Summary of GE Healthcare's Quality Management System (QMS) Covering BioProcess chromatography media, equipment, software, and spare parts

Transcription

1 GE Healthcare Summary of GE Healthcare's Quality Management System (QMS) Covering BioProcess chromatography media, equipment, software, and spare parts

2 Table of content General requirements 3 Documentation requirements 3 Control of documents 3 Control of records 3 Management responsibility 3 Management commitment 3 Customer focus 3 Quality policy 3 Resource management 4 Human resources 4 Infrastructure 4 Work environment 4 Product realization 4 Planning of product realization 4 Customer related processes 4 Design and development 5 Supplier 6 Production and service provision 7 Control of monitoring and measuring devices/equipment AA

3 Summary of GE Healthcare's Quality Management System (QMS) Covering BioProcess chromatography media, equipment, software, and spare parts General requirements GE Healthcare has established, documented, implemented, and maintains the effectiveness of a Quality Management System, with one Quality Manual, in accordance with the appropriate requirements of regulations, standards and directives where GE Healthcare markets and distributes products and services. As an addition, each site has a specific Site Quality Plan providing a cross reference between the Global Quality Manual, the GE Healthcare Global Quality Procedures, the site specific procedures and work instructions, and the appropriate quality standards at the site that together define the site s Quality Management System. Periodic quality audits of GE Healthcare s Quality Management System at each site assure compliance to standards, requirements and guidelines. Documentation requirements Control of documents GE Healthcare has established and maintains a process to control Quality Management System Documents. Control of records GE Healthcare has established and maintains a process to identify appropriate Quality Management System records and provides evidence of conformity to regulatory requirements and company procedures. Management responsibility Management commitment GE Healthcare is committed to a strong Quality Management System that complies with appropriate regulatory requirements and standards. This is achieved by providing an adequate organizational structure and the necessary resources to develop and implement quality planning and objectives. Customer focus Management at GE Healthcare is responsible for confirming that customer requirements are determined and met via Marketing Research methodologies prior to product release and postmarket surveillance methods. Quality policy GE Healthcare has one common Quality Policy across GE Healthcare. This policy has been documented and communicated throughout the organization. The Quality Policy is approved by the President and CEO and the Chief Quality Officer. Quality manual GE Healthcare quality policy provides a global quality roadmap Quality manual QMS procedures Map to regulatory requirements States specific requirements and accountability (interpretation) Business specific requirements technology/market Who, what, when, where Global QMS procedures (interpretation) Business procedures (as required) Work instructions Direct the work of GE Healthcare and ensure compliance to the QMS How Work instructions Fig 1. An illustration of GE Healthcare's quality management system documentation hierarchy AA 3

4 Resource management Human resources GE Healthcare confirms that personnel performing work directly or indirectly affecting product quality are competent on the basis of appropriate education, training, skills, and experience. Training requirements and results are documented. Infrastructure GE Healthcare has determined, provides, and maintains the infrastructure needed to achieve conformity to product and Quality Management System requirements while complaining with applicable global standards and national standards for each country. Work environment GE Healthcare manages the work environment needed to achieve conformity to product and Quality Management System requirements. Procedures are required to address: The health, cleanliness, and clothing of personnel Control or minimize contaminants that have the potential to adversely affect product quality (such as dust, humidity, and insects) Contaminated or potentially contaminated product control to prevent contamination of other product, the work environment or personnel Control of the physical environment and other factors such as temperature and humidity Product realization Planning of product realization GE Healthcare has established and maintains a process and procedures to document the responsibilities for the planning of product realization and identification of assigned resources. The product realization procedures determine the following: Quality objectives and requirements for the product Needed processes, documents, and resources specific to the product Required specifications, verification, validation, monitoring, measurement, inspection, and test activities specific to the product Criteria for product acceptance Records needed to provide evidence that the realization processes and resulting product meet requirements Customer related processes Determination of requirements related to the product GE Healthcare determines: Requirements specified by the customer, including the requirements for delivery and post-delivery activities Statutory and regulatory requirements related to the product Any additional requirements considered necessary by GE Healthcare Review of requirements related to the product GE Healthcare establishes and maintains processes that define responsibility for accurately reviewing the requirements related to the product. This review is conducted prior to a GE Healthcare commitment to supply a product to the customer. The controls include a process to evaluate and confirm the following: Product requirements are defined and documented Contract or order requirements differing from those previously expressed are resolved GE Healthcare has the ability to meet those requirements The results and actions arising from the review are documented and maintained. Customer communication GE Healthcare has established and maintains processes used to communicate with customers. These processes address: Product information Inquiries, contracts, order handling, including amendments Customer feedback, including appropriate handling, reporting and investigation of customer complaints Advisory notices (where applicable) Definition of responsibilities for communication with customers and regulators AA

5 Design and development Design planning GE Healthcare has established and maintains processes and procedures for the design and development planning for products. Design and Development Plans include: Identification of responsibilities and authority for design and development Identification of design and development stages and handoffs Management of interfaces between different groups involved in the design and development process to ensure effective communication and assignment of responsibility Formal design review of design inputs, design verification, design transfer and validation, prior to the product release Design plans are documented, approved and updated as appropriate throughout the design process to reflect the status of the design and development effort. Design inputs GE Healthcare has established and maintains a process and procedures for the development of appropriate product design input requirements to address the intended use(s) of the device, including the needs of the user and patient. Design Inputs include: Product s functional, performance and safety requirements Intended use and user needs (product usability) Applicable statutory and regulatory requirements Information derived from previous similar designs where applicable Other requirements essential for design, development, purchasing, manufacturing, installation and service Output(s) of risk management GE Healthcare Design Input procedures require that design inputs requirements must be adequate, verifiable, complete, unambiguous, and not in conflict with each other. Design Inputs are reviewed for adequacy, approved, and maintained per established procedures. Design outputs GE Healthcare has established processes and procedures to ensure design outputs are documented in terms that provides for verification against the design inputs requirements. Design Outputs are verified and are approved prior to release. Design Outputs shall: Be verified for conformance to design input requirements Include or reference acceptance criteria Identify characteristics of the product that are essential for its safe and proper use Provide Information for purchasing, production, installation and the provision of service The final design output is the verified and validated finished device, including labelling, packaging, and the Device Master Record which includes specification for purchasing materials, manufacturing procedures, assembly drawings, software code, acceptance criteria, test procedures, service and installation manuals, and operator instructions. Design review GE Healthcare has established and maintains process and procedures that define the appropriate stages for systematic reviews of the design. Design Reviews are planned and performed at appropriate stages and documented. Design Reviews include: An evaluation of the design outputs to meet design inputs requirements Identification of potential problems and proposed necessary actions Reviewers include representatives of functions concerned with the design stage(s) being reviewed as well as identified independent reviewer not directly responsible for the product design. Records are maintained of the results of the reviews and any necessary actions. Design verification GE Healthcare has established and maintains Design Verification processes and procedures which demonstrate through provision of objective evidence that the design output meets the design input requirements. Design Verification activities are performed by qualified personnel. Records of Design Verification and results are documented and maintained per established procedures AA 5

6 Design validation GE Healthcare has established and maintains design validation processes and procedures which ensure that the product meets the user needs and intended uses. Design validations are performed on production or production equivalent units, lots, or batches of the finished device. Design validation is performed under actual or simulated use conditions representative of the environment in which the product will be used. Design Validation is completed prior to the delivery or installation of the product. Design changes GE Healthcare has established and maintains design change processes and procedures that define how changes are proposed, reviewed, approved, and incorporated into a product. Design changes are modifications that may affect requirements, form, fit, function, interchangeability or compatibility of a part or assembly; software/firmware; or require change to the assembly or testing of the final product or its components. Design transfer GE Healthcare has established and maintains design transfer processes and procedures that define how the device design is translated into procedures for production, installation, and service for the product. Design transfer includes activities that are performed on the product to validate the production, installation and service processes. Design transfer activities during the design process ensure that design outputs are verified as suitable for manufacturing before becoming final production specifications. Design records GE Healthcare maintains a Design History File in accordance with approved procedures for each product development program. The Design History File contains records necessary to document that the design was developed in accordance with the approved Integrated Design Plan. Supplier Purchasing process GE Healthcare has established and maintained documented processes to ensure that purchased items or services conform to specified purchase requirements. The type and extent of control applied to the supplier and the purchased item/service are dependent upon the effect of the purchased item/service on subsequent product realization or the final product. GE Healthcare will select and qualify suppliers based on their ability to supply product and services in accordance with the organization s requirements. Criteria for supplier selection, qualification, and ongoing performance monitoring have been established and will be maintained as appropriate. Records of the results of qualification and monitoring and any necessary actions arising from the qualification and monitoring are maintained following approved procedures. Purchasing information GE Healthcare will ensure the adequacy of specified purchase requirements prior to their communication to the supplier. To the extent required for traceability, GE Healthcare maintains relevant purchasing information. Purchasing information describes the product to be purchased, including where appropriate: Requirements, including quality requirements that must be met by suppliers, contractors, and consultants Where possible, evaluation of potential supplies, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as appropriate Requirements for approval of products, procedures, processes, and equipment Where possible, requirements that suppliers, contractors, and consultants notify the appropriate GE Healthcare entity of changes in a product or service, as appropriate Requirements for qualification of personnel Quality Management System requirements Verification of purchased product GE Healthcare has established and maintained approved procedures for the inspection and/or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where GE Healthcare or its customer intends to perform verification at the supplier s premises, GE Healthcare states the intended verification arrangements and method of product release in the purchasing information. Records of the verification are maintained AA

7 Production and service provision Control of production and service provision GE Healthcare has established and maintained processes that address production and service provision under controlled conditions. These include: The availability of information that describes the characteristics of the product The availability of documented procedures, documented requirements, work instructions, and reference materials and reference measurement procedures as necessary to ensure product quality The availability and use of suitable equipment and work environments The availability and use of suitable monitoring and measuring devices/equipment The implementation of suitable monitoring and measuring techniques The implementation of release of product, delivery, and post-delivery activities The implementation of labelling and packaging processes Installation activities GE Healthcare develops, provides, and maintains procedures and documentation required to carry out installation and verification activities. GE Healthcare establishes acceptance criteria for verifying installation of products at the customer site. Records of installation and verification are documented and maintained as applicable, following approved procedures. Identification and traceability Identification GE Healthcare has established and maintains a process to control how products are identified. This includes appropriate identification and, as appropriate, isolation of returned product to prevent it being confused with conforming product. Traceability GE Healthcare has established and maintains a process to define traceability requirements, the extent of traceability within a product, and the records required to account for product. At defined points where traceability is requirement, GE Healthcare provides necessary controls to make the product uniquely traceable and to create and maintain a record of the product. Preservation of product GE Healthcare has established and maintains processes and/or work instructions for preserving the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements This preservation includes identification, handling, packaging, storage, and protection. Preservation also applies to the constituent parts of a product. GE Healthcare has established and maintains procedures or work instructions for the control of product with a limited shelf life or which requires special storage conditions, as applicable. Any special storage conditions are to be controlled and recorded. Control of monitoring and measuring devices/ equipment GE Healthcare determines any monitoring and measurement that is to be undertaken and identifies the monitoring and measuring devices/equipment needed to provide evidence of conformity of product to pre-determined requirements. GE Healthcare has established and maintains processes to confirm that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements in accordance with approved procedures. If and when equipment is found not to conform to requirements, GE Healthcare will assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. GE Healthcare will take appropriate action in regards to the equipment and any product affected. Records of the results of calibration and verification activities will be maintained AA 7

8 GE Healthcare Bio-Sciences AB Björkgatan Uppsala Sweden GE, GE monogram, and BioProcess are trademarks of General Electric Company General Electric Company. First published Dec All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. A copy of these terms and conditions is available on request. Contact your local GE Healthcare representative for the most current information. GE Healthcare UK Ltd., Amersham Place, Little Chalfont, Buckinghamshire, HP7 9NA, UK GE Healthcare Europe GmbH, Munzinger Strasse 5, D Freiburg, Germany GE Healthcare Bio-Sciences Corp., 100 Results Way, Marlborough, MA 01752, USA GE Healthcare Dharmacon Inc., 2650 Crescent Dr, Lafayette, CO 80026, USA HyClone Laboratories Inc., 925 W 1800 S, Logan, UT 84321, USA GE Healthcare Japan Corp., Sanken Bldg., , Hyakunincho Shinjuku-ku, Tokyo , Japan For local office contact information, visit AA 12/2015