Quality Manual - ISO 9001 - 2015 & API Q1
Quality Manual - ISO 9001 - 2015 & API Q1
Quality Manual - ISO 9001 - 2015 & API Q1
Quality Manual
ISO 9001:2015
API Q1 9th Edition
President:
Mike Bair
Documentation Scheme
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Quality Manual Distribution
The Quality Manual shall be distributed to the following:
President,
Vice President of Sales,
Director of Corporate Services,
Quality & Manufacturing Manager,
Safety Specialist,
Purchasing / Inventory Control,
Machine Shop Manager,
Pump Shop Manager
Engineering Department
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Section 1: Scope
1.1 General
The quality manual outlines the policies, procedures and requirements of Black Gold Pump &
Supply, Inc.’s Quality Management System. The system is structured to comply with the conditions set
forth in the International Standard ISO 9001:2015 and API Q1 9th Edition.
Black Gold Pump & Supply, Inc. ISO 9001:2015 and API Q1 9th Edition certificates is for the
Design, Product Development, Engineering, Manufacturing, Sales, Service, and Distribution of Oil
Production tools for the Oil Production and Services Industry.
1.2 Application
Black Gold Pump & Supply, Inc. has determined that the following requirements are not applicable to
the operations at this site and are documented as exclusions:
- ISO 9001:2015 – No Exclusions
- API Q1 9th Edition – No Exclusions
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Section 3: Terms, Definitions, and Abbreviations
3.1 Quality Management System Definitions
This section is for definitions unique to Black Gold Pump & Supply, Inc.
▪ Customer owned property - Any type of instrumentation, accessories, manuals, or shipping
containers that belong to a customer.
▪ Customer supplied product - Any type of service or material supplied to be utilized in the
manufacture, modification or repair of customer-owned property.
▪ Conformity - To conform means to meet or comply with requirements. There are many types of
requirements. There are quality requirements, customer requirements, product requirements,
management requirements, legal requirements, and so on.
▪ Continual improvement - a set of activities that an organization carries out in order to enhance
its ability to meet requirements.
Continual improvements can be achieved by carrying out audits, self-assessments,
management reviews, and benchmarking projects.
Continual improvements can also be realized by collecting data, analyzing information, setting
objectives, and implementing corrective and preventive actions.
▪ Non-conforming product - When one or more characteristics of a product and/or service fail to
meet specified requirements, it is referred to as a nonconforming product. When a product and/
or service deviate from specified requirements, it fails to conform.
Nonconforming products and/or service must be identified and controlled to prevent unintended
use or delivery.
▪ Product – The end item result of meeting all contracts terms and conditions.
▪ Quality Records – Documentation of those activities wherein records of said activities must be
maintained will be specified in the procedure or work instruction level documents;
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4.1 Quality Management System
4.1.1 General
Black Gold Pump & Supply, Inc. has established, documented and implemented a Quality
Management System (QMS) in accordance with the requirements of ISO 9001:2015 and API Q1 9th
Edition. The system is maintained and continually improved through the use of the quality policy, quality
objectives, audit results, analysis of data, corrective and preventive action and management review.
To design and implement the QMS Black Gold Pump & Supply, Inc. has:
a. Identified the processes needed for the QMS and their application throughout the
organization and documented them on the ‘Black Gold Core Business Functions & QMS
Process Interaction’ flow diagram at the end of this section of the Quality Manual.
b. Determined the sequence and interaction of these processes, and illustrated them on the
Black Gold Core Business Functions & QMS Process Interaction.
c. Determined criteria and methods needed to ensure that the operation and control of the
processes are effective, and documented.
d. Identified processes that require validation such as Welding, Electro-less Nickel Plating, Heat
Treating, and Black Oxide. (see 5.7.1.5)
e. Ensured the continuing availability of resources and information necessary to achieve
planned results and continual improvement of these processes
f. Established systems to monitor, measure and analyze these processes, and
g. Established processes to identify and implement actions necessary to achieve planned
results and continual improvement of these processes
h. Black Gold Pump & Supply, Inc. manages these processes in accordance with the
requirements of ISO 9001:2015 and API Q1 9th Edition.
i. Where Black Gold Pump & Supply, Inc. chooses to outsource any process that affects
product conformity; Black Gold Pump & Supply, Inc. ensures control over such processes.
Control of such processes is identified within the QMS.
j. Identified legal and other applicable requirements to which Black Gold Pump & Supply, Inc.
claims compliance that are needed to achieve product and/or service conformity.
4.1.2 Quality Policy
Top management ensures that the Quality Policy is compatible and supports Black Gold’s strategic
vision. The Quality Policy is communicated to all Black Gold personnel. It is included in new hire
employee training as well as QMS training. The Quality Policy is posted in prominent places throughout
the facility to maintain high standards within our organization.
Management reviews the Quality Policy at each management review meeting to determine the policy’s
continuing suitability for our organization. The Quality Policy is documented on
BG_412_D_ADM_Quality Policy_RX.X and is available to relevant parties, as appropriate.
4.1.3 Quality Objectives
Quality Objectives are established to support our organization’s efforts in achieving our goal through
our Quality Policy. Black Gold Pump & Supply, Inc. has determined the activities, resources needed,
delegated responsibilities, timeframes, and evaluation methods for meeting the Quality Objectives. The
Quality Objectives are reviewed bi-annually by Top Management for applicability during Management
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Reviews. Quality Objectives are measurable, and reviewed against performance goals at each
Management Review meeting.
a. Improve Customer Satisfaction as measured by Revenue and Customer Complaints.
b. Continuously improve process efficiency as measured by decreasing product defects & delivery
times.
c. Maintain competent workforce as measured by Safety Metrics and Productivity Metrics.
d. Maintain fiscal responsibility by balancing revenue and spending.
4.1.4 Quality Management System Planning
The Quality Management System has been planned and implemented to meet our Quality Objectives
and the requirements of ISO 9001: 2015 and API Q1 9th Edition standards. Quality planning takes place
as changes that affect the quality system are planned and implemented.
Black Gold Pump & Supply, Inc. considers all external/internal issues, requirements of interested
parties, and identifies potential risks as well as opportunities.
4.1.4.1 Organization and Context
Black Gold Pump & Supply, Inc. shall determine and define external and internal issues that are
relevant to its purpose and strategic goal(s) and that affect its ability to meets the intended result(s) of
the Quality Management System.
4.1.4.2 Understanding Interested Parties
Black Gold Pump & Supply, Inc. has determined interested parties that are relevant to the QMS
such as customers, owners/shareholders, Black Gold personnel, and suppliers/channel partners.
4.1.5 Communication
4.1.5.1 Internal Communication
Processes and procedures are established for communication within the organization. Methods of
communicating Black Gold Pump & Supply’s Quality Policy and Quality Objectives as well as the
effectiveness of the QMS include weekly Executive Management meetings, Office Administration
meetings, Departmental Meetings, monthly safety meetings and Management Reviews.
4.1.5.2 External Communication
Black Gold Pump & Supply, Inc. has determined and implemented various methods for
communicating with external organizations, including customers, to ensure requirements are
understood throughout contract execution, where applicable and product realization.
Black Gold Pump & Supply, Inc. has implemented an effective procedure (BG_720_P_SAM_
Customer Related Processes_RX.X) for communicating with customers. External communication is
conducted via email, phone calls, personnel visits to customer sites and/or vendor sites.
External communication addresses the following:
a. execution of inquiries, contracts, or order handling and amendments (see 5.1);
b. provision of product information, including product nonconformities identified after delivery to the
customer (see 5.10.4);
c. feedback and customer complaints (see 6.2.1); and
d. when required by contract, providing information required by product quality plans and subsequent
changes to those plans (see 5.7.2).
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4.2 Management Responsibility
4.2.1 General
Top management has been actively involved in implementing the Quality Management System (QMS).
It has provided the vision and strategic direction for the growth of the QMS, and established quality
objectives and the quality policy.
To continue to provide leadership and show commitment to the improvement of the QMS, management
will do the following.
a. Communicate the importance of meeting customer, statutory, and regulatory requirements;
b. Establish and Measure Quality Objectives;
c. Establish and communicate Black Gold’s Quality Policy;
d. Conduct bi-annual Management Reviews;
e. Ensure the availability of resources.
4.2.2 Responsibility and Authority
An organizational chart has been established to show the interrelation of personnel in the organization.
Job descriptions define the responsibilities and authorities of each of the positions on the organizational
chart. Job descriptions and the organizational chart are reviewed and approved by top management for
adequacy. These documents are available throughout the organization to help personnel understand
responsibilities and authorities.
4.2.3 Management Representative
The Director of Quality and Manufacturing has been appointed by top management as the
Management Representative. As Management Representative, that person has the following
responsibility and authority:
a. Ensure that processes needed for the Quality Management System are established,
approved and implemented.
b. Report to top management on the performance of the Quality Management System, and note
needed improvements.
c. Ensure initiation of corrective/preventative actions to minimize the likelihood of the
occurrence of nonconformities.
d. Promote awareness of customer requirements throughout the organization.
e. Acts as a liaison with external parties such as customers and/or auditors on matters relating
to the QMS.
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4.3.2 Human Resources
4.3.2.1 General
To ensure competence of Black Gold’s personnel, job descriptions have been prepared identifying the
qualifications required for each position that affects product quality. Qualifications include requirements
for education, skills and experience. Appropriate qualifications, along with required training, provide the
competence required for each position.
4.3.2.2 Personnel Competence
Black Gold’s personnel shall be competent within their function(s) based on the appropriate education,
training, skills, and experience needed to meet product and customer requirements. Evidence of
competence of each Black Gold personnel shall be recorded and maintained in personnel files. (see
4.5).
4.3.2.3 Awareness and Training
Qualifications are reviewed upon hire, when an employee changes positions or the requirements for a
position change. Human resources maintain records of employee qualifications. If any differences
between the employee’s qualifications and the requirements for the job are found, training or other
action is taken to provide the employee with the necessary competence for the job. The results of that
training are then evaluated through Management By Planning (MBP) Process to determine if the
training was effective. All records and evaluations are stored in employee file for reference and review.
Training and evaluation are conducted according to the Training procedure.
(BG_622_P_ADM_Competence, Awareness & Training_RX.X)
All Black Gold personnel are trained on the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives.
4.3.2.4 Organizational Knowledge
Black Gold Pump & Supply, Inc. shall determine the knowledge necessary for the operation or its
processes and to achieve conformity of products and services.
Black Gold’s organizational knowledge is documented in departmental procedures stored and
maintained in Black Gold’s SharePoint. Black Gold departments also have hard-copy binders with
controlled documents to utilize as reference when needed.
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i. A master list or equivalent shall be established to identify the current revision status of
documents.
4.4.4 Use of External Documents in Product Realization
When API product or other external specification requirements, including addenda, errata, and updates,
are used in the design or manufacture of the product, Black Gold Pump & Supply, Inc. shall maintain a
documented procedure for the integration of these requirements into the product realization process
and any other affected processes.
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Core Business Processes
Purchasing
Sales/ Planning of Product Design and (5.6)
Marketing Realization Development
(5.1) (5.2) (5.4) Verification and
Validation
Customer Satisfaction
(5.4.5 /5.4.6)
Customer Requirements
Control of
Control Of Non -
Documents and Monitoring and
Conforming Internal Audits
Records Measurement
Product (6.2.2)
(4.4) Equipment
(5.10)
(5.8)
Management Corrective/
Planning and Resources Monitoring and
Data Analysis Preventative
Review Management Measuring
(6.3) Action
(6.5) (4.3) (6.2)
(6.4.2 /6.4.3)
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Section 5: Product Realization
5.1 Contract Review
5.1.1 General
Black Gold Pump & Supply, Inc. has established and maintained a documented procedure
(BG_724_P_ADM_Contract Review_RX.X) for the review of customer and/or supplier requirements related
to the provision of products and required servicing.
Black Gold Pump & Supply, Inc. has a process in place for the review of requirements related to the
product (BG_720_P_SAM_ Customer Related Processes_RX.X). The review is conducted before the
order is accepted.
5.1.2 Determination of Requirements:
Black Gold Pump & Supply, Inc. shall determine the following:
a. Customer requirements
b. Legal and other applicable requirements
c. Requirements not stated by the customer but are considered necessary by Black Gold for the provision
of product(s).
Where the customer provides no documented statement of requirements, the customer requirements
shall be confirmed by Black Gold Pump & Supply, Inc. and records maintained. (see 4.5)
5.1.3 Review of Requirements:
Black Gold Pump & Supply, Inc. shall review customer requirements related to the provision of
product(s). This review shall be done prior to Black Gold Pump & Supply, Inc.'s commitment to
delivery of product to the customer and shall ensure:
a. Requirements are identified and documented;
b. Requirements differing from those previously identified are resolved;
c. Black Gold Pump & Supply, Inc. has the capability to meet the documented customer requirements.
Where customer requirements are changed, Black Gold Pump & Supply, Inc. shall ensure that
relevant documents are amended and that all relevant personnel are made aware of changed requirements.
Records of the results of the review, including resulting actions, and any new requirements shall be
maintained. (see 4.5)
5.2 Planning
Quality planning is required before new products or processes are implemented. The quality planning
may take place as a design project according to the Planning of Product Realization procedure
(BG_710_P_ENG_ Planning of Product Realization_RX.X). During this planning, management or
assigned personnel will identify the following:
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a. The quality objectives and customer requirements for the product(s) and/or service;
b. Processes, documentation and resources required
c. Verification, validation, monitoring, inspection and test requirements
d. Determination of legal requirements
e. Criteria for product and/or service acceptance;
f. Contingencies based on risk assessment (see 5.3)
g. Management of Change (MOC) (see 5.11)
h. The output of planning shall be documented and updated as changes occur.
i. Address records
The output of quality planning includes documented quality plans, processes, procedures and design
inputs/outputs. The plans shall be maintained in a structure suitable for the organization’s method of
operation.
When product and/or service requirements are provided from outside sources, Black Gold Pump &
Supply, Inc. will define the methods and establish control features used to translate these
requirements into the product and service realization process.
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5.4 Design and Development
5.4.1 Design and Development Planning
The design and development procedure (BG_730_P_ENG_ Design and Development_RX.X) outlines
the process for controlling the design and development process. Sales, Engineering and Manufacturing
plan design and development per this procedure. The design plan includes:
a. Design and development stages.
b. Required design reviews (conceptual, interim, and final)
c. Verification and validation methods appropriate to each design and development stage.
d. Resources, responsibilities and authorities for design and development.
e. Identification of the technical interfaces required for the project.
f. Updating of the design plan as the project progresses.
g. When design and development activities are performed at different locations within the same
organization, the procedure shall identify the controls required to ensure that the designs meet
the requirements.
h. When design and development are outsourced, the organization shall ensure the supplier meets
the requirements of Black Gold Pump & Supply, Inc.
5.4.2 Design and Development Inputs
Inputs relating to product requirements are determined and documented according to the Design and
Development procedure (BG_730_P_ENG_ Design and Development_RX.X). All inputs are reviewed
for adequacy and completeness, and to resolve any ambiguous inputs. Inputs include:
a. Functional and performance requirements of products and/or service-related products
b. Customer-specified requirements
c. Applicable environmental, statutory, regulatory and legal requirements.
d. Where applicable, information derived from previous similar designs.
e. Requirements provided from external sources, including API product specifications.
f. methodology, assumptions, and formulae documentation
g. Other requirements essential for design and development as well as results from risk
assessments (see 5.3)
All design and development input results are recorded on a Requirements Traceability Matrix
pertaining to specific product or project.
5.4.3 Design and Development Outputs
Outputs of design and development are documented according to the Design and Development
Procedure (BG_730_P_ENG_ Design and Development_RX.X). They are documented in a format that
enables verification against the inputs, and are approved prior to release. Outputs:
a. Meet the input requirements.
b. Provide appropriate information for purchasing, production and for service provision.
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c. Contain or reference product and/or service acceptance criteria.
d. Reference to product(s) and/or components that are critical to the design;
e. Include results of applicable calculations;
f. Specify the characteristics of the product that are essential for its safe and proper use.
g. Provide controls for the execution of the service, including allowable variations in the service
execution parameters;
All design and development output results are recorded on a Requirements Traceability Matrix
pertaining to specific product or project.
5.4.4 Design and Development Review
The design plan specifies suitable stages of the project to conduct design and development review.
Reviews take place per the design and development procedure; results of design review are recorded in
minutes as well as on Requirements Traceability Matrix of the design review meetings which are maintained
as a quality records. Design reviews:
a. Evaluate the results of design and development activities and determine if they fulfill
requirements.
b. Identify any problems and propose necessary actions.
c. Include representatives of functions concerned with the design and development stage being
reviewed.
5.4.5 Design and Development Verification and Final Review
Design verification is planned and performed to ensure that the design and development outputs have
satisfied the design and development input requirements. Records of the results of the verification and
any necessary actions are maintained in the Requirements Traceability Matrix per the Design and
Development procedure (BG_730_P_ENG_ Design and Development_RX.X).
5.4.6 Design and Development Validation and Approval
Design and development validation is performed per the design plan to ensure that the
resulting product is capable of fulfilling the requirements for the specified or known intended use or
application. Validation and approval is completed prior to delivery. Black Gold Executive Management must
approve product and or project before releasing to customer and/or end user. Records of the validation and
approval activities are maintained per the Design and Development procedure.
5.4.7 Control of Design and Development Changes
The design and development procedure defines a process for identifying, recording, verifying, validating
and approving design changes. (see BG_732_P_ENG_Engineering Change Process and
Control_RX.X). The review of design and development changes includes an evaluation of the effect of
the changes on constituent parts and delivered product. Records are maintained to show the results of
the review and any necessary actions identified during the review.
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5.5 Contingency Planning
5.5.1 General
Black Gold Top Management shall maintain a documented procedure (BG_543_P_ADM_Contingency
Planning_RX.X) for contingency planning needed to address risk associated with impact on delivery and
quality of product and/or service. The contingency plan shall be based on assessed risk and the output
will be documented and communicated to relevant Black Gold personnel and updated as required.
5.5.2 Planning Output
The contingency plan shall include the following:
a. Actions required in response to significant risk scenarios to mitigate effects of disruptive
incidents;
b. Identification and assignment of responsibilities and authorities; and
c. Internal and external communication controls
5.6 Purchasing
5.6.1 Purchasing Control
5.6.1.1 Procedure
A documented procedure (BG_740_P_ADM_Purchasing_RX.X) is followed to ensure that purchased
product conforms to the specified purchase requirements. The procedure outlines
a. The determination of the criticality of the service(s) or products as they are applicable to
conformance to product or customer requirements.
b. Suppliers are evaluated and selected based on their ability to supply product in accordance with
requirements as outlined in the procedure.
c. Type and extent of control applied to the supplier based on the criticality of the product or
service.
d. Criteria for selection, evaluation and re-evaluation are documented in the procedure. Records of
the evaluation and any necessary actions are maintained as quality records.
e. Maintain a list of approved suppliers and scope of approval.
5.6.2 Purchasing information
Purchasing information describes the product to be purchased, including where appropriate:
a. Requirements for approval of product and/or service, procedures, processes and equipment;
b. Requirements for qualification of personnel;
c. Quality management system requirements;
d. Applicable version of specifications, drawings, process requirements, inspection instructions,
traceability, and other relevant technical data;
e. Requirements for acceptance criteria of service and service-related product;
The purchasing documents are reviewed to ensure the adequacy of requirements before orders are
placed with the supplier.
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5.6.3 Verification of purchased product
The Purchasing procedure (BG_421_P_MFG_Shipping and Recieving_RX.X) describes the process
used to verify that purchased product meets specified purchase requirements. If Black Gold Pump &
Supply, Inc. or the customer will perform verification at the supplier’s premises, the verification
arrangements and method of product release are documented in the purchasing information.
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c. Suppliers with excessive non-conformances will be given a Corrective Action /Preventative Action
Report (CPAR) for major non-conformances and will be expected to find root cause and submit a
corrective action plan. The corrective action plan will be audited by Black Gold.
5.6.1.6 Outsourcing
Where Black Gold Pump & Supply, Inc. chooses to outsource any activity within the scope of its
quality management system, Black Gold Pump & Supply, Inc. shall ensure that all applicable
elements of its quality management system are satisfied and shall maintain responsibility for product
conformance to specified requirements, including applicable API product specifications, associated with
product realization.
a. The availability of information that describes the characteristics of the product and/or service
b. The availability of work instructions of product and/or service;
c. Process control documents of product and/or service to include API product specifications or
equivalent, Reference instructions and acceptance criteria, and Customer inspection holds or
witness points if required.
d. Personnel training and competence;
e. The availability and use of monitoring and measuring devices and other suitable equipment;
f. The implementation of monitoring and measurement activities
g. The implementation of product release, delivery and post-delivery activities
h. Implementation of the product quality plan, when applicable;
i. Ensuring design requirements and related changes are satisfied, when applicable;
j. Defined contract requirements;
k. Risks assessment and management;
5.7.2 Validation of Processes for Production and Service Provision
Black Gold Pump & Supply, Inc. validates any processes for production and service provision where
the resulting output cannot be verified by subsequent monitoring or measurement. This includes any
processes where deficiencies become apparent only after the product is in use or been delivered.
Validation demonstrates the ability of these processes to achieve planned results.
Black Gold Pump & Supply, Inc. has documented the validation process by obtaining the following:
a. Defined criteria for review and approval of the processes.
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b. Approval of equipment and qualification of personnel.
c. Use of specific methods and procedures.
d. Requirements for records.
e. Process control documents / Work Instructions
f. Revalidation
5.7.1.3 Process Control Documents
Black Gold Pump & Supply, Inc. shall document process controls in routings, work orders, travelers,
and checklist required by Black Gold Pump & Supply, Inc. and shall include requirements for verifying
applicable product quality plans (see 5.7.2), API product specifications (when applicable), customer
requirements, and/or other product standards. The process control shall include or reference
instructions and acceptance criteria for processes, tests, inspections, and/or required customer’s
inspection hold or witness points.
5.7.1.4 Product and Service Realization Capability Documentation
Black Gold Pump & Supply, Inc. shall develop and maintain documentation that includes but is not
limited to product realization plans (see 7.1) and records of review/verification, validation, monitoring,
measurement, inspection, and test activities, including criteria for product acceptance that
demonstrates the capability of Black Gold Pump & Supply, Inc. to satisfy specified product and/or
service requirements. (See BG_710_F_ENG_Requirements Traceability Matrix_RX.X)
5.7.2 Product and Service Quality Plans
Black Gold Pump & Supply, Inc. shall develop a quality plan that specifies the processes of the QMS
(including the product and service realization processes) and the resources to be applied to the
product.
The product and service quality plan shall include the following:
a. Description of the product and/or service (critical and noncritical);
b. Required activities and documentation for compliance with customer and legal requirements;
c. Identification of responsible functions for each activity, including external parties
d. Required processes and documentation, including required inspections, tests, and records, for
conformance;
e. Identification and reference to control of outsourced activities;
f. Identification of procedures, specifications, and other referenced documentation used in each
activity;
g. Identification of the required hold, witness, monitor, and document review points.
h. Service equipment and monitoring devices (see 5.8);
i. Identification and controls of risk (see 5.3);
j. Identification of the required records.
The quality product and service plans and any revisions to them shall be documented and approved by
Black Gold Pump & Supply, Inc. top management to ensure customer requirements and met.
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When required by contract, the service quality plan and any revisions shall be communicated to the
customer.
5.7.3 Identification and Traceability
Black Gold Pump & Supply, Inc. identifies the product and/or service throughout product and service
realization according to the Identification and Traceability procedure (BG_753_P_MFG_ Identification
and Traceability_RX.X). Product and /or service are identified with respect to monitoring and
measurement requirements.
Black Gold Pump & Supply, Inc. controls and records the unique identification of the product where
ever traceability is a specified requirement.
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5.7.6.1 General
Black Gold Pump & Supply, Inc. shall maintain a documented procedure describing the methods
used to preserve the product and constituent parts throughout product realization and delivery to the
customer in order to maintain conformity to requirements.
As applicable, preservation shall include identification and traceability marks, transportation, handling,
packaging, and protection.
5.7.6.2 Storage and Assessment
The procedure shall identify the requirements for storage and assessment. Black Gold Pump &
Supply, Inc. shall use designated storage areas or stock rooms to prevent damage or deterioration of
product, pending use or delivery.
In order to detect deterioration, the condition of product or parts in stock shall be assessed at specified
intervals identified by the procedure. The interval shall be every month which is appropriate to the
products or parts being assessed.
5.7.7 Inspection and Testing
5.7.7.1 General
Black Gold Pump & Supply, Inc. shall maintain a documented procedure for inspection and testing to
verify that product requirements have been met. The procedure shall include requirements for in-
process and final inspection and testing. Records of required inspection and testing shall be maintained
per documented procedures (see 4.5).
5.7.7.2 In-process Inspection and Testing
Black Gold Pump & Supply, Inc. shall inspect and test the product at planned stages as required by
the product quality plan (see 5.7.2), process control documents (see 5.7.1.3), and/or documented
procedures. Evidence of conformity with the acceptance criteria shall be maintained.
5.7.7.3 Final Inspection and Testing
Black Gold Pump & Supply, Inc. shall perform all final inspection and testing in accordance with the
product quality plan (see 5.7.2) and/or documented procedures to validate and document conformity of
the finished product to the specified requirements.
Personnel other than those who performed or directly supervised the production of the product shall
perform final acceptance inspection at planned stages of the product realization process.
Records shall be maintained to enable identification of the individual releasing the product (see 4.5)
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c. Taking action to preclude its original intended use or delivery; and
d. Authorizing its use, release, or acceptance under concession by relevant authority and, where
applicable, by the customer (see 8.3.3).
The procedure for addressing nonconforming product after delivery shall include controls for:
1. Identifying, documenting, and reporting non-conformances after delivery;
2. Ensuring the analysis of product nonconformance’s, provided the product or documented
evidence supporting the nonconformity is available to determine root- cause (see 8.5.2).
3. Taking action to the effects, or potential effects, of the nonconformance when non-conforming
product is detected after delivery.
5.10.2 Nonconforming Product
The organization shall address nonconforming product by performing one or more of the following:
a. Repair and/or rework with subsequent inspection to meet specified requirements;
b. use for alternative applications;
c. use as is under concession (see 8.3.3); and/or
d. Scrap.
e. Return to Vendor
5.10.3 Release of Nonconforming Product Under Concession
The evaluation and release under concession of nonconforming product that does not satisfy
Manufacturing Acceptance Criteria (MAC) shall be permitted when the organization’s relevant authority
and the customer (where applicable) have authorized the release of product provided that:
a. Product(s) continue to satisfy the applicable DAC and/or customer criteria; or
b. The violated MAC are categorized as unnecessary to satisfy the applicable DAC and/or customer
criteria; or
c. The DAC are changed and the products satisfy the revised DAC and associated MAC requirements.
5.10.4 Customer Notification
Black Gold Pump & Supply, Inc. shall notify customers of product not conforming to DAC or customer
requirements, that has been delivered. Black Gold Pump & Supply, Inc. shall maintain records of
such notifications (see 4.5).
5.10.5 Records
Records of the nature of nonconformities and any subsequent actions taken and maintained (see 4.5).
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Form_RX.X).
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b. Is effectively implemented and maintained.
An audit program has been designed and implemented and identifies an audit schedule based on the
importance of the areas to be audited, as well as the results of previous audits. The audit criteria,
scope, frequency, methods, responsibilities and requirements for planning and conducting audits, and
for reporting and maintaining results, are defined and documented in the Internal Audit procedure
(BG_822_P_ADM_Internal Audit_RX.X).
Audits shall be performed by competent personnel independent of those who performed or directly
supervised the activity being audited to ensure objectivity and impartiality of the audit process.
The management responsible for the area being audited is responsible for ensuring that any necessary
corrections and corrective actions are taken without undue delay to eliminate detected nonconformities
and their causes. Management responsible will be given (30) days to submit Corrective Action plan to
Management Representative. After receiving and approving plan, Management will have and additional
(30) days to implement Corrective Action plan and submit verification that Corrective action is
implemented and effective. A follow-up audit will be scheduled to insure Corrective Action is
implemented and maintained as stated in Corrective Action Plan.
All processes of the QMS claiming conformity to the requirements of this document are audited at least
once a year. Group 1 consisting of Engineering, Sales, and Administration (Doc Control, Purchasing, &
Human Resources) will be audited during a 1-month period. Group 2 consisting of the Pump Shop,
Machine Shop, and Executive Management will be audited the following month. These 2 groups will be
audited every 12 months and documented on an Internal Audit schedule.
All processes of the quality management system required to meet this specification (ISO 9001:2015
and API Q1 9th) shall be audited prior to claiming conformance to the requirements of these
specifications.
6.2.3 Monitoring and Measurement of Processes
Black Gold Pump & Supply, Inc. applies suitable methods for monitoring and, where applicable,
measurement of the quality management system processes. These methods demonstrate the ability of
the processes to achieve planned results. When planned results are not achieved, correction and
corrective action is taken, as appropriate, to ensure conformity of the product. The process for
identifying and carrying out the required monitoring and measuring of processes is documented in the
Monitoring, Measuring and Analysis of Product Realization Processes (BG_824_P_ENG_ Monitoring,
Measuring and Analysis of Product Realization_RX.X) and Management Responsibility procedures
(BG_500_P_ADM_ Management Responsibility_RX.X).
6.2.4 Monitoring and Measurement of Product
Black Gold Pump & Supply, Inc. monitors and measures the characteristics of the product to verify
that product requirements are fulfilled. This is carried out at appropriate stages of the product
realization process identified in Monitoring, Measuring and Analysis of Product Realization Processes
(BG_824_P_ENG_ Monitoring, Measuring and Analysis of Product Realization_RX.X).
Evidence of conformity with the acceptance criteria is maintained. Records indicate the person
authorizing release of product. Product release and service delivery does not proceed until all the
planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant
authority, and where applicable by the customer.
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6.3 Analysis of Data
Black Gold Pump & Supply, Inc. determines, collects and analyses appropriate data to demonstrate
the suitability and effectiveness of the quality management system and to evaluate where continual
improvement of the quality management system can be made. The process for determining, collecting
and analyzing this data is defined in the Management Responsibility procedure (BG_500_P_ADM_
Management Responsibility_RX.X). Appropriate data includes data generated as a result of monitoring
and measurement and from other relevant sources.
The analysis of data provides information relating to
a. Data from the QMS
b. Follow-up actions from previous management reviews,
c. Planned changes that could affect the quality management system,
d. An evaluation of the continuing suitability of the Quality Policy and Objectives.
e. Process performance and conformity.
f. Corrective and preventative actions. (Previous, New, and Pending)
g. Addressing and reviewing customer feedback and/or complaints.
h. Internal Quality Audits.
i. Nonconformities and product failures after delivery or use, provided the product or documented
evidence is available to determine root cause.
j. Supplier Performance.
6.4 Improvement
6.4.1 General
Black Gold Pump & Supply, Inc. continually improves the effectiveness of the quality management
system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective
and preventive actions and management review.
6.4.2 Corrective Action
Black Gold Pump & Supply, Inc. takes action to eliminate the cause of nonconformities in order to
prevent recurrence. Corrective actions are appropriate to the effects of the nonconformities
encountered.
A documented procedure (BG_852_P_MFG_ Corrective Action_RX.X) defines requirements for
a. Reviewing nonconformities (including customer complaints)
b. Determining the root- cause(s) of nonconformities
c. Evaluating the need for action to ensure that nonconformities do not recur
d. Determining and implementing action needed
e. Records of the results of action taken (see 4.5), and
f. Reviewing the effectiveness of the corrective action taken
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g. MOC (see 5.7) when the corrective actions require new or changed controls within the QMS
h. Department management responsible will be given (30) days to submit Corrective Action plan to
the Management Representative. After receiving and approving plan, Management will have and
additional (30) days to implement Corrective Action plan and submit verification that Corrective
action is implemented and effective. A follow-up audit will be scheduled to insure Corrective Action
is implemented and maintained as stated in Corrective Action Plan.
6.4.3 Preventive Action
Black Gold Pump & Supply, Inc. determines action to eliminate the causes of potential
nonconformities in order to prevent their occurrence. Preventive actions are appropriate to the effects of
the potential problems.
A documented procedure (BG_853_P_MFG_ Preventive Action_RX.X) defines requirements for:
a. Determining potential nonconformities and their causes
b. Evaluating the need for action to prevent occurrence of nonconformities
c. Determining and implementing action needed or opportunities for improvement
d. Records of results of action taken
e. Reviewing the effectiveness of the preventive action taken
f. MOC (see 5.7) when the preventive action requires new or changed controls within the QMS.
h. Department management responsible will be given (30) days to submit Preventive action plan to
the Management Representative. After receiving and approving plan, Management will have an
additional (30) days to implement Preventive action plan and submit verification that Preventive
action is implemented and effective. A follow-up audit will be scheduled to insure Preventive
action is implemented and maintained as stated in Preventive Action Plan.
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5.Process Performance
6.Results of Risk Assessments
7.Corrective and Preventative Status/Updates
-Open/Closed:
-Pending:
8.Review of Supplier Performance
9.Review of Product Conformity to include Non-Conformances identified after delivery or use. (Internal
and External)
-Number of Non-Conformances (last 6 months)
10.Recommendation for Improvement
11. Adequacy of Resources.
12. Effectiveness of actions to dress opportunities.
Summary:
6.5.3 Review Output
During these management review meetings, management will identify appropriate actions to be taken
regarding the following issues:
a. Improvement of the effectiveness of the quality management system and its processes
b. Improvement of product and/or service related to customer requirements
c. Root cause and solutions to prevent further quality issues due to production and/or
performance.
d. Resource needs.
Responsibilities for required actions are assigned to members of the management review team. Any
decisions made during the meeting, assigned actions, and their due dates if any are recorded in the
minutes of management review.
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10-22-1
1.0 Initial Release Chris Nonato
2
12-17-1
1.1 Revised based on first GAP analysis Chris Nonato
2
Reviewed and revised sections to incorporate API
1.2 8-22-14 Chris Nonato
Q1
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Updated 4.1 General Requirements section d
and 4.2.1 General Documentation
Requirements section b3 per
BG_CA_00045_BG_API Q1_Surveillance
Audit_032116. Updated Internal Audit section
with the following: ‘Group 1 consisting of
Engineering, Sales, and Administration (Doc
Control, Purchasing, & Human Resources)
1.6 will be audited during a 1-month period. Chris Nonato
Group 2 consisting of the Pump Shop,
Machine Shop, and Executive Management
will be audited the following month. These 2
groups will be audited every 6 months and
documented on an Internal Audit schedule.’
Also, updated header Black Gold Pump & Supply,
Inc. logo.
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Annex A
(Informative)
Use of API Monogram by Licensees
A.1 Scope
The API Monogram® is a registered certification mark owned by API and authorized for licensing by the
API Board of Directors. Through the API Monogram Program (www.api.org/certification-programs/apimonogram-program-
and-apiqr.aspx), API licenses product manufacturers to apply the API Monogram to new products that comply with product
specifications and have been manufactured under a quality management system that meets the requirements of API Q1.
API maintains a complete, searchable list of all Monogram Licensees on the API Composite List website(http://
compositelist.api.org).
The application of the API Monogram and license number on products constitutes a representation and
warranty by the Licensee to API and to purchasers of the products that, as of the date indicated, the
products were manufactured under a quality management system conforming to the requirements of
API Q1 and that the product conforms in every detail with the applicable standard(s) or product
specification(s). API Monogram Program licenses are issued only after an on-site audit has verified that
an organization has implemented and continually maintained a quality management system that meets
the requirements of API Q1 and that the resulting products satisfy the requirements of the applicable API
product specification(s) and/or standard(s). Although any manufacturer may claim that its products meet
API product requirements without monogramming them, only manufacturers with a license from API can
apply the API Monogram to their products.
Together with the requirements of the API Monogram license agreement, this annex establishes the
requirements for those organizations who wish to voluntarily obtain an API license to provide API
monogrammed products that satisfy the requirements of the applicable API product specification(s)
and/or standard(s) and API Monogram Program requirements.
For information on becoming an API Monogram Licensee, please contact API, Certification Programs,
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1220 L Street, NW, Washington, DC 20005 or call 202-682-8145 or by email at [email protected].
NOTE Licensee-specified requirements include those activities necessary to satisfy API-specified requirements.
A.3.5 Licensee
Organization that has successfully completed the application and audit process and has been issued a
license by API.
e) The API Monogram may be applied at any time appropriate during the production process but shall
be removed in accordance with the Licensee’s API Monogram marking procedure if the product is
subsequently found to be out of conformance with any of the requirements of the applicable API
product specification(s) and/or standard(s) and API Monogram Program.
For certain manufacturing processes or types of products, alternative API Monogram marking procedures
may be acceptable. Requirements for alternative API Monogram marking are detailed in the API Policy,
API Monogram Program Alternative Marking of Products License Agreement, available on the API
Monogram Program website at http://www.api.org/alternative-marking.
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