Audit Objectives
The objective of an audit is to verify the adequacy of the operational characteristics of this facility’s quality assurance practices, specifically as they relate to the control of metrology.
Audit Purpose
The purpose of the audit is to ensure that the Quality Assurance Program requirements which address the control of metrology or Measuring and Test Equipment (M&TE), used at facilities that may be subcontracted to Electric Transportation Applications. This includes control measures for all aspects of the calibration and use processes, repair, and rework of defective instrumentation. The Audit Plan shall include, but not be limited to, one or more aspects of the following: • control of the facility’s metrology calibration processes • control of the facility’s metrology calibration standards • control of the facility’s metrology procedures • control of the facility’s metrology records, including retention requirements • Control and reporting of defective metrology • Rework/repair of defective metrology • Rework/repair of metrology which fails in service
Audit Requirements
The Quality Assurance (QA) Plan being audited shall have been developed in accordance with the requirements of The National Bureau of Standards Handbook (NBS/HB)-145, or another similar document. The QA Plan is required to contain controls for those items specified as necessary by the NBS/HB-145. For those items required by the NBS/HB but not specifically contained in the QA Plan, then the NBS requirements for alternatives must have been followed.
Audit Personnel
Personnel who conduct the audit shall either be trained or have experience in this type of activity. Training may be formal, such as through post-secondary or post-graduate studies, or through an approved or generally accepted Industry or Corporate Training Program. Experience should have been gained through actual auditing of QA Activities or Plans at other facilities or companies, which may include those controlled by Federal or State Governments. Individuals should be capable of being certified as an auditor to the requirements of the QA standard used as the basis for the QA Plan being audited.
Audit Documentation
The documentation used and generated during the Audit Process should be retained as a permanent part of the audit package. Copies of the completed audit, including all checklists and reports, noted deficiencies and any corrective action activity reports, shall be made available to all members of the audit team, as well as to the management of the facility being audited. The audited facility shall maintain the results of the Audit in accordance with the external auditing requirements of their QA Plan, if so stipulated. If not otherwise stipulated, the results of the audit shall be maintained until the date of completion of all activities addressed by the governing contract. All documents shall be signed by the person completing the document and the Audit Team Leader. The names of the audit team members shall be listed in the document. The final Audit Package will be signed by all members of the Audit Team, and signed by the Manager of the facility or group being audited, or a designated representative. These final signatures shall be attached following completion of the exit meeting process, and will signify that all signers have been made aware of the audit findings, and have received a copy of the final report. Signatures of additional facility personnel, as required by NBS/HB-145 or the facility’s QA plan or audit program, shall be affixed as appropriate.
Audit Process
The audit shall utilize checklists and interviews to obtain data. Procedures and controls specified by NBS/HB-145 and others as may be specified by the Facility’s QA plan are subject to review. Only data which is relevant to the particular process under review will be collected. Every attempt will be made to keep the identify of interviewees confidential, as individual reproach is not the intent of this effort. Audit findings which in the opinion of the audit team are considered or judged to be unsafe, or could be reasonably expected to jeopardize the safety of the interviewee, other individuals or equipment, or which in turn could jeopardize the safety of subsequent individuals, shall be reported to a senior member of the Subcontractor’s organization.
Audit Protocol
Audit activities shall take place at the subcontractor’s facilities unless otherwise agreed to in advance. Activities are limited to those activities identified in this Plan. Activities not under the scope of this Plan should not be audited but may be otherwise noted or reported. All ETA personnel involved in the audit at the subcontractor’s facility are required to follow the confidentiality guidelines and the security and safety requirements of that subcontractor. All findings of the Audit shall be maintained confidential until the report has been completed, reviewed, and signed by all members of the Audit team, or their designated representative. The final report should be maintained as previously stipulated. It may be maintained for longer periods, as directed by the facility’s requirements for records retention.
Audit Activities
1 Quality Assessment
2 Quality Assurance Program Document
3 Documentation
4 Laboratory Administration
5 Laboratory Records
6 Calibration/Test Report Preparation