Orientation Manual
Documents the necessary steps for induction of new personnel.
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.
Emergency and Evacuation Plan
This SOP outlines the procedure to follow in an emergency situation. It should include details of how to protect any manufacturing that is in process at the time of an evacuation.
Equipment Register
This register lists all the equipment in a facility including critical 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
Competency Framework
Identifies all the SOPs that a person is required to be competent in for each role.
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)
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 […]
Contractor Register
List of approved contractors
Internal Audit Procedure
Describes the process to perform an internal audit
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
Environmental Monitoring Procedure
This document describes the environmental monitoring program for the clean areas of the manufacturing facility. It includes surveillance of temperature, relative humidity and air pressure, microbial contamination and particulate air matter.
Quality Manual
Describes the quality standards to which the facility adheres, the scope, inclusions and exclusions.
Cleanroom Cleaning Procedure
The purpose of this SOP is to outline the procedures and materials used in the routine cleaning of cleanrooms and associated clean areas within the facility.
Organisation Document
Description of the organisation, the staff, management processes and organisation chart.
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.