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1 QUALITY MANAGEMENT STANDARD (QMS)

The Company shall have a Quality Management System established, documented, implemented, maintained and where appropriate, improved.

1. 1 Organizational Structure, Responsibility and Management Authority


The Company shall have an organizational structure, which clearly ensures job function, responsibility and reporting relationships of those staff
whose activities affect product safety, legality and quality are clearly defined and documented.

1. 2 Supplier Approval and Performance Monitoring


The Company shall operate procedures for approval and the monitoring of its suppliers.
1. 3 Product Identification and Traceability
The Company shall have a system with the ability to trace materials from raw material source to finished product and vice-versa.

1. 4 Complaint Handling
The Company shall have a system for the management of product complaints and their investigation.
1. 5 Management Review
The Company shall conduct management reviews to demonstrate the effectiveness of the system.
1. 6 Design Control
The Company shall ensure the product design is effectively controlled to meet with customer, safety, & legality requirements.

1. 7 Internal Audit AND Corrective Action


The Company shall ensure systems exist to investigate the cause of significant non-conformity against standards, specifications and procedures,
which are critical to product safety, legality and quality and corrective action taken.

1. 8 Training
The Company shall ensure that all employees are adequately trained, instructed and supervised commensurate with their activity.

1. 9 Document Control
The Company shall ensure that all documents, records and data critical to the management of product safety, legality and quality are in place and
effectively controlled.
2 GOOD MANUFACTURING PRACTICE (GMP)
The Company shall apply Good Manufacturing Practice so as to prevent contamination and enable the production of safe and legal products.

2. 1 Building Exterior AND Interior


All grounds within the site shall be finished and maintained to an appropriate standard.
2. 2 Layout/Product Flow
Premises and plant shall be designed, constructed and maintained to control the risk of product contamination and damage.

2. 3 Lighting
The fabrication of the facilities including the lighting shall be suitable for the intended purpose with due regard to the risk of product
contamination and damage.
2. 4 Equipment and Maintenance
Equipment shall be suitably designed for the intended purpose and shall be used so as to minimize the risk of contamination and damage of
product.
2. 5 Cleaning
Appropriate standards of cleaning shall be maintained at all times.
2. 6 Health and Personal Hygiene
Appropriate standards of hygiene and housekeeping shall be maintained at all times.
2. 7 Pest Control
The Company shall be responsible for minimizing the risk of pest infestation on the site.
2. 8 Glass Control Program
Appropriate facilities and procedures shall be in place to control the risk of glass or other physical contamination or damage of product.

2. 9 Chemical Residue Control


Appropriate facilities and procedures shall be in place to control the risk of chemical contamination or damage of product.

2. 10 Waste AND Waste Disposition Control


Appropriate procedures shall be in place to manage waste handling and disposal.
3 PRODUCT CONTROL
The Company shall be able to demonstrate effective product control is undertaken.
3. 1 Hazard and Risk Assessment System (HRAS)
The Company shall have a Hazard and Risk Management system in place to ensure that all hazards to consumer safety and product integrity are
identified and appropriate controls established.
3. 2 Product Analysis /Testing
The Company shall undertake or subcontract analyses or testing, critical to confirm product safety, legality and quality, using appropriate
procedures, facilities and standards.
3. 3 Segregation and Stock Rotation
Procedures shall be in place to prevent the cross contamination of raw materials, packaging and finished products.

3. 4 Foreign Body Contamination


The Company shall ensure all necessary steps are taken to identify, avoid, eliminate or minimize the risks of metal or other foreign body
contamination.
3. 5 Control of Non-Conforming Product
The Company shall ensure all out of specification product is clearly identified, labeled and quarantined.
4 PROCESS CONTROL
The company shall be able to demonstrate effective control of all operations undertaken.
4. 1 Control of Operations
Where control of the raw materials, intermediate or finished product, processes and/or environment is required to ensure product safety, legality
and quality, there shall be adequate control, monitoring and record keeping. Where parameters such as raw material quality, in process control
and final inspection which govern product safety, quality and legality these shall be controlled monitored and recorded.

4. 1. 1 Incoming Raw Materials Control

4. 1. 2 Sample and Pre-Production Plan

4. 1. 3 Pilot Run

4. 1. 4 Pattern, Markers, and Spreading

4. 1. 5 Cutting and Bundling

4. 1. 6 In-process control/Testing and Inspection

4. 1. 7 Finishing Processes and Final Inspection

4. 1. 8 Labelling , Ticketing and Packing

4. 1. 9 Storage and Despatch

4. 2 Reference Samples
The Company shall ensure that reference samples, or component samples are held and are available for appropriate personnel or referral.

4. 3 Calibration and Control of Measuring and Monitoring Devices


The Company shall identify measuring equipment used to monitor critical control points and product safety and legality. The identified
measuring equipment shall be calibrated, to a recognised national standard. Where a traceable calibration is not possible, the Company shall
demonstrate the basis by which standardisation is carried out.

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