1. The purpose of the EBME Department is to provide the hospital, clinics and similar departments with a professional and efficient repair and maintenance service on a range of biomedical and associated equipment. When appropriate, the department Manager will offer a consultancy service and advise in the procurement of hospital biomedical and associated equipment.
2. The Department Manager runs a team of qualified and competent technologists. The Department also ensures that sub contracted departments which maintain, repair and service biomedical equipment carry out the operations in a timely, efficient and responsible manner
A wide range of associated workshop and test equipment is used to provide this service. The Department Manager also maintains a "library" of equipment that can be borrowed on a loan basis.
3. In fulfilling the quality management requirements, three separate Quality manuals have been prepared:
- A POLICY Manual
- A PROCEDURES Manual
- WORK INSTRUCTIONS
This document is the POLICY Manual and is available for inspection by any interested third party.
The following parts of this document are broken down into these quality management areas:
4.0 GUIDE TO QUALITY MANAGEMENT SYSTEM
4.1 General Requirements
4.2 Documentation Requirements
5.0 MANAGEMENT RESPONSIBILITY
5.1 MANAGEMENT COMMITMENT
5.2 CUSTOMER FOCUS
5.3 QUALITY POLICY
5.5 RESPONSIBILITY AUTHORITY AND COMMUNICATION
5.6 MANAGEMENT REVIEW
6.0 RESOURCE MANAGEMENT
6.1 PROVISION OF RESOURCES
6.2 HUMAN RESOURCES
6.4 WORK ENVIRONMENT
7.0 SERVICE REALISATION
7.1 PLANNING OF SERVICE REALISATION
7.2 CUSTOMER-RELATED PROCESSES
7.3 DESIGN AND DEVELOPMENT
7.5 PRODUCTION AND SERVICE PROVISION
7.6 CONTROL OF MONITORING AND MEASURING DEVICES
8 0 MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.2 MONITORING AND MEASUREMENT
8.3 CONTROL OF NONCONFORMING SERVICE
8.4 ANALYSIS OF DATA
4. GUIDE TO QUALITY MANAGEMENT SYSTEMS
4.1 GENERALThe processes, sequence and interaction plus any resources needed to efficiently run the EBME Department are described throughout this manual. By monitoring, measuring and analysing, controls are in operation throughout the system to ensure that satisfactory performance is achieved. These are directed towards continual improvement.
4.2 DOCUMENTATION4.2.1. General
A statement of Policy is included in this manual that will be made known to all personnel in the department. Any sub contractors will also be made aware of the Policy statement. The long-term objectives of the department are produced and will be reviewed and updated as the need arises. A list of procedures to supplement this manual is documented. The associated documents are recorded in the associated procedure. Appropriate records are maintained.
4.2.2 Quality Manual.The scope of this Quality System is designed to meet the objectives specified to meet the contractual requirements of the Department in providing a reliable, economical and efficient biomedical engineering service and to ensure that the Policy Statement of this manual is implemented at all levels within the department. It is also designed to ensure that the procedures, processes, and quality planning, of which this Quality Manual forms an integral part, meets the requirements of the QMS for customer.
The Quality ManualThe Quality Manual has been designed in three parts, the Policy Manual and the Processes and Procedures Manual supplemented by any appropriate Work Instructions. The Quality Manual specifies the system and procedures by which the Quality policy and objectives are met. It forms the major part of Quality planning in that all operations within the Department that affect Quality have procedures. It is intended to serve as a guide and also as a basic reference. It will be amended and developed as the need arises.
Distribution of the Quality ManualAlthough all employees are responsible to a greater or lesser extent for Quality it is not necessary to provide everybody in the Department with a copy of the Quality Manual. It is the responsibility of the Quality Assurance Manager to ensure that employees, including sub contractors are familiar with those parts of the manual for which they have responsibility.
Amendments to Quality Manual/DocumentsLists and Master copies of all Quality related documents, including the current revision list are held by the Quality Assurance Manager. All Quality related documents are numbered. The Department Manager is responsible for the authorization, issue, approval, review, layout and presentation of all data, forms and documents plus the safe custody of manufacturer's literature and appropriate Standards. Changes and updates to any document or form will only be accepted by the nominated person responsible for the document. This must be agreed and authorized by the Department Manager. When changes are made all obsolete documents are destroyed. (Unless marked and retained for legal reasons). Quality documents are located in the area where they are used and must be legible.
Changes to Manual and subsequent re-issue are properly controlled.Changes to the manual will only be made by the Quality Assurance Manager. If the changes involve working practices or improvements in the Quality System, the changed section will have its revision number updated. New issues of the Manual will only take place when a major change in the operation of the Department warrants it.
As only one manual (The Master) has been produced, all CONTROLLED documentation will be produced on GREEN paper with headers and footers appearing in RED and normal print in BLACK. All revision changes will be recorded on the Amendment Sheet at the front of the manual.
Any formal drawings are listed, indexed and numbered. Data is backed up regularly, and backed up disks are taken off site for safety. All disks are listed and indexed. The overall responsibility for Document, Drawing and Data control and the maintenance of Quality Records rests with the Quality Assurance Manager.
4.2.3 Control of documentsA procedure has been written to govern the control exercised over the maintenance of Documents and Data. This procedure covers the issue and update of controlled documents that are listed and registered. Master copies of controlled documents are held by the Quality Assurance Manager who will also be responsible for maintaining the register of controlled documents.
All documents affecting Quality will be identified by a unique number and the revision status documented. Controlled documents will be issued and approved by the Quality Assurance Manager and any changes made will also reviewed and be carried out in a controlled manner. The Quality Assurance Manager will also maintain a register of Quality related external documents (e.g. Tenders, PPMs, Acceptance tests, PPQ forms, contracts etc.).
It is the responsibility of the Quality Assurance Manager to maintain, not only an up to date copies of relevant BSI Standards, but also a register of all legal and health authority standards, plus the safe custody and update of external documents relating to Quality. Handwritten documents will be legible. It is the responsibility of the Quality Assurance Manager to ensure that Quality procedures are issued and controlled at all times.
The Quality Assurance Manager will establish, document and maintain procedures to ensure that Quality records are indexed, filed, identified, maintained, protected, collected and properly stored. A list is retained of all Quality Records, together with their retention times. Documentation which is considered to be outside the scope of the Standard and which are not Quality records will be listed.
- Undertake periodic analysis of Quality performance.
- Provide evidence of verification actions during all stages of the Department's operation.
- Refer to historical data for Quality procedures and performance.
- Dispose of Records in an organised manner
Quality related data will be backed up regularly as a controlled operation. Disks will be labelled. Whether in hard copy or electronic form, Quality records will be legible and retained for a minimum of 7 years unless a longer or shorter period is required by particular contract or Authority. The Department Manager is responsible for ensuring that computer data records are backed up and appropriately labelled and safeguarded.
It is the responsibility of the Quality Assurance Manager to ensure that Quality records are maintained.
5.1 RESPONSIBILITY, AUTHORITY & COMMUNICATION
Authorised Senior Manager
The Authorised Senior Manager is ultimately responsible for ensuring that the Quality System associated with the EBME Department functions correctly and is committed to ensuring that customer requirements are met and hence for the implementation and maintenance of the Quality policy and the continued implementation of the QMS. He ensures that manpower and resources are made available to satisfactorily meet the requirements of the Quality Standard. He is responsible for the smooth running and operation of the Department.
5.2 CUSTOMER FOCUS
He is responsible for ensuring that the Quality System is reviewed at regular intervals.
He will set annual objectives for the EBME Manager which will include reference to customer focus ensuring that requirements are not only determined but met, thus maintaining customer satisfaction.
5.3 QUALITY POLICY - STATEMENT OF POLICY
The policy of the EBME Department is to provide a maintenance, repair and consultancy service to all customers that is both professional and maintains the highest standard of workmanship. Hospital, wards and departments, clinics and patients throughout the Hospital are all regarded as our customers together with any external companies or departments under contract. Our objectives are to provide our customers with an efficient, well-organised yet economical EBME Department adopting good workshop practice techniques. Consequently, a system has been adopted which is structured in such a way as to comply with the requirements of Quality Standard ISO 9001 : 2000.
The EBME Manager has full authority and responsibility for the Quality System described in parts 1, 2 and 3 of this manual and for the very highest standards of workmanship. In addition he will initiate all corrective action and are required to represent the Department in all Quality matters. Our aim is on continual improvement.
The maintenance of this standard and total commitment to this policy is communicated to all staff, and an integral part of the role of each member of the department. In addition to implementing this Policy, the Managers and all technologist staff fully support the goals and objectives.
5.4.1 QUALITY RELATED OBJECTIVES
The objectives of EBME Department are to provide a service to the customer that is based on continual measurable improvement in the service provided. Improvement will be measured by sampling customer feedback regularly over three month periods, analysing trends and carrying out appropriate action to maintain improvement.
- Provide objective evidence that services conform to specified requirements.
- Ensure that requirements are determined and satisfied throughout all stages of the workshop process.
- Develop and maintain Quality consciousness amongst management, staff and sub contractors.
5.4.2 Quality Management System planning
Planning the Quality Management system will be carried out to meet the requirements of the Quality Objectives. This manual and the associated processes and procedures will be updated appropriately.
5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION
5.5.1 EBME Manager
The EBME Manager is responsible for the smooth running and operation of the EBME Department. He reports directly to the Authorised Senior Manager in all work related issues. He is also fully responsible for the Quality function within the Department and hence for the implementation and maintenance of the QMS: 2000 within the Department, purchase of stock and spares, ensuring contracts are met and appropriately reviewed and verifying personnel and resources. He is responsible for planning and organising the Quality function with the support of a team of Technologists and clerical staff who carry out the day-to-day running and administration of the department. He will carry out an efficient EBME service to a range of Hospitals, Trusts and Private Sector Customers. He will be responsible for ensuring that all personnel are adequately trained and for ensuring that Good Workshop Practice techniques are implemented.
He is responsible for ensuring that the EBME operational processing complies with any Department of Health Guidelines. He will comply with appropriate MHRA documentation, comply with hazard warnings and safety bulletins and he will enforce strict Health and Safety controls. He will monitor the PPM process and report any irregularities to the Authorised Senior Manager.
He will ensure that staff are adequately trained and will personally represent the Department in Management issues. In addition he is responsible for Quality Planning (which includes provision of and updating of these manuals, resource allocation, controls, processes and skills within the EBME department) and with the Authorised Senior Manager for ensuring that the Quality System is reviewed at regular intervals. He will meet annual objectives set for the department and set appropriate objectives for all other technologists. He will ensure that resources exist for auditing the system and for taking action as appropriate. He will also ensure that communications are maintained at all levels of the Department on the importance of meeting customer, statutory and regulatory requirements.
The Chief technologist will assist the EBME Manager in running the total EBME Processing operation. He oversees the Technologists. He oversees the day-to-day running of the workshop and ensures that the workmanship of the biomedical staff is of the highest standards and carries out on the job training for new and less experienced employees. He acts as Quality Assurance Manager in the absence of the EBME Manager
It is the responsibility of the EBME technical staff to maintain the highest standards or workmanship appropriate to a professional workshop operation. Good workshop practice techniques are paramount. This includes ensuring that all documentation and paperwork are completed satisfactorily, equipment is correctly labelled and stored appropriately, the correct test equipment and tools are utilised, work benches are efficient, one piece of equipment is worked on at any one time, manuals are kept up to date, training is meaningful, non conforming products and parts are segregated and labelled and that the workshop indicates an area of efficiency and professionalism.
Clerical Assistant/Quality co-ordinator
The Clerical Assistant/Quality Co-ordinator reports directly to the EBME Manager and is responsible for maintaining the department's databases and for ensuring that the Department's operational computer system operates and functions to meet the needs of the department. The Clerical Assistant/Quality Co-ordinator ensures that all work is entered onto the database and is aware of the job status of any particular piece of equipment while in the department and will interface with the customer when appropriate and ensure that customer queries (not complaints) are answered appropriately. He/She will follow up on ordered stores and stock for jobs awaiting spares and ensure that the biomedical staff are kept up to date with orders (or delays) She will assist the Quality Assurance Manager in running the administration side of the Quality system.
5.5.2 Management Representative
The EBME/Quality Assurance Manager is the Management Representative for Quality. He has the responsibility and authority for the implementation, co-ordination and delegation of Quality throughout the department and personally monitors customer requirements and complaints and takes any necessary action. He takes responsibility for all Quality related matters, including the identification, recording and solving any Quality problems.
The Quality Assurance Manager will establish, implement and maintain all Quality aspects relating to ISO 9001:2000. This includes total responsibility for all aspects of Quality assurance including, the maintenance of the Quality Assurance Manual and system, plus the issuing of all amendments and liaison with outside bodies on all Quality Assurance matters.
He is also responsible for the identification, investigation and documentation of all non-conformance's, plus the initiation and implementation of action to prevent recurrence of non-conformance's and the implementation of Quality related solutions.
He is also responsible for ensuring that non-conforming processes are controlled and corrected. He will analyse the system and report on the overall performance and suggest improvements at Management Review Meetings
5.5.3 Internal Communication
The EBME Manager will hold regular communications meetings if and when appropriate with the objective of improving customer satisfaction by reviewing aspects of the service being provided, initiate improvements and demonstrate commitment to the Quality system and ensuring that legal and statutory are being complied with. The Quality Assurance Manager will take any appropriate Quality related action as the result of these meetings.
5.6 MANAGEMENT REVIEW
The Quality Assurance Manager will establish, document and maintain processes or procedures to ensure that the Quality system is meeting its objectives. Consideration will always be given to ensure that the policy is reviewed and all necessary changes are made.
A Management Review meeting is conducted regularly which is concerned with every aspect of the Quality system. It will be documented and will include Customer Complaints, Customer satisfaction (and dissatisfaction), Training, Suppliers, Changes to the system and Standard, Audits, Quality, Contract changes, improvements and where appropriate, trend analysis. Actions to maintain improvement will also be documented.
5.6.2 Review Input
Information on review input will be documented in the associated procedure.
5.6.3 Review Output
Improvements and resources required to maintain continual improvement are documented in the appropriate procedure. Associated procedure
EBME 1 Management review
EBME 7 Non conformances and customer Complaints
EBME 10 Corrective and preventive Action
6.1 PROVISION OF RESOURCESThe Authorised Senior Manager will ensure that adequate resources (both human and physical) are available to maintain continual improvements to the system and to ensure that customers are continually satisfied.
6.2 HUMAN RESOURCES6.2.1 General
The EBME Manager will ensure that personnel are competent to carry out the functions allocated to them and that where appropriate, training needs are evaluated. He will also ensure that a satisfactory work environment is allocated to all workshop staff and also ensure that the working conditions and environment in the EBME department are acceptable. The EBME Manager will make random checks of the conditions under which staff are being employed, and if and when appropriate, he will document complaints and approach the workforce to find a satisfactory conclusion.
6.2.2. Competence, Awareness and TrainingThe Quality Assurance Manager will establish, document and maintain procedures to ensure that all personnel are properly trained before commencing any activity affecting Quality. Training needs for employees is an ongoing requirement of the Department. Where personnel have been trained, the effectiveness of the training and the competency at carrying out the tasks allocated will be constantly reviewed. The EBME Manager and the Chief Technologist will ensure that only personnel with the necessary training are employed in specialised areas. Personnel will be made aware of their relevance, contribution and importance to the department. Records of training will be kept on file.
6.3 INFRASTRUCTUREThe Authorised Senior Manager and the EBME Manager will ensure that sufficient information technology, storage space, test equipment, support services, and benches or workspace are available for all personnel.
6.4 WORK ENVIRONMENTThe EBME Manager is responsible for ensuring that a satisfactory work environment exists taking into account staff potentials, safety rules, location, facilities, hygiene, risk analysis results and temperature.
The EBME Manager continually monitors the workmanship of all the departments' employees and for ensuring that environmental conditions meet acceptable standards.
7.1 PLANNING OF SERVICE REALISATIONIn formalising plans for realisation of the services provided by the EBME Department, measurable objectives will be prepared by the EBME Manager to ensure that the major processes are determined. These include handling and verification of customer's and the Trust's requirements, interviewing and selection of suitable staff, ensuring that sub contractors meet the needs of the Department and the Trust, selection of test equipment where appropriate, and maintaining contact with customers. Work Instructions are prepared to ensure that processes are documented and controlled and records are retained of the work carried out. Ensuring that verification, validation, monitoring, test and inspection criteria have been met. When employing new personnel and replacing equipment, statutory and legal requirements will be considered.
7.2 CUSTOMER-RELATED PROCESSES
Formal written contracts may exist between the department and the customer or the Trust. Although a Department outside the scope of this standard are responsible for accepting and administering the initial contract, nevertheless the Authorised Senior Manager and the EBME Manager will ensure that all aspects of the contract are feasible. This will ensure that customer's requests/requirements are clearly understood before acceptance.
Where the customers are unsure of their requirements, the department will investigate on their behalf. (even if not stated). Any differences between the customer's requirements and those in their contract will be agreed and documented. Regular contract reviews will take place and the Department will adhere to an established, documented and maintained procedure to ensure that the manpower, finance and facilities are agreed.
7.2.2. Review of requirements related to the serviceBefore returning a product to the customer, the department will ensure that all requirements have been met, and any changes from the original request have been resolved and documented. Variations to requests and amendments to contracts will be clearly documented and endorsed by both the EBME Manager and the customer. Unwritten requirements will be verified. Relevant personnel will be informed of any changes which affect them.
7.2.3. Customer CommunicationThe EBME Manager or a representative holds regular meetings with customers and where changes to contracts and recommendations are made, they, too, will be documented. Contracts will be continually reviewed to ensure that requirements can be met. When minor work is accepted for which no formal contract exists, the reviews described above will nevertheless take place.. Statutory, Trust and regulatory requirements will always be met.
When it is necessary, meeting customer deadlines is monitored, and where appropriate, customers are kept up to date with information regarding the progress of work. If the work is in the form of a contract, contingency plans are brought into operation if the original contract cannot be met. Nevertheless contractual obligations will always be maintained regarding the provision of service. These plans will be communicated to the customer.It is the responsibility of the EBME Manager to manage the Customer Focus operation, (which includes the maintenance of Customer Focus records and customer complaints) and the responsibility of the Quality Assurance Manager to ensure that the operations described in the procedure are understood by all personnel and controls listed are adhered to. It is also the responsibility of the Quality Assurance Manager to ensure that the Quality procedures are issued and controlled at all times. Associated Procedure:- EBME 3 Customer Focus. EBME 7 Non conformances and customer complaints
7.3 DESIGN AND DEVELOPMENTThe EBME Department does not operate a design and development activity
7.4 PURCHASING7.4.1 Purchasing Process
The EBME Department has produced a procedure to ensure that purchased goods and sub-contractors conform to the stated requirements and orders are only placed with approved suppliers. Most purchases, whether stock or non-stock items, will be carried out using the NHS Supplies Department. This department is in itself an ISO 9002 Registered department and consequently the Quality Administration carried out by NHS Supplies will incorporate all purchases of the EBME Department. Goods will either be delivered to the stores for onward delivery to the department or delivered directly to the department. In either case, the clerical assistant will unpack and check that the received goods are acceptable. Even though purchased through NHS Supplies, suppliers and sub contractors will be continually assessed on their past capability and performance or by certified products and Quality registration schemes by the Quality Assurance Manager.
There will be a feedback system in operation to NHS Supplies. The Quality Assurance Manager may inspect manufacturers or sub contractors premises or workmanship if there is a requirement. A list of all approved suppliers can be obtained by the Quality Assurance Manager, using the Records of the NHS Supplies Department The list is reviewed and updated regularly.
The EBME Manager is responsible for enlisting and organising any sub-contracted labour. This is often in the form of manufacturers who maintain and repair equipment manufactured by their own organisation It is his responsibility to ensure that all sub-contractors are qualified and capable of meeting contractual requirements. It is the responsibility of the Quality Assurance Manager to ensure that all sub-contractors are reviewed as part of the Quality process.
As sub contractors are assessed through NHS Supplies who are themselves accredited to ISO 9000, the list of approved sub contractors is available should the Quality Assurance Manager require it. NHS Supplies will document any changes to the list of Sub Contractors, but will inform the Quality Assurance Manager if the EBME Department is affected.
7.4.2 Purchasing informationPurchase requisitions are generated within the department. They are signed and are comprehensive and unambiguous.
7.4.3 Verification of Purchased product or servicesWhen required by contract, the Department will afford customers the right to verify that products and services offered by the Department reach acceptable Quality standards.
7.5 SERVICE AND SERVICE PROVISION7.5.1 Control of service provision
The EBME Manager and the Chief Technician control the quality of the day to day services provided by EBME Department. Equipment in the form of minor plant or test equipment will be suitable to meet the needs of the Department and where specific work instructions are required they will provide the necessary support. The customer will be given specific information relating to the service provided which will be authentic and accurate. The EBME Manager will ensure that all equipment for which he has responsibility is controlled and where considered necessary fully serviceable and within specifications. He will also ensure that repairs, maintenance and installation conform to specified requirements. The EBME Manager monitors equipment for adequacy and where applicable ensures that external reference standards and good workmanship and professionalism is maintained. Work Instructions and manufacturer's handbooks may be available for verification purposes. Records will show that the equipment is used within acceptable tolerances.
Software used in the Office environment will be adequate to needs of the Department, the Trust and the customer. Only sub contractors on the list of approved suppliers will be used to maintain and repair equipment when required. The Quality Assurance Manager shall establish and maintain procedures to ensure that all workmanship, whether within the workshop environment or on site is carried out in a controlled and efficient manner.
The EBME Manager has the overall responsibility for ensuring Quality workmanship by all in house staff and sub-contractors. This includes not only maintenance and repair and the work normally associated with it, but also all aspects of safety.
It is the responsibility of the Quality Assurance Manager to ensure that these procedures are adhered to and to ensure that they are understood by all personnel including sub-contractors. It is the responsibility of the Quality Assurance Manager to ensure that these procedures are issued and controlled at all times.
Planned Preventative Maintenance is carried out by the department. If PPMs cannot be carried out for any reason, the EBME Manager will use his experience and professionalism in deciding which PPMs are considered priority. If a PPM cannot be carried out the customer will be informed.
All equipment will be identifiable. A maintenance history will be retained of the maintenance and repair process. This is recorded by the Clerical Assistant on the department database. Where equipment and instruments are to be maintained, it will be carried out using the manufacturers specifications. Though maintenance may be carried out by external contractors, the EBME Manager has been given the responsibility for planning and maintaining the process. It is the responsibility of the Quality Assurance Manager to ensure that this procedure is adhered to.
7.5.2. Validation of ServiceIt is unlikely that any special processes are in operation within the department as all processes are verified as they occur. The department will electronically record any processes or parts for service provision. This will ensure that later non-conformities that occur as the result of deficiencies in service are identified. This will produce useful data to reduce time wastage, prevent problems, improve the service and plan training. This will increase communication at all levels.
7.5.3. Identification and traceabilityThe Department will establish and maintain procedures to ensure that identification and traceability are adequately controlled at all times. All jobs are traceable from start to finish. Tracing is carried out at all stages. The status of all jobs is uniquely identified. Work which is not currently being processed will be labelled and segregated. Areas in the workshop have been set aside for "awaiting labour", "awaiting spares", "BLR or BER", "awaiting disposal instructions" and "awaiting financial confirmation". Equipment or apparatus that is contaminated will be labelled and segregated from all other equipment. Similarly test equipment will be adequately marked (See para7.6)
A stores area exists for the storage of stock items. All stock and non-stock items are traceable to dedicated manufacturers or suppliers. It is the responsibility of the Quality Assurance Manager to ensure that all aspects of this procedure are adhered to.
7.5.4 Customer PropertyInvariably all jobs handled by the department for equipment repair or maintenance involve customer's property. When a customer's product, whether in the form of equipment or appliances are handled by the Department, every care will be taken as if they were the Department's own property. They will be checked, correctly stored and maintained. Where the customer's received product is not suitable for use, or is otherwise lost or damaged and is proved to be due to EBME processing, the customer will be informed. It is the responsibility of the Quality Assurance Manager to monitor all customer-supplied products.
7.5.5. Preservation of ProductCare is taken with handling all equipment while in the EBME Department. When equipment is returned to the customer care is taken to ensure that it is packaged adequately and satisfactorily delivered without damage. Care is taken with electronic devises to ensure that static discharge is minimised. Hazardous and dangerous materials are monitored continuously. Care is taken to ensure that perishables and similar goods are rotated.
7.6 CONTROL OF MEASURING AND MONITORING DEVICESAs part of the maintenance and repair process, a range of test and measuring devices are in use within the department. These will be calibrated and labelled appropriately.
The EBME Manager has been given the responsibility for servicing and maintaining all inspection and test equipment in good condition and ensuring that it is available for use within a known state of accuracy. Calibration is traceable to nationally recognised standards, where standards are available. This requirement is applied to all inspection and test equipment, whether owned by or on loan to the department or its employees. A register of all items of inspection and test equipment is maintained, together with records of calibration carried out either in-house or, where appropriate, by an external test authority, from whom certificates of calibration are obtained. The calibration status of each item can be established from records and it is displayed on the item itself, where practicable. Inspection and test equipment is stored under acceptable conditions.
In the event that non-conformity in a piece of measuring equipment is identified, the validity of previous results verified with the faulty equipment are assessed and appropriate action is taken.
8 MEASUREMENT ANALYSIS AND IMPROVEMENT
Plans are in operation through documented procedures to ensure that all repairs and maintenance services carried out by the EBME Department reaches the requirements of the customer, that all staff are aware of the requirements of the quality system and that random sampling is carried out on the elements of the quality system to ensure that continual improvement is being maintained.
8.2 MONITORING AND MEASUREMENT
The EBME Department will continually monitor feedback from the customer. The Authorised Senior Manager or the EBME Manager will hold meetings with both the Trust and Customers and document this process while the EBME Manager will interact regularly with customers and review service and standards and will monitor the customer's perception of whether their requirements have been met. The Quality Assurance Manager will review all customer feedback processes and make recommendations to senior management where appropriate.
8.2.2 Internal audit
An audit of each section of the Quality manual takes place annually, or more frequently should any activity require it, to ensure that Quality performance meets customer requirements. An audit schedule will be prepared and distributed in advance by the Quality Assurance Manager as part of Quality planning. Internal Auditors will be trained to carry out the work planned in the audit schedules.
Audit reports and non-conformances will be analysed by the Quality Assurance Manager and action taken to eliminate causes of non-conformances and further action to ensure that improvements are made to the system. It is the responsibility of the Quality Assurance Manager to implement these procedures. Auditors will not audit their own responsibilities. Thus audits will be independent and unbiased. Audits will be evaluated at Management Review Meetings and at internal communication meetings.
8.2.3 Measurement and monitoring of processes
To ensure that the standard of workmanship carried out and the associated services meets the requirements of the customer, all EBME processes are monitored by competent personnel to ensure that conformity is maintained. Where products fail to pass final inspection and testing, the product will be re-appraised for further work or disposal.
The Department will however monitor and analyse the following areas and produce trends for Management Review in:
8.2.4 Measurement and monitoring of finished product and service
When it is necessary, meeting customer deadlines is monitored, and where appropriate, customers are kept up to date with information regarding the progress of the service. The progress of work is continually monitored by experienced personnel throughout all intermediate stages and product release is documented electronically.
If the request is in the form of a contract, contingency plans are brought into operation if the original contract cannot be met. Nevertheless contractual obligations will always be maintained and these plans will be communicated to the customer.
The product will not be released to the customer until all monitoring and measuring tests have been completed, and where appropriate release is authorised. Non-conforming equipment needed for an emergency may be released under concession, provided that the approval of the EBME Manager or Chief Technician has been obtained and the customer signs a concession form. However sampling is carried out by senior personnel on completed work.
8.3 CONTROL OF NON-CONFORMITY
The Quality Assurance Manager will establish, document and maintain procedures to ensure that non-conforming products and services are easily recognised, isolated and prevented from inadvertent use. These procedures state the methods of segregation and responsibility for authorising the disposition of all non-conforming products, and the corrective actions taken to prevent reoccurrence. Non-conformances include mistakes, errors and workmanship which fails to reach the required standard.
This procedure applies to the following operations:
- Faulty received goods.
- Checking equipment for serviceability
- Disposal of items which are considered no longer serviceable or beyond repair.
- Customer Complaints and feedback.
- Internal Audit process.
- Equipment taken into the workshop(or on site) which has been rejected as either not up to standard during the process or needing repair.
Care is taken to ensure that all non-conforming items are adequately segregated and in most areas marked to prevent inadvertent use. Stores, upon receipt are inspected for non-conformances. Any non-conformances are notified to the supplier immediately and corrective action taken.
During the various phases of repair, constant monitoring ensures that all non-conformances are acted upon immediately. Action will be taken to ensure that equipment which does not reach satisfactory customer requirements is not returned to the customer. Equipment found to be non conforming will not be released until fully validated.
Records are retained of all serious non-conformances. Less serious non-conformances are handled verbally. In the unlikely event that the customer requires delivery of a non conforming product for emergencies, it will be released under concession.
8.4 ANALYSIS OF DATA
The Quality Assurance Manager will determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and will analyse where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data shall provide information relating to
- customer satisfaction (see 8.2.1),
- ensuring the product and service conforms (see 7.2.1),
- characteristics and trends of processes and products including opportunities for preventive action,
Using measurements received and valid data analysed from various sources, the performance of the EBME Department will therefore be analysed and appropriate action taken to redefine plans, objectives and processes. The EBME Manager will analyse the data to determine trends, customer satisfaction, effectiveness and efficiency, success of objectives, financial benefits and competitiveness.
8.5.1 Continual improvement
By continually monitoring the Quality System, trends and analysis, the Quality Assurance Manager will recommend improvements through the use of the policy, updating objectives, audit results, data analysis, corrective and preventive action and management review. Improvements will be continual. The EBME Manager will evaluate these recommendations and update the system appropriately.
8.5.2 Corrective action
The Quality Assurance Manager will establish, document and maintain procedures to ensure that non-conforming services are systematically identified and investigated. Action is taken to prevent reoccurrence. Corrective action is seen to be reactive. In taking action to prevent re-occurrence, Quality Assurance Manager will thoroughly investigate the reasons for non conformances, and then ensure that the corrective actions are meaningful, recorded and monitored as an ongoing process for trend analysis.
The procedure will include:
- reviewing nonconformities (including customer complaints),
- determining the causes of nonconformities,
- evaluating the need for action to ensure that nonconformities do not recur
- determining and implementing action needed,
- records of the results of action taken (see 4.2.4),
- reviewing corrective action taken.
8.5.3 Preventive action
This is the proactive analysis of the processes, whereas corrective action is the re-active action to be taken when problems arise. The process of eliminating causes of potential non conformities is the responsibility of all Biomedical Engineering Technicians while the Quality Assurance Manager will ensure that these are documented and take appropriate proactive action. The Quality Assurance Manager will implement processes which will show that continual (not continuous) improvements are made.
Customer complaints are individually handled by the EBME Manager or the Authorised Senior Manager. The Quality Assurance Manager will monitor this process and ensure that action is taken to eliminate the causes. All customer complaints are logged. The Quality Assurance Manager will monitor all customer complaints. Audit reports are used to eliminate potential problems, and controls are applied to ensure that the system works. Any action taken is discussed at the Management review meeting
John Sandham - 30/09/2014