Role of the Quality Assurance Officer

Role of the Quality Assurance Manager• Use the word Manager, why?• Have you a job description?• Who are you reporting to?Tissue, March 2007 1

Role of the Quality Assurance ManagerThe role must be:-• Documented• Understood• Agreed• Reviewed periodicallyJobDescriptionTissue, March 2007 2

Role of the Quality Assurance Manager• Quality control/ quality assurance• Responsible person, Article 17(2004/23/EC)• Independence of roleTissue, March 2007 3

Role of the Quality Assurance ManagerEnsuring role is effective:-• Included in the Management Team• Position is clear in the organisational chart• Involved in the strategic and planningprocess• Structure in place for Management Teammeetings.Tissue, March 2007 4

Role of the Quality Assurance ManagerEnsuring role is effective:-• Role must be proactive rather than reactive• Direct reporting relationships must bepracticable (i.e. availability)• Review processes must include the QualityAssurance Manager• Change management and communicationssystemsTissue, March 2007 5

Role of the Quality Assurance ManagerEnsuring role is effective:-• Where the tissue establishment is only part ofthe overall process (Hospital setting), it isimportant to identify and document:-- Shared personnel- Shared facilities- Shared materials- Shared equipment- Shared methodologiesTissue, March 2007 6

Role of the Quality Assurance ManagerGroup Workshop ExerciseDraw up a job description for the QualityAssurance Manager in a:-• Fertility Clinic• Peripheral Stem Cell FacilityUsing articles 17 of the Directive 2004/23/ECas a reference document.Tissue, March 2007 7

Template 1 Job Description Tissue March 07Job DescriptionTITLE:REPORTING TO:Quality Assurance Manager (Responsible Person)Clinical DirectorAim:The fundamental philosophy guiding this position is that the Post Holder will take any andall measures that will ensure that the Tissues and Cells are Donated, Procured, Tested,Processed, Preserved, Stored and Distributed in accordance with the requirements ofDirective 2004/23/EC and Best Practice so as to ensure Quality and Safety.Section 1Duties and ResponsibilitiesUnder the direction and control of the Clinical Director, the Quality Assurance Managerwill be responsible for the following:1. To manage the activities of the Quality Assurance Function in the TissueEstablishment so as to ensure Tissues and Cells are Donated, Procured, Tested,Processed, Preserved, Stored and Distributed in accordance with the requirements ofDirective 2004/23/EC.2. Liaise directly with the Irish Medicines Board (IMB) as it applies to:-Regulatory Audits (Pre and Post)-Provision of information following major change to Personnel or Processes-The submission of the annual Report ( Tissue and Cells reconciliation report)-Reporting of Serious Adverse Events and Reactions3. In consultation with all staff to lead the development, implementation and review ofthe Quality Management System to ensure Regulatory requirements are met and bestpractice is achieved.4. To participate in training a team of skilled staff and to promote healthy workingrelationships within the organisation.1

Template 1 Job Description Tissue March 075. To actively participate in and promote continuing education activities consistent withthe position.6. To perform any other functions which may be assigned by the Clinical Director7. Management of the controlled documentation and change control activities.8. Writing, revision and review of Quality Management and Batch ReleaseProcedures.9. Management/ performance of the Internal Quality Audit Programme.10. Management of training traceable to the Training Plan.11. Setting up and maintaining an Asset Register.12. Management of Validation Programmes for critical Equipment and Processes.13. Management of Maintenance/Calibration Programmes for equipment and utilitiesincluding Service Contracts.14. Management and review non-conforming events including product recalls, customercomplaints and internal non-conforming events.15. Management of archived documentation/specimens/samples.16. Chairperson of Monthly Quality Assurance meetings and Annual QualityManagement Review Meetings and providing reports as required to the Clinical Director.17. Perform induction training of new staff (Quality Management Training)18. To develop a system of risk assessment for the clinical areas.2

Template 1 Job Description Tissue March 0719. Implementing a system for the Documentation, Review and Reporting of AdverseEvents and Reactions.20. Implement a procedure for the rapid recall of Tissue and Cells from Distribution.21. Setting up of Service Level Agreements with Third parties for Services that arerelevant to the Authorization processManagerial Responsibilities• To actively participate in formulation of policies, clinical guidelines, operationalpolicy / procedures and the sharing of information.• To investigate customer complaints and provide a timely response in accordancewith defined procedures.• To ensure that annual leave and study leave of all Quality Assurance staff areeffectively scheduled to ensure the availability of cover at all times.• To ensure cost effective use of all Quality Assurance staff and resources.Human Resource Management• Staff attendances are optimised in relation to work schedules.• All annual, examination, parental and other leave is scheduled and recorded.• Tissue Establishment HR policies are complied with.• Tissue Establishment Health and Safety Regulations are complied with.• Staff review and development is carried out for all staff.• Participate as appropriate in the recruitment and selection process of staff.• Implement and foster a high level of moral amongst staff by effective motivationand communication.Section 2ConfidentialityIn the course of your employment you may have access to or hear information concerningthe medical or personal affairs of patients / staff, or other health service business. Suchrecords and information are strictly confidential and unless acting on the instruction of anauthorised officer, on no account must personal information concerning staff, patients or3

Template 1 Job Description Tissue March 07other Tissue Establishment business be divulged or discussed except in the performanceof normal duty. In addition records must never be left in such a manner that unauthorisedpersons can obtain access to them and must be kept in safe custody when no longerrequired.Section 3.Professional RequirementsEmployees are required to submit all educational credentials including certificates /diplomas /degrees etc., which are pertinent to their employment.Signed:__________________________Quality Assurance ManagerDate: __________________________Signed:__________________________Clinical DirectorDate: __________________________Note: This JOB DESCRIPTION is due for review no later than 2 years from theabove date.Person SpecificationEssential RequirementsDesirable RequirementsEducationExperienceA formal Qualification in the fieldof Medical or Biological Sciences.Article17 2004/23/ECAt least 2 years practicalexperience.Article17 2004/23/ECPersonalCharacteristicsSkills4

Workshop Exercise 1 Job Description Tissue March 07Tissue Establishment Type:Job Description________________________________________TITLE:REPORTING TO:Quality Assurance Manager (Responsible Person)________________________________________Section 1Duties and ResponsibilitiesUnder the direction and control of the________________________, the QualityAssurance Manager will be responsible for the following:1.______________________________________________________________________2.______________________________________________________________________3.______________________________________________________________________4.______________________________________________________________________5.______________________________________________________________________6.______________________________________________________________________7.______________________________________________________________________8.______________________________________________________________________9.______________________________________________________________________10._____________________________________________________________________11._____________________________________________________________________12._____________________________________________________________________13._____________________________________________________________________14._____________________________________________________________________15._____________________________________________________________________16._____________________________________________________________________17._____________________________________________________________________

Workshop Exercise 1 Job Description Tissue March 07Duties and Responsibilities18._____________________________________________________________________19._____________________________________________________________________20._____________________________________________________________________Managerial Responsibilities21._____________________________________________________________________22._____________________________________________________________________23._____________________________________________________________________24._____________________________________________________________________25._____________________________________________________________________Human Resource Management Responsibilities26._____________________________________________________________________27._____________________________________________________________________28._____________________________________________________________________29._____________________________________________________________________30._____________________________________________________________________Additional Comments____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________