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.

Change Control Plan

This SOP lays out the procedures in a facility to carry out any changes to documents, processes, equipment, or suppliers

Validation Master Plan

Describes the process of performing validation of new processes (including equipment) and equipment (including facility upgrades)

Risk Management Procedures

This procedure describes the identification of potential risk and risk factors that may impact on the quality and safety of processes and product(s). The impact assessments and calculations form the basis of a risk mitigation (minimisation) plan used to proactively reduce significant risk to an acceptable level where possible. ¬†Occupational Health and Safety and business […]

Risk Assessment List

List of identified risks, and assessment including mitigation strategies and mechanisms for review

Quality Manual

Describes the quality standards to which the facility adheres, the scope, inclusions and exclusions.