Get documents about "Non Conforming Material Report Investigation Protocol
W
Description
Non Conforming Material Report Investigation Protocol document sample
Document Sample
ASTM D-7036-04 Checklist
Ö ¶ Question Location of Answer
Section 5 - Organization and Management
5.1 The AETB has in place a structure, including a quality system that enables it to
continually monitor its ability to deliver its scope of services.
The AETB has in place a structure, including a quality system that enables it to
continually improve its ability to deliver its scope of services.
5.2 The organization of the AETB is clearly defined.
The place of the AETB in any parent organization is clearly defined.
The relationships between quality management, technical operations and support
services are clearly defined.
5.3 The AETB carries out its activities in such a way as to meet the requirements of
ASTM D-7036.
The AETB carries out its activities in such a way as to meet the requirements of
local, state, and federal laws and regulations.
The AETB carries out its activities in such a way as to meet the needs of the client.
The AETB carries out its activities in such a way as to meet the needs of regulatory
authorities.
5.4.1 The AETB has in place a system to collect performance data from all relevant sources.
The AETB has in place a system to document performance data from all relevant
sources.
5.4.2 The AETB provides its employees with the resources to initiate corrective actions.
The AETB provides its employees with the resources to verify and document
the effectiveness of corrective actions.
The AETB provides its employees with the authority to initiate corrective actions.
The AETB provides its employees with the authority to verify and document
the effectiveness of corrective actions.
5.4.3 The AETB is legally identifiable.
The AETB is organized so that its facilities and resources meet the requirements of
ASTM D-7036.
5.4.4 The AETB is organized so that staff members are not subject to undue pressure or
inducement that might inappropriately influence their judgment or results of their
work, including quality issues.
5.4.5 The AETB is organized so that confidence in its independence or judgment and
integrity is maintained at all times.
5.4.6 The AETB is organized so that staff members are aware of both the extent and
limitations of their responsibilities.
5.4.7 The AETB is organized to provide adequate supervision of technical staff, including
trainees, by persons familiar with relevant methods and procedures, the purpose of
the test project, and with assessment of testing results.
The AETB is organized so that only Qualified Individuals may supervise a test.
5.4.8 The AETB has a technical manager or director (however named) who has overall
responsibility for the technical operations of the AETB.
The AETB's technical manager has demonstrated competence in air emissions testing
through education or professional experience or both.
5.4.9 The AETB has a quality manager (however named) who has responsibility for the
quality system and its implementation.
The AETB's quality manager has the responsibility and authority to ensure the
requirements of ASTM D-7036 are implemented and maintained.
The AETB's quality manager has access to the highest levels of management at
which decisions are made on policies affecting the AETB.
5.4.10 The AETB has a Qualified Individual on-site for each project who is qualified for each
test methods performed. Same as 8.3
5.4.11 The AETB is able to provide documentation or otherwise demonstrate on request
that it complies with the relevant and appropriate federal, state, and local
requirements for conducting testing procedures under its scope, including
compliance with ASTM D-7036.
5.4.12 The AETB is able to provide documentation or otherwise demonstrate on request that
it complies with applicable local, state, and federal requirements governing health
and safety, transportation, shipping, and other relevant requirements.
Section 6 - Document Control
6.1 The AETB has established procedures to control all documents that form part of its
quality system (internally generated or from external sources).
The AETB is maintaining procedures to control all documents that form part of its
quality system (internally generated or from external sources).
The AETB's document control procedures are sufficient to preclude the use of invalid
or obsolete documents or both.
6.2 Quality system documents generated by the AETB shall be uniquely identified.
The AETB's unique document identification includes date of issue and/or revision,
page numbering, the total number of pages or a mark to signify the end of the
document, and issuing authority(ies).
6.3 Changes to the AETB's quality documents are reviewed and approved by the same
organizational group that performed the original review unless specifically designated
otherwise.
Personnel conducting a review of the AETB's quality documents have access to
pertinent background information on which to base their review and approval.
Any altered or new text in the AETB's quality documents is identified in the
document or appropriate attachment, where practicable.
6.4 The AETB has defined procedures and authorities for amendment of documents by
hand if the document control system allows for such amendment.
Any document amendments by hand shall be clearly marked, initialed and dated.
Any documents amended by hand shall be formally re-issued as soon as practicable.
Section 7 - Quality System, Audit, and Review
7.1 The AETB has developed a quality policy.
The AETB has disseminated its quality policy.
The AETB's quality policy is a formal statement signed by top management.
The AETB's quality policy states the commitment by top management and staff to
conform to the requirements documented in the quality manual and to ASTM D-7036.
7.1.1 The management of the AETB has defined and documented its quality policy.
The management of the AETB has defined and documented its quality objectives.
The management of the AETB has defined and documented its commitment to quality.
7.1.2 The quality policy of the AETB includes recognition of the needs and expectations of
its customers.
The quality policy of the AETB is understood at all levels within the AETB.
The quality policy of the AETB is implemented at all levels within the AETB.
The quality policy of the AETB is maintained at all levels within the AETB.
7.2 The AETB has established a documented quality system as a means of ensuring that
its operations are appropriate to providing air emission testing services.
The AETB has established a documented quality system as a means of ensuring that
its operations meet the requirements of ASTM D-7036.
The AETB is maintaining its documented quality system.
The AETB is operating under its documented quality system.
7.2.1 The AETB's quality system is designed to ensure the required degree of completeness,
representativeness, comparability, and uncertainty (within the limits of uncertainty
documented in the test method) needed to meet the data quality objectives of each
project undertaken by the AETB.
7.2.2 The AETB's quality system is documented to the extent necessary to ensure consist-
ent achievement of data quality objectives for projects undertaken by the AETB.
The AETB's conformance to the quality system is documented to the extent necessary
to ensure consistent achievement of the data quality objectives for the projects
undertaken by the AETB.
7.3 The AETB's quality system is documented in a quality manual and supporting quality
system documentation.
The AETB's quality manual addresses all relevant topics listed in Appendix X1 of
ASTM D-7036.
The AETB's quality manual and documentation is available for use by the AETB staff.
The AETB's quality system documents are maintained current.
The AETB's quality manager has the responsibility for maintaining the quality
documents.
7.4.1 The AETB conducts annual audits of its activities to verify that its operations continue
to conform to the requirements of the quality system.
The AETB's internal audits are carried out by qualified personnel who, whenever
practical, are independent of the activity audited.
7.4.2.1During internal audit, the AETB's quality manual is evaluated to ensure that it
addresses all relevant requirements of ASTM D-7036 and all relevant topics listed
in Appendix X1 to that Practice.
During the internal audit, conformance of the AETB to its quality manual is
determined by a review of performance data and subsequent corrective actions.
7.4.2.2Deficiencies found by the AETB during internal audits are linked to specific
performance issues.
7.4.2.3The AETB documents the effectiveness of any corrective actions undertaken.
7.4.3 The AETB participates in third party proficiency testing programs if available and
relevant to their scope of work.
The results of any proficiency testing undertaken by the AETB are used to assess the
effectiveness of the quality program.
The AETB has undertaken corrective action for any failed proficiency tests.
7.4.4 The AETB collects performance data.
Results of all performance data collected by the AETB, along with any AETB
comments, are accessible to clients, potential clients and regulatory authorities.
The AETB informs clients that the results of all performance data is available for
review.
Section 8 - Personnel
8.1 The AETB insures the competence of those personnel who:
Operate specific equipment.
Perform tests.
Perform calibrations.
Evaluate results.
Sign test reports.
Sign calibrations.
The AETB provides appropriate supervision to staff undergoing training.
AETB personnel performing specific tasks are qualified on the basis of appropriate
education, qualification, training, experience, examination, demonstrated skills or a
combination thereof, as required.
8.2 The AETB has formulated requirements with respect to the education, training and
skills of AETB personnel.
The AETB has a policy and procedures for identifying training needs.
The AETB has a policy and procedures for providing training to personnel.
The AETB has procedures to evaluate the effectiveness of training.
The AETB's training program is relevant to its present and anticipated tasks.
8.3 The AETB provides Qualified Individuals to oversee and supervise test projects.
The AETB provides at least one Qualified Individual on-site at all times during a test
project who is qualified in the methods employed for that test project.
8.3.2.3The AETB has on file signed statements by all its Qualified Individuals that all test
projects performed under his/her supervision will conform to the AETB's quality
manual and to the requirements of ASTM D-7036.
8.3.7 The AETB has available on-site the qualification credentials of each Qualified Individual.
8.4 The management of the AETB has authorized personnel to:
Perform particular types of sampling.
Perform particular types of testing.
Perform particular types of calibration.
Issue test reports.
Give opinions and interpretations.
Operate particular types of equipment.
The AETB maintains records of the relevant authorizations(s), competence, training,
skills and experience of all technical personnel including contracted personnel.
The training and experience records of the AETB are readily available.
The training and experience records of the AETB include the date on which
authorization, or competence, or both is confirmed.
8.5 If the AETB uses personnel who are employed by or under contract, the AETB
ensures that any contracted or additional technical and key support personnel are
supervised and competent and work in accordance with the AETB's quality system.
8.6 The AETB maintains current job descriptions for managerial, technical, and key
support personnel involved in testing, calibration, or both.
Section 9 - Accommodation and Environment
9.1 The AETB ensures, to the extent practical, that environmental conditions do not
invalidate results or adversely affect the required quality of any measurement.
The AETB documents environmental conditions that can affect the results of tests and
calibrations.
9.2 The AETB, to the extent practical, avoids concurrent actitivities that are incompatible
with the collection or analysis of quality data.
The AETB takes measures to avoid cross-contamination.
9.3 The AETB controls access to and use of areas affecting the quality of the test or
calibration.
The AETB takes measures to ensure good housekeeping in all locations where testing
or analysis activities are conducted.
The AETB prepares special housekeeping procedures where necessary.
Section 10 - Equipment and Reference Materials
10.1 The AETB has access to all items of sampling, measurement, and test equipment
required for the correct performance of the tests, or calibrations, or both (including
sampling, preparation of test and/or calibration items, processing and analysis of
test and/or calibration data).
The AETB ensures that when it uses equipment outside its permanent control, all
requirements of ASTM D-7036 are met.
10.2 The AETB's equipment and software used for testing, calibration, and sampling is
capable of achieving the required accuracy.
The AETB's equipment and software used for testing, calibration, and sampling
complies with specification relevant to the tests and/or calibrations concerned.
10.3 The AETB has established calibration programs for key quantities or values of the
instruments where these properties have a significant effect on the results.
The AETB ensures that before being placed into service, equipment (including that
used for sampling) is calibrated or checked to establish that it meets the AETB's
specification requirements and complies with the relevant standard specifications.
The AETB confirms or establishes a new calibration at an interval established by
relevant regulations.
The AETB establishes calibration intervals sufficient to ensure the equipment
continually meets specification in cases where relevant regulations do not specify a
calibration interval.
10.4 The AETB takes precautions so that malfunctioning or inoperative equipment is not
used in a test project.
10.5 The AETB ensures that, where applicable, all equipment under the control of the
AETB and requiring calibration shall be labeled, coded, or otherwise identified to
indicate the status of calibration.
The AETB's calibration labels or codes include the date last calibrated and the
date or expiration criteria when recalibration is due.
10.6 The AETB ensures that equipment is operated by trained and authorized personnel.
The AETB ensures that up-to-date instructions on the use and maintenance of
equipment (including any relevant manuals provided by the manufacturer of the
equipment) are readily available for use by the appropriate AETB personnel.
10.7 The AETB maintains records of each item of equipment and its software significant to
the tests and/or calibrations performed.
The AETB's equipment records shall include at least the following:
Identity of the item.
Manufacturer's information, model, and serial number or other unique ID.
Calibration, repair, and maintenance history.
Instruction manual or reference to its location.
Current location, if appropriate.
10.8 The AETB has obtained relevant records for rented or loaned equipment.
10.9 The AETB provides for the safe handling, transport, storage, use, and planned
maintenance of measuring equipment to ensure proper functioning and in order
to prevent contamination or deteriorization.
Section 11 - Measurement Traceability and Calibration
11.1 All equipment used for tests, or calibrations, or both, including equipment for
subsidiary measurements (for example, for environmental conditions) having a
significant effect on the accuracy or validity of the result of the test, calibration or
sampling shall be calibrated by the AETB before being put into service.
The AETB shall have an established program and procedure for the calibration of its
equipment. Such a program shall include a schedule of calibration and a method to
insure only properly calibrated equipment is used in the test program.
11.2 Where possible, the AETB shall use reference materials traceable to certified
reference materials.
11.3 Checks needed to maintain the AETB's confidence in the calibration status of reference,
primary, transfer or working standards and reference materials shall be carried out,
as far as technically and economically practicable, in accordance with defined
procedures and schedules.
11.4 The AETB shall have procedures for safe handling, transport, storage and
use of reference standards and reference materials in order to prevent contamination
or deterioration and in order to protect their integrity.
Section 12 - Test Methods
12.1 The AETB shall use appropriate methods and procedures for all testing performed.
These include sampling, analysis, handling, transport, storage and preparation
of items to be tested, or calibrated, or both, and where appropriate, an estimation
of the measurement uncertainty as well as statistical techniques for analysis of test data.
12.2 Methods for air emission testing performed for compliance purposes are currently
defined by applicable regulations. Alternatives or deviations from these methods shall
be detailed in the AETB's test protocol, or the test report, or both along with any
authorizations for the alternatives or deviations.
12.3 A site specific test plan (protocol) shall be used for each test AETB project. All
procedures and activities specified in the test plan shall meet the requirements of
this practice and shall, at a minimum, address the following points:
12.3.1 Objectives and summary of test program,
12.3.2 Description of the source, operating conditions and process to be tested,
12.3.3 Description of the test matrix,
12.3.4 Sampling locations,
12.3.5 Test methods to be used, number of runs to be performed, and sampling duration of each run,
12.3.6 Process data to be collected,
12.3.7 QC procedures and audits (including applicable field blanks),
12.3.8 Reporting format, reporting units and other requirements,
12.3.9 Plant entry and safety requirements,
Responsibilities of test personnel, and
12.3.10
Tentative test schedule
12.3.11
12.4 The AETB's test plan shall be the primary source of information on testing and
quality procedures for the test project.
The contents of AETB's plan shall be communicated to all personnel participating in the test
project prior to the start of the project.
Deviation from test plan shall occur only if the deviation has been documented,
technically justified, authorized, and accepted by the client or any relevant regulatory
authority (as appropriate).
12.5 The AETB shall have instructions on the use and operation of all relevant equipment,
and on the handling and preparation of items for testing, calibration, or both, where
the absence of such instructions could jeopardize the results of tests, or calibration,
or both. All instruction, standards, manuals and reference data relevant to the work
All instruction, standards, manuals and reference data relevant to the work of the
of the AETB shall be kept up to date and shall be made readily available to personnel.
12.6 The AETB shall use test methods, including methods for sampling, which meet the
needs of the client and which are appropriate for the tests it undertakes.
Methods established in international, regional or national standards shall be used
as practicable.
The AETB shall ensure that it uses the latest valid edition of a method unless it is not
appropriate or possible to do so.
When necessary, the method shall be supplemented with additional details to ensure
consistent application.
The AETB shall inform the client when the method proposed by the client is considered
to be inappropriate or out of date.
12.7 The introduction of test and calibration methods developed by the AETB for its own use
shall be a planned activity and shall be assigned to qualified personnel equipped with
adequate resources.
Plans shall be updated as development proceeds and effective communication amongst
all personnel involved shall be ensured.
12.8 Non-standard Methods—When it is necessary to use methods not covered by standard
methods, these shall be subject to agreement with the client and any relevant
regulatory authority and shall include a clear specification of the client’s requirements
and the purpose of the test program. They shall be described in the test
protocol and reported in the same way as standard methods. Any validation data shall
be included in the test protocol.
12.9 When it is necessary for an AETB to perform test methods that it has not performed
previously, but which are established, published, or validated test methods, the AETB
must take appropriate actions to ensure that the applicable requirements of this
practice are properly addressed before and during the performance of the new method.
12.10 AETBs shall have and shall apply procedures for estimating the uncertainty of
measurement. Conformance with this section may be demonstrated by use of
approved test protocols for all tests. When such protocols are used, reference shall be
made to published literature, when available, where estimates of uncertainty for test
methods may be found.
13. Handling of Sampling and Calibration Material
13.1 The AETB shall have procedures for the chain-of custody, transportation, receipt,
handling, protection, storage, retention, or disposal of samples, or both, sampling
media and calibration materials, including all provisions necessary to protect the
integrity of the sample or calibration material, and to protect the interests of the
AETB and the client.
13.2 The AETB shall have a system for identifying samples, sampling media and calibration
materials. The identification shall be retained throughout the life of the item.
13.3 The AETB, upon receipt of the sample, sampling media, or calibration material,
abnormalities or departures from normal or specified conditions, as described in the
test method, shall be recorded.
When there is doubt as to the suitability of an item for use in a test, or when an item
does not conform to the description provided, or the test required is not specified in
sufficient detail, the AETB shall consult the client for further instructions before
proceeding.
13.4 The AETB shall have procedures and appropriate facilities for avoiding deterioration,
loss or damage to the sample, sampling media or calibration material during storage,
handling and preparation.
Handling instructions provided with the item shall be followed. When items have to be
stored or conditioned under specified environmental conditions, these conditions shall
be maintained, monitored and recorded.
Where a sample is to be held secure, the AETB shall have arrangements for storage
and security that protect the condition and integrity of the secured items or portions
concerned.
14. Records
14.1.1 The AETB shall establish and maintain procedures for handling and storage of quality
and technical records.
Quality records shall include reports from customer and regulatory authority feedback,
internal audits and management reviews as well as records of corrective and
preventive actions.
14.1.2 All records shall be legible and shall be stored and retained in such a way that they are
readily retrievable in facilities that provide a suitable environment to prevent damage
or deterioration and to prevent loss.
Retention times of records shall be established.
14.1.3 All records shall be held, by the AETB, secure and in confidence.
14.1.4 The AETB shall have procedures to protect and back-up records stored electronically
and to prevent unauthorized access to or amendment of these records.
14.2.1 The AETB shall retain records of original observations, derived data and sufficient
information to establish an audit trail, calibration records, staff records and a copy of
each test report or calibration certificate issued, for a defined period.
The records for each test or calibration shall contain sufficient information to facilitate,
if possible, identification of factors affecting the uncertainty and to enable the test or of results.
calibration to be repeated under conditions as close as possible to the original.
The records shall include the identity of personnel responsible for the sampling,
performance of each test, or calibration, or both, and checking
14.2.2 Other records include but are not limited to quality records, results of internal and
external audits, training and qualification records for personnel, performance feedback,
gas certifications, and chain of custody records.
14.2.3 Observations, data and calculations shall be recorded at the time they are made and
shall be identifiable to the specific task.
14.2.4 When mistakes occur in records, each mistake shall be crossed out, not erased, made
illegible or deleted, and the correct value entered alongside.
All such alterations to records shall be dated and signed or initialed by the person
making the correction.
In the case of records stored electronically, equivalent measures shall be taken to
avoid loss or change of original data.
15. Reporting
15.1 The results of each test, calibration, or series of tests or calibrations carried out by the
AETB shall be reported accurately, clearly, unambiguously and objectively, and in
accordance with any specific instructions in the test or calibration methods.
15.2 The report shall include all information requested by the client and relevant regulatory
authority and necessary for the interpretation of the test or calibration results and all
information required by the method used.
15.3 Each test report or calibration certificate shall include at least the following
information, unless the AETB has valid reasons for not doing so:
15.3.1 A title,
15.3.2 The name and address of the AETB, and the testing location,
15.3.3 Unique identification of the test report and on each page an identification in order to
ensure that the page is recognized as a part of the test report, and a clear
identification of the end of the test report,
15.3.4 The name and address of the client,
15.3.5 Unambiguous identification of the substance, material or product sampled,
15.3.6 The location of sampling, including any diagrams, sketches or photographs,
15.3.7 Detailed process description and process operations for each test run,
15.3.8 Identification of the method(s) used,
15.3.9 A description and unambiguous identification of the item(s) tested,
The date(s) of performance of the test,
15.3.10
Reference to the test plan and procedures used by the AETB,
15.3.11
The test results with, where appropriate, the units of measurement,
15.3.12
Deviations from, additions to, or exclusions from the test protocol,
15.3.13
test methods, the AETB’s quality manual, or this practice,
Information on specific test conditions, such as environmental conditions,
15.3.14
A
15.3.15 discussion of test results including the uncertainty associated with the test and
discussion of possible errors or limiting conditions,
Calibration certificates for all equipment significant to the testing performed,
15.3.16
Documentation and sufficient raw data to verify and reproduce all report calculations,
15.3.17
The name(s), function(s) and signature(s) or equivalent identification of person(s)
15.3.18
authorizing the test report, and 15.3.19 A signed statement by a responsible official
that the AETB operates in conformance with the requirements of this practice during
the test project.
15.4 In the case of tests or calibrations performed for internal clients, or in the case of a
agreement with external clients, the results may be reported in a simplified way.
15.5 When opinions and interpretations are included, the AETB shall document the basis
upon which the opinions and interpretations have been made.
Opinions and interpretations shall be clearly marked as such in a test report.
15.6 Amendments to a test report after issue shall be made only in the form of a further
document, or data transfer, which includes the statement: “Supplement to Test
Report, serial number ... [or as otherwise identified],” or an equivalent form of
wording.
Such amendments shall meet all the requirements of this practice.
15.7 When it is necessary to issue a complete new test report, this shall be uniquely
identified and shall contain a reference to the original that it replaces.
16. Sub-contracting of Services
16.1 When an AETB subcontracts work whether because of unforeseen reasons (for example,
workload, need for further expertise or temporary incapacity) or on a continuing basis
(for example, through permanent subcontracting, agency or franchising arrangements),
this work shall be placed with a competent subcontractor. A competent subcontractor
is one that, for example, complies with this practice for the work in question.
16.2 The AETB shall advise the client of the arrangement in writing and, when appropriate,
gain the approval of the client, preferably in writing.
16.3 The AETB is responsible to the client for the subcontractor’s work, except in the case
where the client or a regulatory authority specifies which subcontractor is to be used.
16.4 The AETB shall maintain a register of all subcontractors that it uses and a record of
the evidence of compliance with this practice for the work in question.
17. Outside Support and Supplies
17.1 The AETB shall have a policy and procedure(s) for the selection and purchasing of
services and supplies it uses that affect the quality of the tests, or calibrations, or
both. Procedures shall exist for the purchase, reception and storage of reagents and
laboratory consumable materials relevant for the tests and calibrations.
17.2 The AETB shall ensure that purchased supplies and reagents and consumable
materials that affect the quality of tests, or calibrations, or both are not used until they
have been inspected or otherwise verified as complying with standard specifications or
requirements defined in the methods for the tests, or calibrations, or both, concerned.
These services and supplies used shall comply with specified requirements.
Records of actions taken to check compliance shall be maintained.
17.3 Purchasing documents for items affecting the quality of AETB output shall contain data
describing the services and supplies ordered.
These purchasing documents shall be reviewed and approved for technical content
prior to release.
18. Identification and Control of Non-conforming Work
18.1 The AETB shall have policies and procedures that shall be implemented when any
aspect of its testing, or calibration work, or both, or the results of this work, do not
conform to its own procedures or the agreed requirements of the client.
The policies and procedures shall ensure that:
18.1.1 The responsibilities and authorities for the management of nonconforming work are
designated and actions (including halting of work and withholding of test reports, as
necessary) are defined and taken when nonconforming work is identified.
18.1.2 An evaluation of the significance of the nonconforming work is made.
18.1.3 Corrective actions are taken within an appropriate time period, together with any
decision about the acceptability of the nonconforming work.
18.1.4 Where necessary, the client is notified and work is halted or re-done.
18.2 Where the evaluation indicates that the nonconforming work could recur or that there
is doubt about the compliance of the AETB’s operations with its own policies and
procedures, the corrective action procedures given in Section 19 of this practice shall
be followed.
19. Corrective Action
19.1 The AETB shall establish a policy and procedure and shall designate appropriate
authorities for implementing corrective action when nonconforming work or departures
from the policies and procedures in the quality system or technical operations have
been identified.
19.2 Cause Analysis—The procedure for corrective action shall start with an investigation
to determine the root cause(s) of the problem.
19.3 Selection and Implementation of Corrective Actions— Where corrective action is
needed, the AETB shall identify potential corrective actions. It shall select and
implement the action(s) most likely to eliminate the problem and to prevent recurrence.
19.4 Corrective actions shall be to a degree appropriate to the magnitude and the risk of
the problem. The AETB shall document and implement any required changes resulting
from corrective action investigations.
19.5 Monitoring of Corrective Actions—The AETB shall monitor the results to ensure that
the corrective actions taken have been effective.
19.6 Additional Audits—Where the identification of nonconformances or departures casts
doubts on the AETB’s compliance with its own policies and procedures, or on its
compliance with this practice, the AETB shall ensure that the appropriate areas of
activity are audited in accordance with this practice as soon as possible.
APPENDIX - X1. QUALITY MANUAL OUTLINE - minimal requirements
INTRODUCTION
Organization’s quality policy statement including objectives and commitments by
X1.1.1.1
top management;
Organizational chart that identifies all components of the organization, including the
X1.1.1.2
location of the quality assurance manger and AETB organization;
Responsibility and authority of quality assurance manager and other quality assurance
X1.1.1.3
staff, including the line of reporting to senior management;
Discussion of the technical activities or programs that are supported by the quality
X1.1.1.4
system of the organization (that is, scope of AETB activities);
Discussion of the quality assurance/quality control roles and responsibilities of
X1.1.1.5
management, technical staff, and all other staff;
Identification of the types of air emission measurement programs to which the quality
X1.1.1.6
system is to be applied;
How management will assure that applicable elements of the quality system are
X1.1.1.7
understood and implemented in all air emission measurement programs;
Discussion of conflict of interest
X1.1.1.8
Discussion of ethics
X1.1.1.9
A signature page to show concurrence on the Quality Manual.
X1.1.1.10
X1.2 Quality System and Description (ISO 4.2)
X1.2.1 A discussion of the principal components or tools that make up the quality system
would be appropriate to discuss here. A discussion might include how they are used
and the roles and responsibilities of management and staff involved in implementing
these activities or the overall quality system.
This includes (not necessarily all inclusive list):
Quality Manuals (or Plans),
X1.2.1.1
Management Systems Reviews (both self review and independent review),
X1.2.1.2
Data Quality Objectives
X1.2.1.3
Quality Assurance Project Plans (if applicable)
X1.2.1.4
Standard Operating Procedures
X1.2.1.5
Technical Assessments (both self and independent)
X1.2.1.6
Data Quality Assessments
X1.2.1.7
X1.3 Personnel Qualifications and Training (ISO 5.2)
X1.3.1 This section addresses any certifications required for certain jobs (for example, a job description) and any training that is required, or reco
description) and any training that is required, or recommended, or both, to employees. Other training or development/networking opportu
Other training or development/networking opportunities considered, as well.
X1.4 Procurement of Services (ISO 4.5,4.6)
X1.4.1 Procurement of services covers the overall processes for ensuring contracted and
subcontracted activities produce results of acceptable quality. Any issues of
confidentiality and proprietary rights and how they are handled should be
addressed, as well.
X1.5 Documentation and Records (ISO 4.3, 4.12, 5.10)
X1.5.1 Description of the process or reference existing process guidance for:
Identifying quality related documents and their control;
X1.5.1.1
Handling of documents and records to assure accessibility, protection, and retention,
X1.5.1.2
including management/ staff responsibilities;
All
X1.5.1.3 technical guidance document preparation, review, approval, issue, and revision
Ensuring compliance with all requirements for records from environmental programs
X1.5.1.4
and preservation of key records necessary to support the mission of the organization.
X1.5.2 Include reference to existing documentation or establishment of a process or format
for reporting the results established within this section.
X1.6 Equipment (ISO 5.5)
X1.6.1 This section addresses the use of equipment, including hardware and software, in
support of air emission measurement programs. All equipment (that is, bought,
rented, borrowed, and so forth) minimum acceptance standards and procedures used
to familiarize personnel with equipment are addressed here.
Reference to procedures for calibration, verification, and maintenance of equipment
are also appropriate topics.
Procedures for assuring computer programs and equipment are up-to-date and
working properly are important to address here, as well.
X1.7 Planning (ISO 5.3, 5.4, 5.6, 5.7, 5.8, 5.9)
X1.7.1 Any air emission measurement data operations should be planned using a systematic
planning approach.
This is to ensure that all stakeholders participate in the process.
This planning process includes communication between customer, supplier, and
regulatory Agency to ensure a clear understanding among all parties involved.
Development and implementation of procedures appropriate for carrying out these
plans are identified with management/staff responsibility, as well.
The results of this section combined with a little information from other sections of the
QM would constitute documentation such as a test plan or Quality Assurance Project
Plan (QAPP).
X1.8 Implementation of Work Processes (ISO 4.4, 4.7, 4.9, 5.3, 5.4, 5.6, 5.7, 5.8, 5.9)
X1.8.1 Description of the process of how and by whom work shall be implemented within the
organization.
Procedures for ensuring good communications between field test personnel and
management during field testing.
Procedures for handling samples and sample numbering procedures for field
measurement, or samples, or both, (that is, ensuring use of proper sample containers,
proper sample storage during field testing operations, proper sample shipment, and
shipment frequency to adequately meet holding time requirements).
X1.9 Assessment and Response (ISO 4.13, 4.14)
X1.9.1 This section covers the process by which management determines the assessment
activities appropriate for a particular project. It covers the how and by whom
assessments of programs are planned, conducted, and evaluated.
Assessment tools include:
Management Systems Reviews (both self review and independent review) (for
X1.9.1.1
example, lessons learned),
Surveillance,
X1.9.1.2
Audits,
X1.9.1.3
Performance Evaluations
X1.9.1.4
Audits of Data Quality
X1.9.1.5
Peer Reviews (or Technical Reviews, or both)
X1.9.1.6
Readiness Reviews
X1.9.1.7
Data Quality Assessments
X1.9.1.8
X1.10 Quality Improvement (ISO 4.8, 4.10, 4.11)
The organization’s management system for detecting and preventing quality problems
X1.10.1
and for ensuring continuous quality improvement to assure responsibility for
identifying, planning, implementing, and evaluating the effectiveness of quality
improvement activities description. A corrective action program should include prompt
identification of the problem and implications with correction and prevention of
recurrence as soon as practical.
c3d4794b-4f19-4f04-98f8-8ca231377afb.xls
ASTM D-7036-04 Checklist
Ö ¶ Question Location of Answer
Section 5 - Organization and Management
5.1 The AETB has in place a structure, including a quality system that enables it to
continually monitor its ability to deliver its scope of services.
The AETB has in place a structure, including a quality system that enables it to
continually improve its ability to deliver its scope of services.
5.2 The organization of the AETB is clearly defined.
The place of the AETB in any parent organization is clearly defined.
The relationships betweeen quality management, technical operations and support
services are clearly defined.
5.3 The AETB carries out its activities in such a way as to meet the requirements of
ASTM D-7036.
The AETB carries out its activities in such a way as to meet the requirements of
local, state, and federal laws and regulations.
The AETB carries out its activities in such a way as to meet the needs of the client.
The AETB carries out its activities in such a way as to meet the needs of regulatory
authorities.
5.4.1 The AETB has in place a system to collect performance data from all relevant sources.
The AETB has in place a system to document performance data from all relevant
sources. evaluation
5.4.2 The AETB provides its employees with the resources to initiate corrective actions.
The AETB provides its employees with the resources to verify and document
the effectiveness of corrective actions.
The AETB provides its employees with the authority to initiate corrective actions.
The AETB provides its employees with the authority to verify and document
the effectiveness of corrective actions.
5.4.3 The AETB is legally identifiable.
The AETB is organized so that its facilities and resources meet the requirements of
ASTM D-7036.
5.4.4 The AETB is organized so that staff members are not subject to undue pressure or
inducement that might inappropriately influence their judgement or results of their
work, including quality issues.
5.4.5 The AETB is organized so that confidence in its independence or judgment and
integrity is maintained at all times.
5.4.6 The AETB is organized so that staff members are aware of both the extent and
limitations of their responsibilities.
5.4.7 The AETB is organized to provide adequate supervision of technical staff, including
trainees, by persons familiar with relevant methods and procedures, the purpose of
the test project, and with assessment of testing results.
The AETB is organized so that only Qualified Individuals may supervise a test.
5.4.8 The AETB has a technical manager or director (however named) who has overall
responsibility for the technical operations of the AETB.
The AETB's technical manager has demonstrated competence in air emissions testing
through education or professional experience or both.
5.4.9 The AETB has a quality manager (however named) who has responsibility for the
quality system and its implementation.
The AETB's quality manager has the responsibility and authority to ensure the
requirements of ASTM D-7036 are implemented and maintained.
The AETB's quality manager has access to the highest levels of management at
which decisions are made on policies affecting the AETB.
5.4.10 The AETB has a Qualified Individual on-site for each project who is qualified for each
test methods performed. Same as 8.3
c3d4794b-4f19-4f04-98f8-8ca231377afb.xls
5.4.11 The AETB is able to provide documentation or otherwise demonstrate on request
that it complies with the relevant and appropriate federal, state, and local
requirements for conducting testing procedures under its scope, including
compliance with ASTM D-7036.
5.4.12 The AETB is able to provide documentation or otherwise demonstrate on request that
it complies with applicable local, state, and federal requirements governing health
and safety, transportation, shipping, and other relevant requirements.
Section 6 - Document Control
6.1 The AETB has established procedures to control all documents that form part of its
quality system (internally generated or from external sources).
The AETB is maintaining procedures to control all documents that form part of its
quality system (internally generated or from external sources).
The AETB's document control procedures are sufficient to preclude the use of invalid
or obsolete documents or both.
6.2 Quality system documents generated by the AETB shall be uniquely identified.
The AETB's unique document identification includes date of issue and/or revision,
page numbering, the total number of pages or a mark to signify the end of the
document, and issuing authority(ies).
6.3 Changes to the AETB's quality documents are reviewed and approved by the same
organizational group that performed the original review unless specifically designated
otherwise.
Personnel conducting a review of the AETB's quality documents have access to
pertinent background information on which to base their review and approval.
Any altered or new text in the AETB's quality documents is identified in the
document or appropriate attachment, where practicable.
6.4 The AETB has defined procedures and authorities for amendment of documents by
hand if the document control system allows for such amendment.
Any document amendments by hand shall be clearly marked, initialed and dated.
Any documents amended by hand shall be formally re-issued as soon as practicable.
Section 7 - Quality System, Audit, and Review
7.1 The AETB has developed a quality policy.
The AETB has disseminated its quality policy.
The AETB's quality policy is a formal statement signed by top management.
The AETB's quality policy states the commitment by top management and staff to
conform to the requirements documented in the quality manual and to ASTM D-7036.
7.1.1 The management of the AETB has defined and documented its quality policy.
The management of the AETB has defined and documented its quality objectives.
The management of the AETB has defined and documented its commitment to quality.
7.1.2 The quality policy of the AETB includes recognition of the needs and expectations of
its customers.
The quality policy of the AETB is understood at all levels within the AETB.
The quality policy of the AETB is implemented at all levels within the AETB.
The quality policy of the AETB is maintained at all levels within the AETB.
7.2 The AETB has established a documented quality system as a means of ensuring that
its operations are appropriate to providing air emission testing services.
The AETB has established a documented quality system as a means of ensuring that
its operations meet the requirements of ASTM D-7036.
The AETB is maintaining its documented quality system.
The AETB is operating under its documented quality system.
7.2.1 The AETB's quality system is designed to ensure the required degree of completeness,
representativeness, comparability, and uncertainty (within the limits of uncertainty
documented in the test method) needed to meet the data quality objectives of each
project undertaken by the AETB.
c3d4794b-4f19-4f04-98f8-8ca231377afb.xls
7.2.2 The AETB's quality system is documented to the extent necessary to ensure consist-
ent achievement of data quality objectives for projects undertaken by the AETB.
The AETB's conformance to the quality system is documented to the extent necessary
to ensure consistent achievement of the data quality objectives for the projects
undertaken by the AETB.
7.3 The AETB's quality system is documented in a quality manual and supporting quality
system documentation.
The AETB's quality manual addresses all relevant topics listed in Appendix X1 of
ASTM D-7036.
The AETB's quality manual and documentation is available for use by the AETB staff.
The AETB's quality system documents are maintained current.
The AETB's quality manager has the responsibility for maintaining the quality
documents.
7.4.1 The AETB conducts annual audits of its activities to verify that its operations continue
to conform to the requirements of the quality system.
The AETB's internal audits are carried out by qualified personnel who, whenever
practical, are independent of the activity audited.
7.4.2.1During internal audit, the AETB's quality manual is evaluated to ensure that it
addresses all relevant requirements of ASTM D-7036 and all relevant topics listed
in Appendix X1 to that Practice.
During the internal audit, conformance of the AETB to its quality manual is
determined by a review of performance data and subsequent corrective actions.
7.4.2.2Deficiencies found by the AETB during internal audits are linked to specific
performance issues.
7.4.2.3The AETB documents the effectiveness of any corrective actions undertaken.
7.4.3 The AETB participates in third party proficiency testing programs if available and
relevant to their scope of work.
The results of any proficiency testing undertaken by the AETB are used to assess the
effectiveness of the quality program.
The AETB has undertaken corrective action for any failed proficiency tests.
7.4.4 The AETB collects performance data.
Results of all performance data collected by the AETB, along with any AETB
comments, are accessible to clients, potential clients and regulatory authorities.
The AETB informs clients that the results of all performance data is available for
review.
Section 8 - Personnel
8.1 The AETB insures the competence of those personnel who:
Operate specific equipment.
Perform tests.
Perform calibrations.
Evaluate results.
Sign test reports.
Sign calibrations.
The AETB provides appropriate supervision to staff undergoing training.
AETB personnel performing specific tasks are qualified on the basis of appropriate
education, qualification, training, experience, examination, demonstrated skills or a
combination thereof, as required.
8.2 The AETB has formulated requirements with respect to the education, training and
skills of AETB personnel.
The AETB has a policy and procedures for identifying training needs.
The AETB has a policy and procedures for providing training to personnel.
c3d4794b-4f19-4f04-98f8-8ca231377afb.xls
The AETB has procedures to evaluate the effectiveness of training.
The AETB's training program is relevant to its present and anticipated tasks.
8.3 The AETB provides Qualified Individuals to oversee and supervise test projects.
The AETB provides at least one Qualified Individual on-site at all times during a test
project who is qualified in the methods employed for that test project.
8.3.2.3The AETB has on file signed statements by all its Qualified Individuals that all test
projects performed under his/her supervision will conform to the AETB's quality
manual and to the requirements of ASTM D-7036.
8.3.7 The AETB has available on-site the qualification credentials of each Qualified Individual.
8.4 The management of the AETB has authorized personnel to:
Perform particular types of sampling.
Perform particular types of testing.
Perform particular types of calibration.
Issue test reports.
Give opinions and interpretations.
Operate particular types of equipment.
The AETB maintains records of the relevant authorization(s), competence, training,
skills and experience of all technical personnel including contracted personnel.
The training and experience records of the AETB are readily available.
The training and experience records of the AETB include the date on which
authorization, or competence, or both is confirmed.
8.5 If the AETB uses personnel who are employed by or under contract, the AETB
ensures that any contracted or additional technical and key support personnel are
supervised and competent and work in accordance with the AETB's quality system.
8.6 The AETB maintains current job descriptions for managerial, technical, and key
support personnel involved in testing, calibration, or both.
Section 9 - Accommodation and Environment
9.1 The AETB ensures, to the extent practical, that environmental conditions do not
invalidate results or adversely affect the required quality of any measurement.
The AETB documents environmental conditions that can affect the results of tests and
calibrations.
9.2 The AETB, to the extent practical, avoids concurrent actitivities that are incompatible
with the collection or analysis of quality data.
The AETB takes measures to avoid cross-contamination.
9.3 The AETB controls access to and use of areas affecting the quality of the test or
calibration.
The AETB takes measures to ensure good housekeeping in all locations where testing
or analysis activities are conducted.
The AETB prepares special housekeeping procedures where necessary.
Section 10 - Equipment and Reference Materials
10.1 The AETB has access to all items of sampling, measurement, and test equipment
required for the correct performance of the tests, or calibrations, or both (including
sampling, preparation of test and/or calibration items, processing and analysis of
test and/or calibration data).
The AETB ensures that when it uses equipment outside its permanent control, all
requirements of ASTM D-7036 are met.
10.2 The AETB's equipment and software used for testing, calibration, and sampling is
capable of achieving the required accuracy.
The AETB's equipment and software used for testing, calibration, and sampling
complies with specification relevant to the tests and/or calibrations concerned.
10.3 The AETB has established calibration programs for key quantities or values of the
instruments where these properties have a significant effect on the results.
c3d4794b-4f19-4f04-98f8-8ca231377afb.xls
The AETB ensures that before being placed into service, equipment (including that
used for sampling) is calibrated or checked to establish that it meets the AETB's
specification requirements and complies with the relevant standard specifications.
The AETB confirms or establishes a new calibration at an interval established by
relevant regulations.
The AETB establishes calibration intervals sufficient to ensure the equipment
continually meets specification in cases where relevant regulations do not specifiy a
calibration interval.
10.4 The AETB takes precautions so that malfunctioning or inoperative equipment is not
used in a test project.
10.5 The AETB ensures that, where applicable, all equipment under the control of the
AETB and requiring calibration shall be labeled, coded, or otherwise identified to
indicate the status of calibration.
The AETB's calibration labels or codes include the date last calibrated and the
date or expiration criteria when recalibration is due.
10.6 The AETB ensures that equipment is operated by trained and authorized personnel.
The AETB ensures that up-to-date instructions on the use and maintenance of
equipment (including any relevant manuals provided by the manufacturer of the
equipment) are readily available for use by the appropriate AETB personnel.
10.7 The AETB maintains records of each item of equipment and its software significant to
the tests and/or calibrations performed.
The AETB's equipment records shall include at least the following:
Identity of the item.
Manufacturer's information, model, and serial number or other unique ID.
Calibration, repair, and maintenance history.
Instruction manual or reference to its location.
Current location, if appropriate.
10.8 The AETB has obtained relevant records for rented or loaned equipment.
10.9 The AETB provides for the safe handling, transport, storage, use, and planned
maintenance of measuring equipment to ensure proper functioning and in order
to prevent contamination or deteriorization.
Section 11 - Measurement Traceability and Calibration
11.1 All equipment used for tests, or calibrations, or both, including equipment for
subsidiary measurements (for example, for environmental conditions) having a
significant effect on the accuracy or validity of the result of the test, calibration or
sampling shall be calibrated by the AETB before being put into service.
The AETB shall have an established program and procedure for the calibration of its
equipment. Such a program shall include a schedule of calibration and a method to
insure only properly calibrated equipment is used in the test program.
11.2 Where possible, the AETB shall use reference materials traceable to certified
reference materials.
11.3 Checks needed to maintain the AETB's confidence in the calibration status of reference,
primary, transfer or working standards and reference materials shall be carried out,
as far as technically and economically practicable, in accordance with defined
procedures and schedules.
11.4 The AETB shall have procedures for safe handling, transport, storage and
use of reference standards and reference materials in order to prevent contamination
or deterioration and in order to protect their integrity.
Section 12 - Test Methods
12.1 The AETB shall use appropriate methods and procedures for all testing performed.
These include sampling, analysis, handling, transport, storage and preparation
of items to be tested, or calibrated, or both, and where appropriate, an estimation
of the measurement uncertainty as well as statistical techniques for analysis of test data.
12.2 c3d4794b-4f19-4f04-98f8-8ca231377afb.xls
Methods for air emission testing performed for compliance purposes are currently
defined by applicable regulations. Alternatives or deviations from these methods shall
be detailed in the AETB's test protocol, or the test report, or both along with any
authorizations for the alternatives or deviations.
12.3 A site specific test plan (protocol) shall be used for each test AETB project. All
procedures and activities specified in the test plan shall meet the requirements of
this practice and shall, at a minimum, address the following points:
12.3.1 Objectives and summary of test program,
12.3.2 Description of the source, operating conditions and process to be tested,
12.3.3 Description of the test matrix,
12.3.4 Sampling locations,
12.3.5 Test methods to be used, number of runs to be performed, and sampling duration of each run,
12.3.6 Process data to be collected,
12.3.7 QC procedures and audits (including applicable field blanks),
12.3.8 Reporting format, reporting units and other requirements,
12.3.9 Plant entry and safety requirements,
Responsibilities of test personnel, and
12.3.10
Tentative test schedule
12.3.11
12.4 The AETB's test plan shall be the primary source of information on testing and
quality procedures for the test project.
The contents of AETB's plan shall be communicated to all personnel participating in the test
project prior to the start of the project.
Deviation from test plan shall occur only if the deviation has been documented,
technically justified, authorized, and accepted by the client or any relevant regulatory
authority (as appropriate).
12.5 The AETB shall have instructions on the use and operation of all relevant equipment,
and on the handling and preparation of items for testing, calibration, or both, where
the absence of such instructions could jeopardize the results of tests, or calibration,
or both. All instruction, standards, manuals and reference data relevant to the work
All instruction, standards, manuals and reference data relevant to the work of the
of the AETB shall be kept up to date and shall be made readily available to personnel.
12.6 The AETB shall use test methods, including methods for sampling, which meet the
needs of the client and which are appropriate for the tests it undertakes.
Methods established in international, regional or national standards shall be used
as practicable.
The AETB shall ensure that it uses the latest valid edition of a method unless it is not
appropriate or possible to do so.
When necessary, the method shall be supplemented with additional details to ensure
consistent application.
The AETB shall inform the client when the method proposed by the client is considered
to be inappropriate or out of date.
12.7 The introduction of test and calibration methods developed by the AETB for its own use
shall be a planned activity and shall be assigned to qualified personnel equipped with
adequate resources.
Plans shall be updated as development proceeds and effective communication amongst
all personnel involved shall be ensured.
12.8 Non-standard Methods—When it is necessary to use methods not covered by standard
methods, these shall be subject to agreement with the client and any relevant
regulatory authority and shall include a clear specification of the client’s requirements
and the purpose of the test program. They shall be described in the test
protocol and reported in the same way as standard methods. Any validation data shall
be included in the test protocol.
12.9 When it is necessary for an AETB to perform test methods that it has not performed
previously, but which are established, published, or validated test methods, the AETB
must take appropriate actions to ensure that the applicable requirements of this
practice are properly addressed before and during the performance of the new method.
12.10 AETBs shall have and shall apply c3d4794b-4f19-4f04-98f8-8ca231377afb.xls
procedures for estimating the uncertainty of
measurement. Conformance with this section may be demonstrated by use of
approved test protocols for all tests. When such protocols are used, reference shall be
made to published literature, when available, where estimates of uncertainty for test
methods may be found.
13. Handling of Sampling and Calibration Material
13.1 The AETB shall have procedures for the chain-of custody, transportation, receipt,
handling, protection, storage, retention, or disposal of samples, or both, sampling
media and calibration materials, including all provisions necessary to protect the
integrity of the sample or calibration material, and to protect the interests of the
AETB and the client.
13.2 The AETB shall have a system for identifying samples, sampling media and calibration
materials. The identification shall be retained throughout the life of the item.
13.3 The AETB, upon receipt of the sample, sampling media, or calibration material,
abnormalities or departures from normal or specified conditions, as described in the
test method, shall be recorded.
When there is doubt as to the suitability of an item for use in a test, or when an item
does not conform to the description provided, or the test required is not specified in
sufficient detail, the AETB shall consult the client for further instructions before
proceeding.
13.4 The AETB shall have procedures and appropriate facilities for avoiding deterioration,
loss or damage to the sample, sampling media or calibration material during storage,
handling and preparation.
Handling instructions provided with the item shall be followed. When items have to be
stored or conditioned under specified environmental conditions, these conditions shall
be maintained, monitored and recorded.
Where a sample is to be held secure, the AETB shall have arrangements for storage
and security that protect the condition and integrity of the secured items or portions
concerned.
14. Records
14.1.1 The AETB shall establish and maintain procedures for handling and storage of quality
and technical records.
Quality records shall include reports from customer and regulatory authority feedback,
internal audits and management reviews as well as records of corrective and
preventive actions.
14.1.2 All records shall be legible and shall be stored and retained in such a way that they are
readily retrievable in facilities that provide a suitable environment to prevent damage
or deterioration and to prevent loss.
Retention times of records shall be established.
14.1.3 All records shall be held, by the AETB, secure and in confidence.
14.1.4 The AETB shall have procedures to protect and back-up records stored electronically
and to prevent unauthorized access to or amendment of these records.
14.2.1 The AETB shall retain records of original observations, derived data and sufficient
information to establish an audit trail, calibration records, staff records and a copy of
each test report or calibration certificate issued, for a defined period.
The records for each test or calibration shall contain sufficient information to facilitate,
if possible, identification of factors affecting the uncertainty and to enable the test or of results.
calibration to be repeated under conditions as close as possible to the original.
The records shall include the identity of personnel responsible for the sampling,
performance of each test, or calibration, or both, and checking
14.2.2 Other records include but are not limited to quality records, results of internal and
external audits, training and qualification records for personnel, performance feedback,
gas certifications, and chain of custody records.
14.2.3 Observations, data and calculations shall be recorded at the time they are made and
shall be identifiable to the specific task.
14.2.4 When mistakes occur in records, each mistake shall be crossed out, not erased, made
illegible or deleted, and the correct value entered alongside.
All such alterations to records shall be dated and signed or initialed by the person
making the correction.
c3d4794b-4f19-4f04-98f8-8ca231377afb.xls
In the case of records stored electronically, equivalent measures shall be taken to
avoid loss or change of original data.
15. Reporting
15.1 The results of each test, calibration, or series of tests or calibrations carried out by the
AETB shall be reported accurately, clearly, unambiguously and objectively, and in
accordance with any specific instructions in the test or calibration methods.
15.2 The report shall include all information requested by the client and relevant regulatory
authority and necessary for the interpretation of the test or calibration results and all
information required by the method used.
15.3 Each test report or calibration certificate shall include at least the following
information, unless the AETB has valid reasons for not doing so:
15.3.1 A title,
15.3.2 The name and address of the AETB, and the testing location,
15.3.3 Unique identification of the test report and on each page an identification in order to
ensure that the page is recognized as a part of the test report, and a clear
identification of the end of the test report,
15.3.4 The name and address of the client,
15.3.5 Unambiguous identification of the substance, material or product sampled,
15.3.6 The location of sampling, including any diagrams, sketches or photographs,
15.3.7 Detailed process description and process operations for each test run,
15.3.8 Identification of the method(s) used,
15.3.9 A description and unambiguous identification of the item(s) tested,
The date(s) of performance of the test,
15.3.10
Reference to the test plan and procedures used by the AETB,
15.3.11
The test results with, where appropriate, the units of measurement,
15.3.12
Deviations from, additions to, or exclusions from the test protocol,
15.3.13
test methods, the AETB’s quality manual, or this practice,
Information on specific test conditions, such as environmental conditions,
15.3.14
A
15.3.15 discussion of test results including the uncertainty associated with the test and
discussion of possible errors or limiting conditions,
Calibration certificates for all equipment significant to the testing performed,
15.3.16
Documentation and sufficient raw data to verify and reproduce all report calculations,
15.3.17
The name(s), function(s) and signature(s) or equivalent identification of person(s)
15.3.18
authorizing the test report, and 15.3.19 A signed statement by a responsible official
that the AETB operates in conformance with the requirements of this practice during
the test project.
15.4 In the case of tests or calibrations performed for internal clients, or in the case of a
agreement with external clients, the results may be reported in a simplified way.
15.5 When opinions and interpretations are included, the AETB shall document the basis
upon which the opinions and interpretations have been made.
Opinions and interpretations shall be clearly marked as such in a test report.
15.6 Amendments to a test report after issue shall be made only in the form of a further
document, or data transfer, which includes the statement: “Supplement to Test
Report, serial number ... [or as otherwise identified],” or an equivalent form of
wording.
Such amendments shall meet all the requirements of this practice.
15.7 When it is necessary to issue a complete new test report, this shall be uniquely
identified and shall contain a reference to the original that it replaces.
16. Sub-contracting of Services
16.1 When an AETB subcontracts work whether because of unforeseen reasons (for example,
workload, need for further expertise or temporary incapacity) or on a continuing basis
(for example, through permanent subcontracting, agency or franchising arrangements),
this work shall be placed with a competent subcontractor. A competent subcontractor
is one that, for example, complies with this practice for the work in question.
16.2 The AETB shall advise the client of the arrangement in writing and, when appropriate,
gain the approval of the client, preferably in writing.
16.3 c3d4794b-4f19-4f04-98f8-8ca231377afb.xls
The AETB is responsible to the client for the subcontractor’s work, except in the case
where the client or a regulatory authority specifies which subcontractor is to be used.
16.4 The AETB shall maintain a register of all subcontractors that it uses and a record of
the evidence of compliance with this practice for the work in question.
17. Outside Support and Supplies
17.1 The AETB shall have a policy and procedure(s) for the selection and purchasing of
services and supplies it uses that affect the quality of the tests, or calibrations, or
both. Procedures shall exist for the purchase, reception and storage of reagents and
laboratory consumable materials relevant for the tests and calibrations.
17.2 The AETB shall ensure that purchased supplies and reagents and consumable
materials that affect the quality of tests, or calibrations, or both are not used until they
have been inspected or otherwise verified as complying with standard specifications or
requirements defined in the methods for the tests, or calibrations, or both, concerned.
These services and supplies used shall comply with specified requirements.
Records of actions taken to check compliance shall be maintained.
17.3 Purchasing documents for items affecting the quality of AETB output shall contain data
describing the services and supplies ordered.
These purchasing documents shall be reviewed and approved for technical content
prior to release.
18. Identification and Control of Non-conforming Work
18.1 The AETB shall have policies and procedures that shall be implemented when any
aspect of its testing, or calibration work, or both, or the results of this work, do not
conform to its own procedures or the agreed requirements of the client.
The policies and procedures shall ensure that:
18.1.1 The responsibilities and authorities for the management of nonconforming work are
designated and actions (including halting of work and withholding of test reports, as
necessary) are defined and taken when nonconforming work is identified.
18.1.2 An evaluation of the significance of the nonconforming work is made.
18.1.3 Corrective actions are taken within an appropriate time period, together with any
decision about the acceptability of the nonconforming work.
18.1.4 Where necessary, the client is notified and work is halted or re-done.
18.2 Where the evaluation indicates that the nonconforming work could recur or that there
is doubt about the compliance of the AETB’s operations with its own policies and
procedures, the corrective action procedures given in Section 19 of this practice shall
be followed.
19. Corrective Action
19.1 The AETB shall establish a policy and procedure and shall designate appropriate
authorities for implementing corrective action when nonconforming work or departures
from the policies and procedures in the quality system or technical operations have
been identified.
19.2 Cause Analysis—The procedure for corrective action shall start with an investigation
to determine the root cause(s) of the problem.
19.3 Selection and Implementation of Corrective Actions— Where corrective action is
needed, the AETB shall identify potential corrective actions. It shall select and
implement the action(s) most likely to eliminate the problem and to prevent recurrence.
19.4 Corrective actions shall be to a degree appropriate to the magnitude and the risk of
the problem. The AETB shall document and implement any required changes resulting
from corrective action investigations.
19.5 Monitoring of Corrective Actions—The AETB shall monitor the results to ensure that
the corrective actions taken have been effective.
19.6 Additional Audits—Where the identification of nonconformances or departures casts
doubts on the AETB’s compliance with its own policies and procedures, or on its
compliance with this practice, the AETB shall ensure that the appropriate areas of
activity are audited in accordance with this practice as soon as possible.
APPENDIX - X1. QUALITY MANUAL OUTLINE - minimal requirements
INTRODUCTION
Organization’s quality policy statement including objectives and commitments by
X1.1.1.1
top management;
X1.1.1.2 c3d4794b-4f19-4f04-98f8-8ca231377afb.xls
Organizational chart that identifies all components of the organization, including the
location of the quality assurance manger and AETB organization;
Responsibility and authority of quality assurance manager and other quality assurance
X1.1.1.3
staff, including the line of reporting to senior management;
Discussion of the technical activities or programs that are supported by the quality
X1.1.1.4
system of the organization (that is, scope of AETB activities);
Discussion of the quality assurance/quality control roles and responsibilities of
X1.1.1.5
management, technical staff, and all other staff;
Identification of the types of air emission measurement programs to which the quality
X1.1.1.6
system is to be applied;
How management will assure that applicable elements of the quality system are
X1.1.1.7
understood and implemented in all air emission measurement programs;
Discussion of conflict of interest
X1.1.1.8
Discussion of ethics
X1.1.1.9
A signature page to show concurrence on the Quality Manual.
X1.1.1.10
X1.2 Quality System and Description (ISO 4.2)
X1.2.1 A discussion of the principal components or tools that make up the quality system
would be appropriate to discuss here. A discussion might include how they are used
and the roles and responsibilities of management and staff involved in implementing
these activities or the overall quality system.
This includes (not necessarily all inclusive list):
Quality Manuals (or Plans),
X1.2.1.1
Management Systems Reviews (both self review and independent review),
X1.2.1.2
Data Quality Objectives
X1.2.1.3
Quality Assurance Project Plans (if applicable)
X1.2.1.4
Standard Operating Procedures
X1.2.1.5
Technical Assessments (both self and independent)
X1.2.1.6
Data Quality Assessments
X1.2.1.7
X1.3 Personnel Qualifications and Training (ISO 5.2)
X1.3.1 This section addresses any certifications required for certain jobs (for example, a job description) and any training that is required, o
description) and any training that is required, or recommended, or both, to employees. Other training or development/networking op
Other training or development/networking opportunities considered, as well.
X1.4 Procurement of Services (ISO 4.5,4.6)
X1.4.1 Procurement of services covers the overall processes for ensuring contracted and
subcontracted activities produce results of acceptable quality. Any issues of
confidentiality and proprietary rights and how they are handled should be
addressed, as well.
X1.5 Documentation and Records (ISO 4.3, 4.12, 5.10)
X1.5.1 Description of the process or reference existing process guidance for:
Identifying quality related documents and their control;
X1.5.1.1
Handling of documents and records to assure accessibility, protection, and retention,
X1.5.1.2
including management/ staff responsibilities;
All
X1.5.1.3 technical guidance document preparation, review, approval, issue, and revision
Ensuring compliance with all requirements for records from environmental programs
X1.5.1.4
and preservation of key records necessary to support the mission of the organization.
X1.5.2 Include reference to existing documentation or establishment of a process or format
for reporting the results established within this section.
X1.6 Equipment (ISO 5.5)
X1.6.1 This section addresses the use of equipment, including hardware and software, in
support of air emission measurement programs. All equipment (that is, bought,
rented, borrowed, and so forth) minimum acceptance standards and procedures used
to familiarize personnel with equipment are addressed here.
Reference to procedures for calibration, verification, and maintenance of equipment
are also appropriate topics.
Procedures for assuring computer programs and equipment are up-to-date and
working properly are important to address here, as well.
c3d4794b-4f19-4f04-98f8-8ca231377afb.xls
X1.7 Planning (ISO 5.3, 5.4, 5.6, 5.7, 5.8, 5.9)
X1.7.1 Any air emission measurement data operations should be planned using a systematic
planning approach.
This is to ensure that all stakeholders participate in the process.
This planning process includes communication between customer, supplier, and
regulatory Agency to ensure a clear understanding among all parties involved.
Development and implementation of procedures appropriate for carrying out these
plans are identified with management/staff responsibility, as well.
The results of this section combined with a little information from other sections of the
QM would constitute documentation such as a test plan or Quality Assurance Project
Plan (QAPP).
X1.8 Implementation of Work Processes (ISO 4.4, 4.7, 4.9, 5.3, 5.4, 5.6, 5.7, 5.8, 5.9)
X1.8.1 Description of the process of how and by whom work shall be implemented within the
organization.
Procedures for ensuring good communications between field test personnel and
management during field testing.
Procedures for handling samples and sample numbering procedures for field
measurement, or samples, or both, (that is, ensuring use of proper sample containers,
proper sample storage during field testing operations, proper sample shipment, and
shipment frequency to adequately meet holding time requirements).
X1.9 Assessment and Response (ISO 4.13, 4.14)
X1.9.1 This section covers the process by which management determines the assessment
activities appropriate for a particular project. It covers the how and by whom
assessments of programs are planned, conducted, and evaluated.
Assessment tools include:
Management Systems Reviews (both self review and independent review) (for
X1.9.1.1
example, lessons learned),
Surveillance,
X1.9.1.2
Audits,
X1.9.1.3
Performance Evaluations
X1.9.1.4
Audits of Data Quality
X1.9.1.5
Peer Reviews (or Technical Reviews, or both)
X1.9.1.6
Readiness Reviews
X1.9.1.7
Data Quality Assessments
X1.9.1.8
X1.10 Quality Improvement (ISO 4.8, 4.10, 4.11)
The organization’s management system for detecting and preventing quality problems
X1.10.1
and for ensuring continuous quality improvement to assure responsibility for
identifying, planning, implementing, and evaluating the effectiveness of quality
improvement activities description. A corrective action program should include prompt
identification of the problem and implications with correction and prevention of
recurrence as soon as practical.
