assessment of user feedback staff suggestions internal audits – including any improvement findings risk management use of quality indicators reviews by external organisations results of participation in inter-laboratory comparison programmes monitoring and resolution of complaints performance of suppliers identification and control of non-conformities Results of continual improvement including current status of CA/PA follow up actions from previous management reviews changes in the volume and scope of work, personnel and premises that could affect the quality management system Recommendations for improvement, including technical requirements. These are all reviewed to identify any issues/trends developing which could highlight developing problems with process 4.15.4 Review output A record of the meeting is compiled by the Quality manager – Q-Pulse MAN-Q-001 This report is communicated to all staff. Q-Pulse acknowledgement is implemented. The meeting is a review of Quality Management System, policy and objectives. The objectives set at the beginning of the year during the AMR of the previous year are reviewed again for progress/completion. Discussions take place between management including possible improvements to the service the laboratory delivers to users, any improvements that could be made in the Quality management system and its processes and also how to facilitate these improvements. These outputs form quality objectives for the forthcoming year and are documented in in Q-Pulse and communicated to staff .These are also held within the Compliance meeting ‘action tracker’ where they are reviewed monthly with any further goals added as they arise. The AMR includes root cause, trending of non conforming work e.g. IQC,EQA results etc to identify any patterns that may indicate there is a problem with a process and improvement opportunities. 5.0 Technical requirements Personnel. General See MAN-SOP-012 Information for staff
Selection Evaluation of Suppliers Purchasing arrangements Establishment and Maintenance of an Equipment Inventory File Equipment Maintenance, Service and Repair An Inventory of equipment is maintained in Q-Pulse, which includes: Manufacturer’s name. Serial number. Date of purchase or acquisition. Maintenance contract. The Estates department performs electrical safety testing (PAT) on a regular basis. A decontamination certificate is issued before an engineer is allowed to work on the appropriate item of equipment EQP-F-068 Equipment purchase and maintenance is arranged by ABBOTT Ltd via a Managed Service Contract Requirement for new equipment is highlighted to the Management Group via the Laboratory Manager’s Group. A business case is put forward to the Directorate for all new equipment, including upgrading of existing equipment. Selection of appropriate equipment is based on laboratory requirements and cost. Quotations/tenders are obtained from suppliers/manufacturers. A safety assessment is carried out for the positioning of the equipment in the laboratory, and any special requirements noted. For all items over £5000, completion of a Capital Equipment Request Form is required. For all items under £5000, (including IT equipment), the appropriate forms are submitted to the Directorate for approval. A centrally held budget is available for equipment within this category. Training is directed by the supplier/manufacturer of the equipment, and where appropriate both off-site and on-site training are given. Maintenance agreements and scheduled service visits are arranged with the Technical Services Manager. Service and breakdown reports and corrective action taken are filed in Q-Pulse. User, maintenance and decontamination procedures are described in equipment SOPs (EOPs). Disposal of redundant/ broken equipment is arranged through the relevant company or GRI Estates department, and the equipment removed from the asset register. 5.3.1.2 Equipment acceptance testing All new and replacement equipment is assessed before being put into use. This includes: Health and safety implications Throughput Trial by comparison with current methods by testing both methods in tandem. Management review of costs, supply, equipment, staffing and service issues. Production of business plan and specification