4.10. Inspection and Testing
4.10.1. General
This element deals with the testing of your materials as they move through your process as well as the final inspection of the product. The testing operations must be carried out in accordance with your documented procedures and supported with records that indicate the status of the material and eventual satisfactory status of all requirements prior to the product's release.
This element also deals with emergency situations that occur in real life. For example, the standard allows you to release incoming materials for urgent production without inspection. However, if you bypass inspection, you must employ a "positive recall procedure". This procedure requires that you track this material and be able to identify it, should further testing indicate that your materials or workmanship are unsatisfactory.
To comply with this clause:
- You will maintain a documented inspection and testing system to ensure the customer's requirements are met. This activity will be supported by accessible records that show compliance.
- Should you have an emergency requirement that prevents screening for fitness , then you must establish a unique material identity that must be recorded and tracked as it moves through your process should the need for a recall occur (positive recall procedure).
- The positive recall procedure will not apply to final inspection.
4.10.2. Receiving inspection and testing
No material should be incorporated into the product without verification to the product specifications. This does not mean all your material must undergo a full specification inspection. "Partials" are legitimate as long as they meet your inspection plans. If, due to emergency, the incoming material is used without verification, it will require designated authorization, full documentation, and tracking (positive recall procedure). All preverified materials should be maintained in a segregated area according to a documented process.
The verification of the incoming product must conform to your quality plan and documented procedures. Verification can take many acceptable forms and is not necessarily delegated to the receiving inspection organization. However, records must be maintained to meet the defined inspection requirements specified in your procedures. When establishing inspection schemes you should consider recorded evidence of receipt histories as well as the process capability of your supplier.
To verify incoming product:
- You shall establish a documented system that ensures that no incoming material is used until its fitness has been verified to your defined quality.
- When establishing an inspection and testing consideration, you should consider recorded evidence of process compliance, as well as historic evidence of compliance.
4.10.3. In-process inspection and testing
You must document your in-process inspection procedures and test points and carry out the defined inspections. The level of in-process inspection is determined by your own operations, and, with the exception of special process inspections, there is no additional requirement.
If in-process inspection is required, you will need to provide holding points for nonconforming materials. The ISO 9000 standard encourages the use of in-process inspection as a method for minimizing defects and allows in-process inspections and test if appropriate.
This clause requires that:
- You perform in-process test and inspection of the product according to the documented product specification requirements or to your own quality plan.
- You not allow materials to proceed through the process until they have met the test requirements.
4.10.4. Final inspection and testing
You are required to perform a full inspection and test of your final product as specified in your quality plan and documented procedures. This full inspection and test must verify that the inspection data fully meet the specifications of the product, as defined in your quality plan. Final inspection should incorporate the results of previous inspections and their successful satisfaction of requirements. You are required to hold the product and defer its shipment or release until all inspections have been completed and the product has met all the specifications. Your inspection record should indicate who authorized the release of the product (of course, this person must be authorized to do so).
To satisfy this requirement:
- You must perform final inspection and test of the product according to the documented product specification requirements or to your own quality plan to ensure the product meets the customer's specified requirements.
- The final inspection shall include verification of satisfactory in-process inspections.
- No products or materials shall pass final inspection until all requirements have been satisfied and records completed and released by authorized individuals.
4.10.5. Inspection and test records
You must keep records to demonstrate that your product has met the testing requirements and that all the tests were conducted per your quality plan (4.16).
This clause requires that:
- You shall maintain a documented system that ensures that inspection and test records are retained and accessible, demonstrating successful final inspection and test by an identified authorized individual.
