8.0 Management system requirements

Management have shown commitment to the development & implementation of the QMS and to continually improving its effectiveness by:-

• Ensuring laboratory personnel are aware of the importance of meeting the needs & requirements of users as well as regulatory requirements by having these as standing agenda items at management meetings & staff meetings
• Establishing a quality policy. The Quality Policy is reviewed at the AMR
• Establishing quality objectives & plans. This is updated at the AMR. P&O’s are discussion & reviewed at the compliance operational meetings. Management ensures the setting of Plans & Objectives by following QP506 – Annual Management Review Procedure
• Taking actions to address risks and opportunities for improvement
• Performing internal audits for the identification of nonconformities/corrective actions and areas for continual improvement
• An annual management review is held in January for the preceding year. This will be a joint AMR in person, if facilities are available, or via video conferencing/Teams

Management ensure adequate resources are available by careful selection, induction and training of appropriately qualified staff. Accommodation is a state-of-the-art laboratory within the New Lister Building, Glasgow Royal Infirmary & the Laboratories and Facilities Management Building, Queen Elizabeth University Hospital. Equipment & consumables are procured & maintained using the Directorate purchasing procedure. Examination processes are verified & validated before use. Processes are continuously monitored by using IQC and EQA checks

Evidence illustrating our established of a quality management system includes: our Quality Manual, Quality Policy, appointment of a Quality Manager and the implementation of a quality management system. All management documents are accessible to all staff in Q-Pulse document module.

The key documentation that demonstrates this includes:

QP503           Quality Manual

QP500           Quality Policy

QP506           Annual Management Review

QP516           Internal Audit and Audit Training

QP511           Document control

MP513           Control of process & quality records

MP512           Control of clinical material

The Quality Management System is subject to planned and scheduled internal audit processes, against agreed criteria, by personnel trained in internal audit. The records of internal audit include: the activities, areas or items audited, any nonconformities or deficiencies found and the recommendations and time scale for corrective and preventive actions. The results of internal audit are regularly evaluated and decisions taken documented, monitored, reviewed and acted upon.

Audit findings are communicated to appropriate personnel. In addition, audit records are available for scrutiny within Q-Pulse.

Staff are introduced to the Quality Manual at induction and acknowledge the document in Q-pulse. Production of this Quality Manual shows compliance with this standard.

We aim to control our documents, because of the need for traceability, using Q-Pulse software. All documentation is properly controlled and SOPs, forms, worksheets and external documents have a unique identifying code, review date, version number, pagination and name of authoriser (owner), which correctly identifies the type, number and version of the document. This is managed through the Q-Pulse software system. Only active documents are at workstations with obsolete or inactive documents removed and stored indefinitely in the Obsolete Document area of Q-Pulse only. All laboratory documents are:

• Uniquely identified by prefix followed by number
• Approved for adequacy before issue and implemented
• Periodically reviewed and updated
• Documents available at points of use and distribution is controlled. Only active versions available for use
• Changes and the current revision status of documents are identified, either within Q-Pulse document record or handwritten amendment
• Strict document control in place to prevent unauthorised change
• Access restricted to laboratory personnel only

We aim to adhere to the rules governing record control, in order to ensure accuracy & availability of all aspects of our service. The process is defined in MP513. Records & specimens are stored in accordance with RCPath & IBMS guidelines. Quality records are available in Q-Pulse or from the QCM. Process records are stored at workstations or are archived.

The laboratory ensures that all technical records are maintained as per the retention policy and per technical SOP’s. Any amendments to records must be clearly recorded and traceable. All technical records are signed by the appropriate staff member for work carried out by recording date/initial. Any amended record can be tracked to the previous version. Original copies and any other additional copies are retained by the laboratory either through the filing system in place or by electronic record.

We aim to identify risks and opportunities for improvement associated with laboratory activities in order to proactively address potential issues as well as improve overall performance and service delivery. Risk and opportunities for improvement are incorporated into all laboratory conformity investigations and all internal audits. Risks and improvement opportunities are assessed and identified with appropriate actions raised and changes implemented. All decisions are recorded within CAPA record in Q-Pulse, with findings also discussed at monthly quality managers meetings. 

We aim to continually improve the effectiveness of the QMS to ensure the service delivered meets the needs of the user and patients. To achieve this, an internal audit schedule is set each year to aid in with the continual improvement. This encompasses the pre-examination, examination and post examination procedures. All improvement opportunities identified are recorded with Q-Pulse CAPA module as laboratory quality improvements. These are then discussed and evaluated at monthly quality managers meeting and then communicated to all staff at the weekly all staff meetings. Feedback is also received from clinical team, GGC website, suggestions and user surveys to further highlight opportunities for improvement.

8.6.2 Laboratory patients, user, and personnel feedback

We aim to ensure that the service meets the needs and requirements of our users, patients and other personnel by having evaluation and improvement processes in place which includes:

• Assessment of user satisfaction – QP509
• Regular discussion with users of the service to discuss service needs
• Participation in clinical meetings
• Internal audit of the quality management system  - QP516
• External quality assessment
• A process for quality improvement – QP515
• Identification and control of nonconformities – QP510

The results of these evaluation and improvement processes are available to staff and users as required. Analysis, recording and interpretation of the data forms part of the management review, which is contained in the annual review.

We aim to investigate and, where possible, remove the root cause of nonconformities.  Removing the root cause of a problem is true corrective action (preventing recurrence). Identification & control of non-conformances is described in QP510. Corrective action for the identification and elimination of the causes of nonconformities includes:

• Investigation of nonconformities and take immediate action to correct
• Address consequence, with focus on patient safety and clinical impact
• Determination of, and responsibility for, corrective action/RCA
• Implementation of corrective action within an agreed time scale
• Monitoring of corrective action taken

General

All procedures are reviewed periodically as per the Document Control SOP QP511, this also includes a review of the appropriateness of the investigations offered and clinical relevance of tests. Appropriateness of specimens/sample containers etc are examined during audit.

Quality indicators

Quality indicators are set and reviewed by laboratory senior management team. These are reviewed monthly by the compliance-operational team with any outliers recorded and actions.

Internal audits

We aim to continuously interrogate our service by a system of audits, in order to detect weaknesses before they cause an error. There is internal audit of the pre-examination, examination and post-examination processes, which is planned and scheduled, against agreed criteria, by personnel trained in internal audit as per QP516.

The records of internal audit include:

• The activities, areas or items audited
• Any nonconformities or deficiencies found
• Recommendations and time scale for corrective and preventive actions

The results of internal audit are regularly evaluated and decisions taken are documented, monitored, reviewed and acted upon.

Audit findings are communicated to appropriate personnel. In addition audit records are available for scrutiny within Q-Pulse. A risk based approach is taken to departmental audit schedule, with areas identified based on performance (i.e. nonconformities, IQA, EQA, process change etc).  All audit findings are discussed at management meetings and communicated to all staff at the weekly meetings.

Internal audit of the QMS is defined by QP514. The audit schedules are held in Q-Pulse

We aim to regularly review our quality management system, in order to ensure its continued suitability, adequacy & effectiveness in support of patient care.

The Lab Director, Clinical Leads, HOTS, SM, QCM, OM/ QM/ TM’s / Consultants participate in an annual review that considers the following items of information based upon reports produced by managerial and supervisory personnel.

Review Input

Records are kept and key objectives for subsequent years defined and plans formulated for their implementation as defined in QP506 – Annual Management Review Procedure. Senior staff submit end of year reports for their areas of responsibility. Objectives for the forthcoming year are determined at the AMR and are documented in QF551, installed in Q-Pulse and communicated to staff.

Review Output

The review output takes the form of the new and reviewed Plans and Objectives for the service as well as the minutes from the AMR meeting itself which documents decisions, needs and discussions that have ensued relevant to the AMR agenda. The review output is recorded and is embedded in Q-Pulse – QF608 - and displayed on the department Quality noticeboards for staff information.