Requirements For Change Control in a Hospital Blood Bank

Transcription

1 NHS SCOTLAND DOCUMENT Mdel SOP t Meet Requirements f OIG Quality Management System Dcument Reference N: NHSSIG D78_05_01 Requirements Fr Change Cntrl in a Hspital Bld Bank Dcument Prepared Nvember 2005 Dcument Ref D78_05_01 Mdel Change cntrl SOP Page 1 f 1

2 1. Intrductin Change cntrl is a fundamental requirement f any Quality Management System(QMS)and is a specific requirement f the EEC Guide t GMP(Orange Guide) and the QMS fr hspital bld banks prepared by the NHS Operatinal Impact grup. The purpse f change cntrl is t prvide a systematic methd fr assessing the impact f any change n any activity which might have an affect n the labratries prcedures, utputs and services. This plicy applies t all new labratry equipment, cmputer systems, analytical methds and testing kits. 2. Health and Safety There are n specific health and safety implicatins invlved in implementing this SOP, althugh part f the change cntrl prcedure will invlve an assessment f whether r nt there are safety implicatins which need t be taken int accunt during the apprval prcess. Where relevant full Health and Safety risk assessments and COSHH assessments will be undertaken. 3. Materials Nt applicable 4. Staff Staff at many levels are likely t be invlved in the change cntrl prcess. Hwever the respnsibility fr ensuring that develpments are subjected t apprpriate change cntrl prcedures lies with the relevant Head f department ( BMS staff). Cmplex develpments may require the establishment f a prject team in which case the respnsibility then lies with the prject manager. The Quality manager will be the principal surce f advice n the need fr change cntrl and its management. 5. Basics f Change Cntrl Prcedure The basic requirements f this SOP are that planned changes are subjected t effective scrutiny by all parts f the rganisatin which are affected. This SOP is intended t ensure that all these basic requirements are implemented. Dcument Ref D78_05_01 Mdel Change cntrl SOP Page 2 f 2

3 6. Objectives The principal bjectives f Change cntrl are as fllws T ensure that any planned changes r mdificatins t prcesses, prcedures, plicies r cmputer hardware/sftware, which may impact n quality, are cmmunicated t the relevant persnnel within the rganisatin. This prvides an pprtunity fr affected departments t assess any affect, t advise f any areas f cncern, and time t implement any required actins. T plan the implementatin f the change, s that minimum f disruptin is caused T ensure that all the requirements fr validatin prir t implementatin have been cnsidered, addressed and where relevant an apprpriate validatin prtcl and reprt have been prepared and apprved. T ensure that all training requirements have been identified and training carried ut. T ensure that all dcumentatin required has been identified and is in place befre the change is implemented. The minimum dcumentatin required will vary depending n the nature f the change. Examples f dcumentatin required t supprt a change wuld include Cmpleted validatin reprts Cmpleted risk analysis Cmpleted cmmissining reprts Summarised lab test data New revised SOP Evidence f training T ensure that dcumented detail f rganisatinal change is ldged s that a true and traceable recrd is available T ensure that where required effective fllw up studies are carried ut t demnstrate that the change has been implemented as anticipated. 7. Outline f prcedure 7.1 An apprpriate Departmental head r nminated deputy will be respnsible fr ensuring that the change cntrl prcedure is initiated (using relevant change request frms). The request will prvide details f the intended change and any supprting dcumentatin. Dcument Ref D78_05_01 Mdel Change cntrl SOP Page 3 f 3

4 7.2 The change request frm will be submitted t the quality manager. 7.3 The request must be carried ut well in advance f implementing the change. This is imprtant t allw sufficient time fr all relevant actins t be taken and allws QA t advise f the dcumentatin requirements which must be in place fr the change t be apprved. 7.4 The quality manager will liase with relevant managers t decide n which ther parts f the rganisatin need t be made aware f the change and mre specifically which managers/cnsultants need t give apprval. All such managers will receive a cpy f the frm f the change cntrl dcuments and be asked t sign them. The signed frms will be stred in the change cntrl file. 7.5 Each change cntrl request will receive a unique reference number. A file will be pened and this will cntain key dcumentatin t supprt the change. The files will be held fr scrutiny when required. 7.6 Cpies f the cmpleted change cntrl dcuments will be issued t the relevant persnnel. 8. Dcumentatin f change cntrl All requests fr apprval f change cntrl must be made using the specified frms. These can be cmpleted in written frm r electrnically. Examples f these frms fllw n the next few pages. Dcument Ref D78_05_01 Mdel Change cntrl SOP Page 4 f 4

5 Recrd Of Change Cntrl Part 1. SUMMARY OF PROPOSED CHANGE REQUEST REFERENCE NUMBER (t be allcated by QA) AREA PROPOSING/ IMPLEMENTING CHANGE LINE MANAGER/SECTION HEAD PLANNED IMPLEMENTATION DATE DESCRIPTION OF PROPOSED CHANGE. PLEASE INCLUDE GENERAL INFO, SOPS ETC DATE: SIGN: Prpsing Manager Dcument Ref D78_05_01 Mdel Change cntrl SOP Page 5 f 5

6 Recrd Of Change Cntrl Part 2. Recrd f Cnsultatin With Other Managers REF NUMBER SECTIONS AREAS OF LAB AFFECTED BY CHANGE LIST SECTIONS/ DEPTS TO BE NOTIFIED OF PROPOSED CHANGE SECTION/DEPT DATE ISSUED DATE RETURNED RECEIVED BY/SIGN Cnsultatin Cmpleted DATE SIGN Dcument Ref D78_05_01 Mdel Change cntrl SOP Page 6 f 6

7 Recrd Of Change Cntrl Part 3. Cmments Frm Other Managers REFERENCE NUMBER THIS FORM IS USED BY OTHER MANAGERS TO ADVISE OF COMMENTS ON IMPACT OF CHANGE AND SUITABILITY FOR LOCAL IMPLEMENTATION AREA TITLE/DEPT AREA HEAD/LINE MANAGER SUMMARY OF CHANGE IMPACT COMMENTS: I APPROVE/DISAPPROVE/REQUIRE MORE INFO (delete as apprpriate) Signed Date Please return t Dcument Ref D78_05_01 Mdel Change cntrl SOP Page 7 f 7

8 Recrd Of Change Cntrl Part 4. SUMMARY OF QA ASSESSMENT REFERENCE NUMBER ASSESSMENT OF DOCUMENTATION REQUIREMENTS DETAILS OF DOCUMENTATION SATISFACTORY YES/NO SIGNED QUALITY MANAGER DATE DETAILS OF ANy FURTHER ACTION REQUIRED SIGNED QUALITY MANAGER DATE Dcument Ref D78_05_01 Mdel Change cntrl SOP Page 8 f 8

9 Recrd Of Change Cntrl Part 5. FINAL APPROVAL REFERENCE NUMBER Agreed Implementatin Date: INITIATING MANAGER SIGNATURE/ DATE COMMENTS OTHER MANAGERS(SPECIFY) QA MANAGER Dcument Ref D78_05_01 Mdel Change cntrl SOP Page 9 f 9