Introduction

Criterion 1
 Program

Criterion 2
Personnel Training and Qualification

Criterion 3
Quality Improvement

Criterion 4
Documents and Records

Criterion 5
Work Processes

Criterion 6
Design

Criterion 7
Procurement

Criterion 8
Inspection and Testing

8.1

Policy

8.2

Requirements

8.3

Test Control

8.4

Authorities and Responsibilities

8.5

Measuring and Test Equipment

8.6

Nonconforming Items and Activities

8.7

Correction of Nonconforming Conditions

Criterion 9
Management Assessment

Criterion 10
Independent Assessment

CRITERION 8  -  Inspection and Testing


8.1  Policy

Inspection and testing requirements to verify the conformance of quality-affecting items or services to specified criteria will be planned and executed as appropriate for the complexity and risk associated with the performance of the item or service.  

8.2  Requirements

The PI is responsible for establishing and documenting inspection and testing requirements.  The Division QAR will assist in these matters when requested.

Inspection and testing must be performed by qualified persons.  When appropriate, such inspection and testing will be performed by persons who are not directly involved with the work or purchase.

Inspection results including any follow-up or remedial action shall be documented and retained in the project files when appropriate.  

For fabrication by Central Shops (SSD-CS), form ANL-492, Central Shops Fabrication Request, is prepared by the requestor and attached to the Service Request.  If there should be a "Blanket Order" for a year's request, this form needs only to be generated in those situations where it is warranted, which is determined by discussion with the QAR who makes the evaluation based on current conditions and situations.  The PI ensures that appropriate controls are in place, and that inspection requirements are effectively fulfilled.

8.3  Test Control

      Tests required to verify conformance of an item or activity to specified requirements shall be planned with the concurrence of the QAR and executed by the Principal Investigator when necessary.  An inspection test plan prescribes what is to be tested, by whom, when, by what methods, and includes the criteria for acceptance.  The plan shall include the identification of potential sources of uncertainty and error in testing and the needed precision and accuracy.

The QAR reviews test documentation for quality assurance adequacy as part of his or her overview activities.  The PI ensures appropriate controls are in place and that testing requirements are effectively fulfilled.

Test results including any follow-up or remedial action shall be documented and retained in the projects files.

8.4  Authorities and Responsibilities

Any inspections required to verify conformance of an item or activity to specified requirements shall be planned and executed by the Principal Investigator or his designee.  An inspection plan prescribes what is to be inspected, by whom, when, by what methods, and the criteria for acceptance.  The formality of the inspection plan is determined by the Principal Investigator.  The inspection plan shall be reviewed by the QAR for adequacy when requested.

It shall be the responsibility of the Principal Investigator to identify and maintain a record in the project's file of the current status of any critical quality-affecting goods and services.  The Principal Investigator with the concurrence of the QAR shall determine appropriate methods of identifying and tracing the goods and services.

The QAR reviews verification documents for quality-assurance adequacy as a part of the QAR's overview activities for inspections.

8.5  Measuring and Test Equipment

Prescribed measuring and test equipment used for inspection and testing activities are adjusted and calibrated at prescribed intervals by qualified personnel to maintain accuracy and precision within the prescribed limits.  Records will be retained by the PI.

8.6  Nonconforming Items and Activities

The reporting of significant nonconformance in major projects shall be the responsibility of the PI.  The PI is responsible for the interim control, and ultimate correction of significant nonconformance.  Records of such activities will be retained by the PI, as well as documented follow-up evaluation of the corrective action.

If a procurement should involve a nonconformance condition before shipment of items by the supplier, it should be documented on the ANL Form, Form ANL-366, Supplier Disposition Report (SDR).

Nonconforming items must be reviewed by the PI or his designee to determine their disposition.  Such items must be discarded, returned to the vendor, or otherwise controlled by segregation or tagging to prevent their inadvertent use.

8.7  Correction of Nonconforming Conditions

The resolution of unusual operational occurrences shall be based on evaluation of safety and programmatic impacts and on lessons learned to prevent future similar incidents from occurring.

The correction of significant nonconformance in projects is the responsibility of the PI. The PI is responsible for the interim control, and ultimate correction of significant nonconformance.