Purpose

The purpose of this procedure is to ensure that all EBME Quality Records are correctly managed, and that the associated responsibilities are defined.

Scope

This procedure applies to all quality-relayed records held by the EBME Department.

Definitions

Quality Record: All quality management system documentation as described in the list (spreadsheet) of quality records. Computer/cloud storage: All data produced on any EBME databases and associated software that is quality related.

Responsibilities: It is the responsibility of the Quality Assurance Manager to ensure that all aspects of this procedure are adhered to and the responsibility of their senior manager to ensure that adequate facilities exist for the safe keeping of Quality Records.

Procedure: The Document Control procedure includes a list of approved documents and describes the arrangements for approval, issues and changes/modifications to documents.

These documents become quality records following completion of the quality related information for which each document has been designed. These records are then maintained for reference purposes to demonstrate achievement of the required quality and also the effective operation of the quality system.

Records are also maintained for relevant information not included in the quality system, e.g. pertinent subcontractor quality records, hazard warnings, NHS directives, manufacturers handbooks and records of management review meetings etc.

Each type of record is maintained in a suitable electronic folder or hard-backed file and stored in a recognised location, such as a secure server, or in the case of paper based records, in a cupboard or filing cabinet.

Records retained as the result of work related issues must be securely retained for a minimum agreed period that meet the legal need in the event of documentation having to be produced in court.

Purchasing documents are held separately, while all audit related documents are held in a specific audit file held by the EBME manager. The remainder of the quality literature, records and documents are held by the quality assurance manager in a quality records file or in marked locations, while master documents are also held in a secure electronic location, or in a hard back folder. All locations must be logged and accessible to authorised staff. This ensures that retrieval of records can be performed when required and that deterioration and damage is reduced to a minimum.

Quality related data held on an individual computer must be automatically backed up daily. (Administrative and non-quality related data is backed up by the administration assistant at least monthly).

Each type of record is identified and located according to arrangements agreed by the EBME Manager. Certain types of record may be held by other department personnel who carry responsibility for their effective maintenance. Where appropriate records will be filed, collected, protected and indexed. They will be legible, accessible and correctly stored.

Reference to quality records may be made by EBME department personnel. This facility will be extended to customers or their representatives, when agreed in their contract, for a defined period. As a general rule, the quality records associated with this department are normally maintained for a minimum period of seven years. This period may be altered for individual records (e.g. Audits) by agreement with the EBME manager.

The quality assurance manager is responsible for maintaining an index of all quality records, which provides information regarding each type of record, as follows:

• A unique reference number to facilitate identification
• The record title (or suitable description)
• The location of the record. (see above)
• The retention period which applies
• The person responsible for retaining the quality record

The database records must be backed up daily (automatically using its own backup facility). Once a week a copy of the backup is to be retained off-site by the authorised officer. In the event of theft/fire the worst case scenario would be less than 5 working days of lost data.

Note: Paperless records management should be an aspiration of all EBME managers