Non-Conformance Management
This SOP describes the procedures and responsibilities for the management of non-conformances and deviations (planned and unplanned). It relates to non-conforming products, materials, processes, procedures (documentation), environment, facility and equipment.
Document Control SOP
This procedure describes the system, provides instructions and identifies responsibilities for control of documents throughout their lifecycle. It includes the preparation, review, authorisation, issue, identification, legibility, distribution, revision and withdrawal of all controlled documents.
Corrective and Preventative Action SOP
Describes a system, provides instructions and assigns responsibilities for initiating, requesting implementing and verifying the effectiveness of corrective and preventative actions.
Controlled Document List
Lists all documents (including version number) contained within the quality management system.
Cleaning and Maintenance Form
This form lists all cleaning an maintenance that has been performed.
Equipment Maintenance SOP
This procedure describes the system, provides instructions and identifies responsibilities for maintenance of key process equipment and the support systems
Change Control Plan
This SOP lays out the procedures in a facility to carry out any changes to documents, processes, equipment, or suppliers
Training record
Each member of staff will have a record of all training undertaken. This record lists all training undertaken by a member of staff. For each competency listed there should also be a document describing the requirements for proficiency to be assessed, including frequency of training. Training record aligns with the competency framework for a given […]
Internal Audit Procedure
Describes the process to perform an internal audit
Quality Manual
Describes the quality standards to which the facility adheres, the scope, inclusions and exclusions.
Site Master File
Identify all rooms, buildings, warehouses etc included in the Quality Management System. May include a site map, organisation chart, an explanation of the people equipment and quality environment as well as a description of the activities that occur in each room of the facility.
