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Quality, ISO 9002 and haemapheresis service
Transfusion Science 20 (1999) 49±52
Quality, ISO 9002 and haemapheresis service M. Chassaigne *, I. Desbois, B. Herault, P. Gaschard Etablissement de Transfusion, Sanguine Berry-Touraine, Tours, France Received 11 September 1998; accepted 1 November 1998
Abstract Hemotherapy in developed countries is safer than ever but the present perception of society seems dierent than in the past. As Isbister wrote, during recent years, as blood safety has been progressively improved, the legal risks have been increasing. The ®rst task is to study and de®ne the risks for each activity. For me the management of risks may be achieved through the management of quality. The con®dence of society in blood transfusion can probably best be obtained through a kind of recognised external quality assurance. I intend to describe our targets, our diculties and the factors that have made our certi®cation a success. I shall focus on several points: · · · ·
what quality represents; what our haemapheresis service is; what ISO 9002 standards are and why we choose them; our diculties and the factors of success. Ó 1999 Published by Elsevier Science Ltd. All rights reserved.
1. What quality represents Hemotherapy is like a long chain with many links from the promotion of donation up to the recipient. The quality of the system rests on the level of quality of the weakest link. It is important that all the system's processes are of the highest and most homogenous level of quality. ``Quality can be de®ned as the aptitude of a service or a product to meet continually the purchaser's stated or implied needs'' For WHO, quality means ``to deliver to each patient all the diagnostic and therapeutic acts
*
Corresponding author.
which can assure the best results in term of health according to the actual state of medical science, at the best cost for a same result, at the lower iatrogenic risks and for his or her satisfaction in term of processes, results, and human feelings inside the care system''. In most ESFH member countries, regulations and standards of good practice are published by governmental or non governmental organisations, and followed by transfusion sta. Quality assurance de®nes the steps and actions required for the assessment of the level of quality of a given product or service, in accordance with established standards of quality. For quality assurance to be eective, continual evaluation of all factors in¯uencing product or service design and delivery is required. Con®dence in the product or service is promoted through the open communication of information so gathered.
0955-3886/99/$ ± see front matter Ó 1999 Published by Elsevier Science Ltd. All rights reserved. PII: S 0 9 5 5 - 3 8 8 6 ( 9 8 ) 0 0 0 9 1 - 5
50
M. Chassaigne et al. / Transfusion Science 20 (1999) 49±52
Quality management is the overall management function that determines and implements quality policy. Total quality management concerns the whole process, from the promotion of donation through to a successful therapy for the patient. Achieving desired quality requires co-operation, co-ordination, collaboration, and overall communication. For this we aimed to: 1. Place a person in charge who is enthusiastic, and who understands that he or she has to constantly encourage all the sta to maintain quality, 2. Take into account all the quality assessment variables, and their application and management in the whole organisation, to satisfy everyone who uses the product and assure them of the quality of the product and/or of the service. The target is to write what you want to do, to do what is written and to prove you do it 3. Improve collective competency through the creation of space for discussion and creativity, by: establishing written procedures; documenting non-conformity or anomalies and their causes; performing internal audits to allow everybody to take part in the system; to describe what is done without fear of denouncement or culpability. 4. Describe and use indicators increasingly appropriate to the purpose. This will provide the manager with better knowledge of the organisation and thus enable him or her to better manage the enterprise. 2. What is our haemapheresis department This department is part of our blood center. As it is involved with nearly all the other services of the center, it has therefore been involved in certi®cation. It has two separate parts: · the ®rst, for donors, comprises plateletpheresis and plasmapheresis services; · the second, for patients, comprises services such as stem cell collection, plasma or cell exchange, and hemodilution.
These two parts are separate but both are certi®ed. Both have links with other services, so quality procedures are necessary not only for routine or emergency speci®c activities, but also for all the interfaces with other departments. 3. Why ISO 9000 standards? We choose ISO 9002 because we think that conformance to speci®ed requirements can be achieved throughout the haemapheresis process. ISO 9000 standards exist and represent a good methodology for quality assurance. They are international standards. External audit by a special institution (AFAQ) is necessary for certi®cation. This certi®cation is independent of the transfusion system used, granting wider recognition and applicability. These standards are complementary to GMP, accreditation or agreement. 4. Principles of quality implementation: the clauses of ISO 9002 standards Clause 1: Management responsibility. Overall management responsibility is de®ned in terms of policy and organisation. The top manager has to identify the requirements and de®ne the organisation, allocation of resources, and activities such as planning and evaluation. The person chosen to be responsible for quality needs freedom and authority. The quality system has to be reviewed at appropriate intervals by the management and records must be maintained in order to check that this reality meets the objectives. Clause 2: Quality system. A quality manual describes both the organisation and the means by which it achieves quality. For instance, our quality manual contains: · a general overview of the blood center (physical layout, organisation charts) · a description of the activities · the clauses of ISO 9002 standards · a list of procedures involved in the manual This manual can be shown or given to anybody who wants it; it is a way of ensuring transparency of action.
M. Chassaigne et al. / Transfusion Science 20 (1999) 49±52
Clause 3: Contract review. The requirements for contractors (with respect to physicians, patients, fractionating department. . .) are de®ned for the service and the product whether sold or provided free. The aim is that supply should meet expected needs. Clause 4: Conception. This does not apply. Clause 5: Document control. The person responsible for quality has to describe: · how procedure documents are written, approved and issued, · how they are made available for everybody who needs them, · how they are changed and how obsolete ones are removed. Clause 6: Purchasing. Assessment and selection of sub-contractors have to be described. Purchasing data have to describe clearly the product or service wanted and veri®cation. Clause 7: Purchaser's supplied products. We did not consider it to be applicable, because all the requirements are included in the processes. Clause 8: Identi®cation and traceability. Identi®cation and traceability have to be clearly performed and shown at all stages, from the collection of blood up to treatment of the patient. Although it is dicult for most industries to achieve this, it was, for us, an easy clause to ful®l. Clause 9: Process control. Procedures, for both routine and emergency situations, must be identi®ed for each process playing a role in the ®nal quality. That is to say: · procedures shall be written and approved, · equipment and space have to be appropriate, · conformity to requirements proved, · maintenance procedures described and performed. Clause 10: Inspection and testing. In order to show that criteria are met, for every step (reception, in process, ®nal. . .) procedures shall be identi®ed and kept current. It must be shown that only products meeting requirements at every stage are distributed, so records must be kept and shown if needed.
51
Clause 11: Inspection, status of equipment control. This clause describes the assessment of measuring equipment linked to quality. Clause 12: Inspection and test control. Controls must be identi®ed by using markers; records identify the inspection authority responsible for the release of conforming products. Clause 13: Control of non-conforming products. Procedures indicating the conformity or non-conformity of the product in relation to controls must be followed according to the quality manual. It has to be shown that non-conformiting products are either: · reworked, · accepted, · regarded, · or rejected, but never distributed if not accepted. Clause 14: Corrective and preventive actions. Documented and maintained procedures must be established to investigate the cause of non-conforming products, and any corrective action. The target is to de®ne and apply actions to eliminate potential risks. Clause 15: Handling, storage, packaging and delivery. Procedures must be established, documented and maintained. Clause 16: Quality records. Quality records must be identi®ed, collected, indexed, ®led, stored and maintained in order to demonstrate achievement of the required quality. Clause 17: Internal quality audits. Internal audits must be carried out in order to verify whether quality activities comply with planned arrangements. Clause 18: Training. Training is directed towards quality and speci®c techniques. It must be evaluated. Clause 19: Associated services. We did not consider it to be applicable, because we include them in processes. Clause 20: Statistical techniques. Appropriate analyses may need to be performed, for example for follow up of indicators. Recently (September) AABB published the main points for implementation of quality, they cover the same clauses but the content is divided dierently.
52
M. Chassaigne et al. / Transfusion Science 20 (1999) 49±52
5. Factors for success From our experience the main factors for success are: · Firstly, management involvement: It is necessary that this takes into account several points, which for us seem essential: · delegate to the manager responsibility for quality, with precise tasks and resources (means, secretary. . .), · precise de®nition of the limits of certi®cation, · choice of an external consultant competent in ISO 9000 standards, this seems important because he or she can explain the necessity of some actions, and make the acceptance of decisions easier. · true co-operation between the people responsible for each activity, · training all personnel, · step by step follow up, · choice of quality indicators. · Secondly, training and communication: In order to develop co-operation, co-ordination, collaboration, communication. · Thirdly: Respect for the schedule is also of great importance to sta. 6. Diculties Of course quite a lot of diculties have occurred during the 18 months we have been or-
ganising our certi®cation. They can be summarised as follows: · problems concerning motivation and communication, · how to ®nd the time for training and auditing; training is essential for motivating personnel to understand what the quality project is, · how to bear direct and indirect costs (such as training and auditing), · how to determine and follow the right indicators; several kinds of indicators can be used but not all are direct quality indicators, · and for us, one of the major diculties was how to adapt quality standards for the storage area
7. Conclusion In this overview, I have tried to explain that quality program implementation is both easy and dicult to perform: · easy, because I expect every transfusionist can comply without changing many of his/her operations, · dicult because it is necessary to think in terms of proof, recording and assessment. It needs great commitment from top management to be successful.
Quality, ISO 9002 and haemapheresis service M. Chassaigne *, I. Desbois, B. Herault, P. Gaschard Etablissement de Transfusion, Sanguine Berry-Touraine, Tours, France Received 11 September 1998; accepted 1 November 1998
Abstract Hemotherapy in developed countries is safer than ever but the present perception of society seems dierent than in the past. As Isbister wrote, during recent years, as blood safety has been progressively improved, the legal risks have been increasing. The ®rst task is to study and de®ne the risks for each activity. For me the management of risks may be achieved through the management of quality. The con®dence of society in blood transfusion can probably best be obtained through a kind of recognised external quality assurance. I intend to describe our targets, our diculties and the factors that have made our certi®cation a success. I shall focus on several points: · · · ·
what quality represents; what our haemapheresis service is; what ISO 9002 standards are and why we choose them; our diculties and the factors of success. Ó 1999 Published by Elsevier Science Ltd. All rights reserved.
1. What quality represents Hemotherapy is like a long chain with many links from the promotion of donation up to the recipient. The quality of the system rests on the level of quality of the weakest link. It is important that all the system's processes are of the highest and most homogenous level of quality. ``Quality can be de®ned as the aptitude of a service or a product to meet continually the purchaser's stated or implied needs'' For WHO, quality means ``to deliver to each patient all the diagnostic and therapeutic acts
*
Corresponding author.
which can assure the best results in term of health according to the actual state of medical science, at the best cost for a same result, at the lower iatrogenic risks and for his or her satisfaction in term of processes, results, and human feelings inside the care system''. In most ESFH member countries, regulations and standards of good practice are published by governmental or non governmental organisations, and followed by transfusion sta. Quality assurance de®nes the steps and actions required for the assessment of the level of quality of a given product or service, in accordance with established standards of quality. For quality assurance to be eective, continual evaluation of all factors in¯uencing product or service design and delivery is required. Con®dence in the product or service is promoted through the open communication of information so gathered.
0955-3886/99/$ ± see front matter Ó 1999 Published by Elsevier Science Ltd. All rights reserved. PII: S 0 9 5 5 - 3 8 8 6 ( 9 8 ) 0 0 0 9 1 - 5
50
M. Chassaigne et al. / Transfusion Science 20 (1999) 49±52
Quality management is the overall management function that determines and implements quality policy. Total quality management concerns the whole process, from the promotion of donation through to a successful therapy for the patient. Achieving desired quality requires co-operation, co-ordination, collaboration, and overall communication. For this we aimed to: 1. Place a person in charge who is enthusiastic, and who understands that he or she has to constantly encourage all the sta to maintain quality, 2. Take into account all the quality assessment variables, and their application and management in the whole organisation, to satisfy everyone who uses the product and assure them of the quality of the product and/or of the service. The target is to write what you want to do, to do what is written and to prove you do it 3. Improve collective competency through the creation of space for discussion and creativity, by: establishing written procedures; documenting non-conformity or anomalies and their causes; performing internal audits to allow everybody to take part in the system; to describe what is done without fear of denouncement or culpability. 4. Describe and use indicators increasingly appropriate to the purpose. This will provide the manager with better knowledge of the organisation and thus enable him or her to better manage the enterprise. 2. What is our haemapheresis department This department is part of our blood center. As it is involved with nearly all the other services of the center, it has therefore been involved in certi®cation. It has two separate parts: · the ®rst, for donors, comprises plateletpheresis and plasmapheresis services; · the second, for patients, comprises services such as stem cell collection, plasma or cell exchange, and hemodilution.
These two parts are separate but both are certi®ed. Both have links with other services, so quality procedures are necessary not only for routine or emergency speci®c activities, but also for all the interfaces with other departments. 3. Why ISO 9000 standards? We choose ISO 9002 because we think that conformance to speci®ed requirements can be achieved throughout the haemapheresis process. ISO 9000 standards exist and represent a good methodology for quality assurance. They are international standards. External audit by a special institution (AFAQ) is necessary for certi®cation. This certi®cation is independent of the transfusion system used, granting wider recognition and applicability. These standards are complementary to GMP, accreditation or agreement. 4. Principles of quality implementation: the clauses of ISO 9002 standards Clause 1: Management responsibility. Overall management responsibility is de®ned in terms of policy and organisation. The top manager has to identify the requirements and de®ne the organisation, allocation of resources, and activities such as planning and evaluation. The person chosen to be responsible for quality needs freedom and authority. The quality system has to be reviewed at appropriate intervals by the management and records must be maintained in order to check that this reality meets the objectives. Clause 2: Quality system. A quality manual describes both the organisation and the means by which it achieves quality. For instance, our quality manual contains: · a general overview of the blood center (physical layout, organisation charts) · a description of the activities · the clauses of ISO 9002 standards · a list of procedures involved in the manual This manual can be shown or given to anybody who wants it; it is a way of ensuring transparency of action.
M. Chassaigne et al. / Transfusion Science 20 (1999) 49±52
Clause 3: Contract review. The requirements for contractors (with respect to physicians, patients, fractionating department. . .) are de®ned for the service and the product whether sold or provided free. The aim is that supply should meet expected needs. Clause 4: Conception. This does not apply. Clause 5: Document control. The person responsible for quality has to describe: · how procedure documents are written, approved and issued, · how they are made available for everybody who needs them, · how they are changed and how obsolete ones are removed. Clause 6: Purchasing. Assessment and selection of sub-contractors have to be described. Purchasing data have to describe clearly the product or service wanted and veri®cation. Clause 7: Purchaser's supplied products. We did not consider it to be applicable, because all the requirements are included in the processes. Clause 8: Identi®cation and traceability. Identi®cation and traceability have to be clearly performed and shown at all stages, from the collection of blood up to treatment of the patient. Although it is dicult for most industries to achieve this, it was, for us, an easy clause to ful®l. Clause 9: Process control. Procedures, for both routine and emergency situations, must be identi®ed for each process playing a role in the ®nal quality. That is to say: · procedures shall be written and approved, · equipment and space have to be appropriate, · conformity to requirements proved, · maintenance procedures described and performed. Clause 10: Inspection and testing. In order to show that criteria are met, for every step (reception, in process, ®nal. . .) procedures shall be identi®ed and kept current. It must be shown that only products meeting requirements at every stage are distributed, so records must be kept and shown if needed.
51
Clause 11: Inspection, status of equipment control. This clause describes the assessment of measuring equipment linked to quality. Clause 12: Inspection and test control. Controls must be identi®ed by using markers; records identify the inspection authority responsible for the release of conforming products. Clause 13: Control of non-conforming products. Procedures indicating the conformity or non-conformity of the product in relation to controls must be followed according to the quality manual. It has to be shown that non-conformiting products are either: · reworked, · accepted, · regarded, · or rejected, but never distributed if not accepted. Clause 14: Corrective and preventive actions. Documented and maintained procedures must be established to investigate the cause of non-conforming products, and any corrective action. The target is to de®ne and apply actions to eliminate potential risks. Clause 15: Handling, storage, packaging and delivery. Procedures must be established, documented and maintained. Clause 16: Quality records. Quality records must be identi®ed, collected, indexed, ®led, stored and maintained in order to demonstrate achievement of the required quality. Clause 17: Internal quality audits. Internal audits must be carried out in order to verify whether quality activities comply with planned arrangements. Clause 18: Training. Training is directed towards quality and speci®c techniques. It must be evaluated. Clause 19: Associated services. We did not consider it to be applicable, because we include them in processes. Clause 20: Statistical techniques. Appropriate analyses may need to be performed, for example for follow up of indicators. Recently (September) AABB published the main points for implementation of quality, they cover the same clauses but the content is divided dierently.
52
M. Chassaigne et al. / Transfusion Science 20 (1999) 49±52
5. Factors for success From our experience the main factors for success are: · Firstly, management involvement: It is necessary that this takes into account several points, which for us seem essential: · delegate to the manager responsibility for quality, with precise tasks and resources (means, secretary. . .), · precise de®nition of the limits of certi®cation, · choice of an external consultant competent in ISO 9000 standards, this seems important because he or she can explain the necessity of some actions, and make the acceptance of decisions easier. · true co-operation between the people responsible for each activity, · training all personnel, · step by step follow up, · choice of quality indicators. · Secondly, training and communication: In order to develop co-operation, co-ordination, collaboration, communication. · Thirdly: Respect for the schedule is also of great importance to sta. 6. Diculties Of course quite a lot of diculties have occurred during the 18 months we have been or-
ganising our certi®cation. They can be summarised as follows: · problems concerning motivation and communication, · how to ®nd the time for training and auditing; training is essential for motivating personnel to understand what the quality project is, · how to bear direct and indirect costs (such as training and auditing), · how to determine and follow the right indicators; several kinds of indicators can be used but not all are direct quality indicators, · and for us, one of the major diculties was how to adapt quality standards for the storage area
7. Conclusion In this overview, I have tried to explain that quality program implementation is both easy and dicult to perform: · easy, because I expect every transfusionist can comply without changing many of his/her operations, · dicult because it is necessary to think in terms of proof, recording and assessment. It needs great commitment from top management to be successful.