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BH-QUA-025 (EN) - Control of Monitoring, Measurement, Testing and Detection Equipment (BHGE-QUA-025)
BH-QUA-025 (EN) - Control of Monitoring, Measurement, Testing and Detection Equipment (BHGE-QUA-025)
Scope
This document applies to all Baker Hughes Product Companies and Functions.
The requirements of this document apply to all monitoring, measuring testing, and detection
equipment used for development, production and service provision as well as in
determination of criteria for product acceptance within all Baker Hughes business entities.
This procedure is not applicable to Support Equipment (SE) that is used for Sales, Training or
other functions not related to production, inspection, testing, or service of Baker Hughes
products.
The requirements in this procedure identified as [Supplemental API Q1] and/or [Supplemental
API Q2] are mandatory for Baker Hughes Organizations with active API Monogram Licenses,
API Q1 and/or API Q2 Registrations, or claiming conformity to API Q1 and/or Q2.
Description of Activity
1. General Requirements
1.1 Organizations will determine the monitoring, measurement, testing and detection
requirements, and the monitoring, measurement, testing and detection
equipment needed to provide evidence of conformity to these requirements.
1.2 Organizations will establish processes to ensure monitoring, measurement,
testing and detection equipment is calibrated and maintained and that the
Revision History
Rev. RDR Amendment Detail Reviewer Approver Effective Date
Current Revision
Rebranded and changed doc number to reflect the new company name.
2 3136 Updated references to Baker Hughes documents. Corrected reference to par. R. Scala F. Cantini 19 Mar 2020
5. at 5.3.4.
Three Previous Revisions
1 -- Initial Release. R. Scala F. Cantini 28 May 2018
BH-QUA-041 Rev 2
Copyright 2018, 2020 Baker Hughes Company. All rights reserved. The information contained in this document is company confidential and proprietary property
of Baker Hughes and its affiliates. It is to be used only for the benefit of Baker Hughes and may not be distributed, transmitted, reproduced, altered, or used for
any other purpose without the express written consent of Baker Hughes.
Uncontrolled when printed or transmitted electronically Page 1 of 6 Baker Hughes – Company Confidential
BH-QUA-025 (EN) Rev: 2
Effective Date: 3/19/2020
Control of Monitoring, Measuring, Testing, and Detection Equipment
2.5 Organizations will ensure that the environmental conditions are suitable for the
calibrations, inspections, measurements, and tests being carried out. The type of
environment may be varied as needed provided the accuracy of the monitoring
and measuring equipment is not impaired during the process.
3. Calibration Program Requirements for External Providers
3.1 When organizations source calibration services from outside providers, such
providers will be qualified in accordance with BHGE-QUA-014 “Supplier Quality
Management”.
3.2 Unless otherwise specified by Product Company requirements, verification of
implementation by Baker Hughes or third-party assessment of a calibration
provider’s QMS to ISO 9001, API Specification Q1, or of laboratory operations to ISO
17025, satisfies the requirements for qualification.
3.3 Organizations will formally communicate the calibration requirements to
calibration providers including the following, as a minimum:
a. Equipment type;
b. Unique identifier;
c. Check method;
d. Acceptance criteria;
e. Frequency;
f. Record requirements (see 2.4).
4. Calibration Program Documentation Requirements
4.1 Organizations will document their calibration processes including the
management of:
a. Equipment type;
b. Calibration status;
c. Traceability requirements;
d. Frequency of calibration at specified intervals, or prior to use;
e. Calibration or verification method, including adjustments and readjustments,
as necessary;
f. Acceptance criteria;
g. Control of equipment identified as Out of Tolerance to prevent unintended use
(see 5).
5. Control of Nonconforming Monitoring, Measuring, Testing and Detection Equipment
5.1 If the result of calibration prior to any adjustment or repair indicates that the
monitoring, measuring, testing, and detection equipment did not meet the
metrological requirements, this is considered an Out of Tolerance condition. When
Out of Tolerance conditions are identified, immediate actions will be taken to
address both the affected monitoring, measurement, testing, and detection
equipment and any affected product or service-related product.
5.2 Nonconforming monitoring, measurement, testing, and detection equipment will
be identified, removed from service, controlled to prevent unintended use, and not
be returned to service until the reason for the nonconformance condition has
been eliminated.
5.3 Organizations will investigate Out of Tolerance monitoring, measuring, testing, and
detection equipment and the effect on previously accepted product. This
includes:
a. assessing and recording the validity of previous measuring results;
b. documenting the results of the investigation of the Out of Tolerance
monitoring, measuring, testing, and detection equipment and any actions
taken as a result of the investigation.
5.3.1 When the investigation defined in section 5.3 indicates a product could
be adversely affected because of the use of Out of Tolerance
monitoring, measurement, testing, and detection equipment,
organizations will evaluate the affected product. This includes:
a. a determination of affected product;
b. a determination of required customer communication.
5.3.2 [Supplemental API Q1] If it is determined that product does not conform
to Design Acceptance Criteria (DAC) or contractual requirements and
has been shipped, organizations will notify the customers and maintain
records of the evidence of customer notification.
5.3.3 Records will be kept regarding all Out of Tolerance conditions, in
accordance with the requirements of BH-QUA-013 “Control of Records”.
5.3.4 Organizations will define the methods used to establish traceability of
monitoring, measurement, testing, and detection equipment to
products, so that actions defined under section 5. can be executed on
all affected product and product related services, as applicable.
Records
The following records produced by this procedure will be maintained and controlled
according to requirements of BH-QUA-013 Control of Records procedure:
• Record of software confirmation/reconfirmation (1.3).
• Competency records for personnel performing calibration activities (1.5).
• Records of the basis used for calibration or verification of monitoring, measuring,
testing, and detection equipment if no international or national measurement
standards exist (2.1 a.).
• Calibration and verification records for equipment maintained internally (may be in
form of database) (2.4).
• Calibration records (certifications) provided by suppliers/subcontractors (2.4).
• Procurement documents for calibration services (outsourced and/or purchased) (3.3).
• Out of Tolerance condition records, including (5.);
- results of the investigations of Out of Tolerance conditions;
- assessment of the validity of previous measuring results;
- actions to be taken on the affected testing, monitoring and measurement
equipment;
- actions to be taken on affected product.
• [Supplemental API Q1] Evidence of notification to the customer if nonconforming
product has been shipped (5.3.2.).
References
• BH-QUA-002 QMS Transition Policy
• BH-QUA-003 Quality Manual
• BH-QUA-013 Control of Records
• BHGE-QUA-014 Supplier Quality Management
Compliance Requirements
• Refer to BH-QUA-002 for details on Baker Hughes QMS Transition.
Annexes
Not Applicable.