Utilise the Template in Appendix 1, Including Completion of the Front Sheet of the WI Document
WORKING INSTRUCTION
WORKING INSTRUCTION NAME: / Creating and Updating a Working InstructionWORKING INSTRUCTION REFERENCE: / TASC/OPS/WI001/V2
VERSION NUMBER: / 2.0
EFFECTIVE DATE: / 14 November 2013
INTENDED USER: / TASC Members of Staff, Researchers
AUTHOR: / TASC R&D Manager – Improvement & Quality
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TASC/OPS/WI001/V214 November 2013
Summary guidance
Utilise the template in Appendix 1, including completion of the front sheet of the WI document:
- Give a short description as name of Working Instruction (WI)
- Provide a reference in the format:TASC/Activity/SOP##/WI###/V#
- Use a filename in the format: TASC Activity term (as below) followed by WI
number and Version e.g. TASC OPS WI001 V1
The following designated Activities will apply. It is essential to provide reference to any governing TASC SOP.
Term to use / ExplanationQA / *Quality Assurance
RG / *Research Governance
PVS / *Safety & Pharmacovigilance
TM / *Trial Management
APPR / R&D Approvals
COMM / Commercial Research
LEG / Legal & Contracts
MON / Clinical Research Monitoring
OPS / TASC Operations
PORT / Portfolio
* Note:
These category terms are as used on TASC website for SOP groupings.
IMPORTANT - There is a requirement for Working Instructions to be reviewed/updated on amendment of any governing SOP.
- Provide a Version number and Effective date
- Give the Job title of the Author(s).
The WI Author will create the content of the WI, including use of MS PowerPoint process flow diagram wherever possible, and will add Page numbers (note, no Page number on front page) and WI Reference plus Effective date as Footer information. The new or update WI is sent to TASC R&D Manager for Improvement & Quality for QA purposes.
Working instructions can be reviewed and updated at any time.
The TASC R&D Manager – Improvement & Quality will be responsible for compliance to this WI and any applicable SOP on receipt of a new/updated WI, including Reference number, Version and Effective date, Activity area and User information. This will constitute quality assurance in terms of uniformity.
The WI Author of TASC functions where no governing SOP exists will be responsible for the content of the WI, as accountable to TASC Senior Management.
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TASC/OPS/WI001/V214 November 2013
Process Flow – Creating/Updating a WI
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TASC/OPS/WI001/V214 November 2013
APPENDIX 1
Working Instruction Template
(Front Sheet to Complete & New Section to Add Content Information)
WORKING INSTRUCTION
WORKING INSTRUCTION NAME:WORKING INSTRUCTION REFERENCE:
VERSION NUMBER:
EFFECTIVE DATE:
INTENDED USER:
AUTHOR:
[Add Content Information]
[Add WI Reference][Add Page No.][Add Effective Date]