1.0 PURPOSE AND SCOPE - FLW, Inc. · FLW 1.0 PURPOSE This document defines or identifies the...

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FLW RECORD CONTROLAPPROVAL SIGNATURES

Prepared by: _____________________________________Date: ____________Matthew Peek, Assistant to the Quality Manager

Approved: ______________________________________Date: ____________Paul Peek, President, Service Manager, and Quality Manager

FLW SALES & SERVICE CORPORATION DOCUMENT NO: FPD 370 REVISION NO: 8.0Copies of Section 370 of Quality Manual QA-100 may bereleased to customers as an uncontrolled document.

Creation Date: NOV 1995 Revision Date: Sept. 2007

TITLE:Calibration System of 118 QA Manager:

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Document Change Record

Revision SectionDCF ID Number Description of Change

1.0 ALL N/A New Document2.0 ALL 00004 Complete revision to incorporate Z540-1 into the system.

Changed document number from FQD 170 to FPD 370 because it is specific to calibration Measurement and Test Equipment. Added revised footer. Added Form P370-01.

2.1 9.1; 18.4.2 00031 Removed reference to customer owned material. Added 18.4.2 on calibration adjustment.

2.2 10.0 00054, 55 Added procedure to determine the correct calibration procedure. Clarified document revision status.

3.0 4.1,5.2,7.2,9.510,13,18

00071 Changes to bring system into compliance with MIL-STD-45662A.

4.0 0076, 79,80, 81,85,86, 87, 89, 90,91

Added position of Administrative Supervisor ( changes forms P360-5.3, 4.3 & 2.3), added forms P370-22, 24, 28, 23, 25, 26, 28, 13.1

5.0 see DCF 0117 00117 changes for accuracy, clarification, efficiency 5.1 18.4 00126 Clarify calibration intervals5.2 4.1 / 10.7 00130/00132 Responsibility for Form P370-28 / passwords in 10.7,e6.0 4.1.6;

10.1.2.3,.4,.5, .6, .7; 13.8; 18.4; Forms P370-12, 39,40 & 41

00140, 141,142, 143, 144, 146, 147, 148, 149

Verifying information; maintaining calibration documentsfor field use; defining computer data security; Form P370-38; extensions on M&TE; responsibility for monitoringLab environment; responsibility for signing certificates.

7.0 18.6 0175, 0176 Added new form P370-46, modified form P370-2 to include Quality Manager.

8.0 0180, 0181 Added new forms P370-47, 48, 49, 50, 51, 52, & 53. Revised form P370-15 to 15.1.

TABLE OF CONTENTS




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page

1.0 Purpose.................................................................................................................................

...........

5

2.0 References...........................................................................................................................

........

5

3.0 Responsibility And Definitions............................................................................................ 5

4.0 Organization & Management............................................................................. ……..

……………………………

7

5.0 Quality System, Audit and Review.....................................................................

………….les....................................................................................................iles...............

9

6.0 Personnel..............................................................................................................................

........

12

7.0 Accommodation and Environment.................................................................... 13

8.0 Equipment and Reference Materials................................................................ 14

9.0 Measurement Traceability and Calibration...................................................... 15

10.0 Calibration Methods......................................................................................... 17

11.0 Handling of Calibration Items.......................................................................... 20

12.0 Records............................................................................................................ 21

13.0 Certificates and Reports................................................................................... 22

14.0 Sub-Contracting of Calibration.......................................................................... 24

15.0 Outside Support Services and Supplies That Affect Calibration Results......... 24

16.0 Complaints........................................................................................................ 24

17.0 General Requirements for Quality Assurance of M&TE. ................................ 25

18.0 Detailed Requirements for Quality Assurance for M&TE................................. 26

FORM P370 - 01 Audit Check List................................................................ 30

FORM P370 - 02 Job Descriptions................................................................ 59

FORM P370 - 03 Laboratory Capability Documentation Guideline................ 61

FORM P370 - 04 Signatories........................................................................ 75

FORM P370 - 05 Service Organization Chart............................................... 78

FORM P370 - 06 Service Label Identification………………………………. 79

FORM P370 – 07 Calibration Data Report…………………………………. 82

FORM P370 – 09 Type K Thermocouple Calibration Report………………. 84

FORM P370 – 10 FLW Service Payroll……………………………………. 85

FORM P370 – 11 Calibration Certificate…………………………………… 86

FORM P370 – 12 Calibration Extension Request………………………….. 87

FORM P370 – 13 Temperature Uniformity Survey……………………….………… 88

FORM P370 – 14 Manual Revision Verification………………………….…………. 91

FORM P370 – 15.1 Certificate of Calibration……………………………………….. 92




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FORM P370 – 16 ESD Wrist Strap Check Log Sheet……………………………….. 93

FORM P370 – 17 MIL-STD-45662A Checklist ……………………………………. 94

FORM P370 – 18 Certificate of Calibration…………………………………………. 99

FORM P370 – 19 ESD Mat Ground Verification Log………………………………. 100

FORM P370 – 20 Master Manual Index…………………………………………….. 101

FORM P370 – 21 Master Manual Index Log………………………………………... 102

FORM P370 - 22 Technician Work Sheet…………………………………………… 103

FORM P370 - 23 Parts Order Form…………………………………………………. 104

FORM P370 - 24 Certificate of Calibration - Flow Meter………………………… 105

FORM P370 - 25 Calibration Certificate - Force……………………………………. 106

FORM P370 - 26 Calibration Certificate - Force Verification of Testing Machines 107

FORM P370 - 28 Lab Shutdown Log………………………………………………... 108

FORM P370 - 29 Data Report……………………………………………………….. 109

FORM P370 - 31 Type K Thermocouple Calibration Report Worksheet…………… 110


FORM P370 - 39 Field Document Index…………………………………………….. 112

FORM P370 - 40 FLW Service Department Warranty form………………………… 113

FORM P370 - 41 Field Manual Log………………………………………………….

F…

114

FORM P370 - 42 Certificate Attachment……………………………………………. 115

FORM P370 - 44 Certificate of Compliance………………………………………… 116

FORM P370 - 45 Notification of an Out of Tolerance Condition…………………… 117

FORM P370 - 46 Out of Tolerance Standard Evaluation……………………………. 118











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1.0 PURPOSE

This document defines or identifies the policies, procedures and requirements of the FLW Calibration System. It’s purpose is to assist in formulating and providing for the uniform evaluation of the Laboratory’s compliance to the individual requirements of ISO 9001:2000 (E), ISO/IEC 17025:2005(E), and ANSI/NCSL Z540-1:1994. This document follows the format employed by ANSI/NCSL Z540-1. Part 1 of the document deals with the general requirements in accordance with which a calibration laboratory must demonstrate that it operates, if it is to be recognized as competent to carry out specific calibrations; and in the development and implementation of the FLW quality system. Part II deals with the quality assurance requirements for this Supplier’s system to control the accuracy of the measuring and test equipment (M&TE) used to assure that the supplies and services provided comply with prescribed requirements.

The FLW Calibration System is designed to meet the following standards:

• ISO 9001:2000(E)• ISO/IEC 17025:2005(E)• ISO 10012-1:1992(E)• ANSI/NCSL Z540-1-1994• MIL-STD-45662A:1988

This facility may also comply with additional Standards, Regulations, or Accreditation requirements.

2.0 REFERENCES

2.1 International Standard ISO 9002:1994(E)2.2 International Standard ISO 10012-1:1992(E)2.3 ISO/IEC 17025:2005(E) 2.4 ISO 8402:1988 Quality Vocabulary2.5 ANSI/NCSL Z540-1:19942.6 MIL-STD-45662A:19982.7 FLW QA100 - Quality Assurance Manual

3.0 RESPONSIBILITY AND DEFINITIONS

3.1 Responsibility

The QA Manager is responsible for maintaining the FLW Calibration System. The Service Manager is responsible for implementing the policies in this document and training on the policies and procedures contained herein. This document will be reviewed annually or as needed for essential changes.

3.2 Definitions

calibration: The set of operations that establish, under specified conditions, the relationship between values indicated by a measuring instrument or measuring system, and the corresponding standard or known values derived from the standard.

certificate of calibration: A document that presents calibration results and other information relevant to a calibration. Data consisting of ‘pass’ or ‘fail’ is sufficient for most calibrations unless numeric information is requested by the customer.

calibration method: Defined technical procedure for performing a calibration or verification.

certified reference material (CRM): A reference material one or more of whose property values are certified by a technically valid procedure, accompanied by or traceable to a certificate or other documentation which is issued by a certifying body.




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interlaboratory comparisons: Organization, performance and evaluation of calibrations on the same or similar items by two or more laboratories in accordance with predetermined conditions.

international ( measurement ) standard: A standard recognized by an international agreement to serve internationally as the basis for fixing the value of all other standards of the quantity concerned.

influence quantity: A quantity which is not the subject of the measurement but which influences the value of the measurand or the indication of the measuring instrument.

Examples: ambient temperature; frequency of an alternating measured voltage.

Laboratory / calibration laboratory: A body that calibrates or performs calibrations and verifications. In cases where an organization carries out other activities besides calibration, the term laboratory refers only to those parts of that organization that are involved in the calibration process.

limits of permissible error ( of a measuring instrument ) The extreme values of an error permitted by specifications, regulations, etc. for a given measuring instrument. (Also called ‘tolerance’).

measurand: A quantity subjected to measurement, e.g., the Volt. Also called the ‘measured quantity’ or the ‘quantity to be measured’.

measurement: The set of operations having the objective of determining the value of a measurand.

measurement standard: A material measure, measuring instrument, reference material or system intended to define, realize, conserve or reproduce a unit or one or more known values of a quantity to serve as a reference.

measuring and test equipment: ( M & TE ) All of the measuring instruments, measurement standards, reference materials, and auxiliary apparatus that are necessary to perform a measurement. This term includes measuring equipment used in the course of testing and inspection, as well as that used in calibration.

measuring instrument: A device intended to make a measurement, alone or in conjunction with supplementary equipment.

mutual consent standard: An artifact or process that is used as a de facto standard by mutual consent of the supplier and customer when no recognized U.S. national standard is available.

national (measurement) standard: A standard recognized by an official national decision to serve, in a country, as the basis for fixing the value of all other standards of the quantity concerned.

proficiency testing: Determination of the laboratory calibration performance by interlaboratory comparisons or other means.

(quality) audit: A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.

quality manual: A document stating the quality policy, quality system and quality practices of an organization.

quality system: The organizational structure, responsibilities, procedures, processes and resources for implementing quality management.

(quality system) review: A formal evaluation by management of the status and adequacy of the quality system in relation to quality policy and new objectives resulting from changing circumstances.

reference material: A material or substance of which one or more properties are sufficiently well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to




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materials.

reference standard: A standard, generally of the highest metrological quality available at a given location, from which measurements made at that location are derived.

requirement: A translation of the needs into a set of individual quantified or descriptive specifications for the characteristics of an entity in order to enable its realization and examination.

traceability: The property of a result of a measurement whereby it can be related to appropriate standards, generally national or international standards, through an unbroken chain of comparisons.

uncertainty of measurement: Parameter, associated with the result of a measurement, that characterizes the dispersion of the values that could reasonably be attributed to the measurand.

verification: (Also ‘calibration’) Evidence by calibration that specified requirements have been met.

PART I

4.0 ORGANIZATION & MANAGEMENT

4.1 Organization

a) FLW maintains an organization, designated as FLW Service Company, a California corporation solely owned by FLW, Inc., which provides technical support, service, repair facilities and calibration services to FLW customers. FLW Service is responsible for establishing and maintaining traceability of the Electrical, Physical, Mechanical and other Standards and M & TE for which traceability to National Standards is required.

b) The FLW laboratory will maintain an environment of a Type II Laboratory, as specified in Section 7 of this document. Monitoring of the environment of the lab will be the responsibility of the Technical Manager, but will be supported by the Service Manager or Senior Lab Technician in the absence of the Technical Manager. The Technical Manager, Service Manager or Senior Lab Technician will cease all calibration activities in the lab when the environment is outside the defined limits. The Technical Manager, Service Manager or Senior Lab Technician will reinstate the calibration process in the lab, only when the environment stabilizes for a period of at least two hours, to within those conditions specified in Section 7. This event will be recorded on Form P370-28 for which the Service Manager is the responsible authority. There will be no unusual environmental control in the lab outside those requirements set forth in Section 7. If a special requirement in environmental control is required to fulfill those requirements needed for calibration, the Technical Manager will inform the Service Manager of this need, and the Service Manager will seek an appropriate qualified 3rd party source to provide the calibration.

c) The term ‘laboratory’ refers only to those parts on FLW that are involved in the calibration process. Access to the Laboratory and Laboratory storage areas is restricted to Laboratory personnel or those specifically authorized by the Service Manager.

4.2 Management

a) The activities of the Laboratory are directed by the Service Manager who reports directly to the President. Activities are monitored by the Quality Assurance Manager who reports directly to the President. The Technical Manager, who reports to the Service Manager, has overall responsibility for the technical operations. Alternates will be designated in case of absence of the Service Manager, Technical Manager or the Quality Manager.

b) Laboratory management has been given the authority and resources needed to discharge their duties. Laboratory personnel are free from undue pressures which might adversely affect the quality of their




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work by having all communications (priority requests, complaints, status inquiries, etc.) directed through supervision and/or administrative personnel.

c) The Laboratory is expected to operate so that quantity does not influence quality. Employee performance goals are based primarily on the quality of work. Confidence in the Laboratory’s independence of judgment and integrity is maintained at all times.

d) If requested by a customer in order to protect confidential information and proprietary rights, all data pertaining to work accomplished together with any documents received from the customer will be maintained in a key-locked file. Data transmitted from FLW to the customer will be made according to specific directions from the customer in order to preserve his confidentially.

e) Responsibility, authority and interrelation of all personnel who manage, perform or verify work affecting the quality of calibrations are documented in FORM P370-05 Organization Chart and FORM P370-02 Job Descriptions.

f) Laboratory supervisors will have the necessary training and skills in related disciplines sufficient to understand the measurements being made, assess the result, and make decisions that affect the quality of the results.

g) A Technical Manager will be designated whose job description includes the power to make decisions regarding the technical (standard selection, calibration method selection, technical qualification of personnel, etc.) aspects of laboratory operations. The Technical Manager may be assigned other laboratory responsibilities.

h) The responsibility for the quality system of the laboratory is assigned to the Quality Manager who must be free of pressures which represent a conflict to the quality of calibrations. The Quality Manager reports directly to the President. He also has direct access to the Technical Manager.

i) Individuals who have the required knowledge and expertise to assume the duties of the technical or quality manager will be assigned as alternates to provide continuity of operation during absences of the Technical Manager &/or Quality Manager.

j) When possible, the Laboratory will participate in measurement assurance programs (MAPS) or other types of inter-comparison programs between laboratories which provide increased confidence in processes and procedures. The appropriateness of such programs may be determined by the laboratory and/or customer needs.

5.0 QUALITY SYSTEM, AUDIT AND REVIEW

5.1 FLW’s quality system with policies and practices is documented in Quality Manual QA-100. This manual defines the policies and practices which must be followed in the conduct of the Laboratory’s business. This manual defines FLW’s objective for, and its commitment to, good laboratory practice and quality of calibration services. Laboratory management is responsible for ensuring that all Laboratory personnel are aware of, understand, and implement the elements of the quality system. The Quality Manager is responsible for maintaining the Quality Manual.

5.2 Policies and operational procedures established in order to meet the requirements of the referenced standards are contained in the FLW Quality Manual - QA-100. A copy of this manual is available at several locations within FLW and is available to all employees at all times. Employees are encouraged to seek interpretation or clarification of the contents of this manual at any time. Training classes are held such that all Laboratory employees are familiar with the general contents of the manual, especially those contents having the objective of promoting good laboratory practice and quality calibration services.




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5.2 (a) FLW QA 100 Quality Manual contain statements of quality policy including objectives and commitments by top management to provide sound and reliable services to FLW’s customers.

5.2 (b) The organization and management structure of the Laboratory together with job description of key Laboratory management and operational positions are documented in FORM P370-05 and FORM P370-02. An overview of the company is shown on the organizational chart in QA-100. These charts establish the chain of command and identify responsibilities and personnel who have critical positions within the laboratory.

5.2 (c) The relation between management, technical operations, support services and the quality system is described in QA - 100 4.1 - FLW Quality Assurance Manual, Management Responsibility. Also refer to 5.2 (b).

5.2 (d) Procedures for the control and maintenance of documentation in the FLW Quality Control system are found in FQD 110 - Document Control, FQD 111 - Data Control and FQD 112 - Record Control.

5.2 (e) Job descriptions of personnel in positions of responsibility as well as those in support categories in the laboratory and those who are empowered to make decisions are included in FPD 370 FORM P370-02, as are references to the job descriptions of other staff.

5.2 (f) Approved signatories competent to sign accredited laboratory test and calibration reports are defined in FPD 370 - FORM P370-04. Even though the concept of ‘approved signatories’ is a concept of accredited laboratories, FLW wishes to be compliant with this standard.

5.2 (g) Methods and procedures used to establish the traceability path to; a national laboratory, an intrinsic standard or other acceptable source are described in section 9.2 and 9.3 of this document.

5.2 (h) The laboratory’s scope of calibrations and/or verification is listed in FORM P370-03 - Calibration Laboratory Capability Documentation Guideline. This document cites a basic measurement discipline (DC/Low Frequency) and then the various sub-parameters under that specific discipline (voltage, resistance, current, etc.)

5.2 (i) A review of all new work will be made to ensure that the laboratory has the personnel, facilities, equipment, standards, and technical expertise necessary to handle the proposed work effectively before it is accepted . Particular attention is paid to work of a type not currently being performed in the laboratory. Work that is of the same type as previously performed is automatically accepted. New work of a type not previously performed must be approved by the Service Manager or Technical Manager.

5.2 (j) All calibrations conducted by this laboratory are performed in accordance with approved calibration procedures. Development and/or selection of procedures is based on suitability for purpose and customer requirements. All procedures are developed or selected and approved for use in accordance with guidelines found in sections 8 & 9 of this document. These procedures are a controlled document and carry the designated approval signatures and issue date in accordance with FQD 110 - Document Control.

5.2 (k) Requirements for documentation, handling and verification of calibration and verification items, which primarily are customer equipment or ‘devices under test’ are described in FQD 103 - Control of Non-Conforming Material, FQD 110 - Document Control, FQD 112 - Record Control, FQD 140 - Material Identification and Traceability, FQD 141 - Inspection and Test, FQD 142 - Test Status and FQD 150 - Warehouse Control.

5.2 (l) A general description of the measurement systems and measurement standards used by the laboratory are described in sections 8 and 9 of this document..

5.2 (m) Procedures for calibration, verification, and maintenance of all laboratory equipment owned, rented or leased having an affect on the results on the calibration services provided are described 8 and 9 of this document.

5.2 (n) Quality assurance practices are used to (1) determine agreement between laboratories, (2) demonstrate compliance to certain specifications, (3) indicate that the measurement processes are under statistical control (4) demonstrate traceability, and (5) ensure the quality of results. Details are found in Section 5.6 and Section 9 of this document.




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5.2 (o) Procedures to be taken when it is discovered that an error has occurred or procedures were not followed are given in FQD 104 - Corrective Action Procedure. An assessment of the impact of the discrepancy on the results of measurements and a determination of appropriate corrective action shall be conducted. This requirement pertains to discrepancies or departures discovered after they have occurred. Corrective action report(s) must be filed and the discrepancy will come before management review.

5.2 (p) Laboratory management is responsible for ensuring that laboratory policies and procedures are adhered to. There will be no deviations from the guidelines in this document. If any portion of this document needs to be enhanced for better clarification, appropriate CARs and Document Change forms will be generated according to FQD 104 and FQD 110.

5.2 (q) Procedures for dealing with complaints are given in FQD 106 - Customer Complaints and section 16 of this document.

5.2 (r) The laboratory’s procedures for identifying and protecting any customer information or material considered confidential or proprietary is discussed in 4.2 (d) 5.2 (s) An audit is a detailed evaluation of compliance with the quality system. It attempts to find out if the system is in fact working the way it is documented. A review is a comparison of the system with the general standard, other quality needs, and the general business of the laboratory to determine if something needs to be changed in the system which will end up with new or revised documentation. Requirements for audit and review procedures are defined in the referenced documents and in FQD 120 - Quality Audits, FPD 121 - Internal Audits and FPD 122 - Subcontractor/Supplier Audits and in 5.3 through 5.5 below.

5.2 (t) Section 9 of the Standard specifies the requirements for establishing calibration intervals. These procedures are stated in FPD 370 Section 18.4 - Intervals of Calibration and Verification.

5.2 (u) The method of calibration employed will be appropriate for the parameter being calibrated/verified. A detailed calibration procedure will be available and followed to the degree necessary for the calibration/verification being performed. The use of well documented calibration procedures is desired in order to maintain consistency of the measurement process when performed at different times and with different operators. The standards selected and their associated uncertainties or tolerances should be adequate for the calibration/verification being performed.

(Reference: FPD 370 Sections 10 and 11)

5.3 A quality audit is a periodic check to ensure that the laboratory is operating in accordance with the policies and procedures set out in the Quality Manual and related documentation. Quality audits may include audits of results. Audit intervals are based on an analysis of factors such as risk, criticalness of the measurement system, complexity of the system, and failure rates, etc. and may be different for each measurement area. Audits are conducted by persons possessing the knowledge and skills necessary to understand the process being audited as well as the process of auditing and are reviewed by upper management Immediate corrective action must be taken to prevent taking bad data and /or the generation of inaccurate results. If possible, Auditors will be selected and trained under the provisions of ISO 10011-2:1991(E) Qualification Criteria for Quality Systems Auditors. Audits will be performed using the criteria in ISO 10011-1:1990(E) - Guidelines for Auditing Quality Systems.

(Reference: FLW FQD 120 - Quality Audits; FLW FPD 121 - Internal Audits and FLW FPD 122Subcontractor/Supplier Audits, and 5.6 below.)

5.4 A quality system review is an examination of the entire quality system conducted by management to ensure that it is adequate for the achievement of the laboratory’s quality objectives on a continuous basis. Management may delegate the responsibility of scheduling the reviews to the Quality Manager or other appropriate individual but a complete review of the FLW Quality System must be accomplished at least once each Calendar year. Quality “spot checks” may also be performed on an irregular basis. These checks and reviews may include:

a) Matters arising from the previous review;

b) Reports from audits by clients (if applicable);




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c) Results of internal audits and audit spot checks done since the last review, including corrective actions implemented;

d) Details of any complaints from clients;

e) Staff training (for both new and existing staff members);

f) Adequacy of staff, equipment and facility resources; and

g) Future plans and estimates for new work, new staff, new equipment, etc.

5.5 Documentation shall be maintained, in a form suitable for assessment, for all management reviews of the quality system and resulting corrective actions ( if any ). Corrective action is required whenever evidence arises that the quality system is not functioning properly. The person responsible for quality is designated by FLW’s President and is normally the Quality Manager.

(Reference: FQD 104 - Corrective Action Procedure and FPD 121- Internal Audits)

5.6 Internal quality control programs are an integral part of any calibration laboratory program. The extent and detail of the program may vary based on the size and complexity of the laboratory’s range of calibrations. In addition to periodic audits the Laboratory shall ensure the quality of results provided to customers by implementing checks. FLW will consider implementing internal random sampling whereby random items of instruments whose calibrations are completed are re-calibrated either by separate FLW personnel or by an outside laboratory. These sampling schemes may be based on a percentage of instruments calibrated where the percentage may be increased or decreased based on the number of failed inspections if any. Other internal quality control methods may be considered as appropriate in the continuing effort to support the credibility of the Laboratory and support the validity of calibrations performed by the laboratory. Records on sampling need to be kept only where discrepancies are identified.

6.0 PERSONNEL

6.1 The Laboratory will maintain a staff of sufficient size and with the necessary education, training, technical knowledge & experience for their assigned functions, and to satisfy the capacity and technical capability needed to support its workload. The Laboratory workload capacity is enhanced by a continuing program of cross-training between the various technical disciplines; also training in competency in auditing.

6.2 One goal of the Laboratory is to have all technicians trained in all functions handled by the Laboratory. On-the-job training using trained personnel and appropriate technical literature will be provided to new or experienced employees as circumstances permit to enhance their technical skills. Training of Laboratory personnel will be kept up to date consistent with employee assignments and development.

6.3 Current records of technical personnel and their relevant qualifications, skills, work experience, formal education, technical training, on the job training, technical license, certifications, and degrees is maintained and available to laboratory management and employees.

(Reference: FLW employee training files )

7.0 ACCOMMODATION AND ENVIRONMENT

7.1 Laboratory facilities, calibration areas, lighting, temperature, humidity and ventilation shall be such as to facilitate proper performance of calibrations &/or verifications. However, only the environmental factors which could affect the accuracy, stability, or performance of the calibration require control. Human factors such as lighting and ventilation should be sufficient to perform the required tasks.

7.2 The environment in which calibration and verification activities are undertaken in the Laboratory is specified




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below. This environment will not invalidate the results or adversely affect the required uncertainty of measurements. Particular care will be taken when calibration and verification activities are undertaken at sites other than the permanent laboratory premises.

FLW maintains a Type II Laboratory. Minimum Requirements for this Laboratory are:

a) TEMPERATURE will be maintained at 70 ± 2ºF.

b) HUMIDITY will be maintained between 25% and 60%.

c) BAROMETRIC PRESSURE: will be monitored but not recorded or controlled.

d) PRESSURE, LIGHTING, ACOUSTIC NOISE, VIBRATION: no specific requirements.

e) SMOKING will not be permitted inside the entire building.

f) FOOD will not be permitted inside the Type II calibration area.

Temperature and humidity will be continuously monitored within the laboratory and records of this data will be retained. Attention shall be paid to dust, electromagnetic interference, line voltage, sound, vibration levels and any other environmental influence factors which affect the specific measurement being performed appropriate to the concerned calibrations. Since environmental conditions outside the laboratory cannot be controlled, humidity and temperature must be monitored, appropriate correction factors must be applied, where relevant, and identified on calibration reports.

Particular concern will be given to electrostatic discharge effects to sensitive solid state devices. Procedures contained in FQD 102, Procedure for Handling ESD Devices, will be observed.

7.3 The Laboratory shall effectively monitor, control and record environmental conditions as appropriate. Due attention shall be paid, for example, to biological sterility, dust, electromagnetic interference, humidity, line voltage, temperature, and sound and vibration levels, as and if appropriate to the calibrations concerned.

7.4 Incompatible activities in the calibration process may require effective separation by effectively shielding or isolating by distance between neighboring test areas.

7.5 Access to and use of all areas affecting the quality of measurements shall be defined and controlled. Access is allowed only to qualified personnel as determined by the Service Manager. Also the quantity of personnel entering an environmentally controlled area should be limited as the more personnel entering the area, the more dust, dirt and possible temperature rise could be detrimental to the measurements.

7.6 Good housekeeping practices have a positive impact on the quality of the calibration/verification being performed. Therefore adequate measures shall be taken to ensure good housekeeping in the laboratory

8.0 EQUIPMENT AND REFERENCE MATERIALS

8.1 The laboratory shall be furnished with all items of equipment (including reference materials) required for the correct performance of calibrations/verifications. In those cases where the laboratory needs to use equipment outside its permanent control, it shall ensure that the relevant requirements of the standard are met. Borrowed or rented equipment will have on file objective evidence that the calibration was performed in a manner which meets the requirements of this standard. Examples of objective evidence may be:

a) records of FLW audits

b) proof that the calibration laboratory is accredited against this Standard.




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c) acceptance by a government agency showing compliance to this Standard.

d) acceptance conforming to this Standard from the calibration laboratory’ customer.

8.2 All equipment shall be properly maintained. Maintenance procedures shall be documented. Any item of the equipment which has been subjected to overloading or mishandling, or which gives suspect results, or has been shown by verification or otherwise to be defective, shall be taken out of service, clearly identified and wherever possible stored at a specified place until it has been repaired and shown by calibration or verification to perform satisfactorily. The laboratory shall examine the effect of this defect on previous calibrations. The following procedures are in effect:

a) historical maintenance information is kept in a computer program for all FLW M&TE.

b) any instrument that has been subjected to any influence that might cause doubt as to its integrity is removed from service, tagged as “out of calibration” and stored in the special location marked “Non-conforming”.

c) computer records of M & TE allow all instruments that have been calibrated by the suspect unit to be identified. A determination will be made if notification to customers of a recall of previously calibrated equipment is justified.

d) after correction of any default and recalibration, the unit may be tagged with a current valid calibration tag and returned to service.

e) a review of the units’ Calibration Interval will be made and adjusted if required to preclude any future calibration errors.

8.3 Each item of equipment including reference materials shall, when appropriate, be labeled, marked or otherwise identified to indicate its calibration status with:

a) A tag physically attached to the equipment or wired to the equipment as appropriate.

b) If a tag can not be installed on the equipment a calibration tag will be fastened to its container or placed physically close to the equipment to show calibration status.

c) Calibration status may also be determined by entering the serial number or FLW asset number in the M & TE computer program which lists the continuing history of the equipment’s calibration status.

d) No equipment may be used for calibration/verification without evidence of proper, current calibration

8.4 Records shall be maintained of each item of equipment and all reference materials significant to the calibration/verifications performed. The records shall include at a minimum:

a) The name of the item of equipment;

b) The manufacturer’s name, type identification, and serial number or other unique identification;

c) Current location, where appropriate;

d) Where applicable, dates and results of calibration and/or verifications and date or criteria when the calibration and/or verification expires;

e) Details of maintenance carried out to date;




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f) History of any damage, malfunction, modification or repair;

g) Measured value observed for each parameter found to be out of tolerance during calibration/verifications

9.0 MEASUREMENT TRACEABILITY AND CALIBRATION

9.1 All measuring and testing equipment having an effect on the accuracy or validity of calibrations shall be calibrated and/or verified before being put into service. The laboratory has established this program for the calibration and verification of its measuring and test equipment to ensure the recall or removal from service of any standard or equipment which has exceeded its calibration interval or is otherwise judged to be unreliable.

FLW computer calibration records identify:

a) M & TE in calibration that is usable in the calibration/verification process.

b) M & TE requiring calibration, i.e. a recall system that includes identification of overdue itemsin the recall system and removal of such items until corrected.

c) M & TE that is broken, out of tolerance, unstable or intermittent in operation.(Reference: FQD 103 - Control of Non-Conforming Material; FQD 142 - Test Status)

Any M & TE borrowed or rented for calibration/verification purposes will be treated as FLW M & TE while at FLW. Computer records are kept as if the equipment were FLW owned and maintained for a period equal to FLW M & TE. Thus the same history and recall mechanism is available with this equipment

The recall system uses the M & TE data base which allows complete identification of the M & TE as well as a history of any calibration or operational problems. Equipment is tracked for timely recalibration cycles. Any equipment out of calibration cycle will be taken out of service until calibrated. Repeated problems such as out-of-tolerance conditions of the same parameter of the same unit will be investigated. Equipment showing abnormal behavior will be temporarily removed from the active inventory until the problems have been clearly identified and can be controlled. Once any problems are understood and corrected the equipment can be entered into active inventory after adequate calibration.

9.2 The overall program of calibration and/or verification of equipment shall be designed and operated so as to ensure that, wherever applicable, measurements made by the laboratory are traceable to national, international, or intrinsic standards of measurement where available. Calibration certificates and/or reports shall, wherever applicable, state the traceability to national, international, or intrinsic standards of measurement and shall provide the measurement results and associated uncertainty of measurement and/or a statement of compliance with an identified metrological specification. It is not necessary to state further identifiers such as bookkeeping numbers, NIST report numbers, etc.

9.3 Where traceability to international, national, or intrinsic standards of measurement is not available, traceability requirements may be satisfied by:

a) Participation in a suitable program of interlaboratory comparisons or proficiency testing;

b) Internationally accepted standards in the field concerned;

c) Suitable reference materials;

d) Ratio or reciprocity-type measurements;or

e) Mutual consent standards which are clearly specified and mutually agreed upon by all parties concerned.




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9.4 Reference standards of measurement held by the laboratory shall be used for calibration or verification only and for no other purpose, unless it can be demonstrated that their performance as reference standards will not be invalidated.

9.5 Reference standards of measurement shall be calibrated by a competent body that can provide traceability as described in 9.2 or 9.3. FLW has established a program of calibration and verification for reference standards. (Reference: Part II of this document.)

9.6 Where relevant, reference standards and measuring and calibration equipment shall be subject to in-service checks between calibration and verifications. In some applications certain standards and equipment might require additional checks and verifications in addition to the normal calibrations performed based on the official recall system. Such checks help in providing trend and control charts, improve the maintenance of drift rates, and increase confidence in measurement capability.

9.7 Reference materials shall, where possible, be traceable to national or international standards of measurement, or the national or international standard reference materials.

10.0 CALIBRATION METHODS

10.1 The laboratory has documented instructions on the use and operation of all relevant equipment, on the handling and preparation of items, and for calibration/verification, where the absence of such instructions could jeopardize the calibration/verification. All instructions, standards, manuals, and reference data relevant to the work of the laboratory are maintained up-to-date and are readily available to the staff. Documented instructions do not necessarily mean hard copy documents. Documentation can be in the form of software, CD ROM, microfilm or other suitable medium.

The detail and instructions necessary to accomplish a measurement vary according to the skill and experience of the metrology engineer or technician, the complexity of the calibration being performed and the frequency that the calibration is performed. A senior technician may not need to refer to the documentation as often as an entry level technician.

Documentation can include:

a) Calibration procedures or procedure checklists

b) Equipment installation, operator and service manuals,

c) Reference books, such as engineering tables, ISO International Vocabulary, technical textbooks and,

d) Equipment manufacture’s application notes.

10.1.1 Determining the Calibration Procedure to Utilize.

Calibration procedures should meet the customers’ needs. If the customer has special calibration procedures required, they will take priority. If no special process is required then the manufacturers’ procedure will be utilized. If the manufacturer’s calibration procedure cannot be obtained, then an acceptable published industry standard such as GUIDEP, IPTS, ASTM, ANSI, etc., may be utilized. Where no procedures can be found, a local procedure may be written with the Technical Manager’s signature of approval.

10.1.2 Control of Calibration Procedures

10.1.2.1 All procedures utilized in the laboratory by FLW service personnel will have a special FLW Procedure Number. This number will be identified as “SXXXX” and will be identified in whole numbers. Each procedure will have a unique number attached.




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10.1.2.2. Procedures utilized in the field will be identified by the FLW “SXXXX” number or by the specific procedure as described in 10.1.1 of this document.

10.1.2.3. All calibration procedures utilized in the laboratory will be listed in the Master Manual Index. Section 1 of the Master Manual Index identifies procedure location, manufacturer, model number & description, revision and revision date of procedure, last date reviewed by FLW personnel, special FLW procedure number, master or secondary. The master copy is utilized for calibration. The secondary copies are for reference only. The Master Manual Index will be reviewed and updated annually or sooner when required. A Master Manual Index Log (Form P370-21) will be utilized to keep track of the updates.

10.1.2.4 Each calibration document will have a front page entry listed as Manual Revision Verification. Ref. Form P370-14. This front page will identify the copy as either the Master or Secondary; Revision level of manual and Revision date; the latest revision level and date supplied by manufacturer, if different from the one being utilized; a statement stating if a later revision of the document will have procedures that will have a significant affect on the results; who verified the information and date. Signature for verification of Form P370-14, for those procedures that come from Manufactures, existing National standards, or existing special processes, may only be given by technicians who have signatory approval. All new procedures generated by FLW personnel and documented in the Master Manual Index must be signed by either the Technical Manager or the Service Manager.

10.1.2.5 Field Service technicians will each be given a Field Service Manual that will contain calibration procedures. These procedures will be copies of the “Masters” procedures. The front page in each of these manuals shall contain Form P370-39, the Field Document index. This form will contain the manual identification number, technician’s signatory upon receipt, a list of all procedures that are enclosed by FLW Doc #, manufacturer, model number and/or description, date of entry, and initials of the person who made the entry. Only the Service Manager or Technical Manager is authorized to add new procedures to this manual.

10.1.2.6 Section 2 of the Master Manual Index will be used for controlling those procedures that are installed in each of the field service manuals. This section will maintain duplicate copies of Form P370-39, one for each of the manuals. The front page of Section 2 will contain Form P370-41, the Field Manual Log. This log will contain the manual number, signatory of the technician to whom the manual is issued, date of issue, initial of the person who issued the manual, date of manual return, and initials of the person verifying the return. It will be the responsibility of each of the technicians to maintain this manual as long as they are employees of FLW. Only the Service Manager or the Technical Manager shall authorize the verification of issuing and returning of a manual.

10.1.2.7 It will be the Service Managers responsibility for maintaining the process for controlling the Field Service Manual. 10.2 The laboratory shall use appropriate methods and procedures for all calibrations/verifications and related activities within its responsibility (including, but not limited to, sampling, handling, transport and storage, preparation of items, estimation of uncertainty of measurement and analysis of calibration data).

a) Calibration procedures shall contain the required range and tolerance or uncertainty of each item or unit parameter being calibrated or verified. In addition, the procedures shall contain the generic description of the measurement standards and equipment needed with the required parameter, range, tolerances or uncertainties, and specification for performing the measurement of the calibration or verification, and/or representative type (manufacturer, model, option ) that are capable of meeting the generic description for the measurement standards. The procedures shall be consistent with the accuracy required, and with any standard specifications relevant to the calibrations/verifications concerned. A procedure utilized for calibration need not be the latest revision if the results of the procedure are not significantly effected by a newer revision.

b) The laboratory shall ensure that the calibration uncertainties are sufficiently small so that the adequacy of the measurement is not affected. Well defined and documented measurement assurance techniques or uncertainty analyses may be used to verify the adequacy of the measurement process. If such techniques or analyses are not used, then the total (collective) uncertainty of the measurement standards shall not




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exceed 25% of the acceptable tolerance (e.g., manufacturer’s specification) for each characteristic of the measuring and test equipment being calibrated or verified. If this 4:1 ratio cannot be met due to the limitation placed by the nature of physics or technology, then a statement of ratio will be placed on the calibration report.

10.3 The method for finding total (collective) uncertainty will be derived by adding the relative uncertainty of the unit, plus the uncertainty of the equipment used to calibrate it. Additional uncertainties may be added where relevant, in which select methods of identifying these uncertainties have been published in international or national standards, those published by reputable technical organizations, or in relevant scientific texts of journals. These additional uncertainty factors must be identified on the certificate.

10.4 Where it is necessary to employ methods that have not been well established, these shall be subject to agreement with the customer, be fully documented and validated, and be available to the customer or other recipients of the relevant reports.

10.5 Where sampling is carried out as part of the calibration method, the laboratory shall use documented procedures and appropriate statistical techniques to select samples.

10.6 Calculations and data transfers shall be subject to appropriate checks. Appropriate checks may include:

a) Review of calculations

b) Comparison to previous results

c) Review of abnormal and/or unexpected results

d) Comparison of original data sheet against the final report

e) Investigation of out-of-tolerance results

10.7 Where computers or automated equipment are used for the capture, processing, manipulation, recording, reporting, storage or retrieval of calibration data, the laboratory shall ensure that:

a) The requirements of this Standard are complied with;

b) Computer software is documented and adequate for use;

c) Procedures are established and implemented for protecting the integrity of data; such procedures shall include, but not be limited to, integrity of data entry or capture, data storage, data transmission and data processing;

d) Computer and automated equipment is maintained to ensure proper functioning and provided with the environmental and operating conditions necessary to maintain the integrity of calibration data;

e) Data security on all service computers will be maintained in accordance to FPD 302, Section 5.3. Any changes in software utilized for maintaining records on M&TE, including software utilized for the calibration of M&TE, will be controlled in accordance to FPD302, Section 5.4.1 and 5.5.

The use of automated equipment does not relieve the Laboratory of its responsibility to meet all of the requirements of this standard

10.8 Consumable Materials

Consumable materials used for the technical operation of the laboratory that can affect the results of calibrations should be purchased from an approved vendor’s listing. A receipt inspection of these products is appropriate to ensure that the correct product has been delivered as specified by the purchase order. Handling and storage of this




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material may require special procedures, especially for flammable, toxic or dangerous materials which will require a Material Safety Data Sheet to be on file.

Examples of consumables are:

a) Fluid for oil or temperature baths;

b) Special preservatives for machined surfaces;

c) Reagent grade chemicals;

d) Certain cleaning compounds or fluids;

e) Compressed gases;

f) Certain grades of cloth or paper wipes; and

g) Batteries.

Material used in the routine operation of the laboratory such as office, hygiene, and housekeeping products normally do not require documented controls as outlined in this paragraph.

11.0 HANDLING OF CALIBRATION ITEMS

11.1 The laboratory has developed a computerized system for uniquely identifying the items to be calibrated, to ensure that there can be no confusion regarding the identity of such items at any time.The Laboratory uses this computer program for tracking equipment and standards received for calibration for the purpose of identifying ownership, special calibration requirements, special handling, or other details unique to each item. The computer identifies each item with such information as asset number, manufacturer, model, serial number, customer name and address, customer purchase order or identification number. Identification regarding the M&TE used in the calibration is also recorded on each calibration record. Calibration records may be sorted by Customer name and by M&TE identification number in case notification must be made because of M&TE failure or any out-of-tolerance conditions.

11.2 Upon receipt of the calibration item, any abnormalities or departures from standard condition as prescribed in the relevant calibration method shall be recorded. Where there is any doubt as to the item’s suitability for calibration, where the item does not conform to the description provided, or where the calibration required is not fully specified, the laboratory shall consult the customer for further instruction before proceeding. The laboratory shall establish whether the item has received all necessary preparation, or whether the customer requires preparation to be undertaken or arranged by the laboratory.

Examples of abnormal conditions, any of which must be reported to the customer and which will be noted on the individual calibration report are:

a) Physical damage in shipping or handling either while in transit from the customer to the laboratory or while in the laboratory.

b) Items submitted for calibration that are not capable of meeting requested calibration requirements. A customer may ask more from the calibration than the item is capable of meeting. A “Limited Calibration” tag or label to identify conditions that are outside normal requirements may be used. Limitations on the calibration can also be documented in the Calibration Report.

c) Equipment failure during the calibration.

11.3 The laboratory has documented procedures and has appropriate facilities to avoid deterioration or damage to the calibration item, during storage, handling, preparation, and calibration; any relevant instructions provided with




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the item shall be followed. Where items have to be stored or conditioned under specific environmental conditions, these conditions shall be maintained, monitored and recorded where necessary. Where a calibration item or portion of an item is to be held secure (for example, for reasons of record, safety or value, or to enable check calibrations to be performed later), the laboratory will provide unique storage and security arrangements that protect the condition and integrity of the secured items or portions concerned.

(Reference: FQD 150 - Warehouse Control)

11.4 The laboratory shall have documented procedures for the receipt, retention or safe disposal of calibration items, including all provisions necessary to protect the integrity of the laboratory.

(Reference: FLW FQD-140, FQD-141, FQD-142, FQD 150)

11.5 Tamper-resistant seals shall be affixed to operator accessible controls or adjustments on measurement standards or measuring and test equipment which, if moved, will invalidate the calibration. The laboratory’s calibration system provides instructions for the use of such seals and for the disposition of equipment with damaged or broken seals.

Methods of sealing operator adjustments may include:

a) Calibration adjustments sealed with torque paint

b) Anti-sabotage seals placed over equipment covers or doors so that internal adjustments need not be sealed

c) Lead wire seals or paper seals may be used to seal doors on large consoles, and

d) Dip seal on mechanical gages that are subject to wear may be used to indicate usage.If the gage has not been used then recalibration should not be required.

If seals have been broken the equipment will be taken out of service until recalibration/verification may be made. A notification will be made on the computer record for this equipment.

12.0 RECORDS

12.1 The laboratory maintains a record system to suit its particular circumstances and to comply with any applicable regulations. The records for each calibration shall contain sufficient information to permit the repetition of the calibration. The records shall include the identity of personnel involved in preparation and calibration.

12.2 All records including those listed in 8.4 pertaining to calibration equipment, certificates and reports shall be safely stored and held secure and in confidence to the customer for the period specified in FLW FQD112 section 4.3.1.

(Reference: FQD-110, FQD-111, FQD-112)

13.0 CERTIFICATES AND REPORTS

13.1 When a certificate or report is issued, the results of the calibration, or series of calibrations carried out by the laboratory shall be accurate, clear, unambiguous and objective, in accordance with any instructions in the calibration methods. The results should normally be reported in a calibration report or certificate and shall include all the information necessary for the interpretation of the calibration results and all information required by the method used.

13.2 Each certificate or report shall include at least the following information:

a) A title, e.g. ‘Calibration Report’ or ‘Calibration Certificate’ or suitable other title;

b) Name and address of laboratory, and location where the calibration was carried out if different from the address of the laboratory;




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c) Unique identification of the certificate or report (such as serial number) and of each page, and the total number of pages;

d) Name and address of customer, where appropriate;

e) Description and unambiguous identification of the item calibrated;

f) Characterization and condition of the calibration item;(a remark should be made on the calibration certificate if the equipment was damaged on arrival or during processing and if the equipment arrived out of calibration.)

g) Date(s) of performance of calibration, and date of next calibration, where appropriate;

h) Identification of the calibration procedure used, or unambiguous description of any non-standard method used; (sufficient information must be provided to allow for the replication of the calibration.)

i) Reference to sampling procedure, where relevant;

j) Any deviation from, additions to, or exclusions from the calibration method, and any other information relevant to a specific calibration, such as environmental conditions;

k) Measurements, examinations and derived results, if appropriate, supported by tables, graphs, sketches and photographs, as required, and any failures identified;

l) A statement of the total uncertainty of the calibration results, when numeric data is given( where relevant). Note: where pass/fail data is requested by customer, uncertainty values are not relevant.

m) A signature and title, or an equivalent identification of the person(s) accepting responsibility for the content of the certificate or report (however produced), and date of issue;

n) Where relevant, a statement to the effect that the results relate only to the items calibrated;

o) A statement that the certificate or report shall not be reproduced except in full, without the written approval of the laboratory;

p) Special limitations of use; and

q) Traceability statement.

13.3 13.3 Where the certificate or report contains results of calibrations performed by sub-contractors, these results shall be clearly identified. These reports will be attached to a Calibration Certificate generated by FLW with the statement “See Attached” located under “Standards used”.

13.4 Particular care and attention shall be paid to the arrangement of the certificate or report, especially with regard to presentation of the calibration data and ease of assimilation by the reader. The format shall be carefully and specifically designed for each type of calibration carried out, but the headings shall be standardized as far as possible.

13.5 Material amendments to a calibration report or calibration certificate after issue shall be made only in the form of a further document, or data transfer including the statement ‘Supplement to Calibration Report ( or Calibration Certificate), serial number... (or as otherwise identified)’ or equivalent form of wording. Such amendments shall meet all the relevant requirements of 13.2 of this standard.

13.6 The laboratory shall notify customers promptly, in writing, of:




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a) Any event such as the identification of defective calibration equipment that casts doubt on the validity of results given in any calibration report or certificate, or amendment to a report or certificate. Such notification shall quantify the magnitude of error created in the calibration results.

b) Any customer’s measuring and test equipment found significantly out-of-tolerance during the calibration/verification process. Measurement data shall be reported so that appropriate action can be taken.

13.7 The laboratory shall ensure that, where customers require transmission of calibration results by telephone, telex, facsimile or other electronic or electromagnetic means, staff will follow documented procedures that ensure that the requirements of this Standard are met and that confidentiality is preserved.

13.8 The Service Manager, Technical Manager, or designee will sign all Calibration Certificates that are processed through subcontractors. The Service Manager or designee will also screen intermittently, at random, Calibration Certificates of all technicians for verification of proper procedures and data. This process does not need to be documented.

14.0 SUB-CONTRACTING OF CALIBRATION

14.1 Where the laboratory sub-contracts any part of the calibration, this work shall be placed with a laboratory complying with the requirements of this Standard. The laboratory shall ensure and be able to demonstrate that its sub-contractor is competent to perform the activities in question and complies with the same criteria of competence as the laboratory with respect of the work being sub-contracted. The laboratory shall advise the customer of its intention to sub-contract any portion of the calibration to another party.

14.2 The laboratory shall record and retain details of its investigation of the competence and compliance of its sub-contractors and maintain a register of all sub-contracting.

15.0 OUTSIDE SUPPORT SERVICES AND SUPPLIES THAT AFFECT CALIBRATION RESULTS

15.1 Where the laboratory procures outside services and supplies, other than those referred to in this document, in support of calibrations, the laboratory shall use only those outside support services and supplies that are of adequate quality to sustain confidence in the laboratory’s calibrations.

15.2 Where no independent assurance of the quality of outside support services or supplies is available, the laboratory shall have procedures to ensure that purchased equipment, materials and services comply with specified requirements. The laboratory should, wherever possible, ensure that purchased equipment and consumable materials are not used until they have been inspected, calibrated or otherwise verified as complying with any standard specification relevant to the calibrations concerned.

(Reference: FQD 160 - Purchasing)

15.3 The laboratory shall maintain records of all suppliers from whom it obtains support services or supplies required for calibrations.

(Reference: FQD 160 - Purchasing)

16.0 COMPLAINTS

16.1 The laboratory shall have documented policy and procedures for the resolution of complaints received from customers or other parties about the laboratory’s activities. A record shall be maintained of all complaints and of the actions taken by the laboratory.

16.2 Where a complaint, or any other circumstance, raises a concern regarding the laboratory’s compliance with the laboratory’s policies or procedures, or with the requirements of this Standard or otherwise concerning the quality of the laboratory’s calibrations, the laboratory shall ensure that complaints in those areas of activity and responsibility involved are promptly resolved.




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NOTE: complaints are handled in accordance to procedures outlined in ISO-9000. Reference is made to FQD-106 - CUSTOMER COMPLAINTS and to

FQD-104 - CORRECTIVE ACTION PROCEDURE

PART II

Part II of this standard applies to the control of measuring and test equipment (M&TE) used to assure that supplies and services comply with prescribed customer requirements.

17.0 GENERAL REQUIREMENTS FOR QUALITY ASSURANCE OF MEASURING AND TEST EQUIPMENT (M&TE)

17.1 A system to control the calibration/verification of M&TE has been established and documented. Documentation of all procedures and practices implementing the calibration/verification system promotes uniformity of understanding, continuity of operations when key personnel changes occur and provides a means of demonstrating the intent, criteria and approach in satisfying the requirements of the standard.

17.2 M&TE used to determine compliance with customer technical specifications shall be calibrated or verified in accordance with this Standard. In order to comply with this section, all of Part I is required of the calibration source.

17.3 FLW has a program to recall for calibration or verification, or remove from service, M&TE that has exceeded its calibration interval, has broken calibration seals, or is suspected to be malfunctioning because of mishandling, misuse, or unusual results. M&TE that has been calibrated must be in compliance with 18.4 and 18.10 of this standard.

(Reference: Section 9.0 of this Standard)

17.4 All operations performed by FLW in compliance with this Standard shall be subject to customer verification at unscheduled intervals.

(Reference: FPD 121 - Internal Audits)

17.5 FLW shall carry out or arrange to be carried out, periodic quality auditing of the calibration and verification system in order to ensure its continuing effective implementation and compliance with the requirement of this Standard. A procedure is in place for internal Quality Audits on a periodic basis. Customer audits may also be used to fill this requirement.

(Reference: FQD 120 - Quality Audits and FPD 121 - Internal Audits)

17.5.1 Based on the results of the audits, assessments and any other relevant factors, such as customer feedback, FLW shall review and modify the system as necessary. It is to be remembered that the results of audits and customer feedback should be viewed as opportunities to improve the Quality system.

17.5.2 Plans and procedures for the audits or assessments shall be documented. The conduct of the audit or assessment and any subsequent corrective action shall also be documented. Documentation should be maintained, in a form suitable for assessment, for all management reviews of the quality system and resulting corrective actions (if any). Corrective action is required whenever evidence arises that the quality system is not functioning properly. The person responsible for quality is designated by laboratory management and is normally the quality manager.

(Reference: FQD 120 - Quality Audits, FQD 104 - Corrective Action Procedure, FPD 121 - Internal Audits)

18.0 DETAILED REQUIREMENTS FOR QUALITY ASSURANCE FOR MEASURING AND TEST EQUIPMENT

18.1 Calibration system description: FLW provides and maintains a written description of the calibration/verification system covering M&TE and measurement standards. The description is sufficient to satisfy each requirement of Part II of this Standard and any deviations shall be submitted with supporting justification to




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the customer for approval.

Note: In compliance with this requirement a standardized format for the written calibration/verification system description is not required. The documentation used in the inspection or quality program is appropriate. The typical system description could describe the requirement, identify responsibility, and provide a method, procedure, or standard practice, including quantification where appropriate, for each specific requirement of the standard. This information may be found on the standard computer generated Calibration Report. There will be no deviations made to these requirements. An enhancement for better clarification may be made with the appropriate CARs and Document Change Forms, per instructions on FQD 104 and FQD 110.

18.2 Adequacy of measurement standards: Measurement standards used by FLW for calibrating M&TE and other measurement standards comply with the requirements of this Standard.

(Reference: Sections 8.1, 9.1 and 10.2 of Part I of this standard).

18.3 Environmental conditions: M&TE are used in an environment controlled to the extent necessary to ensure valid results. Due consideration is given to temperature, humidity, lighting, vibration, dust control, cleanliness, electromagnetic interference and any other factors affecting the results of measurements. These factors shall be monitored, and/or controlled per section 7.2.

(Reference: Sections 7.1 and 7.2 of this standard)

18.4 Intervals of calibration and verification: M&TE requiring calibration is calibrated or verified at periodic intervals established and maintained to assure acceptable reliability, here reliability is defined as the probability that M&TE will remain in-tolerance throughout the interval. Intervals shall be established for all M&TE requiring calibration unless the equipment is regularly monitored through the use of check standards in a documented measurement assurance process. Check standards must closely represent the item parameters normally tested in the process and the check standard must be verified periodically. Where intervals are used to ensure reliability, the interval setting system must be systematically applied and shall have stated reliability goals and a method of verifying that the goals are being attained. Intervals may be based on usage or time since last calibration or verification. All exemptions from periodic calibration or verification shall be documented. The recall system for FLW M&TE provides temporary extensions on it’s own equipment, utilizing the approval form P370-12. This approval may only be authorized by the Service Manager or Technical Manager.

18.4.1 Calibration Intervals

18.4.1.1 Calibration Reliability Target - Calibration intervals for individual items of controlled M&TE will be assigned and adjusted to maintain at least 75% reliability on each unit. To attain the data to meet this requirement, the following equation will be applied:

n-r x 100% = % Reliability n

Where: n = number of times unit calibrated

r = number of times unit calibrated and adjusted for out of tolerance conditions.

18.4.1.2 Interval Adjustment - The Technical Manager will be responsible for adjusting calibration intervals to maintain 75% reliability on each unit.

The Technical Manager or his designee will evaluate calibration records after each calibration to verify that the interval adjustment program is yielding the desired 75% reliability target. Exceptions to the procedure for setting up a reliability target will be determined by the Technical Manager. Exceptions would be made on instruments that rely on repeatability targets rather than targets set by nominal numbers. Other exceptions will be identified with a letter stating reason for changes, signed by the Technical Manager, and placed in the standards folder for future reference.




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Calibration intervals of 1,2,3,4,6,9,12,18,24,36,and 60 months will be assigned. Exceptions to these intervals must be approved by the Technical Manager.

Initial interval assignments will be made on the basis of experience with similar instruments.

Calibration interval adjustments will be based on the history of individual instruments.

Instruments may be assigned shorter calibration intervals at the request of the user.

An instrument may be assigned longer or shorter calibration intervals if analysis of the instrument’s history reveals that an interval was assigned in error, or for other valid reasons.

Adjustments of interval, and the rationale for making them, will be documented in the instrument’s history file.

18.4.1.3 Interval Reduction - If one range, one value or one function of an instrument is found to be outside its tolerance limits, the instrument will be considered out of tolerance and should be brought to the Technical Manager’s attention for consideration of reducing its calibration interval.

An instrument that is found to have significant defects, or to be inoperative or malfunctioning upon recall will be considered out of tolerance. An instrument that fails and is returned for repair during its certification period will not be considered out of tolerance.

An instrument that is found, upon recall, to have broken calibration seals or to have seals that have been tampered with ( for example, to be oil soaked ) will be considered out of tolerance, unless a credible explanation has been accepted by the Technical Manager.

18.4.1.4 Interval Expansion - The calibration interval for a particular instrument may be lengthened to a longer interval whenever it is found to have met a 90% reliability target with a minimum of 4 calibration cycles on record. This can only be made with the approval of the Technical Manager.

18.4.1.5 Temporary Interval Extension - A calibration interval for a particular instrument, or group of instruments, may be temporarily extended for a specified, limited time, not to exceed 30 days, when such extension is judged to be in the interest of both the customer and the Laboratory. Calibration extension requests will be maintained with the hard copy files of the M&TE.

The Service Manager responsible for the calibration will issue a ‘CALIBRATION EXTENDED’ label for the instrument, upon written request by the customer, provided an analysis of the instrument history supports such an extension.

18.4.2 An “Out of Tolerance” or “Significant Out of Tolerance” condition exists when the total error (including uncertainties) exceeds those specifications listed by the manufacturer or stated, in writing, by the customer. If a unit being calibrated meets 70 to 100% of its specified tolerance, the technician may, at his discretion, opt to make adjustment to equipment being calibrated to “center up” or “optimize” the actual performance of the instrument. This procedure should not be utilized if the customer wants to check for long term drift or instability characteristics which can not be observed if the continual “center up” technique is used. Instruments not readjusted to “optimize” their calibration will still be within the stated accuracy specification and within the appropriate Test Uncertainty Ratio appropriate for the calibration. An “optimize” adjustment does not have to be addressed on a calibration report.

18.5 Calibration procedures: Procedures used to calibrate/verify FLW’s M&TE comply with the requirements of this document.

(Reference: Section 10.1 and 10.2 of Part I of this Standard )

18.6 Out-of tolerance conditions: If any M&TE is found to be significantly out of tolerance during the calibration/verification process, FLW’s system provides for notification to the user of the out-of-tolerance condition with the




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associated measurement data so that appropriate action can be taken. An out-of-tolerance evaluation form will be completed, making sure to mote if past customer calibration has been affected, and will be filed with M&TE calibration certificate.

Note: An interpretation of Z540 suggests that M&TE should be considered ‘significantly’ out of tolerance when their condition could adversely affect product quality, measurement integrity, or safety. The specific parameter and degree of out of tolerance condition which constitute adverse performance are largely dependent upon the use and application of the M&TE. Accordingly, determination of a ‘significantly’ out of tolerance condition is generally based on an analysis of the instrument’s use requirements, the effect of the out of tolerance condition on the parameter being measured or calibrated, and ultimately the effect on the end product or material being delivered. FLW has established a reporting system to notify the user of all out of tolerance MT&E. The determination of whether the out of tolerance condition is significant or not is then left with the user.

18.7 Adequacy of calibration system: FLW has established documented procedures to evaluate the adequacy of the calibration system and to ensure compliance with the requirements of this document.

(Reference: FQD 120 - Quality Audits, FQD 104 - Corrective Action Procedure, FPD 121- Internal Audits )

18.8 Calibration sources: M&TE requiring calibration shall be calibrated or verified by laboratories meeting the requirements of this document.

(Reference: Section 9 of this document)

18.9 Records: The requirements of this document are supported by records documenting that established schedules and procedures are followed to maintain the adequacy of all M&TE. The records for M&TE requiring calibration include an individual record of calibration or verification, or other means of control, providing a description or identification of the item, calibration interval, date calibrated, identification of the calibration source, calibration results ( data and/or condition status) and calibration action taken (adjusted, repaired, new value assigned, derated, etc.).

18.10 Calibration status: M&TE is labeled to indicate calibration or verification status. The label shall identify specific date calibrated (day, month, year), the specific calibration due date or usage equivalent, instrument identification number, and signature or stamp of the person performing the work. Items not calibrated to their full capability or which have other limitations of use, shall be labeled or otherwise identified as to the limitations. When it is impractical to apply a label directly to an item, the label may be affixed to the instrument container or some other suitable means may be used to reflect calibration status. Tamper-resistant seals are affixed to operator accessible controls or adjustments which if moved will invalidate the calibration. The quality system provides instructions for the disposition of equipment with broken tamper-resistant seals.

18.11 Control of subcontractor calibration: FLW is responsible for assuring that any subcontractor’s calibration system conforms to this document to the degree necessary to assure compliance with contractual requirements. Accreditation of a laboratory to this document by a third party activity acceptable to the customer may serve as the basis for compliance with this requirement.

18.12 Storage and handling: M&TE is handled, stored, and transported in a manner which shall not adversely affect the calibration or condition of the equipment.

(Reference: FQD 150 - Warehouse Control)




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