definitions: clarification of the major terminology used in the document.
• Duties: roles and responsibilities off staff and others in relation to the document.
• Monitoring: how will the effectiveness of the document be demonstrated.
• References: The author should ensure that all sources referred to are included.
• Equality Impact Assessment: outline the results of the assessment (this should be the last appendix).
Further formatting information can be found in the organisation’s SOP for Formatting Procedural Documents
9. Equality Impact Assessment
Provide applies the statutory duty that all public bodies have under a range of equal opportunities legislation to assess and consult on how their procedural documents and functions impact on race, disability and gender. The organisation will also apply the principles of this legislation to age, sexual orientation and religion and belief. Every
procedural document must have an Equality Impact Assessment produced. The assessment and publication form to be used attached as Appendix J & K
The organisation aims to design and implement services, procedural documents and measures that meet the diverse needs of the organisation’s service, population and workforce, ensuring that none are placed at a disadvantage over others. The Equality Impact Assessment Tool is designed to help you consider the needs and assess the impact of the procedural document.
10.Review and Revision Arrangements including Version Control
Process for Reviewing a Procedural Document
All procedural documents will be reviewed prior to their review date or as local / national guidance dictates. The committee responsible for the document will agree the review date which will be risk based, ordinarily this is expected to be three yearly, however policies underpinned by national legislation may be reviewed five yearly in line with national updates.
All documents will remain current and in date until reviewed or superseded by updated guidance. All procedural documents beyond their review date will be permitted a 6 month tolerance period to allow for thorough review. The Quality and Safety Team will monitor document review dates and escalate concerns to Assistant Directors, Directors and the Board through the Quality and Safety Committee and FRC.
All reviews and revision to any procedural document must be approved according to section 6 of this document. The exception to this rule is for the Standing Orders and Standing Financial Instructions, Delegation of Authority which will be reviewed every 12 months. If it is known that changes have been made to clinical procedures, government policy or legal advice has changed then the procedural document following the process outlined in this policy should be updated/reviewed accordingly.
Version Control
All documents will be the subject of strict version control and will have a version number which will be co-ordinated by the Clinical Quality Team. Every document must have a version control sheet completed by the document author
Timeline
The document author will be notified of a document requiring review six months prior to the review date. First drafts of the reviewed document should be sent for consultation to key stakeholders three months before the document review date. The document should be presented to the appropriate sub group/expert group prior to the document review date ensuring sufficient time is available for further amendments and then final ratification at the relevant committee.
A virtual approval process must be completed on occasions where a sub group is not scheduled to take place before the document review date or when an expert group cannot convene prior to the document review date. All members of staff that are sent a procedural document for virtual approval must complete a virtual approval/comments form (Appendix
I) and ensure it is returned to the document author in line with the response deadline set out in the virtual approval/comments form.
Document Identification Number
The allocation of procedural document reference numbers will be completed by the Clinical Quality Team following ratification of the document by the appropriate committee.
11.Dissemination and Implementation
Dissemination
Following committee ratification the Clinical Quality Administration Team will arrange for the procedural document to be uploaded to MyCompliance.
All staff will be notified of new/reviewed procedural document content via MyCompliance and Clinical Matters. Provide Board receives notification of ratified documents via receipt of Quality and Safety Committee and Finance and Risk Committee Minutes.
Where compliance monitoring is also required, procedural documents will be disseminated via Metacompliance (the Organisation’s Procedural Document Compliance System). Document authors must complete a Metacompliance Summary Sheet which must then be submitted to the Metacompliance & Policy Management Group for approval. If approved the procedural document will then be added to the Metacompliance Schedule.
Implementation of Procedural Documents
Procedural Documents must clearly outline how they are to be implemented and the relevant governance committees will be responsible for monitoring this
12.Document Control Including Archiving Arrangements
All procedural documents are electronically archived by the Clinical Quality Administration Team held in line with the timescales stipulated by the Department of Health Records Management NHS Code of Practice Part 1 & 2 Annex D1 Health records retention schedule.
Register/Library of Procedural Documents
All current documents will be available to access on MyCompliance. In addition the Clinical Quality Administration Team will maintain an electronic database of all procedural documents.
13.Monitoring Compliance With and the Effectiveness of Procedural Documents
It is essential that procedural documents are followed by staff and are effective.
Process for Monitoring Compliance and Effectiveness
Provide will monitor the operation of this policy in order to: -
• Measure its effectiveness
• Comply with Provide’s legal obligations
• Highlight practical issues and seek solutions.
The relevant committee/sub-group/expert group that is responsible for developing the procedural document will be responsible for monitoring compliance and effectiveness and instigating any necessary action as a result of this.
This policy will be monitored in line with operational fitness. Review will be undertaken in line with routine review schedule and in the event of any incidents suggesting that there may be need to revisit the parameters of the policy.
Compliance will be monitored against the quality of documents presented for ratification.
The Clinical Quality Team will monitor the document library that is held electronically in a secure, central location and will carry out cross checks against the content available on MyCompliance to ensure up to date procedural document content is available to all Provide staff.
14.References
The evidence base for procedural documents should be demonstrated with up to date references. It is recommended that all references are cited in full using the following example: -
Health and Social Care Act 2001
The Race Relations Act 1976 (as amended by the Race Relations (Amendment) Act 2000)
The Disability Discrimination Act 1995 amended 2005
The Gender Recognition Act 2004
The Civil Partnership Act 2004
Employment Equality (Religion or Belief) Regulations 2003
Employment Equality (Sexual Orientation) Regulations 2003
Sex Discrimination (Gender Reassignment) Regulations 1999
The Human Rights Act 1998
The Sex Discrimination Act (as amended) 1975
The Equal Pay Act (as amended) 1970
Promoting Equality and Human Rights in the NHS - A Guide for Non-Executive Directors of NHS Boards (2005) Department of Health
