Example of Quality Manual based on API Q1

0. Introduction

0.1 The Company

// Include your company profile

0.2 Products & Services

// Include your company’s product and services

1.0 Scope

Scope of the Quality Management System of XXX is:

“ Include the scope of your company

Application & Exclusion

In accordance with API Spec Q1, Section 1, XXX has identified the following products from design and development based on API advisory 6 since the exclusion cannot “affect the organization’s ability, or responsibility, to provide products and related servicing that meets customer and applicable regulatory requirements”; and, by API Spec Q1, Section 4.4.1 b), item 1, the justification for the design and development exclusion has been documented within our quality manual and quality management system.

API Spec …………………………………………….
API Spec ……………………………………………
API Spec …………………………………………..

2.0 Normative References

1. API Spec Q1, 9th Edition Specification for Quality Management System Requirement for manufacturing organization for the Petroleum and Natural Gas Industry

2. API Spec …. …………………………………………………………

3. API Spec …. ……………………………………………………………

4. API Spec … ……………………………………………………………

3.0 Terms & Definitions for API Q1

3.1 Abbreviations

XXX: Company name

GM: General Manager

QM: Quality Manual

QMS: Quality Management System

SAS: Systems & Automated Solutions (Divn.)

MR: Management Representative

WI: Work Instructions

Amend: Amendment

BOS: Business Operating System

CAPA: Corrective and Preventive Action

IQA: Internal Quality Audit

MRM: Management Review Meeting / Minutes

NC: Nonconformity

PO: Purchase Order

QA / QC: Quality Assurance / Quality Control

QMSM: Quality Management System Manual

RM: Raw Material

Sec: Section

TS: Technical Specification

OPE: Operator

API: American Petroleum Institute

CFT: Cross-Functional Team

ISO: International Organization for Standardization

QMS: Quality Management System

WI: Work Instruction

QMSP: Quality Management Procedure

D&D: Design & Development

DAC: Design Acceptance Criteria

ITP: Inspection Test Plan

KPI: Key Performance Indicator

MAC: Manufacturing Acceptance Criteria

MOC: Management of Change

MPS: Manufacturing Process Specification

PCP: Process Control Plan

QAP: Quality Activity Plan

QP: Quality Plan

QMS: Quality Management Systems

3.2 Definitions

1 Acceptance criteria

Specified limits of acceptability applied to process or product characteristics.

2 Acceptance inspections

Demonstration through monitoring or measurement that the product conforms to specified requirements.

3 Calibrations

Comparison to a standard of known accuracy and making any needed adjustment(s).

4 Collections

Process of obtaining, assembling, and/or organizing applicable information with the intent of meeting the requirements

5 Compliance

Act or process of satisfying the legal and other applicable requirements of a regulation or regulatory body

6 Critical

The XXX, product specification deem that, or customer as mandatory, indispensable or essential, needed for a stated purpose or task, and requiring specific action.

7 Delivery

Point in time and physical location at which the agreed transfer of ownership takes place

8 Design acceptance criteria (DAC)

Defined limits placed on characteristics of materials, products, or services established by XXX, customer, and/or applicable specifications to achieve conformity to the product design.

9 Design validations

Process of proving a design by testing to demonstrate conformity of the product to design requirements

10 Design verification

Process of examining the result of design and development output to determine conformity with specified requirements

11 First article

A representative sample of a product, component, or output from a process is used to verify that prescribed activities have satisfied the requirements as specified by XXX.

12 Key performance indicator (KPI)

Quantifiable measure that XXX uses to gauge or compare performance

13 Legal requirements

Obligations imposed on XXX, including those that are statutory or regulatory.

14 Management

Person or group of people, as defined by XXX, who directs and controls all or part of a facility, location, department, or other function; has the fiscal responsibility for XXX, and is accountable for ensuring compliance with legal and other applicable requirements.

15 manufacturing acceptance criteria (MAC)

Defined limits placed on characteristics of materials, products, and services established by the XXX to achieve conformity to the manufacture or service requirements.

16 Outsource

Function or process that is performed by an external supplier on behalf of XXX.

17 Preventive maintenance

Planned action to minimize the likelihood of equipment failure and unscheduled interruptions

18 Procedure

Organization’s documented method for performing an activity under controlled conditions to achieve conformity to specified requirements.

19 Risks

Situation or circumstance that has both a likelihood of occurring and a potentially negative consequence

20 Service

Performance of an activity by one function or XXX for another

21 Servicing

Product maintenance, adjustment, repair, and/or on-site installation when applicable product specifications require installation

4.0 QUALITY MANAGEMENT SYSTEM – REQUIREMENTS

4.1 Quality Management System

4.1.1 General

XXX Scope of Quality Management System documentation is defined, established and revision of documents, and their distribution, is controlled. New documents and revisions are reviewed and approved before issue and are identified concerning their revision level. Appropriate documents are available at locations where they are used. Obsolete documents are removed from points of use. Documents of external origin are identified and their distribution is controlled. Quality Records are identified and indexed to facilitate their retrieval and are stored in a suitable environment to minimize deterioration. Quality Records are retained for a minimum period of 10 Years as required by the customer/API product specifications.

XXX has established, documented, implemented, and maintained at all times a Quality Management System for all products and services provided for use in the petroleum and natural gas industry. XXX measures the effectiveness and improvement of the Quality Management System by the requirements of API Spec Q1. Processes for XXX with inputs, outputs and sequences are given in Annexure-II & III. Processes include:

………………………………………………………………………………………………………………….
………………………………………………………………………………………………………………….
………………………………………………………………………………………………………………….
………………………………………………………………………………………………………………….
etc……

Outsourced processes: The calibration of the equipment is outsourced to an external calibration agency. Transportation/delivery of products is often outsourced if necessary. The performance of the outsourced agencies is monitored and controlled. The management provides necessary resources for the processes through HR and their responsibilities & authorities are defined and documented. Risks and opportunities for each process are determined and necessary actions are planned to enhance desirable effects and eliminate/reduce undesired effects. Related Documented Information:

Documented Information	Ref. no
Overall Process Map	Annexure – II
Process Maps : for processes	Annexure – III

4.1.2 Quality Policy

The top management of XXX has established, implemented and maintained a Quality Policy, which is appropriate to the purpose and context of the organization. It provides a commitment to satisfy applicable requirements and continual improvements of the Quality Management system.

The documented Quality Policy is shown in the Annexure.

The Quality policy is communicated, understood and applied within the organization and made available to the relevant interested parties.

Quality Policy to ensure that it is appropriate to XXX is the basis for the development of its Objectives (Refer 4.1.3), and is communicated, understood, implemented, and maintained at all relevant functions and levels within XXX. The policy includes a commitment to the company with requirements and continually improves the effectiveness of the quality management system by specifications API Q1 and ISO 29001:2022.

Authority

Quality policy is established by the top management and is approved by the Chairman. The General Manager must approve any changes to the policy.

Role of the policy

The main role of the Quality policy is to communicate the company’s commitments and aspirations about Quality and to define principal objectives for the Quality Management system.

The policy provides a framework for establishing specific quality objectives and provides direction for the continual improvement effort. The use of policy in setting quality objectives is addressed in this manual

Communication

The Quality policy is posted throughout the company, and its role is explained and discussed at the general orientation training provided to all employees.

The Quality policy is also communicated to customers, consumers and other interested parties. For this purpose, it is displayed in the reception area and posted in the company work area.

Review

The policy is periodically reviewed within the framework of management reviews of the quality system. This is to ensure its continual relevance and suitability. The process for reviewing the policy is defined in the Quality Management System Procedure, Management Review Meetings

XXX policy includes a commitment to comply with requirements and continually improve the effectiveness of the Quality Management System.

4.1.3 Quality Objectives

Quality objectives for all processes are defined and are available to the respective department heads. These are consistent with the quality policy and measurable. Quality Objectives are defined with a focus on achieving product and service conformity and enhancing customer satisfaction. Objectives are monitored and communicated. Documented information on Quality Objectives is maintained. Management, with approval from top management, ensures that Quality Objectives, including those needed to meet product and customer requirements, are established at relevant functions and levels within XXX.

Planning for the achievement of the Objectives is done by covering the action plan, resources responsibility and period. The performance is measured and monitored by the relevant Departments and Management Representatives.

Management Representative in consultation with the Department heads determines fulfilment of the quality objectives periodically and puts forward the results of achievements for Management Review. The relevance and updating of the Quality objective itself is carried out once a year and where a change is required they are suitably done by MR authorized by the General Manager.

4.1.4 Planning

4.1.4.1 General

Management ensures that:

Criteria and methods needed for the operation and control of all Quality Management System processes are determined, managed, and effective; and
Planning of the Quality Management System is carried out to meet the requirements of this specification.

XXX shall determine and define external and internal issues that are relevant to its purpose and strategic goal(s) and that affect its ability to meet the intended result(s) of the Quality Management System. Organizational contexts related to internal & external issues that are relevant and can affect its ability to achieve the intended results of the QMS are identified and documented by the respective departments with proposed actions. Information about these external and internal issues is regularly monitored and reviewed.

XXX has determined interested parties that are relevant to the QMS such as customers, owners/shareholders, Black Gold personnel, and suppliers/channel partners. The interested parties for XXX include Clients, Principals/Service Providers, Employees, Higher Management, and Government / Regulatory Bodies. The departments identify and take care of the needs and expectations of interested parties. Management of XXX is always committed to fulfilling the needs and expectations of all interested parties. The main needs and expectations of the interested parties are given below.

4.1.4.2 Exclusions

In the development and implementation of this Quality Management System by API Spec Q1, XXX has identified, considered and committed that there is no exclusion of the quality management system requirements of API Q1. However, where applicable design and development of products which fall under the provision of API advisory 6 may be applied but are limited to:
• API Spec 6A: • Tees and Crosses; • Ring Joint Gaskets; • Top Connectors; • Flanged Connectors (except Type 6B); • Threaded Connectors; • Adapter and Spacer Spools; • Bullplugs; and • Valve Removal Plugs

4.1.5 Communication

Mode of internal and external communications is informed to the personnel by Department Heads. It includes what to communicate, whom to communicate and when.

4.1.5.1 Internal

Management ensures that appropriate communication processes are established within the XXX and the effectiveness of the Quality Management System is communicated. XXX has established a process to ensure that:

The importance of meeting customer, legal, and other applicable requirements is communicated at relevant functions within the XXX; and
Results of the analysis of data are communicated at relevant levels and functions within XXX.
Internal memos, e-mail communication, phone calls, meetings, training and toolbox meetings do internal communications in XXX.

4.1.5.2 External

XXX determines and implements a process for communicating with external organizations, including customers, to ensure requirements are understood throughout contract execution and product realization. The communication process addresses:

Execution of inquiries, contracts, or order handling and amendments
Provision of product information, including product nonconformities identified after delivery to the customer.
Feedback and customer complaints,
When required by contract, providing information required by product quality plans and subsequent changes to those plans.

The point of contact for the execution of inquiries, contracts, or order handling & and amendments Feedback and customer complaints in XXX is the Commercial officer.

The point of contact for the Provision of product information, including product nonconformities identified after delivery to the customer and when required by contract, providing information required by product quality plans and subsequent changes to those plans is the Machine shop Manager & Quality Systems Manager.

Customer communication

Communication with customers includes

Providing information relating to products and services
Handling inquiries, contracts or orders, including changes
Obtaining customer feedback relating to products and services, including customer complaints
Handling or controlling customer property
Establishing specific requirements for contingency actions, when relevant

Customers are communicated regarding the product information through the letter, verbal, and/ or through phone, Fax, e-mail. If any amendments in inquiries, purchase orders it will be communicated through Phone, letter & Email. The customer complaints are registered in the customer complaint register and the corrective action taken is communicated.

4.2 MANAGEMENT RESPONSIBILITY

4.2.1 General

Management ensures the availability of resources essential to establish, implement, maintain, and improve the Quality Management System. Management provides evidence of its commitment to the development and implementation of the Quality Management System and continually improves its effectiveness by:

Ensuring that Quality Objectives are established including key performance indicators for use in data analysis; and
Conducting Management Reviews.

XXX’s Management has demonstrated leadership and commitment concerning the quality management system through

Taking accountability for the effectiveness of the quality management system by periodical review of the quality management system through management review meetings, Quality objectives review and providing necessary resources.
Management has established the quality policy and quality objectives for the quality management system and is compatible with the context and strategic direction of the organization.
Management has determined the organizational processes and integrated them with the quality management system requirement through process maps & Interaction this can be demonstrated.
The established procedure for promoting the use of the process approach and risk-based thinking.
Ensuring that the resources needed for the quality management system are available, is being periodically reviewed through management review meetings.
Communicating the importance of effective quality management and conforming to the quality management system requirements
Ensuring that the quality management system achieves its intended results
Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system by providing training, conducting awareness programs and
Promoting improvement by introducing the suggestion scheme, Kaizens and conducting meetings.
Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

Customer focus

XXX management has demonstrated leadership and commitment concerning customer focus by ensuring that:

Customer and applicable statutory and regulatory requirements are determined, understood and consistently met.
The risks and opportunities that can affect the conformity of products and services and the ability to enhance customer satisfaction are determined and addressed
The focus on enhancing customer satisfaction is maintained and the procedure for customer satisfaction is addressed

4.2.2 Responsibility and Authority

Responsibilities, authorities, and accountabilities of personnel within the scope of QMS are defined, documented, and communicated throughout XXX. 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.

XXX’s management has ensured that the responsibilities and authorities for relevant roles are assigned communicated and understood within the organization. While assigning roles, responsibility, and authority, top management has considered and ensured that

The quality management system conforms to the requirements of this API Q1 standard.
The processes are delivering their intended outputs
Reporting on the performance of the quality management system and opportunities for improvement, in particular, to top management
The promotion of customer focus throughout the organization
The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

(Refer Organization Chart & Responsibilities, authorities & accountabilities)

4.2.3 Management Representative

Top management appoints and maintains a member of XXX management who, irrespective of other responsibilities, has responsibility and authority that includes:

Ensuring that processes needed for the Quality Management System are established, implemented, and maintained;
Reporting to top management on the performance of the Quality Management System and any need for improvement;
Ensuring initiation of action(s) to minimize the likelihood of the occurrence of nonconformities; and
Ensuring the promotion of awareness of customer requirements throughout XXX.

4.3 ORGANIZATION CAPABILITY

4.3.1 Resources and Knowledge

4.3.1.1 Resources

XXX determines and allocates the resources needed to implement, maintain, and improve the effectiveness of the requirements of the Quality Management System. Resources needed, which include people, infrastructure, environment, monitoring & measuring resources are determined by the respective Department heads and approved by the General Manager. To determine the resources, internal resources’ capabilities and constraints and required competency are considered.

The requirements of personnel and the infrastructure are identified by departmental heads for effective operation and control of QMS and are approved by the General Manager. Personnel could be internal or through external providers. Infrastructure includes:

Systems used for planning & recording (such as ERP) including hardware and software
Processing and testing equipment at the workshop
Information and communication technology

4.3.1.2 Knowledge

XXX determines the knowledge necessary for its operations and to achieve conformity of its products and services. These include:

Product information provided by the external providers / Principals
Information related to repair and servicing (particularly any special processes)
Information on systems and applications installed (such as ERP system, HR system etc.)
Specific product/service related

Product information from training programs/conferences is documented and shared. Service-related information (e.g. discrepancies, customer grievances) is documented and shared. Whenever there a changing requirements, acquiring or accessing additional knowledge or updates are done and documented by the concerned department.

4.3.2 Human Resources

4.3.2.1 Personnel Competence

XXX maintains a documented procedure for defining personnel competency and identifying training requirements or other actions to achieve the necessary competency of personnel whose responsibilities fall within the scope of the Quality Management System. The procedure includes the provision for determining and documenting the effectiveness of the training or other actions taken toward the achievement of required competency.

Management ensures that the personnel performing work which affects conformity to service requirements are competent based on education, training, skills and experience. Where necessary, training is provided to personnel to acquire necessary competence and the effectiveness is evaluated. Personnel competencies are based on the appropriate education, training, skills, and experience needed to meet product and customer requirements. Evidence of the determination of competence of personnel is recorded and maintained. Documented information is maintained as evidence of competence.

4.3.2.3 Training

XXX maintains a documented procedure for training. The procedure includes

Determining the necessary content and frequency of training.
Offering training on the quality management system.
Providing job-specific training, ensuring personnel understand the significance of their roles and how they impact the organization’s quality objectives.
Delivering customer-specific or customer-provided training as needed.
Assessing the efficacy of training.
Documenting essential training records.

XXX

Provides Quality Management System training and job training;
Ensures that customer-specified training and/or customer-provided training, when required, is included in the training program;
Ensures that the frequency and content of training is identified;
Ensures that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the Quality objectives; and
Maintains appropriate records of education, training, skills, and experience
Maintains appropriate records of Personal training

4.3.3 Work Environment

XXX determines, provides, manages, and maintains the work environment needed to achieve conformity applicable to the manufacture of the product. The work environment includes:

Buildings, workspace, and associated utilities;
Process equipment and its maintenance (both hardware and software) ;
Supporting services (e.g. transport, communication, information systems); and
Conditions under which work is performed such as physical, environmental, or other factors.

4.4 DOCUMENTATION REQUIREMENTS

4.4.1 General

Documented information includes manuals, procedures, records, information received or communicated by e-mail etc. Documented information is maintained as required by the quality management system and those determined by the organization for effective operations.

The Quality Management System documentation includes:

Statements of Quality Policy and Quality Objectives;
A Quality Manual that addresses the requirements specified in the standards API Q1
- The scope of the Quality Management System, including the justification for any exclusion to specific Quality Management System elements (Refer to Scope of QMS);
- A description of the sequence and interaction between the processes of the Quality Management System; (Annexure: Sequence and interaction of process)
- Identification of processes that require validation; and
- Reference to documented procedures that control the Quality Management System processes;
- Documented procedures established for the Quality Management System
- Documents and records to ensure the effective planning, operation, and control of its processes and compliance with specified requirements;
- Identification of legal and other applicable requirements to which XXX claims compliance that are needed to achieve product conformity.

4.4.2 Procedures

All procedures referenced within this specification will be established, documented, implemented, and maintained for continued suitability.

Following are ensured while creating & updating documentation.

Identification & description (title, date, reference no)
The format is maintained in the system or as a hard copy.
Reviewed and approved by the authorized person (department head or by MR, as applicable).

4.4.3 Control of Internal Documents

XXX maintains a documented procedure for the identification, distribution, and control of documents required by the Quality Management System and this specification, including required documents of an origin external to XXX. Documented information is controlled so that these are available and suitable for use. Those are protected from improper use, loss of confidentiality, as applicable. For control of documented information, following are ensured:

Distribution to concerned functions.
Ensuring accessibility and retrieval when required.
Ensuring storage and preservation
Version or revision control after changes
Defining retention period and disposition methods.
Ensuring that documents of external origin are identified and their distribution controlled,

The procedure specifies the responsibilities for approval and re-approval and identifies the controls needed to ensure that the documents required by the Quality Management System, including revisions, translations, and updates:

Are reviewed and approved for adequacy prior to issue and use,
Identify changes and revision status,
Remain legible and readily identifiable, and
Are available where the activity is being performed.

Documents of external origin controlled to ensure that the relevant versions are used and maintained. Obsolete documents are removed from all points of issue or use, or otherwise identified to ensure against unintended use if they are retained for any purpose. Procedures, work instructions, and forms required by the Quality Management System are controlled.

4.4.4 Control and Use of External Documents

When API product or other external specification requirements, including addenda, errata, and updates, are used in the design or manufacture of the product, XXX maintains a documented procedure for the integration of these requirements into the product realization process and any other affected process. XXX maintains a documented method for managing externally originated documents needed for product realization and utilized by the organization, such as API or other external specifications. This procedure covers:

Identifying and recording essential documents;
Ensuring access to and distribution of these documents, including the correct versions;
Incorporating these document requirements into product realization and any other relevant processes;
Establishing a procedure to recognize changes to these documents, including addenda, errata, and updates;
Evaluating the effects of these changes; and
Implementing relevant changes into the processes.

Normative references that are identified within API products or other external specifications and are required during product realization are also considered external documents.

4.5 CONTROL OF RECORDS

XXX maintains a documented procedure to identify the controls and responsibilities needed for the identification, collection, legibility, correction, storage, protection from unintended alteration, damage, loss, retrieval, retention time, and disposition of records. Records, including those originating from outsourced activities, are established and controlled to provide evidence of conformity to requirements and XXX Quality Management System. Records remain legible, identifiable, and retrievable. Records are retained for a minimum of ten years or as required by customer, legal, and other applicable requirements, whichever is longer.

5.0 PRODUCT REALIZATION

Planning of the product realization process starts with the review of customer enquiry, contracts, and amendments of contracts if any as described and specified below; This may include but not be limited to product or service requirements as specified by the customer, specification or other statutory or regulatory requirements; development of required process and process documentation; and establishment of product verification and validation programs. The plan also defines the requirement for records necessary to demonstrate process and product conformity.

5.1 CONTRACT REVIEW

5.1.1 General

XXX maintains a documented procedure for Contract Review to review the requirements related to the provision of products and required services. Before committing the products/services, the concerned department reviews that :

The requirements could be met including requirements for delivery and post-delivery activities.
Any statutory and regulatory requirements applicable for the product/services.
Any other requirements to be considered, are not specified by the customer.
Acceptance criteria for the products are defined
Any difference in order requirements from previously expressed ones.

Record is maintained for the results of review of contracts.

5.1.2 Determination of Requirements

XXX determines:

Requirements specified by the customer;
Legal and other applicable requirements; and
Requirements not stated by the customer but considered necessary by XXX for the provision of the product.

Where the customer provides no documented statement of the requirements, the customer requirements are confirmed by the XXX and records are maintained.

5.1.3 Review of Requirements

XXX reviews the requirements related to provision of products. This review conducted prior to XXX commitment to deliver product to the customer and ensures that:

Requirements are identified and documented;
Requirements differing from those previously identified are resolved; and
XXX has the capability to meet the documented requirements.

Where contract requirements are changed, XXX ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements. Records of the results of the review, including resulting actions, are maintained.

5.2 PLANNING

Operational planning is carried out by Individual departments of XXX so that customer requirements are met. The Planning cover:

Requirements of product/services to be provided.
Processes, documents / documented information and resources needed for the product & services
Verification, inspection and measurement activities as applicable.
Acceptance criteria for the products

Delivery schedule is prepared at the quotation stage including service requirements if any. The schedule for delivery and services are monitored to identify and plan the processes and documents needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the Quality Management System (Refer 4.1.4). In planning, XXX addresses the following:

Required resources and work environment management (Refer 4.3);
Product and customer-specified requirements (Refer 5.1);
Legal and other applicable requirements;
Contingencies based on risk assessment (Refer Risk Assessment and Management) and (Refer Contingency Plan);
Design and development requirements (Refer to Design & Development);
Required verification, validation, monitoring, measurement, inspection, and test activities specific to the product and the criteria for product acceptance;
Management of change (MOC) (Refer Management of Change) and
Records needed to provide evidence that the product realization processes meet requirements.

The output of planning is documented and updated as changes occur. The plans are maintained in a structure suitable for XXX method of operations.

Product realization planning

Product realization planning includes, as applicable:

Definition and evaluation of manufacturing operations and process
Development of adequate and capable process
Identification of special process
Consideration of associated risks and consequences
Establishment and implementation of appropriate process control measures
Development of instructions and training for process operators, and
Requirements for records necessary to demonstrate process conformity
Product realization plans are established in collaboration between Marketing, Production, Engineering, and Quality Assurance. The plans are defined in various types of production documents, such as production work orders, operator instructions, etc.,
QMS Procedures related to Control of Production and Operations; explain how outputs of product realization planning are used.

Product verification and validation planning

Product verification and validation plans determine the inspection and testing program for a product, and for materials that are incorporated into the product. This includes:

Identification of inspection and testing points
Inspection and testing scope, frequency, and method
Acceptance criteria, and
Requirements for records necessary to demonstrate product conformity

5.3 RISK MANAGEMENT

5.3.1 General

All Department heads have identified risks for individual processes and controls are developed for all the identified risks. The risks and the issues are addressed with a view to

enhance desirable effects
reduce or prevent undesired effects
achieve improvements

The control actions are implemented considering the potential impact on the conformity of products and services. Actions taken to address the risks and issues are regularly monitored by MR & Department Heads for strict implementation. The department heads maintain the risks, issues and controls thereof as Documented Information. Opportunities for achieving desired improvements are identified by the Department heads and implemented to the extent possible. The results of such implementations are reviewed and achieved improvements are assessed. XXX maintains a documented procedure (Risk Assessment and Management) to identify and control risks associated with impact on the delivery and quality of the product. The procedure identifies the techniques, tools and their application for risk identification, assessment, and mitigation.

5.3.2 Risk Assessment

5.3.2.1 Product Delivery

Risk assessment associated with product delivery includes:

Facility/equipment availability and maintenance; and
Supplier performance and material availability/supply.

5.3.2.2 Product Quality

Risk assessment associated with product quality includes, as applicable:

Delivery of nonconforming products;
Availability of competent personnel.

Records of risk assessment and management including actions taken and maintained

5.3.2.3 Changes Impacting Product Quality

Should any of the below alterations adversely affect the product’s quality, a risk assessment concerning product quality will be conducted by XXX:
a) modifications to the XXX’s structure;
b) shifts in crucial staff members;
c) changes in the supply chain for essential products, components, or processes;
d) adjustments to the scope or methods of the management system;
e) modifications affecting the organization’s ability to execute necessary processes for product realization.
These changes may stem from internal or external sources.

5.3.3 Contingency Planning

XXX maintains a documented procedure for Contingency Planning and needs to address Risks associated with the impact on the delivery and quality of the product. Contingency planning is based on assessed risks, and output is documented, communicated to the relevant personnel, and updated as required. The contingency plan includes, at a minimum:

Necessary actions in response to significant risk scenarios to mitigate effects of disruptive incidents;
Identification and assignment of responsibilities and authorities; and
Internal and external communication controls.

5.3.4 Records

Records of risk assessment and management including actions taken are maintained

5.4 DESIGN

5.4.1 General

As XXX is responsible for the design of products, the requirements of 5.4 shall apply.

5.4.1 Design Planning

XXX maintains a documented procedure (Procedure for Design to Plan) and controls the design and development of the product. The procedure identifies:

The plan(s), including plan updates, used for design.
The design stages;
The resources, responsibilities, authorities, and their interfaces;
The review, verification, and validation activities necessary to complete each design stage;
The requirements for a final review of the design.

When design activities are performed at different locations within XXX, the procedures identify the controls required to ensure that the requirements of designs are met. When design and development are outsourced, XXX ensures the supplier meets the requirements of Outsources given in 5.5.1.7.

5.4.3 Design Inputs

Inputs are identified and reviewed for adequacy, completeness, and lack of conflict. Inputs include functional and technical requirements, and the following, as applicable:

Customer-specified requirements;
Requirements provided from external sources, including API product specifications;
Environmental and operational conditions;
Methodology, assumptions, and formulae documentation;
Historical performance and other information derived from previous similar designs;
Legal requirements; and
Results from risk assessments (Risk Assessment and Management).

Records of design inputs are maintained.

5.4.4 Design Outputs

Outputs are documented to allow verification against the design input requirements.

Outputs:

Meet the input requirements for design;
Provide appropriate information for purchasing, production, and service;
Identify or reference design acceptance criteria (DAC);
Include identification of, or reference to, products, components and /or activities deemed critical to the design;
Include results of applicable calculations; and
Specify the characteristics of the product that are essential for its safe and proper use.

Records of design outputs are maintained.

5.4.5 Design Review

At suitable stages, review performed:

To evaluate the suitability, adequacy, and effectiveness of the results of design stages to meet specified requirements; and
To identify any problems and propose necessary actions.

Participants in such reviews include representatives of functions concerned with the design stages being reviewed. Records of the results of the reviews and any necessary actions are maintained.

5.4.6 Design Verification and Final Review

To ensure that the design, and outputs have met the design input requirements, design and development verification and a final review are conducted and documented by planned arrangements Records of design verification and the final review are maintained.

5.4.6 Design Validation and Approval

Design validation is performed by planned arrangements to ensure that the resulting product is capable of meeting the specified requirements. Validation is completed before the delivery of the product, when possible. The completed design is approved after validation. Competent individuals other than the person or persons, who developed the design, approve the final design. Records of the design validation, approval, and any necessary actions are maintained

5.4.7 Design Changes

Design changes are identified. The changes are reviewed, verified, and validated, as appropriate, and approved before implementation. The review of design changes includes an evaluation of the effect of the changes on the product and/or their constituent parts already delivered. Design changes, including changes to design documents, require the same controls as the original design and development. Records of design changes, reviews of those changes, and any necessary actions are maintained.

5.5 PURCHASING

5.5.1 Purchasing Control

5.5.1.1 Procedure

Products and services provided by external providers are directly delivered to the customers on behalf of XXX. The external providers of products and services for XXX are client / consultant-approved suppliers, with whom agency agreements are made. External providers for IT services are selected by the IT department based on credentials and experience.

XXX maintains a documented procedure (Refer to Control of Externally provided products/Services) to ensure that purchased products, components or activities conform to specified requirements. The procedure address:

Identification of critical products, components or activities;
Initial evaluation and selection of suppliers based on their ability to supply products, components or activities by the XXX requirements;
Type and extent of control applied to the supply chain for critical products, components or activities;
Criteria, scope, frequency, and methods for reassessment of suppliers;
Maintaining a list of approved suppliers and scope of approval; and
Type and extent of control to be applied to outsourced activities.

5.5.1.2 Initial Supplier Evaluation – Critical Purchases

For the purchase of critical products, components or activities, the initial evaluations of suppliers by XXX are site-specific for each supplier and include the following:

Verification that the supplier’s Quality Management System conforms to the quality system requirements specified for suppliers by XXX; and
Verification of the type and extent of control applied by the supplier, internally and to their supply chain, to meet XXX requirements; and
Assessment of the supplier to ensure its capability to meet the XXX specified requirements by one or more of the following:
- Performing an on-site evaluation of relevant activities, or
- Performing first article inspection to ensure conformance to stated requirements, or
- Identifying how the supplied product, component or activity conforms to stated requirements when limited by proprietary, legal, and/or contractual arrangements.

5.5.1.3 Initial Supplier Evaluation – Critical Purchases – Customer Specified, Proprietary, and/or Legal Limited

For the purchase of critical products, components, or activities where the supplier is specified by the customer or involves proprietary and/or legal requirements that limit the application of 5.5.1.2, the initial evaluation of XXX includes the verification of the supplier’s quality management system implementation and conformity to quality system requirements specified for suppliers by the organization and/or the customer’s requirements; and identifying how the supplied product, component or activity conforms to specified requirements.

5.5.1.4 Initial Supplier Evaluation – Noncritical Purchases

For the purchase of noncritical products, components, or activities that impact product realization or the final product, the criteria for evaluation of suppliers by XXX meet the requirements of Refer 5.5.1.2 or satisfy one or more of the following:

Verification that the supplier’s Quality Management System conforms to the Quality system requirements specified for suppliers by the XXX; or
Assessment of the supplier to meet the XXX purchasing requirements; or
Assessment of the product or component upon delivery, or activity upon completion.

5.5.1.5 Supplier Re-evaluation

XXX determines the supplier re-evaluation frequency based on supplier risk and supplier quality performance. For the re-evaluation of suppliers of critical products, components or activities, the requirements of Refer 5.5.1.2 apply. For the re-evaluation of suppliers of non-critical products, components or activities, the requirements of Refer 5.6.1.4 apply.

5.5.1.6 Records

Records of the results of all evaluations including objective evidence and any necessary actions arising from the evaluations will be maintained. Records of identification of approved suppliers, customer-specified suppliers, and suppliers limited by proprietary, and/or legal requirements will be maintained

5.5.1.7 Outsourcing

Where XXX chooses to outsource any activity within the scope of its Quality Management System, XXX ensures that all applicable elements of its Quality Management System are satisfied and maintains the responsibility for product conformance to specified requirements, including applicable API product specifications, associated with product realization. For the workshop, the calibration of equipment is outsourced to an external calibration agency. Transportation/delivery of products is often outsourced if necessary. The performance of the outsourced agencies is monitored and controlled. Records of outsourced activities are maintained.

5.5.2 Purchasing Information

After confirmation of orders by the customer, specifications of products, quantity, terms & conditions, etc. are communicated to the external providers in the Purchase Order. It includes prior approved products/services. Requirements of competence and qualification of personnel as appropriate ( in case of post-delivery installations, maintenance etc. )are specified when services are needed to be provided.

XXX ensures the adequacy of specified purchasing information before their communication with the supplier. Purchasing information provided to the supplier documented and adequately described the product or activity to be purchased, including acceptance criteria, and where appropriate:

Requirements for approval of supplier’s procedures, process, and equipment;
Applicable version of specifications, drawings, process requirements, inspection instructions, traceability, and other relevant technical data;
Requirements for qualification of supplier’s personnel; and
Quality Management System Requirements.

5.5.3 Verification of Purchased Products, Components or Activities

5.5.3.1 General

Controls are applied at their selection and post-delivery performance (output) stages as follows:

External Providers are selected based on their credentials, capability to meet the requirements of the concerned products/services and their record of supply.
The performance of external providers is monitored based on the quality of the products & services supplied and delivery commitments. Records of their evaluations are maintained.
Verification/inspection of products & services is done to ensure that products/services meet the requirements.

XXX maintains a documented procedure (Refer Verification of Purchased Products and Activities) for the verification or other activities necessary for ensuring that purchased products, components or activities meet specified purchase requirements.

5.5.3.2 Critical Purchases

For critical products, components or activities, the procedure addresses the following:

Review of XXX required documentation from the supplier; and
Verification that the applicable versions were used when specifications, drawings, process requirements, inspection instructions, traceability, and other relevant technical data are specified.

Additionally, for critical products and components, the procedure includes requirements for the testing or inspection methods, frequency and responsible party for these activities. The requirements are based on risk associated with supplier product quality. Where XXX or its customer intends to perform verification at the supplier‘s premises, XXX states the intended verification arrangements and method of product release in the purchasing information. XXX ensures and provides evidence that purchased products and activities conform to specified requirements.

5.5.3.3 Noncritical Purchases

All Noncritical products, components or activities are verified as per the XXX’s documented procedure.

5.5.3.4 Records

XXX maintains records of verification activities and evidence of conformity to specified requirements.

5.6 Control of Product Realization

5.6.1 General

The activities of XXX are carried out under controlled conditions. Controlled conditions include:

Availability of documented information describing product characteristics and services to be provided and the results to be achieved.
Availability and use of suitable monitoring and measuring resources.
Implementation of monitoring and measurement activities at appropriate stages to verify outputs and that the acceptance criteria are met.
Engaging competent persons, with requisite qualification and experience for servicing & inspection activities.
Implementation of release, delivery and post delivery activities.
Validation to achieve planned results where the resulting outputs cannot be verified by monitoring and measurement. Such process may include
supply of alignment systems and monitoring systems whose functions can be validated over a period of their functioning.
Special processes such as painting / coating required in servicing.

Concerned engineer obtains feedback from customer for validation.

Production

XXX maintains a documented procedure that describes controls associated with the production of products. The procedures address the following:

The availability of information that describes the characteristics of the product;
Implementation of the product quality plan, when applicable;
Ensuring design requirements and related changes are satisfied, when applicable;
The availability and use of suitable production, testing, monitoring, and measurement equipment;
The availability of work instructions, when applicable;
Process control documents;
Implementation of monitoring and measurement activities; and
Implementation of product releases, including applicable delivery and post-delivery activities.

Servicing

XXX maintains a documented procedure (Control of Servicing) that describes controls associated with the Servicing of products. The procedures address the following:

Review and implementation of the XXX customer-specific, product servicing, and other servicing requirements;
The availability and use of suitable Servicing, testing, monitoring, and measurement equipment;
The availability of work instructions, when applicable;
Ensuring identification and traceability requirements are maintained throughout the Service process;
The implementation of monitoring and measurement activities;
Process control documents ; and
Requirements for release of the product that was serviced.

5.6.2 Quality Plan

When required by contract, XXX develops a quality plan that specifies the processes of the Quality Management System (including the product realization processes) and the resources to be applied to a product. The Quality Plan required by contract are address each of the following as a minimum:

Description of the product to be manufactured;
Required processes and documentation, including required inspections, tests, and records, for conformance with requirements;
Identification and reference to control of outsourced activities;
Identification of each procedure, specification, or other document referenced or used in each activity; and
Identification of the required hold, witness, monitor, and document review points.

These quality plans and any revisions to them are documented and approved by the XXX to ensure customer requirements are met. These Quality Plans and any revisions will be communicated to the customer.

5.6.3 Process Control Documents

Process controls are documented in routings, travellers, checklists, process sheets, or equivalent controls required by XXX and include requirements for verifying conformance with applicable quality plans, API product specifications, customer requirements, and/or other applicable product standards/codes. The process control documents includes, reference instructions and acceptance criteria for process, tests, inspections, and required customer’s inspection hold or witness points. XXX maintains documents of process control.

XXX develops and maintains the documentation that includes but is not limited to product realization plans and records of review/verification, validation, monitoring, measurement, inspection, and test activities, including criteria for product acceptance that demonstrates the capability of XXX to satisfy specified product and/or Service requirements.

5.6.4 Validation of Processes

XXX validate processes for production and Servicing where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequence, deficiencies become apparent only after the product is in use or the Service has been delivered. (Validation of Process for Production and Service) Validation demonstrates the ability of these processes to achieve planned results. Where an XXX chooses to outsource a process that requires validation, XXX requires that the supply chain conform to these requirements.

XXX maintains a documented procedure to address methods for review and approval of the process including:

Required equipment;
Qualification of personnel;
Use of specific methods, including identified operating parameters;
Identification of acceptance criteria;
Requirements for records; and
Revalidation.

XXX validates those processes identified by the applicable product specification as requiring validation. If these processes are not identified, or there is no product specification involved, the process requiring validation (if applicable to the product) include, as a minimum;

Non-destructive examination;
Welding;
Heat treating; and
Coating & Plating (when identified as critical to product performance by product specification or by XXX

5.6.5 Identification and Traceability

All material received from external providers are appropriately identified by description and product codes before delivery to customers. For repair /servicing, identification tags are put showing Job number, customer ID. Customer Log is maintained job wise which enables traceability of the products. Where traceability is a requirement, unique identification of the outputs are done and documented information is retained to enable traceability. XXX maintains a documented procedure (Refer Identification and Traceability) for identification and traceability while the product is under control of XXX as required by the XXX, the customer, and/or the applicable product specifications throughout the product realization process, including applicable delivery and post-delivery activities. The procedure includes requirements for maintenance or replacement of identification and/or traceability marks. Records of identification and traceability are maintained.

5.6.6 Inspection/Test Status

XXX maintains a documented procedure (Refer Product Inspection/Test Status) for the identification of product inspection and/or test status throughout the product realization process that indicates the conformity or nonconformity of product with respect to inspections and/or tests performed. XXX ensures that only product that meets requirements or that is authorized under concession is released.

5.6.7 Externally Owned Property

XXX is committed to the protection the External provider and customer while it is under the custody of XXX or in use. Such properties include :

Products supplied by customers for repair/servicing. A Log is maintained for the products.
Customer drawings/sketches, specifications etc. These are kept in safe custody. Soft copies if any are maintained with appropriate access controls.
Manuals provided by equipment suppliers. These are kept in cabinets for reference.
External providers’ supplied products are preserved in stores till delivery. Records maintained on receiving the items and also inspection & delivery records maintained.

In case of any damage or deterioration of customer/external provider’s property takes place, it is immediately informed by the Dept. Head and further actions are taken in consultation with the customer/ external provider. Records of such communication are maintained. XXX maintains a documented procedure (Refer to Customer or External Provider’s Property) for the identification, verification, safeguarding, preservation, maintenance, and control of customer-supplied property, including intellectual property and data, while under the control of the XXX. The procedures include requirements for reporting to the customer any loss, damage, or unsuitability for use of the customer-supplied property. Records for the control and disposition of customer-supplied property maintained.

5.6.8 Preservation of Product

All products are appropriately identified and stored to ensure their conformity. The concerned department head is responsible for appropriate storage conditions. Where necessary, the original Packaging of the products as received, is kept till delivery or consumption. Chemicals (such as paints, and thinners ) & welding consumables are preserved in the workshop as per Material Safety Data Sheet provided by suppliers. All items are kept in a safe place. Where preservation requirement is agreed with the Customer or where found necessary, the same is followed.

XXX maintains a documented procedure (Refer to Preservation of Product) describing the methods used to preserve the product and constituent parts throughout product realization and delivery to the intended destination to maintain conformity to requirements. As applicable, preservation includes identification and traceability marks, transportation, handling, packaging, and protection.

Storage and Assessment

The procedure identifies the requirements for storage and assessment. XXX uses designated storage areas or stock rooms to prevent damage or deterioration of products, pending use or delivery. To detect deterioration, the condition of product or constituent parts in stock is assessed at specified intervals identified by the procedure. The interval is appropriate to the products or constituent parts being assessed. Records of the results of assessments are maintained.

5.6.9 Inspection, Testing, and Verification

5.6.9.1 General

XXX maintains a documented procedure (Refer Inspection and Testing) for inspection and testing to verify that product requirements have been met. The procedures include requirements for in-process inspection, testing, and/or verification methods and their application. It also includes requirements for final inspection, testing, and/or verification methods and their application. Records of required inspection and testing are maintained per documented procedures.

5.6.9.2 In-process Inspection, Testing, and Verification

XXX inspects, tests or varifies the product at planned stages as required by the Quality Plan, process control documents, and documented procedures. Evidence of conformity with the acceptance criteria is maintained.

5.6.9.3 Final Inspection, Testing, and Verification

XXX performs all final inspection and testing or verification by the product Quality Plan and 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 perform final acceptance inspection at planned stages of the product realization process.

5.6.9.4 Records

XXX maintains the records of all required inspection, testing, verification, and final acceptance.

5.6.10 Preventive Maintenance

XXX maintains a documented procedure (Preventive Maintenance) for the establishment of preventive maintenance for equipment used in product realization. The procedures identify requirements for:

Type of equipment to be maintained;
Frequency; and
Responsible personnel.

Records of preventive maintenance are maintained.

5.7 Product Release

XXX maintains a documented procedure (Refer Product Release) to ensure release of the product to the customer does not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority (QA/QC Engineer in XXX) and, where applicable, by the customer. Records are maintained to enable identification of the individual releasing the product.

Post-delivery activities

Post-delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services and supplementary services such as recycling or final disposal. Where required in the contract, XXX carries out post-delivery activities which are usually services during the warranty period. Services are carried out by the equipment suppliers except for some batteries and UPS for which services are done by XXX internally. All services are monitored by the concerned dept. and service records are kept with feedback from customers. After servicing / repairs of equipment at the workshop, periodic maintenance or servicing ( in the warranty period) is done if required in the contract. A record of services is maintained.

5.8 Testing, Measuring, Monitoring, and Detection Equipment (TMMDE)

5.8.1 General

XXX determines the testing, detecting, monitoring, and measurement requirements and the associated equipment needed to provide evidence of conformity to those requirements. All TMMDE owned and maintained by XXX, employee-owned equipment, and TMMDE from other sources (e.g. third-party, proprietary, and customer-owned) used to provide evidence of product conformity and monitor process parameters are controlled. TMMDE are to be calibrated at specified intervals. When the specified interval is based on the date of first use, the date of first use is documented.

5.8.2 Procedure

XXX maintains a documented procedure (Refer Control of Testing, Measuring, and Monitoring Equipment) in order to ensure that testing, measurement, and monitoring equipment is calibrated and maintained and that the equipment is used in a manner that is consistent with monitoring and measurement requirements. The procedures include requirements for the specific equipment type that address:

Unique identifier;
Calibration status;
Equipment traceability to international or national measurement standards; where no such standards exist, the basis used for calibration or verification is recorded
Frequency of calibration, at specific intervals or prior to use;
Calibration or verification method, including adjustments and readjustments, as necessary;
Acceptance criteria;
Control of equipment identified as out-of-calibration in order to prevent unintended use; and
When the equipment is found to be out of calibration, an assessment of the validity of previous measurements and actions to be taken on the equipment and product, including maintaining records and evidence of notification to the customer if the suspect product has been shipped.

5.8.3 Equipment

Testing, measuring, and monitoring equipment:

Are calibrated or verified, or both, against measurement standards;
Have the calibration status identifiable by the user for the activities being performed at all times;
Are safeguarded from adjustments that would invalidate the measurement result or the calibration status;
Are protected from damage and deterioration during handling, maintenance, and storage; and
Are used under environmental conditions that are suitable for the calibrations, inspections, measurements, and tests being carried out.

When used in the testing, monitoring, or measurement of specified requirements, the ability of computer software to satisfy the intended application is confirmed prior to initial use and reconfirmed as necessary.

5.8.4 TMMDE Equipment from Other Sources

When the equipment is provided from a source external to the XXX, including third-party, proprietary, employee – and customer-owned equipment, XXX verifies that the equipment is suitable and provides evidence of conformity to the requirements of this section. XXX maintains a registry of the required testing, measurement and monitoring equipment used to determine product conformity to requirements that includes a unique identification, specific to each piece of equipment.

5.8.5 Records

XXX maintains a registry of the TMMDE includes a unique identification, specific to each piece of equipment. Records of the results of calibration are maintained. If calibration of the third-party, proprietary, and customer TMMDE is limited by customer, contract, or licensing agreement, the organization shall maintain records of the limitations imposed.

5.9 Control of Nonconforming Product

5.9.1 Procedure

5.9.1.1 General

XXX identifies and controls the nonconforming products and services to prevent their unintended use or delivery. It is applicable also if non-conforming products/services are detected after delivery. XXX maintains a documented procedure (Refer-Control of Nonconforming Products) to identify the controls and related responsibilities and authorities for addressing nonconforming products. Non-conforming outputs are dealt with in one or more of the following ways:

Corrections of the faults identified (of minor nature )
Segregation and re-work of the products/services
Obtaining replacement through the product supplier (for products received).
Obtaining authorization from customers for acceptance

Corrective actions are taken to prevent the recurrence of the non-conformity. After corrections are done, conformity to the requirements is verified. Records are maintained for the non-conformances, showing:

Description of non-conformity
Description of the actions taken
Any concessions obtained.
Authority deciding the corrections & corrective actions.

5.9.1.2 Nonconforming Product During Product Realization

XXX maintains a documented procedure(s) (Refer-Control of Nonconforming Products) to identify the controls and related responsibilities and authorities for addressing nonconforming products. The procedure for addressing nonconforming products identified during product realization includes controls for:

Product identification to prevent unintended use or delivery;
Addressing the detected nonconformity;
Taking action to preclude its original intended use or delivery; and
Authorizing its use, release, or acceptance under concession by the relevant authority and, where applicable, by the customer.

5.9.1.3 Nonconforming Product After Delivery

The procedure for addressing nonconforming products identified after delivery includes controls for:

Identifying, documenting, and reporting non-conformances or product failures identified after delivery;
Ensuring the analysis of product non-conformance or failure, provided the product or documented evidence supporting the nonconformity is available to facilitate the determination of the cause (Refer 6.4.2);
Taking action appropriate to the effects, or potential effects, of the non-conformance when a non-conforming product is detected after delivery.

5.9.2 Nonconforming Product

XXX addresses the nonconforming products by performing one or more of the following:

Repair or rework with subsequent inspection to meet specified requirements;
Re-grade for alternative applications;
Release under concession (Refer 5.10.3); and/or
Reject or scrap.

5.9.3 Release of Nonconforming Product Under Concession

The evaluation and release under concession of the non-conforming product that does not satisfy manufacturing acceptance criteria (MAC) permitted when the XXX relevant authority and the customer (where applicable) have authorized the release provided that:

Products continue to satisfy the applicable DAC and/or customer criteria; or
The violated MAC are categorized as unnecessary to satisfy the applicable DAC and/or customer criteria; or
The DAC are changed and the products satisfy the revised DAC and associated MAC requirements.

5.9.4 Customer Notification of Nonconforming Product

XXX notifies customers of products not conforming to DAC or contract requirements, which has been delivered. XXX maintains records of such notifications.

5.9.5 Records

Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained are maintained. The Records includes

the description of the nonconformity;
subsequent actions taken, including concessions obtained;
rationale to support the release of the product under concession; and
relevant authority.

5.10 MANAGEMENT OF CHANGE (MOC)

5.10.1 General

Changes in the product/ service requirements if any are reviewed by the concerned department. The Results of the review and any actions needed are recorded and approved by the department head ensuring conformity with the requirements. XXX maintains a process (Refer to Management of Change) for MOC. XXX ensures that the integrity of the Quality Management System is maintained when changes to the Quality Management System are planned and implemented. For MOC, XXX identifies the potential risks (Refer Risk Assessment and Management) associated with the change and any required approvals prior to the introduction of such changes. XXX maintains the records of MOC activities (Refer to Control of Records). The MOC procedure shall address:

description of, and the need for, the change;
availability and allocation of resources (including personnel);
potential risks that may arise from implementing the change;
review, approval, and implementation of the change;
notifications
verification of the completion of MOC activities and impact on the QMS.

5.11.2 MOC Application

XXX uses the MOC process for any of the following that may negatively impact the quality of the product:

Changes in the organizational structure;
Changes in essential personnel;
Changes in suppliers of critical products, components or activities; and/or
Changes to the management system procedures, including changes resulting from corrective and preventive actions.

5.11.3 MOC Notification

XXX notifies relevant personnel, including the customer when required by contract, of the change and residual or new risk due to changes that have either been initiated by XXX or requested by the customer.

6.0 QUALITY MANAGEMENT SYSTEM MONITORING, MEASUREMENT, ANALYSIS AND IMPROVEMENT

6.1 GENERAL

XXX has planned and implemented the monitoring, measurement, analysis and evaluation processes needed:

to demonstrate conformity of the product,
to ensure conformity with the quality management system, and
to continually improve the effectiveness of the quality management systems.

Documented information is maintained for monitoring, measurement, analysis and evaluation, which includes customer satisfaction, meeting the planned time frame for services, complaints, the effectiveness of the actions taken on risks & opportunities, and the performance of external providers. Measurement and analysis are performed at least once a year. XXX plans and implements the monitoring, measurement, analysis, and improvement process needed to ensure conformity of the Quality Management System to the requirements of this specification and to continually improve the effectiveness of the Quality Management System. Quality Management System Monitoring, Measurement, Analysis, and Improvement include the determination of applicable methods, including techniques for the analysis of data, and the extent of their use.

Process Evaluation

XXX applies suitable evaluation methods to demonstrate the ability of the Quality Management System processes to achieve planned results, including conformity to product requirements. When planned results are not achieved, correction and corrective actions are taken, as appropriate.

6.2 MONITORING, MEASURING, AND IMPROVING

6.2.1 Customer Satisfaction

As one of the performance of quality management systems, the Organization monitors information relating to customer perception as to whether the Organization has met customer requirements. XXX is performing regular customer surveys by using a customer feedback form. Customer feedbacks are reviewed by GM and analysis of customer feedback is presented and discussed during management reviews where the needful corrective and preventive actions can be initiated. Where feedbacks are not received such as from ministries and oil sectors, customer perception is evaluated based on performance such as timely delivery and complaints if any. Customer complaints are considered very vital for improving XXX’s performance. They are recorded and handled as per the documented mechanism of Corrective and Preventive Procedure. XXX maintains a documented procedure (Refer-Customer Satisfaction) to measure customer satisfaction. The procedure addresses the frequency of measurement, obtaining customer feedback, key performance indicators (KPIs), and other information that XXX uses to determine whether XXX has satisfied customers in meeting identified requirements. Records of the results of customer satisfaction information are maintained.

6.2.2 Internal Audit

6.2.2.1 General

The organization conducts internal audits at planned intervals to determine whether the quality management system conforms to the planned arrangements, to the requirements of ISO 9001 and to the quality management system requirements established by the Organization, and that it is effectively implemented and maintained. An audit program is planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency, and methods are defined through documented procedures and relevant records. Selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process. Auditors do not audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and retaining documented information are defined in a documented procedure. The management responsible for the area being audited ensures that corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of actions taken and the reporting of verification results. Documented information is retained by the Management Representative as evidence of the implementation of audit programs and audit results. Results of internal audits are reported to the higher management in review meetings. XXX maintains a documented procedure (Refer to internal Audit) to define responsibilities for planning, conducting, and documenting internal audits. Audits verify that the Quality Management System is effectively implemented and maintained and conforms to the requirements of this specification. The planning of internal audits takes into consideration the results of previous audits and the criticality of the process being audited. XXX identifies the audit criteria, scope, frequency, and methods to ensure that all processes of the Quality Management System claiming conformity to the requirements of this specification are audited at least every 12 months. Outsourced activities that impact the quality of the product and that are performed at the XXX facility are included as part of the internal audit of the XXX.

6.2.2.2 Performance of Internal Audit

Audits 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. Records of the audits provide objective evidence that the Quality Management System is implemented and maintained. All processes of the Quality Management System required to meet this specification are audited before claiming conformance to the requirements of this specification.

6.2.2.3 Audit Review and Closure

XXX identifies response times for addressing detected nonconformities. The management responsible for the area being audited ensures that any necessary corrections and corrective actions follow the requirements of corrective action. The results of internal audits and the status of corrective actions are reported in the management review. Records of internal audits are maintained.

6.3 Analysis of data

Individual department heads analyse and evaluate data and information generated from customer feedback, complaints, service reports, and supplier evaluation records, achievement of quality objectives, risks & opportunities. Needs for improvements are identified based on the analysis and evaluation. XXX maintains a documented procedure (Refer Analysis of Data) for the identification, collection, and analysis of data to demonstrate the suitability and effectiveness of the Quality Management System. The analysis includes data generated from monitoring and measurement, internal audits, management reviews, and other relevant sources.

The data analysis output provides information relating to:

Customer satisfaction;
Conformity to product requirements;
Nonconformities and product failures identified after delivery or use, provided the product or documented evidence is available to facilitate the determination of the cause;
Characteristics and trends of processes and products including opportunities for preventive action;
Supplier Performance; and
Quality Objectives.

XXX uses data to evaluate where continual improvement of the effectiveness of the Quality Management System can be made.

6.4 IMPROVEMENT

6.4.1 General

Management of XXX determines opportunities for improvements and implements necessary actions thereof. These include:

Improvement in the products & services for meeting the requirements effectively and also considering future needs and expectations.
Implementing corrective actions and preventive measures to eliminate or reduce undesired effects.
Improving performance and effectiveness of quality management system.

XXX 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.

Continual Improvements

XXX continually improves the suitability, adequacy and effectiveness of the quality management system through analysis, evaluation and outputs of Management Review and determines any need for opportunity for continual improvement.

6.4.2 Corrective Actions

XXX takes actions to eliminate the causes of non-conformities including complaints to prevent recurrence. The corrective actions taken are appropriate to the effect of non-conformities encountered and their consequences. XXX maintains a documented procedure (Refer Corrective Action) to correct nonconformities and to take corrective actions, both internally and with suppliers, to eliminate the causes of nonconformities to minimize the likelihood of its recurrence. Corrective actions are appropriate to the effect(s) of the nonconformity encountered. The procedures identify requirements for:

Reviewing a process nonconformity (including customer complaints);
Determining and implementing corrections;
Identifying the root cause of the nonconformity and evaluating the need for corrective actions;
Implementing corrective action to reduce the likelihood that nonconformity recurs;
Identifying the timeframe and responsible person(s) for addressing corrections and corrective action;
Verification of the effectiveness of the corrections and corrective action taken; and
MOC, (Refer 5.11) when the corrective actions require new or changed controls within the Quality Management System.

Records of the activities for control of a nonconforming process are maintained. Records identify the activities performed to verify the effectiveness of the corrective actions taken.

6.5 MANAGEMENT REVIEW

6.5.1 General

Top management of XXX reviews the Organization’s quality management system annually, to ensure its continuing suitability, adequacy, and effectiveness. This review includes assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Management Review minutes are generated as documented information and distributed to all concerned for review and necessary actions.

XXX’s Quality Management System is reviewed at least every 12 months by the XXX management to evaluate the continuing suitability, adequacy, and effectiveness. This review includes assessing opportunities for improvement and the need for changes to the Quality Management System, including the Quality Policy and Quality Objectives (Refer to Management Review).

6.5.2 Input Requirements

The input to Management Review includes, as a minimum:

Effectiveness of actions resulting from previous management reviews;
Results of audits;
Changes that could affect the Quality Management System, including changes to legal and other applicable requirements (such as industry standards);
Analysis of customer satisfaction, including customer feedback;
Process performance
Results of Risk Assessment (Refer to Risk Assessment and Management)
Status of corrective actions;
Analysis of supplier performance;
Review of the analysis of product conformity, including nonconformities identified after delivery or use (Refer to Control of Nonconforming Products) and
Recommendations for improvement.

6.5.3 Output Requirements

The output from the management review includes a summary assessment of the effectiveness of the Quality Management System. The assessment includes any required changes to the processes and any decisions and actions, required resources, and improvement to products in meeting customer requirements. Top management reviews and approves the output of management reviews. Management reviews are documented and records of these reviews are maintained.

7.0 API MONOGRAM PROGRAM REQUIREMENTS

ANNEX A – API Spec Q1, 10^th EDITION

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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 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, 1220 L Street, NW, Washington, DC 20005 or call 202-682-8145 or by email at certification@api.org.

A.2 Normative References

API Q1, Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry

A.3 Terms and Definitions

For purposes of this annex, the following terms and definitions apply.

A.3.1 API monogrammable product

Product that has been manufactured by an API Licensee utilizing a fully implemented API Q1 compliant quality management system and that meets all the API-specified requirements of the applicable API product specification(s) and/or standard(s).

A.3.2 API product specification

Prescribed set of rules, conditions, or requirements attributed to a specified product that address the definition of terms; classification of components; delineation of procedures; specified dimensions; manufacturing criteria; material requirements, performance testing, design of activities; and the measurement of quality and quantity with respect to materials; pr XXX takes actions to eliminate the causes of non-conformities including complaints to prevent recurrence. The corrective actions taken are appropriate to the effect of non-conformities encountered and their consequences. products, processes, services, and/or practices.

A.3.3 API-specified requirements

Requirements, including performance and Licensee-specified requirements, outlined in API Q1 and the applicable API product specification(s) and/or standard(s).

NOTE Licensee-specified requirements include those activities necessary to satisfy API-specified requirements.

A.3.4 Design package

Records and documents required to provide evidence that the applicable product has been designed in accordance with API Q1 and the requirements of the applicable product specification(s) and/or standard(s).

A.3.5 Licensee

Organization that has successfully completed the application and audit process and has been issued a license by API

A.4 Quality Management System Requirements

An organization applying the API Monogram to products shall develop, maintain, and operate at all times a quality management system conforming to API Q1.

A.5 Control of the Application and Removal of the API Monogram

XXX shall control the application and removal of the API Monogram in accordance with the following:

Products that do not conform to API-specified requirements shall not bear the API Monogram.
XXX shall develop and maintain an API Monogram marking procedure that documents the marking/monogramming requirements specified by this annex and any applicable API product specification(s) and/or standard(s). The marking procedure (Refer API Monogram marking procedure):
- Defines the authority responsible for application and removal of the API Monogram
- Defines the method(s) used to apply the Monogram
- Identifies the location on the product where the API Monogram is to be applied;
- Requires the application of the Licensee’s license number and date of manufacture of the product in conjunction with the use of the API Monogram;
- Requires that the date of manufacture, at a minimum, be two digits representing the month and two digits representing the year (e.g. 05-12 for May 2022) unless otherwise stipulated in the applicable API product specification(s) or standard(s)
- Requires controls for the application of the additional API product specification(s) and/or standard(s) marking requirements, as applicable.
Only an API Licensee shall apply the API Monogram and its designated license number to API monogrammable products.
The API Monogram license, when issued, is site-specific and subsequently the API Monogram shall only be applied at that site specific licensed facility location.
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.

A.6 Design Package Requirements

Each Licensee and/or applicant for licensing shall maintain a current design package for all of the applicable products that fall under the scope of each Monogram license. The design package information shall provide objective evidence that the product design meets the requirements of the applicable and most current API product specification(s). The design package(s) shall be made available during API audits of the facility.

In specific instances, the exclusion of design activities is allowed under the Monogram Program, as detailed in Advisory #6, available on API Monogram Program website at http://www.api.org/advisories.

A.7 Manufacturing Capability

The API Monogram Program is designed to identify facilities that have demonstrated the ability to manufacture equipment that conforms to API specifications and/or standards. API may refuse initial licensing or suspend current licensing based on a facility’s level of manufacturing capability. If API determines that additional review is warranted, API may perform additional audits (at the organization’s expense) of any subcontractors to ensure their compliance with the requirements of the applicable API product specification(s) and/or standard(s).

A.8 API Monogram Program: Non-conformance Reporting

API solicits information on products that are found to be nonconforming with API-specified requirements, as well as field failures (or malfunctions), which are judged to be caused by either specification deficiencies or nonconformities with API-specified requirements. Customers are requested to report to API all problems with API monogrammed products. A non-conformance may be reported using the API Non-conformance Reporting System available at http://compositelist.api.org/ncr.asp.