Inspecting and Testing

Purpose

The purpose of this procedure is to ensure that materials and products are inspected and tested for conformance or non-conformance before a product is released, used or installed.

Background

Documented procedures shall be established and maintained to ensure all materials and products used in the manufacturing process are inspected and tested prior to use and release.

Scope

This policy applies to the testing of materials and products used in the manufacturing process, including product received from suppliers, in-process product and/or final product. 

Responsible Manager is responsible for:

• Defining means of identifying the test status of received material, in-process product or final product
• Ensuring materials and products are identified and/or segregated by status (e.g., tested/untested, conforming/non-conforming)
• Ensuring the proper disposal of all materials and products failing inspection or testing

Manufacturing staff is responsible for:

• Implementing testing procedures for all identified product and materials
• Ensuring that test equipment is properly calibrated at all times and that the calibration status is current
• Properly disposing of all materials and products failing inspection or testing with authorisation from the responsible manager

Quality Control is responsible for:

• Ensuring all measurement and test equipment is calibrated as required
• Maintaining inspection and test records

Definitions

“Responsible Manager” means the individual directly responsible for ensuring a high quality organisation by complying with policies or procedures.

Procedure

Inspection and Testing – General

1. All products and materials used in the manufacturing process shall be identified and any required test criteria identified.  Inspection may be visual, functional, dimensional, specification or other.

2. An inspection and testing sample plan shall be prepared, identifying number, frequency and type of test required.

3. Identified products shall be tested and results recorded prior to release, use or installation.

4. All incoming material and product shall be received in accordance with What do we do with Defective Product.  Received product and materials that do not pass receiving and/or testing shall not be released to manufacturing.

5. Test records shall identify the test method, test criteria, result, test status and person conducting the test, at a minimum.

6. Tested product and material shall be clearly labelled or segregated to differentiate it from untested or un-inspected product and material.  A tab, label, traveller, checklist, lot or other appropriate method may be used to document the status.

7. Products and materials tested and found to be non-conforming must be clearly identified and placed in a specified area labelled for non-conforming material to avoid any mix-ups.  See What do we do with Defective Product.

8. Personnel performing identified tests shall be trained on the equipment and test method.  Training records shall be maintained and the re-certification cycle identified.

Inspection and Test Records

1. Records shall be maintained to provide evidence that the product has been inspected and/or tested.

2. Records shall clearly show pass/fail status and defined acceptance criteria.

3. Where required, inspection and test records shall accompany the unit/product until final release.

4. Once product is released, inspection and test records shall be forwarded to Quality Control for document control.