Quality Manual
Quality Manual
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METROLOGY LABORATORY
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QUALITY MANUAL
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REVISION 12
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TABLE OF CONTENTS
Quality Policy................................................................................................................... i
Statement of Authority.................................................................................................... ii
Section 4.0 Management Requirements ................................................................... 1
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Subsection 4.1 Organization .......................................................................................... 1
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Subsection 4.2 Quality System ...................................................................................... 7
Subsection 4.3 Document Control ................................................................................. 8
Subsection 4.4 Review of Requests, Tenders, and Contracts........................................ 8
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Subsection 4.5 Subcontracting of Tests and Calibrations.............................................. 9
Subsection 4.6 Purchasing Services and Supplies ....................................................... 10
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Subsection 4.7 Service to the Customer ...................................................................... 11
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Subsection 4.8 Complaints........................................................................................... 11
Subsection 4.9 Control of Nonconforming Testing and/or Calibration Work ............ 11
Subsection 4.10 Continuous Process Improvement...................................................... 13
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Subsection 5.4 Equipment............................................................................................ 21
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Subsection 5.5 Measurement Traceability ................................................................... 20
Subsection 5.6 Sampling.............................................................................................. 23
Subsection 5.7 Handling of Test and Calibration Items .............................................. 23
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Subsection 5.8 Assuring the Quality of Test and Calibration Results......................... 23
Subsection 5.9 Reporting of Results............................................................................ 24
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Attachment 1 Organization Chart ............................................................................... 26
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Edison Metrology Laboratory Quality Manual
QUALITY POLICY
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and to satisfy them on every job.
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Our goal is to continuously measure and improve the processes that
contribute to our effectiveness, efficiency and productivity in order to
deliver quality products and services at competitive prices. Ultimately
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the quality of our services is the responsibility of each employee.
It is the policy of Shop Services & Instrumentation Division (SSID)
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to involve the work force in all aspects of issues related to their work
activities. We will strive to stimulate creativity, initiative, and sense
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of responsibility and to provide an environment that fosters a spirit of
"pride in workmanship and teamwork" among employees. All
employees will embrace the SCE vision of Leading the Way in
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STATEMENT OF AUTHORITY
Edison ESI a subsidiary of Southern California Edison, and the Metrology Laboratory recognizes the
importance of quality in industry and is committed to continuous improvement in the quality of work
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controlled under our Quality Management System.
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The Metrology Laboratory Quality Management System has been prepared to document the processes
that control calibration activities and contractual agreements between the customer and Edison.
This quality management system meets the requirements of ISO/IEC 17025, NIST Handbook 150,
10CFR50 Appendix B, ANSI/NCSL Z540-1-1994, IEEE-498, Regulatory Guide 1.33 as applicable,
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and MIL-STD 45662A and satisfies the requirements of our accreditation organization(s). By
implementing ISO/IEC 17025, the Metrology Laboratory satisfies the requirements of QS 9000 for an
acceptable subcontractor.
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Contractual arrangements between the customer and the Metrology Laboratory through Edison ESI
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which specify requirements in addition to those specified by this quality management system, shall be
applied providing such requirements do not compromise the quality of our service or this quality
management system.
Confidentiality and proprietary rights for customer provided information shall be respected and
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protected. Metrology Laboratory personnel shall not copy or otherwise reproduce any customer
provided confidential or proprietary document. All customer provided confidential or proprietary
documents shall be returned to the customer when the scope of work is completed.
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The Metrology Laboratory has the capabilities to perform repair and calibration of measuring and test
equipment (M&TE) in the following disciplines: Dimensional, Electrical, Mass, Pressure, Temperature
and Humidity, Torque, Force, Gas Flow, Time, Frequency and Vibration. The management and
administrative sections of this quality management system apply to all Metrology activities. Certain
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technical requirements apply only to accredited metrology disciplines. When requested, on-site
(customer location) calibrations shall be performed in accordance with the requirements contained
within the quality management system.
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Identify and record problems.
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Initiate, recommend or provide solutions.
Verify implementation of solutions.
Control further processing of nonconforming conditions until corrected.
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The organization is comprised of the Manager of Shop Services & Instrumentation
Division (SSID), Technical Services Manager, Metrology Laboratory and Quality
Assurance. Purchasing and Warehousing personnel perform support functions, when
requested.
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The Manager of SSID reports to the Vice President of Southern California Edison
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Company and is responsible for all aspects of the operation; is authorized to make
contractual and binding commitments; develops policy, and is responsible for the
growth and development of new business. The Manager of SSID maintains
responsibility for the quality management system.
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Edison ESI provides sales, marketing and purchase order negotiations to customers
external to SSID and the Edison International business units. Edison ESI performs no
quality affecting activity in its support of the Metrology Laboratory.
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The Technical Services Manager reports to the Manager of SSID and is responsible for
the implementation of Metrology Laboratory activities and for the implementation of
this quality system. The deputy for the Technical Services Manager is the Metrology
Services Manager.
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The Metrology Services Manager reports to the Technical Services Manager and is
responsible for activities in the Technical Services Processing Area, Metrology
Engineering Services and the Metrology Laboratory. The Metrology Services Manager
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The Metrology Supervisor is responsible for the day to day operations in the laboratory
to include administrative support service such as calibration procedure maintenance,
personnel training, and ensuring the technical capability of the lab is maintained.
The Processing Area Supervisor reports to the Metrology Services Manager and is
responsible for the day to day operations and administrative support such as purchase
order review, directing receiving and vendor functions. The Processing Area
Supervisor shall ensure timely and accurate customer communications in the area of
recall and status.
The SONGS Program Manager reports to the Processing Area Supervisor, and is
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responsible for associated customer requests, procurement activities associated with
SONGS, and reporting as outlined in the SONGS agreement with Metrology. The
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Metrology Supervisor shall perform functions/responsibilities in the absence of the
Processing Area Supervisor.
Metrology Team Leaders report to the Metrology Supervisor and are responsible for
directing calibration work assignments and priorities, review and approval of
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calibration documentation and procedures, calibration of M&TE and routine laboratory
operations.
Customer Administrative Support personnel report to the Processing Area Supervisor
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and are responsible for shipping and receiving activities, order entry, contract review,
and maintenance of all applicable documents and delivery of equipment to the
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appropriate calibration laboratory.
The Metrology Technical Specialist (Metrologists) receives direction from the
Metrology Team Leader and is responsible for the calibration and repair of M&TE, the
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preparation, verification review and revision of calibration procedures and the review
and correctness of calibration documentation.
The Metrology Engineer reports to the Metrology Supervisor and is responsible for the
following duties: calibration failure evaluation, deriving equipment accuracy
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The Procedure Coordinator reports to the Metrology Supervisor and is responsible for
the generation, revision, and maintenance of all ECI documents.
The Software Controller reports to the Technical Services Manager and is responsible
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for all software operations within the Metrology Department. The software controller
will coordinate Metrology software and LAN operations with the Metrology
Supervisor, software management, and hardware management personnel in SSID.
The Health Physics (H.P.) on-site representative administratively reports to the
Technical Services Manager. The H.P. Representative administrates the Health Physics
Program at SSID, designed to provide radiological health and safety controls for repair
and calibration of radioactive equipment. These activities are conducted under the
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The Quality Assurance Manager reports to the Manager of SSID and has the
responsibility and authority for ensuring that this quality management system is
implemented and followed at all times. The Quality Manager has direct access to the
highest level of management at which decisions are made on laboratory policy or
resources. The Quality Manager is committed to and responsible for ensuring this
quality management system is compliant with NIST Handbook 150, ISO/IEC 17025,
10CFR50 Appendix B, ANSI/NCSL Z540-1-1994, IEEE-498, MIL-STD 45662A and
Regulatory Guide 1.33. The Quality Manager has appointed the Quality Assurance
Lead Auditor as the Deputy Quality Manager. The Deputy Quality Manager shall
perform theses functions/responsibilities in the absence of the Quality Manager.
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Purchasing is responsible for translating Procurement Request (PREQ) requirements
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into purchase orders. Translation of material service requests requirements and
issuance of procurement documents are corporate purchasing functions, controlled by
corporate procedures, and are outside the scope of the quality management system.
Metrology Laboratory personnel review requests, select approved suppliers, and inspect
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parts and equipment at receipt to verify compliance to procurement document
requirements.
Warehouse personnel provide support services to the Metrology Supervisor, as
requested.
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In the event that any individual in the organization is absent or otherwise unavailable to
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perform functions or responsibilities, those functions and responsibilities may be
performed by a superior or delegated to a qualified subordinate within the organization.
The Metrology Department retains full responsibility for implementation of the quality
management system.
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All employees are responsible for the quality of the products and services under their
control and for following procedural requirements during all processes they are
involved in. All employees have the responsibility and authority to identify quality
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4.1.2 Resources
.1 The Metrology Supervisor will assign trained personnel to manage, perform and
verify activities affecting quality. Personnel assigned these tasks are qualified on
the basis of experience and/or training.
.2 The Technical Services Manager shall ensure that the quality of the work performed
is not influenced by any undue internal/external commercial, financial, or other
pressures or influence. This is accomplished by establishing fair and reasonable
departmental goals and expectations. Efficient work practices, individual
accountability and adhering to the quality guidelines ensure that personnel
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performance eliminates negative influences.
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.3 Job descriptions have been developed for managerial, technical, and key support
personnel involved in providing calibration services.
.4 The Metrology Supervisor shall maintain documented authorization for personnel
assigned to perform special calibrations, when applicable.
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4.1.3 Management Representative
.1 The Management Representative has been appointed by the Manager of SSID and
Technical Services Manager and is responsible for ensuring this quality system is
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maintained, understood and implemented at all levels of the organization. The
Management Representative is also responsible for reporting on the performance of
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the Quality Management System during the annual management review.
4.1.4 Quality Policy
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.1 The Quality Policy at the Metrology Laboratory is affirmed in a statement from the
Manager of SSID and the Technical Services Manager and is located in the front of
this Quality Manual. This policy will be understood, implemented, and maintained
by all personnel. A copy of the Quality Policy has been distributed to all employees
and is posted in conspicuous locations.
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Metrology Laboratorys quality management system are reviewed:
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.1 Results of internal, customer and external body audits;
.2 Results of corrective/preventive action reports;
.3 Results of supplier corrective action reports;
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.4 Customer feedback (positive and negative);
.5 Metrology Laboratory goals, objectives, and Quality Policy;
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.6 Suitability and effectiveness of the quality system in meeting, ISO/IEC 17025,
NIST Handbook 150, ANSI/NCSL Z540-1-1994, MIL-STD 45662A, IEEE-498,
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Regulatory Guide 1.33 as applicable, and 10CFR50 Appendix B;
.7 Training accomplishments and future training needs;
.8 Reports from managerial and supervisory personnel (staff observations and
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suggestions);
.9 Results of inter-laboratory comparisons and specific department metrics;
.10 Recommendations for improvement;
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.1 The Quality Management System described in this manual encompasses the
controls necessary for qualified personnel to provide, material, and services in
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accordance with, ISO/IEC 17025, NIST Handbook 150, ANSI/NCSL Z540-1-1994,
MIL-STD 45662A, IEEE-498, Regulatory Guide 1.33 as applicable, 10CFR50
Appendix B and contractual requirements. This quality management system
provides for activities affecting quality to be achieved under controlled conditions
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in an appropriate environment and it takes into account the need for standards,
measurement and test equipment, tools, and skills to achieve the required quality.
4.2.2 The Quality Management System consists of:
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.1 Quality Manual - describes Metrology Laboratory approach to the aforementioned
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requirements.
.2 Production Control (Metrology) Procedures - documents specific Metrology
functions and activities.
.3 Quality Assurance Procedures - documents generalized functional responsibilities
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.7 Controlled Forms.
4.2.3 Quality Planning
.1 The Metrology Laboratory has implemented a system of procedures and instructions
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.2 Review and approval of procedures and instructions are defined in implementing
procedures. Forms are controlled. External documents that affect product quality
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and are used or referenced in the quality management system shall be controlled.
.3 Master lists and logs identifying all quality system documentation and data by
revision and date have been established. These lists and logs identify either the
assigned individual or the location where the documents are located.
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.4 Control of documents and data ensures that the pertinent issues are available to all
personnel performing activities. Obsolete or invalid documents are promptly
removed from all points of issue and use. Historical copies shall be archived for
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reference and marked Superseded with an inked stamp on the approval page.
Quality system documents are identified by number, date, and revision. Quality
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management system documents shall be reviewed annually to ensure their
effectiveness and current application to the scope of work performed. ECIs are
reviewed upon use.
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.1 Revisions to documents and data shall be reviewed and approved by the original
approving organization, unless specifically designated otherwise. The designated
organizations shall have access to historical background information to assist in
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review.
.2 Changes to documents shall be identified by use of a side bar indicating the text
change. Revised documents shall be issued upon approval in accordance with QAP-
002.
4.4 Review of Requests, Tenders, and Contracts
4.4.1 General
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.1 The controls defined in the quality management system applies to all customer
orders received by the Metrology Laboratory. Customer orders can be by hard copy
purchase order, including blanket orders, faxes, or by other instructions provided by
the customer.
4.4.2 Customer Order Review
.1 Customer Administrative Support personnel receive customer orders and review the
orders to ensure that: (1) the customer procurement document agrees with the
offered quote (if applicable); and, (2) Metrology Laboratory can meet the
customers technical requirements. Verbal orders are not accepted.
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.2 Approval is required for intervals of customers requiring ISO/IEC 17025.
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.3 ESI authorized personnel are responsible to review and accept customers purchase
orders for commercial terms and conditions.
.4 If ESI is unable to meet the customers terms and conditions, ESI authorized
personnel shall contact the customer to notify them of the circumstances and
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attempt to resolve concerns. If resolution cannot be achieved the customers order
will not be processed and, if applicable, the customers equipment returned.
.5 If ESI and the Metrology Laboratory are able to meet the customers requirements,
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the administrative support person shall interpret and document the type of
calibration required and any special requirements in MudCats.
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.6 The equipment is then forwarded to the laboratory for calibration.
.7 Amendments to customer orders are processed, as was the original order.
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4.5.1 The Metrology Laboratory may use suppliers to perform equipment calibrations that are
within, or outside, our scope of calibration capabilities. Suppliers of calibration
services shall be evaluated and placed on the Approved Suppliers List by one or more,
of the following methods: on-site audit; Commercial Grade Dedication; review of their
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supplier must either submit an ISO 17025 accreditation certification or have an ISO
17025 quality management system that has been successfully audited by SSID QA and
Metrology Laboratory technical personnel.
4.5.3 Records of acceptable subcontractors shall be maintained in accordance with
documented procedures.
4.6 Purchasing Services and Supplies
4.6.1 Software used in the calibration of measuring and test equipment shall be procured (after
December 31, 2000) from suppliers approved in accordance with QAP-015, Supplier
Qualification. with the exception of software developed by Metrology Engineering
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Services (MES). MES has a quality management system that complies with the
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requirements of 10CFR50 Appendix B, 10CFR 21. The MES quality management
system is audited annually by SSID QA. Records of acceptable suppliers shall be
maintained in accordance with MET-010, Quality Records.
4.6.2 Parts and components used in the repair and calibration of customer equipment are
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inspected at receipt and functionally tested during calibration. Suppliers of parts,
components and miscellaneous materials are not required to be evaluated for placement
on the Approved Suppliers List. The critical attributes of these items are that they meet
purchase order requirements and that the customers equipment can be successfully
calibrated.
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4.6.3 Receipt inspection of parts and components is defined in section titled, Inspection and
Testing of this quality manual. Calibration is defined in the specific Equipment
Calibration Instruction.
4.6.4 Return of customer equipment shall be by freight carriers designated by the customer or
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These procurement documents contain data describing the service, including where
applicable: the type, class, grade, or other precise identification; calibration
instructions, standards or other technical information; and, the title, number, and
issue of the quality system standard to be applied.
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.2 All Material Service Requests are reviewed and approved by authorized individuals
prior to release. Amendments to procurement documents are subject to the same
requirements and controls as were utilized in the preparation of the original.
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the Metrology Laboratory shall retain the responsibility for product conformance
and release.
4.7.1 Customer equipment received at the Metrology Laboratory for calibration shall be
received and verified against the customers supplied documents as applicable. The
assigned individual shall verify that the customers equipment is adequately identified,
that there is no apparent damage to the equipment (unless pre-identified by the
customer), and that the equipment identification matches the customer paperwork.
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4.7.2 Customer equipment is tracked through the use of the serial number or unique
identification.
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4.7.3 Any concerns regarding the acceptability of the customers equipment upon receipt shall
be reconciled with the customer prior to forwarding the equipment to the calibration
laboratory.
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4.7.4. If the customers equipment is lost, damaged, or becomes unsuitable for use due to the
fault of the Metrology Laboratory after receipt, it shall be reviewed by the Metrology
Supervisor to determine if corrective action documentation is required. The Metrology
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Supervisors hall ensure that further processing of the equipment is halted and shall
consult with the customer to determine what action is to be taken (i.e. replacement or
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repair).
4.7.5 The Metrology Laboratory shall afford all customers the opportunity to clarify any
request and to monitor our calibration practices and performance in relation to work
performed for that customer.
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4.7.6 The Metrology Laboratory reserves the right to prohibit customers from reviewing
information, data, and/or calibration/repair activities being performed for another
customer.
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4.8.1 Complaints received from customers, or other parties shall be evaluated and if deemed to
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4.9.1 General
.1 Within the Metrology Laboratory nonconforming items are classified as follows:
Parts and/or components used in the repair of M&TE that do not meet purchase
order requirements;
M&TE received from suppliers without proper paperwork or damaged;
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Customer equipment received in damaged condition;
Discrepancies noted during calibration activities;
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Metrology Laboratory owned equipment that has AS-FOUND data exceeding
required acceptance criteria.
4.9.2 Review and Disposition of Nonconforming Product
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.1 A calibration failure evaluation shall be performed in accordance with the
requirements of MET-001, Calibration Production Control, whenever the
Metrology Laboratory owned equipment has as-found data exceeding documented
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acceptance criteria or when instances of mishandling occur which are known or
suspected of having an adverse effect on calibrations.
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.2 M&TE received from suppliers with documentation problems (incorrect paperwork,
missing Certificate of Calibration and/or data, etc.) shall be put into a designated
hold area until the receipt inspection issues are resolved. Should the equipment be
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.4 Discrepancies observed during calibration and actions taken to resolve issues shall
be noted on the calibration certificate as required by MET-001, Calibration
Production Control.
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4.9.4 Management is responsible for authorizing the resumption of work after appropriate
actions have been initiated.
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4.10.1. Metrology shall plan and implement measurement, monitoring, analysis and
improvement processes needed to evaluate and improve the quality system
effectiveness. Facilitation of continual improvement of the quality system is to include
the use of the Quality Policy, quality objectives, audit results and analysis of data,
corrective and preventive actions and the Management Review. This evaluation is
conducted in accordance with MET-012, Continuous Process Improvement.
4.11. Corrective Action
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4.11.1. Conditions that are adverse to quality, item related, process, or programmatic, shall be
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identified documented and resolved in accordance with QAP-008, Corrective Action,
and also, if required, in accordance with QAP-010, Reporting Problems Pursuant to 10
CFR Part 21.
4.11.2. When it is determined that an adverse quality condition exists, a Corrective Action
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Report (CAR) shall be issued. The Corrective Action Report shall identify the root
cause of the issue, immediate action taken to correct the issue and action taken to
prevent recurrence.
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4.11.3. The responsible individual(s) is given 30 days from the date of issuance to respond to
the corrective action or request an extension.
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4.11.4. Quality Assurance shall then evaluate the response to ensure the root cause, immediate
corrective action, and supplemental action is adequate to resolve the adverse condition.
This evaluation shall be completed within five working days of QAs receipt of the
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4.11.6. When a resolution cannot be achieved, the matter shall be elevated to the Manager of
SSID or to the Technical Services Manager (if supplier related).
4.11.7. Within 30 days following the proposed implementation date, QA shall verify that all
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4.12.1. The Quality Assurance Manager is responsible for evaluating preventive actions
reported through the corrective action system. During the audit of the quality system
the Quality Assurance Manager shall evaluate work operations; customer complaints;
previous audit results and corrective action documents to determine if a negative trend
has developed. Actions will be taken to eliminate negative trends.
4.12.2. A proactive process for identifying potential negative programmatic or technical issues
and needed improvements shall be implemented. Potential sources for preventive
action implementation, either technical or concerning this quality management system,
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shall be identified by one or more of the following:
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.1 Implementation of the employee idea database that includes process/program
improvement suggestions;
.2 Customer feedback database;
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.3 Results of department metrics;
.4 Results of inter-laboratory comparisons; and/or
.5 Results of calibration certificates review.
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4.12.3. Records of corrective and preventive actions shall be maintained as quality records and
shall be reviewed by executive management during the periodic management review of
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the quality management system.
4.13. Control of Records
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4.13.1. Procedures have been developed to define controls for the identification, collection,
indexing, access, filing, storage, maintenance, and disposition of quality and technical
records. The records shall include at least the following: results of management
reviews, inspections, tests, audits, corrective and preventive action reports, contract
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maintained.
4.13.2. Records shall be legible and stored in a manner that permits adequate retrievability and
prevents damage, deterioration and loss. Record retention times have been established
for all records identified in MET-010, Quality Records.
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4.13.3. Metrology Laboratory customers are granted free access to all records controlled under
the auspices of this quality system that are relevant and that pertain to the particular
customer.
4.13.4. All Metrology Laboratory personnel have been instructed to transmit calibration results
and information regarding a particular customer only to that customer (individual will
be identified). No allowances for customers to review or receive other customers
records will be permitted.
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4.14. Audits
4.14.1. General
.1 Personnel who do not have direct responsibility for performing the activities audited
shall perform audits in accordance with documented procedures or checklists.
.2 Audit results shall be documented, reported to, and reviewed by the Quality
Assurance Manager.
.3 These requirements are applicable to both internal and supplier audits.
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4.14.2. Audit Scheduling
.1 The Metrology Laboratory Quality Program shall be assessed annually to ensure
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continuous compliance to committed requirements.
4.14.3. Audit Personnel
.1 The Quality Manager shall assure that audit team members are trained.
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4.14.4. Audit Performance
.1 Audits shall be performed in accordance with QAP-017, Audits and
Surveillances.
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.2 Auditors shall have access to previous audit results to aid in audit preparation.
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.3 Selected program elements shall be evaluated against specific requirements.
.4 Objective evidence shall be examined to the depth necessary to determine if
program elements are effectively implemented.
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documented on the finding report or on documents traceable to the report and shall
specify completion dates.
4.14.7. Audit Follow-Up
.1 Follow-up audit activities shall verify and record the implementation and
effectiveness of the corrective action taken.
.2 Records of audits and associated corrective actions shall be maintained as required
by documented procedures.
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4.15.3. Parts and/or components used in the repair of M&TE do not require unique
identification and/or traceability to the end use.
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4.16. Process Control
4.16.1. MudCats software combines several databases to provide current information for
managing the flow of work through the Metrology department. MudCats is used to
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track the equipment status through the Metrology Laboratory, permits generation of
work travelers, shipping documentation, etc., and provides management with cost and
manpower data.
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4.16.2. Repair and adjustment activities are performed by personnel using controlled equipment
manufacturers manuals and OEM provided controlling software. Repair and adjustment
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activities are not critical to product quality since the final calibration validates the
conformance of the equipment. Calibrations shall be performed in accordance with
issued work travelers.
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4.16.3. Equipment used in the calibration of M&TE shall be calibrated at defined intervals that
assure measurement standards and calibration devices are traceable to the international
system of units (SI) via nationally recognized standards maintained by National
Institute of Standards and Technology (NIST), other national laboratories with which
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performed. If the item is acceptable, the Metrology Calibration Certificate shall
be stamped or initialed to indicate acceptance. The Metrology Supervisor shall
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make the determination if a Supplier Corrective Action Report is to be issued in
accordance with QAP-008, Corrective Action.
.3 Material Service Requests are maintained in Metrology as quality records.
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4.17.2. In-Process and Final Tests
.1 Final tests are performed by qualified personnel in accordance with MET-001 and
the applicable calibration work instruction. In-process inspections and tests are not
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applicable to Metrology Laboratory calibration services.
4.17.3. Inspection and Tests Records
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.1 Receiving and final test and inspection records shall be maintained in accordance
with documented procedures.
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to requester.
4.18.3. Receiving inspection status for customer equipment shall be documented on the
customers shipping documents. Only customer equipment received in proper condition
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in the remarks section of the calibration report along with actions taken to correct the
unsatisfactory condition.
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4.19.2. Statistical techniques and analysis are employed at the primary level for certain
disciplines in order to maintain control of secondary level equipment.
4.19.3. Statistical techniques used during the calibration process are to monitor measurement
uncertainties, drift, and to provide data for analysis to ensure process control where
needed.
4.19.4. The methods used are described and maintained in MET-008, Statistical Process
Controls.
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4.20. Design Control
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4.20.1. Design Control activities are not applicable to Metrology Laboratory calibration
services.
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.1 Personnel performing activities described in this quality manual shall meet the
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requirements established in their job description. Prior to performing activities
affecting quality, each employee shall receive hands-on training and be observed
performing the task. The Metrology Supervisor and Processing Area Supervisor
shall maintain records of employee qualifications.
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5.1.3 Indoctrination and Training
.1 Personnel (permanent/contractor) employed by the Metrology Laboratory that are
involved in activities affecting quality shall be indoctrinated in the requirements of
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the Quality Program. Personnel will be retrained in the program requirements at the
discretion of the Quality Assurance Manager.
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.2 Personnel shall also be trained in the requirements of procedures and instructions
that are pertinent to their area of activity. Training shall be current, documented and
maintained as quality records as required by this quality manual.
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.3 The Metrology Supervisor and Processing Area Supervisor are responsible for
ensuring that the status of personnel qualification and training is current.
5.1.4 Job Descriptions
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.1 Job descriptions shall be maintained for managerial, technical, and key support
personnel involved in the tests and/or calibrations.
5.2 Accommodation and Environmental Conditions
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acceptable calibrations.
5.2.2 As necessary, electrostatic discharge controls shall be in place to prohibit damage to
customer and laboratory owned equipment.
5.2.3 Access to the laboratory shall be controlled. Authorized personnel and accompanied
guest are allowed in the laboratory area. Each access point shall be marked
accordingly.
5.2.4 Housekeeping requirements are defined in MET-001, Calibration Production Control.
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5.2.5 The calibration environment at the customers site, when applicable, shall be monitored
for both humidity and temperature using a calibrated device. The technician shall
ensure that conditions appropriate to the calibration to be performed at a customers site
meet the minimum specification for the type of device being calibrated or apply
compensation corrections when appropriate. Environmental conditions must be
recorded, if not, then monitored and stated, or a statement of not monitored included on
the calibration report.
5.2.6 Calibrations shall be separated by discipline, where applicable, and be performed in the
area in which it has been determined optimum for that discipline.
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5.3 Test and Calibration Methods and Method Validation
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5.3.1 Calibration procedures may take the form of OEM manuals, internally generated
equipment calibration instructions (ECI), or industry standards. The latest valid edition
shall be used unless it is inappropriate or not possible to do so.
5.3.2 Equipment calibration instructions shall contain:
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.1 The range and accuracy of the device under test; however stated;
.2 The range and accuracy of the devices used to test; however stated;
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.3 The generic description of the devices used to test; however stated; and
.4 Generic description of methodologies used.
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5.3.3 Deviations from approved calibration procedures shall be documented on the
calibration report, technically justified, reviewed by the Metrology Supervisor and
offered to the customer for acceptance.
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5.3.5 ECIs have been proven by historical use. Validation criteria for calibration processes
are defined in MET-005, Preparation and Control of Equipment Calibration
Instructions (ECIs).
5.3.6 Measuring and test equipment shall have their uncertainty documented and maintained
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by the Metrology Engineer. Methods for performing uncertainty analysis are described
in MET-011, Uncertainty Analysis and Maintenance of Error Budgets. Uncertainty
calculations shall be subjected to appropriate checks and documented.
5.3.7 Calculations and data transfers shall also be subjected to appropriate checks and
documented by the Metrology Supervisor.
5.3.8 Internally generated spreadsheets affecting calibration results shall be independently
verified and maintained in accordance with MET-003, Metrology Software Control
Program. External software used in conjunction with a calibration must be procured in
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Edison Metrology Laboratory Quality Manual
accordance with Section 4.6 of this quality manual. Software used as part of a
calibration is listed in the approved ECI. Software is approved for use upon approval of
the ECI.
5.4 Equipment
5.4.1 Equipment Availability
.1 The Metrology Supervisor shall ensure equipment availability to perform correct
calibrations. Use of equipment outside the laboratorys permanent control is
prohibited unless the provider of the equipment is qualified and placed on the
Approved Suppliers List or the equipment is recalibrated by the laboratory or an
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approved supplier. Customer supplied equipment may be used for calibration
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support at customer facility. Use of such equipment shall be documented on the
calibration report at the discretion of the Metrology Supervisor.
5.4.2 Equipment Selection
.1 All Metrology Laboratory equipment selections and calibrations are based on
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factors affecting measurement uncertainty.
5.4.3 Equipment Identification
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.1 Measures shall be established in procedures to ensure that Metrology owned
measuring and test equipment being calibrated is properly identified.
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.2 Measuring and test equipment, and associated software, shall be identified to
provide unique traceability to associated calibration records, and to indicate the
calibration status of the measuring and test equipment. All active measuring and
test equipment must be calibrated prior to use.
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.3 All measuring and test equipment shall be properly maintained. Any item which
has been subjected to overloading or mishandling, or which gives suspect results, or
is shown to be defective shall be taken out of service.
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and test equipment are affected, customers shall be notified in writing. When
measuring and test equipment is found to be out-of-tolerance it shall be repaired,
recalibrated, or replaced in accordance with MET-001, Calibration Production
Control.
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.5 Obsolete or damaged beyond repair equipment are identified and removed from the
laboratory. Equipment may be sold or discarded.
5.4.4 Status Indicators
.1 All measuring and test equipment that require calibration (new and customer
owned) shall be subjected to test, calibration, and inspection as required. The
acceptance status of each instrument shall be maintained through the use of status
indicators such as tags, physical location, and or documented records of test,
calibration and/or inspection as applicable.
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Edison Metrology Laboratory Quality Manual
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.2 Manufacturer, model number, serial number, and asset number, where
applicable;
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.3 All items are assumed to be in the laboratory, in the possession of a technician,
or out for calibration unless otherwise noted;
.4 Dates and results of calibrations and/or verifications and date when the
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calibration and/or verification expires;
.5 Results of maintenance, as applicable;
.6 Manufacturers instructions, if applicable, or reference to their location; and
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.7 Maintenance performed on equipment including any damage, malfunction,
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modification, or repair to the equipment.
5.4.7 Test and calibration equipment, including both hardware and software, shall be
safeguarded from adjustments that would invalidate the test and/or calibration results.
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exist. Where such standards do not exist, calibration shall be performed to meet the
manufacturers recommended specifications or the basis for calibration shall be
documented (Report of Calibration).
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5.6 Sampling
5.6.1 Sampling is not part of the calibration process employed by the Metrology Laboratory.
5.7 Handling of Test and Calibration Items
5.7.1 Measuring and test equipment shall be handled in a manner not to negatively affect
readings or accuracy. Carts may be used to move heavy pieces of measuring and test
equipment around the calibration laboratory. Lighter pieces of measuring and test can
be hand carried to points of destination.
5.7.2 Items shall be stored as follows:
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.1 Items are staged on shelves, carts, or on the floor in the original container, until the
calibration laboratory receives the equipment.
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.2 Parts and/or components are stored in bins, boxes or manufacturer envelopes and
are identified by part number or description.
.3 Items in the process of calibration shall be staged on work benches or shelving in a
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manner not to cause damage or deterioration to the equipment.
.4 Items being shipped are staged on tables, shelves, or floor for larger items in the
processing area until completion of the data package.
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.5 Protective environments, including moisture and temperature parameters have been
established as defined in MET-001, Calibration Production Control.
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5.7.3 As necessary, all measuring and test equipment shall be packaged in foam, peanut
insulation, etc., to limit impact and damage during shipment.
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5.7.4 The methods and controls for assuring that equipment is delivered in a safe manner are
described in MET-004, Administrative Processes.
5.7.5 From time of receipt all measuring and test equipment shall be stored on tables, work
benches, shelves, or on the floor in the original manufacturers container, if provided, to
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Edison Metrology Laboratory Quality Manual
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.3 Unique identification of the certificate or report and of each page, and the total
number of pages;
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.4 Name and address of customer;
.5 Description and identification of the item calibrated;
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.6 Characterization and condition of the calibration item;
.7 Date of receipt of the calibration item where this is critical to the validity and
application of the results and the date on which the calibration was completed;
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.8 Identification of the calibration procedure used or manufacturer specification used
to determine in/of tolerance of measuring and test equipment;
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.9 Any deviation from, additions to, or exclusions from the calibration procedure, and
any other information relevant to the calibration, such as environmental conditions
that may influence the calibration;
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.13 The standards used to perform the calibration and their calibration due date;
.14 A statement of accuracy and uncertainty (when appropriate);
.15 Details of any servicing, adjustments, repairs, or modifications performed;
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.18 A statement that the certificate shall not be reproduced except in full, without the
written approval of the Edison Metrology Laboratory;
.19 A statement that the report must not be used by the client to claim product
endorsement by any accreditation body or any agency of the U.S. Government;
.20 Signature, or initials, of reviewing party;
.21 Traceability statement; and
.22 Opinions and/or interpretations, as applicable.
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Edison Metrology Laboratory Quality Manual
5.9.3 Amendments
.1 Material amendments to a Calibration Certificate, after issue, shall be made only in
the form of another document. A statement Corrected Copy shall appear
identifying the amended copy.
5.9.4 Transmission of Results to Customers
.1 Should the Metrology Laboratory be requested to electronically transfer results of
calibrations to the customer the individual transmitting the information shall
complete a facsimile sheet identifying the individual the information is sent to and a
statement of confidentiality.
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5.9.5 When subcontractors perform calibrations, the Metrology Laboratory shall issue a
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Calibration Certificate identifying the subcontractor and shall attach the subcontractors
calibration certificate.
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Edison Metrology Laboratory Quality Manual
Vice President
Southern California
Edison Company
Manager of SSID
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Quality
Assurance
Manager
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Technical
Services Manager
Metrology
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Services Manager
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Metrology SONGS Program
Engineers Manager
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Health Physics
Procedure
On Site
Coordinator
Representative
Customer
Lead Metrologists
Administrative
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Support
Production
Metrologists
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ATTACHMENT 1
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