AC7101/1 AC71 01/1 REV. REV. F
AUDIT A UDIT CRITERIA
Issued 1993-05 Revised 2014-06
161Thorn Hill Road Warrendale, PA 15086-7527
Superseding AC7101/1 REV. E
TO BE USED ON AUDITS STARTING ON OR AFTER SEPTEMBER 14, 2014 Nadcap AUDIT CRITERIA CRITERIA FOR FOR MATERIALS MATERIALS TESTING TESTING LABORATORIES LABORATORIES GENERAL REQUIREMENTS FOR ALL LABORATORIES Editorial Changes made to 2.1 on May 12, 201 5 K
1.
SCOPE This Audit Criteria was developed by the Nadcap Materials Testing Laboratories Task Group (MTLTG) for the evaluation of testing facilities for Nadcap Materials Testing Laboratories Accreditation Program. While the criteria in t his checklist may appear redundant with ISO/IEC 17025/AS9100 audit criteria, the Task Group determined that its aerospace auditors needed to assess compliance from the aerospace perspective. This Audit Criteria is applicable to all laboratories. Supplemental checklists provide additional detailed criteriaon the specific test methods. Appendix A of this document is required for all laboratories accredited to AS/EN/JISQ 9100 in lieu of ISO/IEC 17025, or AC7006. The MTL Aduit Handbook provides many details to ensure a successful auidt experience. The Handbook should be used as a companion to the Audit Criteria. The Handbook is located on www.eAuditNet.com www.eAuditNet.com under under Resources Documents Public Documents Materials Testing Laboratories Audit Information. →
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Written customer requirements always take precedence over Nadcap audit criteria.
This section is for the use of auditors, as necessary, for notes during the audit. No NCRs will be written against section 1.
PRI operating procedures provide that "This report is published by PRI to advance the state of technical, engineering, and quality sciences. The use of this report is entirely voluntary, and its applicability and suitability for any particular use, including any patent infringement arising there from, is the sole responsibility of the user." PRI values your input. To provide feedback on this document, please contact the appropriate commodity staff staff engineer. (Contact information is located at http://www.eauditnet.com under “Contact Us”.) Copyright 2014 Performance Review Institute. All rights reserved. t-frm-15
10-Apr-2014
PRI
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Audit Category Initial Full Scope – Reaccreditation SV1 – Reaccreditation SV2 – Reaccreditation Add Scope Verification Internal Audit (NUCAP)
1.2
Audit Scope AC7006 AC7101/1 AC7101/2 AC7101/3 AC7101/4 AC7101/5 AC7101/6 AC7101/7 AC7101/8 AC7101/9 AC7101/11 AC7109/5 AC7110/13
1.3
OPEN / CLOSE Meeting Attendance
2.
ACCREDITATION REQUIREMENTS REQUIREMENTS
2.1
The laboratory demonstrates compliance to an acceptable quality system as defined in PD 1100. Nadcap Materials Testing Laboratories recognizes existing quality systems approvals in the form of ISO/IEC 17025 certifications by an ILAC Approved source (www.ilac.org).
YES
NO
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For captive laboratories, Nadcap Materials Testing Laboratories also recognizes AS/EN/JIS Q9100 certifications by registrars that are approved and listed in the IAQG Oasis database (www.iaqg.org/oasis). Where no recognized quality systems approvals exsist, Nadcap requires assessment using AC7006 Audit Criteria Equivalent to ICO/IEC 17025. Note: AS/EN/JIS Q 9100 accredited captive laboratories must also meet the requirements of Appendix A. 2.2
The following summaries are complete (format not cause for NCR, only content) •Personnel Summary: A tabular summary of personnel which perform the accredited test methods. The summary shall include the following information: oName and job title oTest codes oQualifications (education, training or examinations) oYears of laboratory testing experience •Procedure Summary: A tabular summary of procedures used to perform the accredited test methods. The summary shall include the following information: oDescription of test oTest code or method oIdentification of procedures used for testing oCurrent revision of procedures at time of current audit oRevision of procedures at date of last PRI audit •IRR/PT Summary: A tabular summary of IRR/PT activity which support the accredited test methods. The summary shall include the following information: oDescription of test oTest code or method oName of proficiency testing provider oReference of the last PT report (for quick retrieval of the report during audit) oDate(s) PT was performed oRequired frequency of PT oDescription of any outliers oReference of the last IRR/operators report (for quick retrieval of the report during audit) oDate(s) IRR was performed oRequired frequency of IRR/operators oDescription of any outliers oReference of the last IRR/equipment report (for quick retrieval of the report during audit) oDate(s) IRR was performed oRequired frequency of IRR/operators oDescription of any outliers
YES
NO
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2.3
Procedure(s) are used to ensure Nadcap notification in accordance with OP 1107: Nadcap will be notified of any changes to the content on form number t-frm-11 “Notification of change/request for revised certification”.
YES
NO
2.4
Self-Audit was completed with references which will satisfy all audit criteria in all applicable checklists in the current audit scope.
YES
NO
2.5
A minimum of one Observation of Test is performed by the PRI auditor for each testing method in the scope of accreditation within the course of two audits. Each test was performed in accordance with the applicable procedures and/or test specification.
YES
NO
2.6
A minimum of three job audits were performed by the PRI auditor. Job audits met requirements below (any NO answer results in a NCR for this criterion. Auditor documentation of each “job audit” shall show assessment of all the requirements): • Laboratory received and documented customer requirements • Test requirements are accurately documented in laboratory testing documentation (routers/travelers/ other ways to communicate testing requirements to test operators). • Laboratory performed required testing in accordance with its procedures and/or customer requirements. • Certifications and reports document the methods of data unit conversion, if applicable, and rounding method if not defined by, referenced by, or different from test specification.
YES
NO
3.
FACILITY (GENERAL)
3.1
Environmental conditions in the laboratory are in accordance with test technical requirements such as to facilitate correct performance of the tests and/or calibrations.
YES
NO
3.2
Environmental conditions are monitored, controlled and recorded as required. Test environment conditions are considered in creating test method procedures.
YES
NO
3.3
Cleanliness of test area minimizes contamination.
YES
NO
3.4
Employees demonstrate compliance to applicable safety program.
YES
NO
3.5
Facility operations affecting specific testing – Procedures ensure notification of customers in the event of interruption due to power outage or equipment failure that has an effect on the test results.
YES
NO
NA
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4.
QUALITY SYSTEM DOCUMENT (MANUAL )
4.1
Records are available to the customer upon request within three working days.
YES
NO
4.2
A procedure is used to control records (technical data and test reports) generated by the laboratory in compliance with customer requirements including record retention policy.
YES
NO
4.3
Records (technical data) are maintained, traceable to each certification, such that the laboratory could reproduce the test method or identify incorrectly tested material.
YES
NO
4.4
Current revisions of test procedures are used.
YES
NO
4.5
Laboratory management assigns responsibility for the review and approval of test results, training and qualification of personnel, and procedures.
YES
NO
5.
QUALITY ASSURANCE FUNCTION (Q.A.)
5.1
The Q.A. function in the laboratory has stop-work/stop-ship authority.
YES
NO
5.2
The Q.A. function participates in the organization or planning of equipment definition and selection.
YES
NO
5.3
The Q.A. function participates in the organization or planning of maintenance and calibration of test facilities and equipment.
YES
NO
5.4
The Q.A. function participates in the management (creation, revision, implementation, etc.) of test procedures.
YES
NO
5.5
The Q.A. function has authority to require the implementation, extension or modification of internal technical documents.
YES
NO
5.6
The Q.A. function oversees training and qualification of personnel.
YES
NO
5.7
The Q.A. function participates in the organization or planning of subcontractor selection and survey.
YES
NO
6.
TRAINING AND QUALIFICATION OF PERSONNEL
6.1
Qualification and training of laboratory personnel complies with laboratory quality manual and/or procedures, applicable customer requirements and is documented.
YES
NO
6.2
Qualification of laboratory personnel includes documented periodic “observations of test” to assess the employee’s compliance to procedures used for Nadcap test codes.
YES
NO
6.3
Individual training records and supporting procedures indicate participation in inter-operator comparison as defined by the laboratory.
YES
NO
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6.4
Operators are trained to recognize proper operation of the equipment.
YES
NO
6.5
Operators are trained to recognize a properly executed analysis or test, to distinguish between valid and invalid test data, and to justify invalidating data.
YES
NO
6.6
If degreed personnel “or equivalent” are required, definition of “equivalent” is documented.
YES
NO
7.
EVALUA TION, APPROVAL, AND SURVEY OF SUBCONTRACTORS
7.1
Subcontractor evaluation is based on Nadcap accreditation, customer qualification list or at least 3 of the following:
SECTION NA YES
NO
• Documentation and initial survey • 100% inspection of product/service • Sampling inspection of product/service • Periodic on-site survey by the Q.A. function 7.2
Access to subcontractor facilities is provided to the laboratory for quality audits if requested.
YES
NO
7.3
Applicable quality assurance requirements specified in the contract are transmitted to subcontractors.
YES
NO
8.
PROCEDURE SYSTEM
8.1
Procedures are approved by the customer, when required.
YES
NO
8.2
Procedure(s) are used for calibration of all Measuring and Test Equipment (M&TE) used for testing or producing results.
YES
NO
8.3
A procedure is used to review the requirements presented to the laboratory, however defined. The procedure addresses: • how the requirements are assessed • how the requirements are effectively communicated to the laboratory • how the laboratory determines if the requirements can be met Note: For captive labs, this pertains to how the requirements are directly communicated to the laboratory, and does not include full traceability through the company to end-customer requirements.
YES
NO
8.4
Procedures are used to ensure use of ASTM E 29 for rounding unless the method is otherwise stated in the certificate of test/test report.
YES
NO
8.5
Procedures define methods and test specifications used to perform data unit conversions.
YES
NO
NA
8.6
Procedures are used to ensure all software programs and equipment automation are validated prior to use.
YES
NO
NA
NA
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8.7
Procedures are used to ensure all software programs and equipment automation are revision controlled and that the correct revision is used for testing and data analysis/compilation/reporting.
YES
NO
8.8
Procedures that are used for each test method reference the source of the requirement. For example: specific industry standard(test specification) or customer specification.
YES
NO
8.9
Procedures are sufficiently detailed so that the test can be consistently repeated.
YES
NO
8.10
Details required to reproduce non-standard tests are documented and traceable to the test report/results.
YES
NO
8.11
Procedures are used to ensure technical revisions of standards publications (e.g. ASTM, EN, ISO and any other revision controlled documents used within test method procedures) in the laboratory’s scope of accreditation are implemented/incorporated within six months from the date the standard/document is issued. A record of revision review is maintained which includes date of reference document revision, date of laboratory incorporation, brief summary of actions taken to demonstrate the revision review was completed.
YES
NO
9.
EQUIPMENT CALIBRATION AND MAINTENANCE
9.1
Calibration
9.1.1
Calibration cycle extension: When calibration cycles are extended, procedures are used in accordance with NCSL (National Conference of Standard Laboratories), recommended Practice 1, or other recognized statistical review process to support the extended time interval. Any calibration cycle extensions are in accordance with standard methods or customer requirements.
YES
NO
9.1.2
Calibration: The laboratory uses a calibration schedule with frequencies in accordance with manufacturers’ recommendations, Appendix E, or the individual checklist requirements for all internal and external calibrations performed on testing equipment. This schedule documents duration between calibrations (frequency) and responsibility for calibration (source).
YES
NO
NA
NA
NA
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9.1.3
Calibration: Procedures are used during calibration certificate review to ensure the following: •calibration certificates document the name and address of the agency performing the calibration. • approved calibration suppliers are used. •description(s) of equipment and operating range, including the precision of the instrument, are documented on the calibration certificate. • primary standards or equipment are documented on the calibration certificate and are traceable to a national standard. • the calibration method is documented on the calibration certificate. • the date of calibration is documented on the calibration certificate. • the "as found" and "as left" conditions are documented on the calibration certificate when the instrument was adjusted or repaired during the course of calibration. • the calibration personnel are documented on the calibration certificate. • the environmental conditions are documented on the calibration certificate where required by standard/spec/customer.
YES
NO
9.1.4
Calibration: Calibration status is identified for each test machine or associated laboratory equipment requiring calibration.
YES
NO
9.1.5
Calibration: Procedures are used to address the calibration and use of “employee-owned” Measuring and Test Equipment (M&TE).
YES
NO
9.1.6
Calibrations not performed by the laboratory are performed by an ISO17025 accredited source or documented evaluation.
YES
NO
9.2
Maintenance
9.2.1
Maintenance: Procedures are used to ensure planned maintenance of measuring equipment is performed to ensure proper functioning and in order to prevent contamination or deterioration.
YES
NO
9.2.2
Maintenance: Procedures are used to ensure maintenance records identify the maintenance plan, maintenance activities to date, any damage, malfunction, modification, adjustment or repair to the equipment.
YES
NO
9.2.3
Maintenance: Procedures are used to identify equipment which is out of service.
YES
NO
9.2.4
Maintenance: When maintenance is performed to address a malfunction of calibrated equipment, procedures are used to assess the possible effect on test values.
YES
NO
NA
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10.
SPECIMEN IDENTIFICATION AND TRACKING SYSTEM
10.1
Unique identification is assigned to each test specimen in accordance with a procedure. The identification is retained throughout the life of the test specimen and is traceable to the final documentation.
YES
NO
10.2
Transfer of work outside the laboratory for sub-contracted processes is performed in accordance with procedures which ensure (1) traceability of documents/records with test articles is maintained and (2) verification that work performed was in accordance with purchase order requirements.
YES
NO
11.
REPLACEMENT TESTING AND RE-TESTING
11.1
Procedures are used to ensure RETESTS allowed by material or customer specification, are performed in accordance with the material or customer specification.
YES
NO
11.1.1
Unless otherwise specified, procedures are used to ensure a minimum of three RETESTS per NON-CONFORMING TEST-RESULT are performed and reported.
YES
NO
11.2
Procedures are used to ensure replaced tests are recorded and crossreferenced with the original tests, including explanations where applicable.
YES
NO
11.3
Procedures are used to ensure records of replaced tests are reviewed periodically for trends which could indicate test process deterioration. Procedure(s) are used to respond to defined criteria for test process deterioration which requires corrective action.
YES
NO
12.
ERRORS IN TESTING
12.1
Procedures are used to ensure errors in testing are assessed. The laboratory reports errors in testing in accordance with the time period that is required by the customer.
YES
NO
13.
CERTIFICATE OF TEST/CERTIFICA TE OF CONFORMANCE/TEST REPORTS
13.1
The certificate of test/test report meets the requirements of the applicable specification.
YES
NO
13.2
The certificate of test/test report includes the name and address of the laboratory, and the location where the tests and/or calibrations were executed, if different from the address of the laboratory.
YES
NO
13.3
The certificate of test/test report includes the name and address of the customer.
YES
NO
NA
NA
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13.4
The certificate of test/test report includes identification of the test article and identification and issue(s)/revision(s) of the material specification(s) used for conformance disposition. (Example: Inco 718, AMS5662 Rev H).
YES
NO
13.5
The certificate of test/test report identifies the testing specification or procedure used, if not called out by the material specification. Any nonstandard practices must be documented.
YES
NO
13.6
The certificate of test/test report includes the numerical results of all tests and inspections performed for which the material specification establishes numerical requirements.
YES
NO
13.7
Test values on the certificate of test/test report are recorded, at a minimum, to the number of digits as defined by the controlling specification(s).
YES
NO
13.8
The certificate of test/test report includes descriptions of the results (e.g., conform/non-conform) of all tests for which the material specification does not establish numerical requirements.
YES
NO
NA
13.9
Any unusual observations are noted on the certificate of test/test report (and identified as such, e.g. as “Observation”). Applicable at laboratory discretion.
YES
NO
NA
13.10
Test results for all specimens in the same set are included on the same certificate of test/test report; that is, separate certificates of test/test reports are not issued for conforming versus nonconforming material.
YES
NO
13.11
The certificate of test/test report includes appropriate description of test specimens (quantity, form, and condition, etc), when applicable, and all identification necessary to assure traceability of laboratory report to the material supplier/customer records (e.g., sample number, heat number, lot number, P.O. number).
YES
NO
13.12
The certificate of test/test report includes a statement that it shall not be reproduced except in full without the written approval of the laboratory.
YES
NO
13.13
The certificate of test/test report includes each page numbered "page __ of__ ".
YES
NO
13.14
The certificate of test/test report includes unique identification traceable to the laboratory identification system.
YES
NO
13.15
The certificate of test/test report includes, when applicable, appropriate error corrections and revision indication. Manual corrections are prohibited. Digital documents must have a means for recording corrections such that the original and corrected data can be observed during an audit.
YES
NO
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13.16
The certificate of test/test report includes re-test values, and values known to be nonconforming (i.e., when compared against mandatory specification values), and they shall be clearly identified as such.
YES
NO
13.17
The certificate of test/test report includes documentation of all test articles provided to the laboratoryfor testing. Example of test without results: "Specimen 4A253: No Test - broke in grips”. Test values from replaced specimens need not be reported.
YES
NO
13.18
The certificate of test/test report is traceable to the request to perform work.
YES
NO
13.19
The certificate of test/test report includes a statement of work with conformance requirements stated. If the conformance requirements are written in the statement of work (rather than a specification or similar document) and revised after submission to the laboratory, revision to those requirements is documented in the certificate.
YES
NO
13.20
The certificate of test/test reports includes description(s) of any applicable thermal treatments performed by the laboratory.
YES
NO
13.21
Computer generated certificates of test/test reports require either (a) an actual or facsimile signature, or (b) a letter accompanying the certificate, signed by the laboratory's representative attesting that the laboratory is using a computerized system, the typed name on the document is an authorized employee, and the laboratory is responsible for the information it contains. If a laboratory uses computer-generated certificates with an actual or facsimile signature, or typed name, the system has security (password or other identity control) to ensure the name on the document represents the individual who performed the indicated function.
YES
NO
13.22
The certificate of test/test report documents a statement of conformance when testing is performed for conformance to material specifications.
YES
NO
13.23
Procedures are used to ensure correct transcription of data from the original source to the certificate of test/test report. Procedure(s) are used to respond to transcription errors.
YES
NO
13.24
Procedures are used to address revision of certificates of test/test reports and notification of customers when errors are found. Customers are notified within the time period that is required by the customer.
YES
NO
14.
PROFICIENCY TESTING AND INTERNAL ROUND ROBIN REQUIREMENTS Participation in proficiency testing (PT) and internal round robins (IRR) is required. Frequency requirements are given in Appendix B. Selection of proficiency test providers is described in Appendix C. Testing protocol for PT and IRR is described in Appendix D.
14.1
Internal Round Robin Testing
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14.1.1
The internal round robin program meets the established requirements as described in Appendix D.
YES
NO
14.1.2
Internal round robin programs are in place to compare testing equipment used for the same test/method, if required. (see Appendix B for frequency and requirements)
YES
NO
NA
14.1.3
Internal round robin programs are in place to compare testing personnel performing the same test/method, if required. (see Appendix B for frequency and requirements)
YES
NO
NA
14.1.4
Participation in the internal round robin program meets the frequency requirements for all test codes held by the laboratory as described in AC7101/1 Appendix B.
YES
NO
14.1.5
Procedures are used to ensure participation in Internal Round Robin Programs and analyze the results of internal round robins against defined acceptance criteria.
YES
NO
14.2
Proficiency Testing
14.2.1
Procedures ensure participation in Proficiency Testing Program(s)
YES
NO
14.2.2
The laboratory used a Proficiency Testing provider in accordance with Appendix C.
YES
NO
14.2.3
The participation of the laboratory in Proficiency Testing Program(s) is documented.
YES
NO
14.2.4
Participation in the Proficiency Testing meets the frequency requirements for all test codes held by the laboratory (see Table 1 of Appendix B).
YES
NO
YES
NO
14.2.5
The requirements in Appendix D were followed.
14.3
Statistical Analysis
14.3.1
Statistical analysis and correlation of the data are performed and documented for both internal round robin testing and proficiency testing, if applicable. It is the host facility’s duty to provide a statistical evaluation of the data in the final report, if applicable.
YES
NO
14.3.2
Procedure(s) are used for investigation of outliers.
YES
NO
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APPENDIX A ADDITIONAL QUESTIONS FOR CA PTIVE LAB ORATORIES CERTIFIED TO A S/EN/JISQ 9100 IN LIEU OF ISO/IEC 17025
A.1
QUAL ITY SYSTEM DOCUMENT
A.1.1
Quality System Document: If the laboratory is part of an organization performing activities other than testing and/or calibration, the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest.
YES
NO
A.1.2
Quality System Document: The laboratory has arrangements to ensure that its management and personnel are free from any undue internal and external commercial, financial, and other pressures and influences that may adversely affect the quality of their work.
YES
NO
A.1.3
Quality System Document: The laboratory has policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgment or operational integrity.
YES
NO
A.1.4
Quality System Document: Written policy addressing errors in testing is established through the Quality Systems Documentation.
YES
NO
A.1.5
Quality System Document: Procedures define the responsibility for review and approval of test results, authorization of re-testing, and preparation or approval of test procedures.
YES
NO
A.2
UNCERTAINTY
A.2.1
Estimation of Uncertainty of Measurement: A calibration laboratory, or a testing laboratory performing its own calibrations, shall have and shall apply a procedure to estimate the uncertainty of measurement for all calibrations.
YES
NO
A.2.2
Estimation of Uncertainty of Measurement: For non-standard tests, or those tests developed by the laboratory for which there is no published method, the Estimated Uncertainty for the test shall be determined for any test whose frequency is ten times or more in a six month period, and to which the requirements of the appropriate AC 7101 checklist apply. In certain cases, the nature of the test method may preclude rigorous, metrologically and statistically valid, calculation of uncertainty of measurement. In these cases, the laboratory shall at least attempt to identify all the components of uncertainty and make a reasonable estimation, and shall ensure that the form of reporting of the result does not give a wrong impression of the uncertainty. Reasonable estimation shall be based on knowledge of the performance of the method and on the measurement scope and shall make use of, for example, previous experience and validation data.
YES
NO
A.2.3
Estimation of Uncertainty of Measurement: When estimating the
YES
NO
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uncertainty of measurement, all uncertainty components which are of importance in the given situation shall be taken into account using appropriate methods of analysis. A.3
UNAUTHORIZED PERSONNEL
A.3.1
The laboratory is secure from unauthorized personnel. Access to and use of areas affecting the quality of tests and/or calibrations shall be controlled. The laboratory shall determine the extent of control based on its particular circumstances.
A.4
SELECTION OF METHODS
A.4.1
YES
NO
Selection of Methods: For sampling, which meet the needs of the customer and which are appropriate for the tests and/or calibrations it undertakes. Methods published in international, regional, or national standards shall preferably be used. The laboratory shall ensure that it uses the latest valid edition of a standard unless it is not appropriate or possible to do so. When necessary, the standard shall be supplemented with additional details to ensure consistent application.
YES
NO
A.4.2
Selection of Methods: When the customer does not specify the method to be used, the laboratory shall select appropriate methods that have been published either in international, regional, or national standards, or by reputable technical organizations, or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment. Laboratory-developed methods or methods adopted by the laboratory may also be used if they are appropriate for the intended use and if they are validated. The customer shall be informed as to the method chosen. The laboratory shall confirm that it can properly operate standard methods before introducing the tests and calibrations. If the standard method changes, the confirmation shall be repeated.
YES
NO
A.4.3
Selection of Methods: The laboratory shall inform the customer when the method proposed by the customer is considered inappropriate or out of date.
YES
NO
A.5
TEST REPORTS
A.5.1
Test reports include where appropriate and necessary for the interpretation of the test reults, opinions and interpretations.
YES
NO
A.6
RECORDS
A.6.1
Procedures are used to control and secure records.
YES
NO
A.7
CONTROL OF TEST MATERIALS
A.7.1
Procedures are used to control all test materials from the point of entering the laboratory through the final disposition.
YES
NO
A.8
ERRORS IN TESTING
A.8.1
Errors in Testing: Specific responsibility (individual or title) for
YES
NO
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notification of affected customers is documented. A.9
CAL IBRA TION
A.9.1
Applicable to non-ISO17025 calibra tion source: Procedures are used to ensure standards are calibrated compliant to ISO17025 and segregated and controlled to prevent use for anything other than calibration.
A.10
PROCEDURES
A.10.1
A.10.2
YES
NO
Procedures are used to ensure correct versions of the test procedures are used at the time of testing and obsolete procedures/documents are unavailable for use in testing.
YES
NO
Procedures are used for issue, change management, review and approval of documents/procedures issued to personnel. Personnel authorized for this activity are documented such that names and roles and responsibilities are clear.
YES
NO
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APPENDIX B PROFICIENCY TESTING AND INTERNAL ROUND ROBIN REQUIREMENTS TABLE 1 – FREQUENCIES FOR PROFICIENCY/ROUND ROBIN TESTING PROGRAMS Note: PT and IRR requirements are listed here by checklist. Some checklists do not have PT/IRR requirements.
B.1 CODE
TEST TYPE
Profici ency Testing Frequency
Date Performed
AC7101/2 – Chemi cal Anal ysi s Every 2 Years
1
Direct Current plasma (DCP)
Every 2 Years
1
F2
Inductively Coupled Plasma (ICP)
Every 2 Years
1
F3
Spark/Arc (OES)
Every 2 Years
1
F4
Glow Discharge (GD)
Every 2 Years
1
F5
High Temperature Hollow Cathode
Every 2 Years
1
G
Combustion or Fusion
G1
Carbon
Every 2 Years
1
G2
Hydrogen
Every 2 Years
1
G3
Nitrogen
Every 2 Years
1
G4
Oxygen
Every 2 Years
1
G5
Sulfur
Every 2 Years
1
S
X-Ray Fluorescence (XRF)
Every 2 Years
1
V
Mass Spectroscopy
Every 2 Years
1
W
Atomic Absorption
W1
Flame (AAS)
Every 2 Years
1
W2
Graphite Furnace (GFAA)
Every 2 Years
D
Wet Chemistry
F
Atomic Emission Spectroscopy
F1
1
Notes for Chemistry Analysis IRR/PT Requirements 1
Proficiency testing programs to include all applicable alloy families (Ni, Co, Al, Ti, Fe-High Alloy, Fe-Low Alloy, Cu and Mg) within 6 Years Maximum.
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B.2 CODE
TEST TYPE
Internal Round Robin Frequency for Operators
Date Perfor med
Internal Round Robin Frequency for Equipment
Date Perfor med
AC7101/2 – Chemi cal Anal ysi s D
Wet Chemistry
F
Atomic Emission Spectroscopy
F1
Direct Current plasma (DCP)
Every 2 Years ,
1 2
1 2
Every 2 Years ,
1 2
Every 2 Years ,
1 2
Every 2 Years ,
1 2
Every 2 Years ,
1 2
Every 2 Years ,
1 2
Every 2 Years ,
1 2
Every 2 Years ,
1 2
Every 2 Years ,
1 2
Every 2 Years ,
1 2
Every 2 Years ,
1 2
Every 2 Years ,
1 2
Every 2 Years ,
1 2
Every 2 Years ,
1 2
Every 2 Years ,
1 2
Every 2 Years ,
Inductively Coupled Plasma
F2
1 2
Every 2 Years ,
1 2
Every 2 Years ,
(ICP)
F3
Spark/Arc (OES)
Every 2 Years ,
F4
Glow Discharge (GD)
Every 2 Years ,
F5
High Temperature Hollow Cathode
Every 2 Years ,
G
Combustion or Fusion
G1
Carbon
Every 2 Years ,
G2
Hydrogen
Every 2 Years ,
G3
Nitrogen
Every 2 Years ,
G4
Oxygen
Every 2 Years ,
G5
Sulfur
Every 2 Years ,
S
X-Ray Fluorescence (XRF)
Every 2 Years ,
V
Mass Spectroscopy
Every 2 Years ,
W
Atomic Absorption
W1
Flame (AAS)
Every 2 Years ,
W2
Graphite Furnace (GFAA)
Every 2 Years ,
1 2 1 2 1 2
1 2 1 2 1 2 1 2 1 2 1 2 1 2
1 2 1 2
Notes for Chemistry Analysis IRR/PT Requirements 1
Internal Round Robin programs to include all applicable alloy families (Ni, Co, Al, Ti, Fe-High Alloy, Fe-Low Alloy, Cu and Mg) within 6 Years Maximum . 2
IRR shall be performed for either operators or eq uipment at the specified frequency. Example 1: IRR could be performed with one equipment and multiple operators every two years and satisfy the requirement. No IRR for equipment would be required for this example. Example 2: IRR could be performed with one operator and multiple equipments every two years and satisfy the requirement. No IRR for operators would be required for this example.
B.3 CODE
TEST TYPE
Profici ency Testing Frequency AC7101/3 – Mechan ical Test in g
A
Room Temperature Tensile
Every 2 Years
B
Elevated Temperature Tensile
Every 2 Years
C
Stress Rupture
Every 2 Years
XA
Creep
Every 2 Years
CT
Compression Testing
Not Required
KR
Curve (Resistance to Fracture) Testing
Not Required
N
Impact Testing
Not Required
O
High Cycle Fatigue
Every 5 Years
P
Fracture Toughness
Every 5 Years
Y
Low Cycle Fatigue
Every 5 Years
XE
Crack Propagation/Crack Growth Testing
Every 5 Years
XN
Bend Testing
Not Required
Date Performed
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Notes for Mechanical Testing IRR/PT Requirements – No Notes.
B.4 CODE
Internal Round Robin Frequency for Operators
TEST TYPE
Date Perfor med
Internal Round Robin Frequency for Equipment
Date Perfor med
AC7101/3 – Mechan ical Test in g A
Room Temperature Tensile
Every 2 Years
Every 2 Years
B
Elevated Temperature Tensile
Every 2 Years
Every 2 Years
C
Stress Rupture
Every 2 Years
Every 2 Years
XA
Creep
Every 2 Years
Every 2 Years
CT
Compression Testing
Not Required
Not Required
KR
Curve (Resistance to Fracture) Testing
Not Required
Not Required
N
Impact Testing
Not Required
Not Required
O
High Cycle Fatigue
Every 5 Years
Every 5 Years
P
Fracture Toughness
Every 5 Years
Every 5 Years
Y
Low Cycle Fatigue
Every 5 Years
Every 5 Years
XE
Crack Propagation/Crack Growth Testing
Every 5 Years
Every 5 Years
XN
Bend Testing
Not Required
Not Required
Notes for Mechanical Testing IRR/PT Requirements 1.If an IRR is performed for Creep, then Stress rupture IRR is not required. 2.Suppliers are allowed to propose an IRR/PTP test plan for task group approval. Plan may include SPC and/or Gage R&R data/analyses.
B.5 CODE
TEST TYPE
Profici ency Testing Frequency
AC7101/4 – Metall og rap hy and Micr oi nd ent ation Hard ness L
General Metallography
Not required
Grain Size Measurement
Every 2 Years
Inclusion Rating
Not Required
L1
Microindentation Hardness
Every 2 Years
L2
Alloy Depletion
Not Required
L3
Oxidation/Corrosion Layers
Not Required
L4
Casting (Mold) Reactions
Not Required
L5
Microindentation (Surface-case depth)
Every 2 Years
L5X
Microindentation (Surface) (ARP1820)
Not Required
L6
Nitriding
Not Required
L7
IGA / IGO
Not Required
L8
Alpha Case: Wrought
L8 or L9 Every 2 years
L9
Alpha Case: Castings
L8 or L9 Every 2 years
L10
Carburization/Decarburization
Not Required
LS
Near-Surface Examinations
Not Required
XL
Macro Examination
Not Required
Notes for Metallography and Microindentation Hardness IRR/PT Requirements – No Notes.
Date Performed
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B.6 CODE
Internal Round Robin Frequency for Operators
TEST TYPE
Date Perfor med
Internal Round Robin Frequency for Equipment
Date Perfor med
AC7101/4 – Metall og rap hy and Micro in den tatio n Har dn ess L
General Metallography
Not required
Not required
Grain Size Measurement
Every 2 Years
Not Required
Inclusion Rating
Every 2 Years
Not Required
L1
Microindentation Hardness
Every 2 Years
Not Required
L2
Alloy Depletion
Every 2 Years
Not Required
L3
Oxidation/Corrosion Layers
Every 2 Years
Not Required
L4
Casting (Mold) Reactions
Every 2 Years
Not Required
L5
Microindentation (Surface-case depth)
Every 2 Years
Not Required
L5X
Microindentation (Surface) (ARP1820)
Every 2 Years
Not Required
L6
Nitriding
Every 2 Years
Not Required
L7
IGA / IGO
Every 2 Years
Not Required
L8
Alpha Case: Wrought
L9
Alpha Case: Castings
L10
Carburization/Decarburization
Every 2 Years
Not Required
LS
Near-Surface Examinations
Every 2 Years
Not Required
XL
Macro Examination
Every 2 Years
Not Required
L8 or L9
Not Required
Every 2 Years L8 or L9
Not Required
Every 2 Years
Notes for Metallography and Microindentation Hardness IRR/PT Requirements – No Notes.
B.7 CODE
TEST TYPE
Profici ency Testing Frequency
Date Performed
AC7101/5 – Hardn ess (Mac ro ) M1
Hardness (Brinell)
Every 2 Years
M2
Hardness (Rockwell)
Every 2 Years
M3
Hardness (Vickers)
Every 2 Years
Notes for Hardness IRR/PT Requirements – No Notes.
B.8 CODE
Internal Round Robin Frequency for Operators
TEST TYPE
Date Perfor med
Internal Round Robin Frequency for Equipment
Date Perfor med
AC7101/5 – Hardn ess (Mac ro ) M1
Hardness (Brinell)
Every 2 Years
Every 2 Years
M2
Hardness (Rockwell)
Every 2 Years
Every 2 Years
M3
Hardness (Vickers)
Every 2 Years
Every 2 Years
Notes for Hardness IRR/PT Requirements – No Notes.
AC7101/6 – Corr os io n: No PT/IRR Req ui rem ent s B.9 CODE
TEST TYPE
Profici ency Testing Frequency
AC7101/7 – Mechan ical Test in g Specimen Preparat io n Z2
Low Stress Grinding and Polishing
Every 2 Years
Notes for Mechanical Testing Specimen Preparation IRR/PT Requirements – No Notes.
Date Performed
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B.10 CODE
Internal Round Robin Frequency for Operators
TEST TYPE
Date Perfor med
Internal Round Robin Frequency for Equipment
Date Perfor med
AC7101/7 – Mechan ical Test in g Specimen Preparatio n Z2
Low Stress Grinding and Polishing
Every 2 Years
Every 2 Years
Notes for Mechanical Testing Specimen Preparation IRR/PT Requirements – No Notes.
AC7101/8 – Diff eren ti al Ther mal An aly si s: No PT/IRR Req ui rem ent s AC7101/9 – Test Spec im en Resp on se/Capab il it y t o Heat Treat : No PT/IRR Requi rem ent s AC7101/11 – Fasten er Test in g B.11 CODE
TEST TYPE
Profici ency Testing Frequency
Date Performed
AC7101/11 – Fasten er Test in g 15
Torque – Tension
Not Required
31
Torque – Locking, Torque-Out
Not Required
40L2
Metallography – Alloy Depletion
Not Required
40L3
Metallography – Oxidation / Corrosion
Not Required
40L7
Metallography – IGA / IGO
Not Required
40L8
Metallography –Alpha Case: Wrought Titanium
Every 2 Years
40L10
Metallography – Decarburization / Carburization
Not Required
40L25
Metallography – Grain Size
Every 2 Years
6-M2
Hardness – Rockwell
Every 2 Years
6-M3
Hardness – Vickers
Every 2 Years
6-L5
Hardness – Microindentation Hardness
Every 2 Years
8-P
Tensile Test – Proof Load (nuts / screws)
Not Required
8-A
Tensile Test – Axial Tensile
Every 2 Years **
8-W
Tensile Test – Wedge Tensile
Every 2 Years **
18
Tensile Test – Elevated TempTensile
Every 2 Years **
10
Stress Rupture
Every 2 Years *
11
Fatigue
Every 5 Years
13
Shear Strength – Double Shear
Every 2 Years
5
Stress Durability – External Threads
Not Required
14
Stress Durability – Internal Threads
Not Required
Q
Corrosion – Salt Spray
Not Required
QF
Corrosion – Copper Sulfate
Not Required
Notes for Fastener Testing IRR/PT Requirements 1. See also AC7101/11 Table 1 regarding assignment of test codes 2. Any of the above PT or IRR requirements, if not fastener specific, can be met through other accredited checklists (does not apply to fatigue). 3. * If result of a stress rupture test is to discontinue at a defined point, no PT or IRR is necessary. 4. ** If elevated temp tensile has been performed for PT or IRR (and all operators are the same), equivalent room temperature participation is not necessary. 5. Only one room temperature tensile PT is required. Separate participation is not required for axial or wedge. 6. If case depth utilized microhardness, separate PT for microhardness is no t required.
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B.12 CODE
TEST TYPE
Internal Round Robin Frequency for Operators
Date Perfor med
Internal Round Robin Frequency for Equipment
Date Perfor med
AC7101/11 – Fasten er Test in g 15
Torque – Tension
Every 2 Years
Not Required
31
Torque – Locking, Torque-Out
Every 2 Years
Not Required
40L2
Metallography – Alloy Depletion
Not Required
Not Required
40L3
Metallography – Oxidation / Corrosion
Not Required
Not Required
Not Required
Not Required
40L7
Metallography – IGA / IGO
40L8
Metallography –Alpha Case: Wrought Titanium
Every 2 Years
Not Required
40L10
Metallography – Decarburization / Carburization
Not Required
Not Required
Every 2 Years
Not Required
40L25
Metallography – Grain Size
6-M2
Hardness – Rockwell
Every 2 Years
Every 2 Years
6-M3
Hardness – Vickers
Every 2 Years
Every 2 Years
6-L5
Hardness – Microindentation Hardness
Every 2 Years
Every 2 Years
8-P
Tensile Test – Proof Load (nuts / screws)
Not Required
Not Required
8-A
Tensile Test – Axial Tensile
Every 2 Years **
Every 2 Years **
8-W
Tensile Test – Wedge Tensile
Every 2 Years **
Every 2 Years **
18
Tensile Test – Elevated Temp.Tensile
Every 2 Years **
Every 2 Years **
10
Stress Rupture
Every 2 Years *
Every 2 Years *
11
Fatigue
Every 5 Years
Not Required
13
Shear Strength – Double Shear
Every 2 Years
Every 2 Years
5
Stress Durability – External Threads
Not Required
Not Required
14
Stress Durability – Internal Threads
Not Required
Not Required
Q
Corrosion – Salt Spray
Not Required
Not Required
Corrosion – Copper Sulfate
Not Required
Not Required
QF
Notes for Fastener Testing IRR/PT Requirements 1. See also AC7101/11 Table 1 regarding assignment of test codes 2. Any of the above PT or IRR requirements, if not fastener specific, can be met through other accredited checklists (does not apply to fatigue). 3. * If result of a stress rupture test is to discontinue at a defined point, no PT or IRR is necessary. 4. ** If elevated temp tensile has been performed for PT or IRR (and all operators are the same), equivalent room temperature participation is not necessary 5. Only one room temperature tensile PT is required. Separate participation is not required for axial or wedge. 6. If case depth utilized microhardness, separate PT for microhardness is no t required.
AC7109/5 – Coati ng Eval uat io n L abo rat or y Pr act ic es: See AC7109/5 fo r PT/IRR requ ir emen ts AC7110/13 – Evalu ati on of Weld s: No PT/IRR requ ir emen ts
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AC7101/1 Revisi on F
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APPENDIX C SELECTION OF A PROFICIENCY TEST (PT) PROVIDER
When not practical or feasible to use a provider from the PRI list of recognized providers (found at www.eAuditNet.com, Resources Documents Public Documents Materials Testing IPT Information), three other options are available in this appendix. →
Option 1
→
→
→
Using an unrecognized Proficiency Testing provider The laboratory can participate in PT by other commercial providers if at least 8 of the “Rules for acceptance of commercial proficiency testing providers” (listed below) are validated by the provider and verified by the laboratory.
Option 2
How to use a Subscriber Program as a Proficiency Testing Provider The laboratory can use a Subscriber specific program only after PRI Staff Engineer and Subscriber concur regarding confidentiality and method validation.
Option 3
Option 3 – Submit a plan to meet the intent of proficiency testing for Task Group approval. Supplier shall retain an approved plan to meet this requirement.
Laboratories are responsible to ensure the provider they use conforms to the rules of this appendix (listed below) at time of use. Rules for acceptance of commercial proficiency testing providers. The *Full Process Provider, to be recognized by the MTLTG, shall be compliant with Criterion 1 or Criterion 2 *Full Process Provider - A provider that supplies the sample in a condition to require participating testing laboratory to utilize their entire process (e.g. sample preparation and testing). (Not one that submits photographic sample for review only.) Criterion 1: ISO Guide 43 or ILAC G-13 Compliance and 3rd party accreditation (such as ISO 9001, ISO 17025, and the scope of the accreditation corresponding). OR Criterion 2: ISO Guide 43 or ILAC G-13 Registration and the following rules. Rule 1
Materials and tests scope offered by the provider comply with our aeronautic requirements (Standard used are listed in our referenced documentation).
Rule 2
Homogeneity study of material shall be explained and compliant with Rules 3 and 4:
Rule 3
20 specimens per sheet, tubes or batch is recommended for the homogeneity analyses. Less than 10 specimens per sheet, tubes or batch analyses will not be accepted.
Rule 4
Risk analyses to exclude a participant because of an inhomogeneous material shall be less than 5%.
Rule 5
The number of participants per test program shall be more than 30 to have a robust statistical analyse (less than 10 not accepted (per ASTME2489)).
Rule 6
Time process between the beginning and the end of the program shall be less than 6 Months
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(Root cause analyses concern). Rule 7
Time process between the final reporting of results and the data analysis report shall be less than 3 months (Root cause analyses concern).
Rule 8
Numbers of specimens per test (sufficient number of specimens to ensure repeatability).
Rule 9
Statistical analyses performed (repeatability, median & sigma or k studies).
Rule 10
Interpretability of the report shall be easy and without waste off time for the auditor (the raw data record the method used shall clearly appear).
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AC7101/1 Revisi on F
D.
APPENDIX D
D.1
SPECIFIC TESTING PROTOCOL FOR INTERNAL ROUND ROBINS
- 24 -
(A) Membership – A coordinator of the Internal Round Robin program shall be assigned. It is the coordinator’s responsibility to design the test method protocol, distribute testing materials, guide the testing phase, and construct a final report based on the data obtained. (B) Participants – Participants are qualified operators or candidates for qualification. It may be one operator using various equipment or procedures to perform the same test method (e.g. comparing results from three different Rockwell hardness testers). It may also be several qualified operators using the same equipment and operating procedures to produce test results. (C) Quantity of Test Results (Replicates) per test method – The minimum number of replicates per operator or equipment will normally be two to estimate repeatability. Three or four replicates per operator or equipment is desirable for chemical, mechanical and optical tests depending on time as well as cost factors associated with the test method. The laboratory procedure shall define the minimum quantity of tests to be conducted and also establish criteria for increasing the number of replicates per operator or equipment. (D) IRR testing protocol is in accordance with general testing protocol for IRR and PT below D.2
GENERAL TESTING PROTOCOL FOR INTERNAL ROUND ROBINS (IRR) AND PROFICIENCY TESTING (PT) (A) Basic Design – The testing protocol should be designed such that the results obtained from the chosen method can be classified easily to study the within – and between – facility variability without the influence of secondary effects. (B) Within facility variability, referred to as repeatability, concerns the variability between independent testing results obtained within a single facility in the shortest practical period of time by a single operator with a specific set of test apparatus using test specimens taken at random from a single quantity of homogeneous material obtained or prepared for the study. The single operator – single set of apparatus requirement means that given a particular step in the measurement process, the same combination of operator and apparatus is used for every test result (replicate) and on every material. Thus, one operator may prepare the test specimens, a second operator measure the dimensions and a third operator may perform the test. (C) Timing Precision - “Shortest practical period of time” means that the test results, at least for one material, are obtained in a time not less than in normal testing and not so long as to permit significant changes in the test material, equipment or environment. (D) Between facility variability, referred to as Reproducibility, deals with the variability between single test results obtained in different facilities, each of which has applied the test method to the test specimens taken at random from a single quantity of homogeneous material obtained or prepared for the study.
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(E) Data Classification – One form of classification suggested is a separate matrix table for each property tested, in which the rows represent the facilities and the columns represent the materials (or vice versa). Each cell, the intersection of a row with a column, contains the test results made by a particular laboratory for a particular material. (For practicality reasons regarding certain test methods, the terms material and property may be interchanged in this paragraph). (F) Test Method – The actual measurement process and the written description of the process. A written draft of the test method shall be constructed that describes the test procedure, identifies test conditions affecting the test results, and specifies the proper degree of control of the test. The number of significant digits to be reported shall also be designated and shall follow, as a minimum. The test method shall include any special calibration procedure and the frequency of calibration required, if applicable. (G) Global Instruction - The name, address, e-mail address, telephone and fax number of the key person(s) coordinating and supervising the proficiency testing should be provided in the protocol. The participating laboratories shall be instructed to contact the coordinator when any questions arise as to the conduct of the proficiency testing. (H) Test Identification – Clearly identify the test method, specifying any option(s) in apparatus or procedure selected. Test units and test data sheets should be given for each option. (I) Material Consistency - Each material selected shall be supplied by one source and made to be as homogeneous as possible, prior to its subdivision into test specimens. The location of every test specimen from the bulk material shall be traceable through a letter and/or number designation indicated on each sample. In other words, a log or schematic of the location referencing where each test specimen originated from the bulk material shall be maintained. The samples shall be randomized before distribution and a record shall be maintained of which facilities (EPT) or operators and equipment (IRR) are testing which sample number(s). (J) Calibration Procedures – Calibration procedures required before every test result should be described in detail in the test method, if applicable. (K) Specific Conditions Analyses – Characterize any special circumstances that must be addressed in executing the repeatability conditions (e.g. the length of time between obtaining the test results for the same material). (L) Handling and Conditioning – Stipulate the required care, handling and conditioning of the material(s) to be tested, if applicable. Describe the coding system used to identify the material(s) to be tested. (M) Host Facility Data Collection – The host laboratory or provider may provide data sheets for recording the raw data as observed. Supply sheets on which test results can be calculated or combined with the raw data sheet(s), if applicable. Request that all raw data be sent as soon as the testing is completed, or at regular intervals for testing which extends over several weeks.
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(N) Data sheets should be provided so that each laboratory can record any special events that arise during any phase of the testing. In addition to a ‘comments’ section, questions pertinent to the test method may be asked to get a better idea of how the test was carried out as long as the information is not proprietary. Any information that would ensure that the laboratory complied with the requirements specified for the test method or that may be needed to prepare for the final report should also be requested. The recorded comments will serve as a valuable source of information both in handling outlying data and for improving the test method for future proficiency testing. Obtain suggestions for future testing regarding the test method and test materials. (O) Replacement – The protocol must contain information about the availability of the material(s) for replacement tests. It is recommended that the host laboratory prepare enough of each material to supply 50% more than needed by the number of facilities committed to the testing program. Instruct the facilities to notify the test coordinator immediately whenever an error in test procedure occurs. It can then be determined whether a new set of test specimens needs to be provided for a replacement test of the material(s). (P) Final Report – A formal report shall be distributed by the host to all participants, containing a description or summary of the test method, materials and the reported test results from all participants. Testing sponsored by Nadcap-accredited facilities should clearly state which Nadcap testing requirement(s) are met (e.g. This testing fulfills Nadcap requirements for Stress Rupture in January of 2010). Participants shall be identified by code to minimize the possibility of bias during data analysis. Each participant shall be informed of its code assigned by the host to maintain confidentiality.
PRI
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APPENDIX E CAL IBRATION FREQUENCY (MAXIMUM) GENERAL EQUIPMENT Precision Indicators (e.g., Test Temperature Indicators) Laboratory Facility Temperature/Humidity Measuring Instruments
REQUIRED FREQUENCY 3 Months
1 Year
Recording Systems: To + 1% of full scale range (e.g., X-Y Strip Charts)
6 Months
Precision Potentiometers
3 Months
Micrometers/Verniers
6 Months
Optical Comparator
1 Year
Oscilloscopes
1 Year
Note: Calibration cycles may be extended as defined by the NCSL (National Conference of Standards Laboratories), Recommended Practice 1, or other recognized statistical review process to support the extended time interval. Calibration frequencies defined by standard methods or supplier requirements shall not be extended. Calibration extension shall be allowed only if documented historical data and standard calibration practices substantiate the extension of calibration frequencies.
