Quality Management Systems For Nondestructive Testing Agencies

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The key takeaways are that this standard outlines requirements for establishing and maintaining a quality management system for nondestructive testing agencies. It references other standards for criteria and terminology.

The scope of this standard (Section 1) is to cover general requirements for establishing and maintaining a quality management system for agencies performing nondestructive testing. It utilizes criteria from other ASTM standards.

Section 9 lists the requirements for establishing a quality management system, including defining the management responsibility, quality system, document control, purchasing, control of customer-supplied product, product identification and traceability, process control, inspection and testing, control of inspection and test equipment, inspection and test status, nonconforming product, corrective and preventive action, handling, storage, packaging and delivery, control of quality records, internal quality audits, training, and servicing operations.

Designation: E1212 − 12

Standard Practice for


Quality Management Systems for Nondestructive Testing
Agencies 1
This standard is issued under the fixed designation E1212; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.

1. Scope* destructive Testing Personnel


1.1 This practice covers general requirements for the estab- 2.3 ANSI/ASQ Standards:
lishment and maintenance of a quality management system for A8402 Management and Quality Assurance-Vocabulary4
agencies engaged in nondestructive testing (NDT). Q9000 Series of Quality Management and Quality Assur-
1.2 This practice utilizes criteria contained in Practice E543. ance (Q9000 through Q9004 inclusive) Standards (These
are exact equivalents to the ISO 9000 through ISO 9004
1.3 This practice utilizes criteria contained in American series)
National Standard ANSI/ISO/ASQ Q9001–2008, Quality man-
agement systems—Requirements. 2.4 AIA Standard:
NAS 410 NAS Certification and Qualification of Nonde-
1.4 This practice recognizes the importance of establishing structive Testing Personnel5
minimum safety criteria.
1.5 The use of SI or inch-pound units, or combinations 3. Terminology
thereof, will be the responsibility of the technical committee 3.1 Definitions of Terms Specific to This Standard:
whose standards are referred to in this standard.
3.1.1 agency, n—the public, independent, or in-house non-
1.6 This practice does not purport to address all of the destructive testing organization selected by the authority to
safety concerns, if any, associated with its use. It is the perform the examination(s) required by the purchase order or
responsibility of the user of this practice to establish appro- specification.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use. 3.1.2 authority, n—the owner, prime contractor, engineer,
architect, or purchasing agent in responsible charge of the
2. Referenced Documents work, or duly recognized or designated representative.
2.1 ASTM Standards:2 3.1.3 continual quality improvement, n— an ongoing quality
E543 Specification for Agencies Performing Nondestructive improvement activity for achieving results. Improvement may
Testing be directed at individual processes, finished products, or
E1359 Guide for Evaluating Capabilities of Nondestructive administrative processes. The continual quality improvement
Testing Agencies program utilizes statistical methods, team projects, and other
2.2 ASNT/ANSI Standards:3 tools as appropriate to obtain and sustain improvements.
ASNT Recommended Practice No. SNT-TC-1A Personnel 3.1.4 customer, n—customer is used with the same meaning
Qualification and Certification in Nondestructive Testing as “authority.”
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ANSI/ASNT CP 189 Qualification and Certification of Non-


3.1.5 process capability, n—the degree to which a process
can produce the same results without variation, that is, repro-
1
This practice is under the jurisdiction of ASTM Committee E07 on Nonde-
ducibility.
structive Testing and is the direct responsibility of Subcommittee E07.09 on 3.1.6 process control, n—managing a process to ensure that
Nondestructive Testing Agencies.
Current edition approved Nov. 1, 2012. Published November 2012. Originally it is performing to its designed capability.
approved in 1987. Last previous edition approved in 2009 as E1212 - 09. DOI:
10.1520/E1212-12.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4
contact ASTM Customer Service at [email protected]. For Annual Book of ASTM Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Standards volume information, refer to the standard’s Document Summary page on Milwaukee, WI 53203, http://www.asq.org.
5
the ASTM website. Available from Aerospace Industries Association of America, Inc. (AIA), 1000
3
Available from American Society for Nondestructive Testing (ASNT), P.O. Box Wilson Blvd., Suite 1700, Arlington, VA 22209-3928, http://www.aia-aerospace.org.
28518, 1711 Arlingate Ln., Columbus, OH 43228-0518, http://www.asnt.org.

*A Summary of Changes section appears at the end of this standard


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E1212 − 12
3.1.7 quality management system, n—the organizational 5.4 Quality Planning—Planning for each new or modified
structure, responsibilities, practices, procedures, processes, and process or test method should define those characteristics to be
resources for implementing and maintaining the quality pro- controlled. Quality planning also includes providing for ad-
gram. ministrative processes needed to implement compliance with
3.1.8 quality manual, n—a comprehensive document stating this practice.
the quality policy and specifying organizational structure, 5.5 Quality Manual—The quality policy and system shall be
practices, and procedures necessary to empower the quality documented and be in accessible form, such as a quality
policy and quality management system. manual or series of manuals. Key elements should include, as
3.1.9 quality objectives, n—specific obtainable improve- necessary:
ment goals supporting the quality program. 5.5.1 The general quality statement,
3.1.10 quality policy, n—the overall intentions and direction 5.5.2 A description of the quality system,
of an organization regarding quality as formally expressed by 5.5.3 A general description of quality planning requirements
top management. with specifics for each product category where appropriate,
5.5.4 The requirements of Practice E543 pertaining to the
3.1.11 quality records, n—formal documentation of exami-
laboratory procedure manual, and
nation results or data supporting the quality management
5.5.5 Typically used examination procedures.
system.
3.1.11.1 Discussion—Examples are: audit reports, calibra- 5.6 Administration—Clear lines of authority shall be estab-
tion data, NDT records, process qualification results, qualifi- lished to administer the quality management system.
cation data, and test data. 5.6.1 Quality Responsibility—The quality responsibility of
each unit within the organization shall be approved by the chief
4. Significance and Use operation officer of each unit.
4.1 This practice covers procedures for establishing and 5.6.2 Quality Performance Reporting—Responsibility for
maintaining a quality system for nondestructive testing agen- reporting performance against stated quality objectives to
cies. higher management should rest with functions independent of
those responsible for the attainment of those objectives. Pro-
4.2 Controlling the quality of service rendered is a continu- cedures for documentation and record retention should be
ing process. This practice provides guidelines for establishing established.
a quality management system that provides for: calibration,
5.6.3 Quality System Audits—To provide assurance, a peri-
standardization, reference samples, examination plans, and
odic audit of the quality management system should be made
procedures.
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by an organizational element independent of the unit being


4.3 The basic requirements for a quality management sys- audited or by a qualified third party to monitor the effectiveness
tem encompass the following areas, all of which shall be of various quality management system processes. It may
documented. include, as appropriate:
4.3.1 Quality policy statement, planning, and 5.6.3.1 Management audits to determine how well quality
administration, policy and objectives are being met,
4.3.2 Organization, 5.6.3.2 System audits, including examination process audits
4.3.3 Human resources, to determine how well quality planning has been implemented
4.3.4 Physical resources, and and to identify areas where changes would be beneficial to the
4.3.5 Quality management. quality services performed, and
5.6.3.3 Records documenting findings and corrective and
5. Quality Policy Statement, Planning, and preventive actions taken.
Administration
5.1 Policy Statement—A policy statement shall describe 6. Organization
management’s specific intention and policy with respect to
6.1 The following information concerning the organization
quality. The policy statement should specify an organized
of the agency shall be documented.
approach for carrying out those intentions and should address
6.1.1 A description of the organization including:
itself to all major quality parameters. It should be approved by
the chief executive officer for company-wide policies or by 6.1.1.1 The complete legal name and address of the main
subordinate officers for specialized policies. Periodic audits office,
should be required to ensure adherence to quality policies. 6.1.1.2 The names and positions of the principal officers and
directors,
5.2 Quality Objectives—Objectives should be established 6.1.1.3 The agency’s ownership, managerial structure, and
for appropriate key elements of performance such as safety principal members,
requirements, internal performance levels, vendor 6.1.1.4 The functional description of the agency’s organiza-
performance, training, and qualification of personnel. tional structure, operational departments, and support depart-
5.3 Quality Management System—A quality management ments and services. This may be demonstrated in the form of
system shall be established that will carry out the stated charts that depict all the divisions, departments, sections and
policies and objectives. units, and their relationships,

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6.1.1.5 All relevant organizational affiliates of the agency 8.1.2.4 Properties of the equipment subject to standardiza-
and principal officers of affiliates and directors of affiliates tion or calibration,
where applicable, 8.1.2.5 The range of operation and range of calibration,
6.1.1.6 External organizations and organizational compo- 8.1.2.6 Reference to a recognized calibration procedure,
nents and their functions that are utilized for significant 8.1.2.7 Frequency of calibration, and
technical support services, and 8.1.2.8 Allowable tolerances or maximum sensitivity.
6.1.1.7 A brief history of the agency including its relation- 8.1.3 A system of written procedures for each NDT service
ship with its organizational component affiliations and other performed by the agency. The procedures shall include a
supporting information. description of the methods used for NDT and the methods used
6.1.2 A listing of the relevant technical services offered. for data recording, data processing, data reporting, and for
6.1.3 A list giving applicable dates of qualifications and certification of the results. When required, customer approval
accreditations. shall be obtained.
8.1.4 An inventory of reference material including a library
7. Human Resources of standards, applicable technical publications, and pertinent
7.1 General—Those aspects of the quality system where the specifications and amendments.
work of the employees will affect the quality of products shall
be identified, and specific action taken to control them. 9. Quality Management
7.2 Management Responsibilities—The quality-related 9.1 Purchased NDT Equipment, Materials, and Services:
requirements, duties, and responsibilities of all personnel shall 9.1.1 General—The quality management system shall in-
be identified. Job criteria that are quality-related should be clude procedures to ensure effective supplier quality manage-
specified in job descriptions to permit proper employee selec- ment for all purchased materials and services. Controls shall be
tion. provided for materials, equipment, and any subcontracted
services.
7.3 Employee Selection and Training—Employees shall be
9.1.2 Supplier Quality Program and Selection Methods—
selected on the basis of capability and experience or the
Procedures shall be established for the selection and qualifica-
potential to fully qualify for the job. A training program shall
tion of suppliers, such as supplier surveys, past quality history,
be maintained to ensure employees develop and retain skill
and industry history. Each supplier’s quality capability shall be
competence. Nondestructive testing (NDT) personnel shall be
periodically evaluated, including audit visits where
qualified in accordance with a nationally recognized NDT
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appropriate, based upon performance. The requirements for


personnel qualification practice or standard such as ANSI/
quality management shall be established in the purchase
ASNT-CP-189, ASNT/SNT-TC-1A, AIA/NAS 410, or a simi-
agreement. The purchase agreement should include the ele-
lar document. The practice or standard used and the applicable
ments of the quality management system that are to be
revision shall be specified in the contractual agreement be-
performed by the supplier in assuring quality.
tween the using parties.
9.1.3 Receiving Inspection—For those purchased items
7.4 The agency shall provide the following documentation: where inspection upon receipt is acceptable, inspection of
7.4.1 A written outline or chart giving operational personnel submitted items shall be performed to the degree and extent
positions and their lines of responsibility and authority, and needed to determine acceptability. Receiving inspection shall
7.4.2 A summary job description for each professional, include well-maintained records so that past supplier perfor-
scientific, supervisory, and technical position category includ- mance is available. Adequate facilities and procedures for
ing the required education, training and experience, storage, handling, protection, and controlled release of pur-
certification, or professional licenses. chased materials shall be established. Materials inspected,
7.5 The agency shall provide a description of its methods of tested, and approved shall be separated from withheld or
maintaining personnel records to document the qualifications, rejected materials.
work experience, and training history of each person in the 9.1.4 Nonconforming Material Control—Control of non-
positions described in 7.4.2. The agency shall also provide a conforming purchased supplies or equipment shall be main-
description of its means of ensuring confidence in its human tained to ensure that such items are not used.
resources including the maintenance of records. 9.1.5 Subcontracted Services—When the agency utilizes the
services of another agency to perform all or part of its services,
8. Physical Resources provisions shall be made to ensure that the activities are
8.1 The agency shall provide an inventory of its relevant performed in accordance with the purchaser’s requirements.
physical resources including: Actions to be taken shall be included in the agency’s quality
8.1.1 A general description of the agency’s facilities for assurance manual. The requirements of Guide E1359 shall be
NDT related activities. used as a guide in evaluating the quality system of the
8.1.2 An inventory of equipment used to perform NDT subcontracted agency.
including the following for each item of equipment: 9.2 Measuring and Test Equipment:
8.1.2.1 Type of equipment and use, 9.2.1 Measuring and test equipment shall be of the type,
8.1.2.2 Name of manufacturer, range, accuracy, precision, stability, and resolution appropriate
8.1.2.3 The equipment model and serial number, for its intended use.

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9.2.2 Measuring and test equipment shall be calibrated and 9.5.2 Content and Use of Records—All quality records
controlled to ensure accuracy of measurement of product and shall:
processes to specified requirements. A calibration system shall 9.5.2.1 Be current, complete, accurate, legible, and
be established to ensure that measuring and test equipment are pertinent, showing (where required) information such as iden-
maintained by periodic calibration against certified equipment tification and quality of product examined, date, examination
traceable to nationally recognized standards and serviced so procedures followed, and examination results,
that equipment will function properly and are within their 9.5.2.2 Contain the date of origination of the records,
prescribed limits. 9.5.2.3 Be traceable to product, process, or production
9.2.3 The calibration system shall be an integral part of the period,
quality management system that will ensure the quality of the 9.5.2.4 Where required, be identifiable as to individuals
product or services provided. The calibration system shall be responsible for their preparation,
documented and shall require that the appropriate records be 9.5.2.5 Where required, show quantity, type, and severity of
maintained to substantiate conformance with specified require- discrepancies found, and
ments. 9.5.2.6 Be retained in accordance with a stated record
retention policy, so as to be available for periodic independent
9.3 Document Control—All examinations shall be per-
reviews as may be needed to comply with the customer’s
formed in accordance with instructions, procedures, or other
contractual requirements. Protection from fire, theft, pilferage,
documents appropriate to the circumstances. All such work
and water damage shall be considered.
instructions, procedures, specifications, and drawings shall be
9.5.2.7 The methods to be used for management of records
controlled by the quality management system. Documents shall
shall be documented in the agency’s quality manual or proce-
be reviewed for correctness and adequacy prior to release to the
dures.
appropriate work station. The system shall ensure that correct
revisions of applicable documents are available for use at the 9.6 Process Control:
locations where the activities affecting quality are performed. 9.6.1 Control of Operations—The quality management sys-
The system shall also provide for the timely recall of obsolete tem shall ensure that all required operations are performed in
documents. the specified manner and sequence. Operations should be
defined to the maximum practical extent by documented work
9.4 Handling, Storage, and Shipping: instructions. Exceptions made to provide for details of com-
9.4.1 Factors potentially affecting the quality of items being mon practice should be limited.
examined as they move within the activity or on their way to 9.6.2 Receipt of Items—Items shall be inspected upon re-
the customer shall include handling damage, corrosion or ceipt to ensure they are the items specified in the customer’s
infestation, degradation, loss from vandalism, and loss or order. Records shall be maintained of this inspection, traceabil-
obliteration of identifying markings. Methods for ensuring ity data (such as lot, batch, heat, or other identification), shall
quality during handling, storage, and shipping include: be recorded.
9.4.1.1 Control of Handling Methods—Use of established 9.6.3 Special Process Control—Processes having param-
methods to prevent handling damage, such as special eters that affect results require special controls. To ensure
containers, environments, or vehicles, adequate control of these processes, the following procedures
9.4.1.2 Item Audit—Periodic audits of stored items to ensure shall be considered:
against deterioration or expiration of shelf life, 9.6.3.1 Periodic verification of accuracy and variability of
9.4.1.3 Control of Shipping Methods—Monitoring shipping the equipment used in examination of the product, for example,
procedures to ensure that transit requirements are met and that standardization of ultrasonic testing (UT) equipment.
required shipping documents are used, and 9.6.3.2 Periodic verification of the continuing capabilities of
9.4.1.4 Environment Control—Review of procedures main- operators to meet specific process quality requirements.
taining special protective environments, such as temperature, 9.6.3.3 Periodic verification of special environments, times,
moisture, or gas pressure. temperatures, or other factors affecting product quality; for
example, solution control for radiographic testing (RT) film
9.5 Records: processors.
9.5.1 Types of Quality Records—Basic information for an 9.6.4 Control of Item Status—The quality management sys-
effective quality system shall include, where appropriate: tem shall clearly identify the status of material and assemblies.
9.5.1.1 Product identification to allow traceability of what Such identification may take the form of stamps, tags, or
has been examined, which materials and equipment were used, notations on travelers or records that accompany the items.
and by what operation, and on what date. 9.7 Control of Nonconforming Material:
9.5.1.2 Examination and quality management system 9.7.1 Measures shall be established to identify and control
procedures, with applicable standards, checks, and tests. These nonconforming material. Controls shall apply to items that do
are the working instructions of the quality management system. not comply with acceptance criteria and to nonconforming
9.5.1.3 Records as evidence that the prescribed examina- equipment or material. Nonconforming items shall be as
tions have been performed and results thereof. follows:
9.5.1.4 Identification and recording of rejected product with 9.7.1.1 Identified with a clear mark, such as using a
assurance that it had been properly reported to the customer. “HOLD” tag or stamp,
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9.7.1.2 Segregated in a designated holding area, where techniques) it may be possible to identify and eliminate root
practical, with access restricted to those authorized to make causes of potential problems. The method to be used shall be
disposition, and documented in the agency’s quality manual or procedures.
9.7.1.3 Reviewed by a clearly defined authority designated 9.9.3 A procedure shall be developed to focus on the quality
by management and customer requirements. improvement effort, so that it is used to maximum benefit.
9.8 Corrective Action—The agency shall have a system to 9.10 Interface with Other Quality Management Systems:
ensure that repetitive conditions adverse to the quality of the 9.10.1 When the agency is part of a larger operation, the
agency’s work are identified and corrected. The method to be quality management system supporting nondestructive testing
used shall be documented in the agency’s quality manual or may be integrated as a sub-system of the larger (parent) system.
procedures. The corrective action program should be extended Though the parent system may be supporting separate quality
to suppliers as appropriate. specifications, those specifications usually provide for the
9.9 Continual Quality Improvement: nondestructive testing agency to operate as a separate agency.
9.9.1 Continual quality improvement should be used to 9.10.2 Data collected by the nondestructive testing agency
continually improve the effectiveness of the quality manage- may serve as a primary source for data analysis by the
ment system processes as well as to maintain satisfactory customer. Whether the customer is internal or external, provi-
performance levels, as defined by the customer’s requirements. sion needs to be made to support the customers requirements
In some instances, improvement action might be maintaining for data analysis.
or returning to previous levels of performance. In other
10. Customer Satisfaction
instances, the data analysis may support a “breakthrough” and
allow achieving improved performance. Examples would in- 10.1 Establishing clear customer requirements prior to the
clude the following: start of work, and communicating the importance of meeting
9.9.1.1 Analysis of calibration data to obtain the optimum customer requirements to employees of the agency is necessary
calibration cycle. to have a meaningful purchase order. Customer satisfaction is
9.9.1.2 Analysis of data to identify inconsistent perfor- ensured when customers experience that requirements have
mance. Note that inconsistent performance does not always been met and that there is active communication and discussion
mean unacceptable performance. of any issues that concern either party.
9.9.1.3 Analysis of data to identify opportunities to improve
a process. 11. Keywords
9.9.2 Preventive Action—Corrective action (see 9.8) may 11.1 nondestructive testing agency; process control; quality
not be enough to identify and prevent a loss of control or control program; quality management system; quality manual;
change in a process. Through use of data analysis (statistical quality objectives; quality policy; quality records
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SUMMARY OF CHANGES

Committee E07 has identified the location of selected changes to this standard since the last issue (E1212 –
09) that may impact the use of this standard. (November 1, 2012)

(1) Revised SNT-TC-1A title in 2.2. (2) Updated ANSI/ISO/ASQ Q9001 to 2008 in 1.3.

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