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.