API Q1 Specification for Quality Management System Requirements for Manufacturing Organizations for the Petroleum and Natural Gas Industry
The American Petroleum Institute (API) developed API Spec Q1 9th Edition specifically for manufacturing companies that provide products or services to the oil and gas industry. It’s one of the most prestigious company-based certifications that your organization can obtain to demonstrate its commitment to a sound quality management system. Furthermore, it allows your organization to meet the global demands of an increasingly competitive environment. For starters, ISO 9001:2015 is the basis for most (if not all) of the industry-specific quality management standards. It’s a flexible international standard that outlines the framework and guiding principles for quality management. Achieving ISO certification allows manufacturers to improve the quality of products or services while simultaneously lowering the cost of quality. On the other hand, API Spec Q1 9th Edition structurally deviates from the standard ISO 9001 series, but the results of a compliant quality management system are still the same. API Spec Q1 builds upon the classic structure of the ISO 9001 series by addressing risk and other QMS elements, but takes a different approach to quality management by bringing risk assessment and risk management into the fold. Additionally, there are some other key differences between ISO 9001 and API Q1, including:
- Formalizing employee competency and training
- Reinforcing risk assessment and risk management throughout the standard
- Contingency planning
- Controlling the supply chain
- Preventative maintenance
- Validation of designs
- Change management
API Monogram Licensing Program Requirements Part 1 – General Requirements
- The information contained herein details the applicable requirements for Organizations seeking approval to use the API Monogram Mark.
- To obtain and retain an API Monogram license, an Organization must have a documented and functioning quality management system in place that meets both the requirements of API Spec Q1® (Quality Programs for the Petroleum, Petrochemical and Natural Gas Industry), and at least one of the applicable API Product Specifications.
- Issuance of the license(s) is dependent upon a successful evaluation of the Organization’s quality manual, API Spec Q1 Conformity Matrix and satisfactorily passing an on-site audit of the Organization’s facility and processes by API through its designated auditors. Site audits are required to verify demonstrated capability of the Organization to meet program requirements. Associated audit expenses will be paid by the facility.
- Review the requirements stated in API Spec Q1 and the applicable API Product Specification(s) for which your Organization is seeking a license. If your Organization feels that its manufacturing processes meet all the stated quality requirements to obtain an API Monogram License for one or more product specifications, please complete and submit the following:
- API Certification Programs Application If your Organization is seeking one or more API Monogram licenses and/or registrations, this form must be completed and signed.
- API Monogram License Agreement For each API Product Specification for which you are requesting licensing, a separate License Agreement must be completed and signed. NOTE: The applicant is not allowed to use the API Monogram until all steps in the process have been completed (including satisfactorily passing an on-site audit), the applicant has paid the applicable fees, the applicant has agreed to comply with all terms and conditions of the agreement, and signed the License Agreement.
- Licensing Information Form: For each API Product Specification for which you are requesting licensing, a separate Licensing Information Form must be completed. Please submit the appropriate forms as applicable to the Product Specification(s).
If you do not have a Licensing Information Form for any of the API Product Specifications listed, you may obtain one online at website at www.api.org/certifications/monogram/documents/licensing-forms.cfm.
To request a form, please contact API Certification Programs:
API Certification Programs 1220 L Street, NW Washington, DC 20005-4070, USA
Phone: (+1) 202-962-4791 Fax: (+1) 202-682-8070
Email: email@example.com Web: www.api.org/monogram
Do not submit a Licensing Information Form(s) without a completed API Monogram License Agreement(s) (see Part 4 – API Monogram License Agreement), your API Certification Programs Application, your Quality Manual, API Spec Q1 Conformity Matrix and License Fee. For instructions on where to send your submission, see Part 6 – Fee Schedule.
Structure of API Q1: 9th Edition
This section review section 1, scope, of the API Q1 9th edition specification.
This specification established the minimum quality management system requirements for organizations that manufactured products or provide manufacturing-related processes under a product specification for use in the petroleum and natural gas industry.
When an organization performs activities addressed by this specification, no claims to exclusion of those activities are permitted. When exclusions are permitted, they are limited to the following sections:
|API Q1 Clauses||Sections|
|5.4||Design and Development|
|126.96.36.199||Validation of process for Production and Servicing|
|5.7.5||Customer Supplied Property|
|5.8||Control of Testing, Measuring, and Monitoring|
As stated, any organization who performs Design (5.4); Servicing (188.8.131.52); Required to do Validation of Processes (184.108.40.206; has or utilizes Customer Supplied Property (5.7.5) or Calibration (TMME) (5.8); shall not claim an exclusion to the specification.
2.0 Normative references
The following reference document is indispensable for the application to this specification.
ISO 9000, Quality Management Systems – Fundamentals and vocabulary.
3.0 Terms, Definition and Abbreviations
In addition to new terms, this section focuses on existing terms that are applied differently in API Spec Q1 and the industry.
3.1 Terms and Definition
For the purpose of API Q1: 9th Edition, the terms and definitions given in ISO 9000 and the following shall apply:
3.1.1 acceptance criteria: Specified limits of acceptability applied to process or product characteristics.
3.1.2 acceptance inspection: Demonstration through monitoring or measurement that the product conforms to specified requirements.
3.1.3 calibration: Comparison to a standard of known accuracy and making any needed adjustment(s).
3.1.4 collection: Process of obtaining, assembling, and/or organizing applicable information with the intent of meeting the requirements of 4.5. Control of documents
3.1.5 compliance: Act or process of satisfying the legal and other applicable requirements of a regulation or regulatory body.
3.1.6 critical: That deemed by the organization, product specification, or customer as mandatory, indispensable or essential, needed for a stated purpose or task, and requiring specific action.
3.1.7 delivery: Point in time and physical location at which the agreed transfer of ownership takes place.
3.1.8 design acceptance criteria DAC: Defined limits placed on characteristics of materials, products, or services established by the organization, customer, and/or applicable specifications to achieve conformity to the product design.
3.1.9 design validation: Process of proving a design by testing to demonstrate conformity of the product to design requirements.
NOTE Design validation can include one or more of the following (this is not an all-inclusive list):
a) prototype tests,
b) functional and/or operational tests of production products,
c) tests specified by industry standards and/or regulatory requirements,
d) field performance tests and reviews.
3.1.10 design verification: Process of examining the result of design and development output to determine conformity with specified requirements.
NOTE Design verification activities can include one or more of the following (this is not an all-inclusive list):
a) confirming the accuracy of design results through the performance of alternative calculations,
b) review of design output documents independent of activities of design and development,
c) comparing new designs to similar proven designs.
3.1.11 first article: Representative sample of a product, component, or output from a process used to verify that prescribed activities have satisfied the requirements as specified by the organization.
NOTE Samples can include trial purchases and prototypes.
3.1.12 key performance indicator KPI: Quantifiable measure that an organization uses to gauge or compare performance.
3.1.13 legal requirement: Obligation imposed on an organization, including those that are statutory or regulatory.
3.1.14 management [noun]: Person or group of people, as defined by the organization, who directs and controls all or part of a facility, location, department, or other function; has the fiscal responsibility for the organization, and is accountable for ensuring compliance with legal and other applicable requirements.
NOTE For some organizations, top management (see ISO 9000) and management are the same.
3.1.15 manufacturing acceptance criteria MAC: Defined limits placed on characteristics of materials, products, and services established by the organization to achieve conformity to the manufacturing or servicing requirements.
3.1.16 outsource [outsourced activity]: Function or process that is performed by an external supplier on behalf of the organization.
3.1.17 preventive maintenance: Planned action to minimize the likelihood of equipment failure and unscheduled interruptions
3.1.18 procedure: Organization’s documented method for performing an activity under controlled conditions to achieve conformity to specified requirements.
NOTE This definition was previously identified as a “control feature” in earlier editions of this specification.
3.1.19 risk: Situation or circumstance that has both a likelihood of occurring and a potentially negative consequence.
3.1.20 service: Performance of an activity by one function or organization for another.
3.1.21 servicing: Product maintenance, adjustment, repair, and/or on-site installation when installation is required by applicable product specifications.
For the purposes of this specification, the following abbreviations shall apply. 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
QM: quality manual
QMS: quality management system
QP: quality plan
4 Quality Management System Requirements
4.1 Quality Management System
For all the products and services provided by the organization for use in the petroleum and natural gas industry, the organization must establish, document, implement, and maintain a quality management system in accordance with the requirement given in the API Q1 Standard which must be measured and improved upon at all times.
The Process-Based Management System Model supports all of the other API and ISO management system standards and specifications. The model starts off with understanding of Organization Customer Requirement, this in an INPUT to the organization’s Product Realization is where the product/service takes place producing an OUTPUT (Product/Service) to the Customer satisfaction. Product Realization must be constantly measured, analyzed and when needed, improved to ensure customer requirements and satisfaction is maintained. The results of the analysis goes to Top management , who is responsible to act upon the results and properly allocate resources to the organization to ensure that Product and services will continue to keep up with Customer requirement.
4.1.2 Quality Policy
As a commitment to its quality, the organization must define and document its Quality policy. Quality policy should be the basis for the development of quality objectives. The policy must have a commitment to comply with requirements of the quality management system and to continually improve the effectiveness of the quality management system.The organization’s top management must approve the Quality policy prior to its implementation. The Quality policy must be communicated, understood, implemented, and maintained at all relevant functions and levels within the organization. The organization’s top management must review the quality policy to ensure that it is appropriate to the organization,
The quality policy must be appropriate to its purpose and there is a commitment to continually improving the quality management system, and the quality objectives are consistent with the quality policy.The policy does not have to include objectives but should create a framework for establishing them. The policy should be stated in such a way that it aims toward continual improvement. It should be reviewed and possibly revised to meet higher aspirations. Develop and implement a policy that is consistent with the company’s codes of conduct and business practices. The policy should be signed by senior management and commit to:
- Preventing process loss or quality impacts;
- Complying with obligations and legal requirements;
- Promoting continual improvement;
- Adopting best practice;
- Creation of measurable and achievable targets for performance improvement;
- Providing resources to achieve targets;
- Communicating and consulting with all stakeholders regarding the QMS;
- Meeting customer requirements.
Tell everyone about it.
- Making sure it is written.
- Making sure people know it and understand it.
- Giving it to people who have an interest in your business (e.g. clients/suppliers/manufacturers/staff).
- Publishing it on your website.
The example includes written Quality policy, company induction, basic training, toolbox talks.
4.1.3 Quality Objectives
Management must ensure that quality objectives re established at relevant functions and levels within the organization. It must also include objectives to meet product and customer requirements. It must measurable. It must be consistent with the Quality Policy. The Top management must approve the Quality objectives.
No quality plan can be complete without having measurable quality objectives. An objective should include a description of who is responsible, what is the target, when is it planned to be achieved. Progress must be monitored. Also, requires objectives to be set for relevant processes. Ensure that whatever objectives you implement are SMART
Some key rules are as follows:
- Make sure they comply with the law and industry standards.
- Make sure they conform with the products and services to make them better.
- Monitor your objectives periodically to check what you are doing.
- Tell the staff what they are and what you expect of them.
- Updated when the management changes something.
Keep records of this. This should be included in the customer SLA and planning should be in place to ensure you can resource this response rate. An example could be Understanding the total number of planned maintenance, the number of reactive maintenance to ensure you calculate the appropriate levels of resources. Organizations need to clearly understand how these will be realized. For example, if your aim is to provide national coverage, how will this be achieved? What resources will you allocate, recruiting staff co
In order to meet the requirements of API Q1 standard, Management must ensure that Planning of the quality management system is carried out. The criteria for the operation must be determined and effectively managed. The methods for the operation must be determined and effectively managed. Also controls for all QMS processes must be determined and effectively managed.
In order to meet the requirements for the delivery of products and services, the organization needs to plan, implement, and control its processes. The first step is to determine the requirements for products and services, meaning what features the product or service will have. Then, the organization needs to define how processes will be performed and what criteria the product or service needs to meet to be accepted for release. Finally, the organization needs to determine the resources needed for the processes and the records needed to demonstrate that the processes were carried out as planned. Once they have done their planning for what they are going to sell, they then must plan the detail of how this can be done operationally. The organization may need to :
- Set up supplier accounts/trade accounts.
- Purchase stock.
- Ensure staff have the correct skills and understand the process.
- Purchase tools and vehicles.
- Make sure you have enough staff.
- Issue clear instructions, drawings, procedures risk assessments to enable them to do the job.
The organization needs to show clear control of the process. They will be expected to check that delivery is as expected and when there are deviations that this is managed and negative impacts controlled. The same control should be applied to subcontractors.
This clause includes both internal and external communication about the QMS. Processes for internal and external communication need to be established within the QMS. The key elements of Communication that an organization must establish are
- what needs to be communicated?
- when it needs to be communicated?
- how it should be done?
- who needs to receive the communication? and
- who will communicate?
It should be noted here that any communication outputs should be consistent with related information and content generated by the QMS for the sake of consistency. This is a straightforward clause and is simply about effectively communicating to all those within the organization and those affected by it. Internal communications can include briefings to staff on:
- new policies;
- new or amended objectives;
- new or amended strategies;
- new clients;
- new or amended technology;
- new products;
- issues with suppliers;
- anything that will have an impact on them.
Designate a person responsible for updates may be department head
Management, not Top Management, is responsible for establishing a formal, documented communication process that:
o Ensures that all relevant functions within organization are aware of all relevant customer, legal, and other applicable requirements.
o Ensures that all relevant levels and functions within in the organization are aware of the results of data analysis
Top management must communicate the effectiveness of quality management system
220.127.116.11 External Communications
To understand the requirements and other external organizations throughout contract execution and product realization, the organization must determine and implement a process for communicating with the customers and other external organizations . The communication process must address execution of inquiries, contracts, or order handling and amendments , feedback and customer complaints. The organization must also provide product information, including product nonconformities identified after delivery to the customer . When its required by contract, the organization must provide information required by product quality plans and subsequent changes to those plans .
An organization may choose to communicate with other interested parties, but the requirements under 18.104.22.168 were targeted and mandated to occur between the manufacture and the operator (customer). It was also intended to go from manufacture to affected suppliers. External communication is to manage risk that occurs throughout the execution of the contract. Many will do this up front, but this occurs during tendering, contract review, and execution.
4.2 Management Responsibility
This section focuses more on the roles and responsibilities of management and top management. This section focuses more on the roles and responsibilities of management and top management Top management must ensure essential resources are availability necessary for establishing, implementing, maintaining, and improving the quality management system. Resources can include human resources and specialized skills, organizational infrastructure, financial resources, and technology.
The responsibility of management within the organization is to provide evidence of its commitment to the development and implementation of the quality management system. Management continually improve its effectiveness by ensuring that quality objectives are established including key performance indicators for use in data analysis. The management must conduct management reviews.
Responsibilities of Top Management in API Q1 standard
- Approval of Quality policy
- Review of Quality policy
- Approval of Quality objectives
- Availability of Resources
- Appointment of Management Representative
- taking report from the Management Representativeon the performance of the quality management system
- Review and approve output of Management Review
Responsibilities of Management in API Q1 standard
- Establishment of quality objective at relevant functions and levels
- criteria and methods needed for the operation and control of all quality management system processes are determined, managed, and effective
- planning of the quality management system is carried out in order to meet the requirements of this specification.
- ensure that appropriate communication processes are established
- the effectiveness of the quality management system is communicated
- provide evidence of its commitment to the development and implementation of the quality management system
- Review of Organization’s Quality Management System
4.2.2 Responsibility and Authority
Responsibilities, authorities, and accountabilities of personnel within the scope of this document shall be defined, documented, and communicated throughout the organization.
The organization must ensure that responsibilities are allocated across the organization to maintain the management system to make sure what is supposed to happen is happening. While allocating Roles, Responsibilities, and authorities, the organization must remember the customer at all times and the outcome of the business processes, and how they can be improved. Remembering to update the system as and when you change how you work or the intended process is amended. The organization must be defining job roles prior to recruitment, allocating job descriptions to personnel, and linking this to the processes within the business. For eg A sales administrator might be expected to have 12 months’ experience in writing quotations. When they join there would be a period of training and reinforcing this through a written job description. The output would be a more senior colleague reviewing quotes, confirming they are correct, and ensuring that the customer is being quoted for what they asked for. If a form or process is amended along the way advising the sales administrator and ensuring the new versions are applied.
4.2.3 Management Representative
Management Representative must be appointed by the Top management. Management Representative must be a member of the organization’s management. The Top management must always maintain the Management Representative. Irrespective of the other responsibilities the Management Representative may have, He/She shall also have responsibility and authority to ensure that processes needed for the quality management system are established, implemented, and maintained. Report to to top management on the performance of the quality management system.Report for any need for improvements. Ensuring of initiation of action(s) to minimize the likelihood of the occurrence of nonconformities and ensuring the promotion of awareness of customer requirements throughout the organization.
The management representative ensures that the QMS processes are established, implemented, and maintained. This may involve review and planning of internal audits, discussion with process owners, or even review of the processes in person to ensure they are properly maintained. If this were not the responsibility of the management representative, then it would be a responsibility distributed among the process owners, and when this happens no one really has the responsibility at all. By having a focal point for the overall processes, the management representative can not only ensure that each process is functioning, but that the interaction of the processes is maintained. By doing this, the interactions can then start to be optimized, because it is not always the case that optimization in one process is the best thing for the overall system.
The management representative has a second responsibility to report to top management on how well, or poorly, the QMS is performing. Identifying any needs for improvement to top management is also part of this responsibility. As has already been said, top management needs to be fully supportive of the Quality Management System implementation if it is going to provide true benefit to the company. In order for this to function, there needs to be a point of focus for top management to use when reviewing the resource needs of the QMS, and how best to support the improvement needed. Being the voice of the QMS for top management can be the critical factor in a QMS providing return on investment for the company, or not.
The management rep will gather this sort of information from the monitoring and measurement activities in the organization , as well as the results of the internal audits, and when the company uses a management review meeting, this is the sort of information that is presented.
The last responsibility is to ensure that people are aware of customer requirements throughout the organization. Since one of the main thrusts of an ISO 9001 Quality Management System is customer satisfaction, it is vital that all employees understand what the customer needs, and how they are able to affect how well the company satisfies these needs. Customer focus is one of the main Seven Quality Management Principles behind ISO 9001 requirements, and as such needs to have an advocate in the company. By being the “voice of the customer” in the organization, the quality management representative can make great strides in how satisfied customers are. If the company implemented a quality management system to improve customer satisfaction, it only makes sense that someone is responsible to promote the customer needs in the company, and the management rep is the leader of this initiative.
The quality management representative becomes the one name that the Auditing organization (like API) can call, or the customer can contact with complaints. It is often these optional responsibilities that are seen as the main role of the management rep, but in fact these could be done by one of many other people without affecting the effectiveness and success of the QMS.
4.3.1 Provision of Resources
The organization shall determine and provide the resources needed to implement, maintain, and improve the effectiveness of the requirements of the quality management system.
The organization must have the resources it needs to ensure the effective operation of the QMS. Resources may include raw materials, infrastructure, finance, personnel, and IT, all of which can be either internally or externally provided. The organization must have a clear understanding of:
- what an organization has in house and whether this is sufficient/fit for purpose to achieve its goals and objectives.
- what additional support might be needed externally.
For example Specialist skills that are better outsourced due the size of the organization (e.g. security screening, health, and safety advice).
4.3.2 Human Resources
The organization shall establish a documented procedure for determining competency of its employees and other personnel . The procedure must also identifying training requirements or other actions to achieve the necessary competency of these employees and other personnel. The procedure must also determine and documenting the effectiveness of the training or other actions taken toward the achievement of required competency.
he Four Levels of Learning In adult learning, there are four stages of learning to reach mastery. Three of the four have been incorporated into the term competent in API Spec Q1, 9th edition.
22.214.171.124 Personnel Competence
Personnel shall be competent based on the appropriate education, training, skills, and experience needed to meet product and customer requirements. Evidence of the determination of competence of personnel shall be recorded and maintained.
The organization needs to determine the necessary competence of its employees, and ensure those employees are competent on the basis of appropriate education, training, and experience. The organization must have a process for determining the necessary competence and achieving it through training or other means. Determining competence is a necessity in any organization. Working out on the skills your team has and the skills they don’t yet have and the skills they will need to achieve the company’s objectives. For example to achieve the objective of “Increase in sales”, you need to improve the competency of your sales team by training them.
126.96.36.199 Training and Awareness
The organization must provide for quality management system training and job training. The must also ensure that customer-specified training and/or customer-provided training, when required, is included in the training program. They must ensure that the frequency and content of training is identified. They must ensure 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 maintain appropriate records of education, training, skills, and experience .
The content of awareness training may include items covered in induction training, specific training, toolbox talks or any other quality, environmental, or health and safety issues that affect a number of employees in the workplace. You should seek evidence to confirm that this requirement has been applied by your organization to ensure that the people who need to be made aware now include all the people who work on your organization’s behalf that affect the conformity of your organization’s management system or products. You ensure that these people are aware of:
- The quality policies;
- Relevant quality objectives;
- Their contribution to the effectiveness of the management system;
- Benefits of improved performance;
- The implications of not conforming to management system requirements.
This also is to take into account all legal and other requirements that it subscribes to or is required to comply with. Not having an understanding of these “legal and other applicable requirements” not only puts employees at risk, but it has a potential negative impact on organizational processes and the environment,
The awareness training does not need to follow the format of long classroom sessions. Training techniques can include short training segments supplemented with videos and hands-on demonstrations that address key elements of the management system. Other methods to promote and reinforce awareness training sessions include communication via electronic bulletin boards, posters, newsletters and informational meetings. The requirements for general awareness training apply to all employees including those whose work may cause impacts on customer / product or service requirements. Awareness training is intended to provide an overview of the organization’s policy, objectives and targets, and overall management system. Your organization must ‘establish and maintain procedures to make its employees and members at each relevant function and level aware of’:
- The importance of conformance with the policy and the management system procedures and requirements;
- The actual and the potential significant impacts and risks of the activities, products, and/or services;
- The benefits of improved personal performance;
- The employees’ roles and responsibilities in achieving conformance with policies and procedures;
- The employees’ roles and responsibilities towards emergency preparedness and response;
- The potential consequences of departure from specified operating procedures.
The awareness training materials may also include additional elements that address:
- The organization’s objectives and targets;
- The employees’ actions to minimize/eliminate impacts and risks and how they can contribute;
- The importance of compliance with operational and regulatory requirements;
- The overall improvement of the management system performance and the potential financial return;
- The importance to interested parties.
General awareness training should be undertaken in accordance with task demands. All new recruits (workers, contractors and temporary staff) must receive induction briefings and periodic Quality management system awareness training appropriate to the duration of their responsibilities to ensure they are aware of importance of ethical behavior e.g. codes of conduct, internal management, working relationships, fair treatment, confidential reporting mechanisms, protecting anonymity, no-blame-culture, awareness campaigns, notice boards, posters, training programs including:
- Core values and policies;
- Company overview;
- History of the company;
- The people and structure;
- Contract of employment;
- Induction pack;
- Health, safety and environmental briefing.
The induction record should be completed, signed by each participant and sent to the Human Resources Manager.
4.3.3 Work Environment
The organization must determine, provide, manage, and maintain the work environment needed to achieve conformity applicable to the manufacture of the product. 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.
The environment for the operation of processes clause ensures that the organization determines, provides, and maintains an environment necessary for the operation of its processes and to achieve conformity. The term environment refers to the work environment and is used to describe the set of conditions in which employees perform their work and under which products and services are produced. Conditions can include physical, social, psychological, and environmental factors (such as temperature, lighting, recognition schemes, social and occupational stress, ergonomics, etc). It can also relate to conditions on how work is actually done (complex, repetitive, creative, interactive, team, etc.) in work processes and procedures. The environment that you work in and may include the following:
- Equality Opportunities, whistle blowing, the anti-bullying policy.
- Violence at work, counseling support, lone working.
- Office-based risk assessment, space, noise levels.
The manufacture (organization) is responsible for identifying and knowing the different types of servicing and SRP that they will produce or support. They are also responsible for ensuring that the work environment needed to meet those requirements has been provided, is managed, and maintained to ensure conformity requirements are met. This includes organization’s facilities, workspace, utilities, process equipment, and physical and environmental conditions where servicing and SRP are produced. Work environment includes the organization’s facilities, mobile work environments, and the well sites where services and SRP are utilized. Besides understanding what is considered the work environment, the organization also needs to understand the servicing and product conformity requirements.
4.4 Documentation Requirements
The quality management system documentation must include Quality manual, statements of Quality policy, statements of Quality objectives and. documented procedures. It must also include documents and records required for effective planning, operation, and control of its processes and compliance with specified requirements. Legal and other applicable requirements needed for product conformity must also be identified. Quality manual must include
1. the scope of the quality management system, including justification for any exclusions to specific quality management system elements ;
2.a description of the sequence and interaction between the processes of the quality management system;
3.identification of processes that require validation ; and
4.reference to documented procedures that control the quality management system processes;
The quality manual describes the quality management system in accordance with the stated quality policy and objectives, while the procedures describe the processes and activities required to implement the quality management system.Organizations can address the requirements of the standards by preparing a management system manual and by implementing procedures to control processes.The quality manual, the polices, processes and procedures are all about what organization has decided is important to ensure they can provide the services and products that continually meet customer requirements, deliver satisfaction and for the business to meet its own targets and objectives. The quality manual provides the scope of the management system . Also, the manual contains an overview of management’s and employee responsibilities as well as conformity statements applicable to the Q1 causes that are contained and supported by your management system. The management system processes and procedures provide detailed requirements for each of your key processes with the intent to specify who does what, when, where, how the process, action, or task is performed, and what documentation is used to verify that all required the quality related activities have been executed as required.
All procedures mentioned in API Q1 standard must be established, documented, implemented, and maintained for continued suitability. One or more procedures can be contained in a single document or requirement of a documented procedure can be contained in one or more documents.
Documented Procedure Required by API Q1 standard
- defining personnel competency and identifying training requirements
- identification, distribution, and control of documents
- integration of external specification requirements into the product realization process and any other affected processes
- the identification, collection, storage, protection, retrieval, retention time, and disposition of records
- review of requirements related to the provision of products and required servicing (Contract Review)
- identify and control risk associated with impact on delivery and quality of product.
- plan and control the design and development of the product.
- contingency planning
- procedure to ensure that purchased products or outsourced activities conform to specified requirements.
- the verification or other activities necessary for ensuring that purchased products or activities meet specified purchase requirements
- controls associated with the production of products.
- controls associated with the servicing
- Validation of Processes for Production and Servicing
- identification and traceability
- product inspection and/or test status
- Customer-supplied Property
- Preservation of Product
- Inspection and Testing
- preventive maintenance for equipments
- Calibration and Maintenance of testing, measurement, and monitoring equipment.
- release of product
- Control of non conforming product
- customer satisfaction
- Internal audit
- Analysis of data
- correct nonconformities and to take corrective actions,
- Preventive action
4.4.3 Control of Documents
The organization must establish a documented procedure for the identification, distribution, and control of its documents or that of the external origin. The procedure shall specify responsibilities for approval and re-approval of the documents. It must identify the controls needed to ensure that the documents are reviewed and approved for adequacy prior to issue and use. It must identify changes and revision status. Document must remain legible and readily identifiable, and are available where the activity is being performed. Documents of external origin must be controlled to ensure that the relevant versions are used and maintained. The organization must ensure against unintended use of obsolete documents and removed from all points of issue or use, or otherwise identified if they are retained for any purpose. All Procedures, work instructions, and forms must be controlled.
Organization must control the documents required by the its QMS. A suitable process must be implemented to define the controls needed to; approve, review, update, identify changes, identify revision status and provide access. The procedure should define the scope, purpose, method and responsibilities required to implement these parameters. In order to comply with the document requirements, it is essential that all personnel understand what types of information that should be controlled and more importantly, how this control should be exercised. To get the most out of your procedure it must communicated to ensure that staff and other users of the documentation information understand what they must do in order to manage that information effectively and efficiently. Demonstrate the organization’s arrangements for controlling document required by API Q1 and your organizations own requirements, including
- Availability e.g. document accessibility (hard copy, electronic media), readily available at the point of use;
- Suitability e.g. format, media suitable to the environment, ease of understanding, language, interpretation;
- Protection e.g. document authentication, document markings (official, secret, restricted, confidential, private, sensitive, classified, unclassified), access controls (individual, role specific),
- Physical security (master documents, server rooms, libraries) IT security (User ID, password, servers, download, back up, encryption, ‘read only’, ‘read/write’), protection from corruption and unintended alterations.
- Demonstrate the organization’s arrangements for document retention e.g. organization/legal/contractual retention periods, storage, preservation, back up, retention of knowledge, disposal, obsolescence e.g. withdrawal, replacement, legacy archive and suitable identification (‘for information only’, ‘not to be used after….’, ‘uncontrolled copy’, ‘for reference purposes only’, etc.
Ensure your organization protects electronic data, e.g. security policy, system access profiles, password rules, storage and back-up policy including protection from loss, unauthorized changes, unintended alteration, corruption, physical damage. Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the document.
4.4.4 Use of External Documents in Product Realization
The organization must establish a documented procedure for the integration of the requirements coming from external specification such as API product including addenda, errata, and updates into the product realization process and any other affected processes when such requirement are used in the design or manufacture of the product.
External documents are the documents relevant to the quality management system (QMS) and issued by an external entity. Examples of those issuers can be: customers, suppliers, legislators, regulators, standardization bodies, or business partners. Documents of external origin relevant for the QMS can be, for example, Product Specifications, Logistics Specifications, Material Safety Data Sheets, Legislation, Permits, Standards, Platform Rules, or Work Instructions.Organization must determine what the relevant documents of external origin are used in design and manufacture of the products. The organization must ensure that external document is still updated.If the document was changed, what are the implications on the specification of the product. Do the changes in the document imply changes in the manufacturing process. The procedure must include:
- what are the relevant documents of external origin
- who is responsible for checking, with what frequency,
- who is going to do what when there are changes or new documents;
- get new versions or new document
- update register
- distribute new version or new document
- check if it is applicable
- plan changes
- implement changes
- confirm that changes were implemented
4.5 Control of Records
The organization must establish a documented procedure for control of Records. The procedure must identify the controls and responsibilities needed for the identification, collection, storage, protection, retrieval, retention time, and disposition of records. Records should remain legible, identifiable, and retrievable. The retention of record should be based on customer, legal, and other applicable requirements or 5 year whichever is more.The records including those of outsourced process must be e established and controlled to provide evidence of conformity to requirements and the organization’s quality management system.
Records Required by API Q1 standard
- records of education, training, skills, and experience
- records to ensure the effective planning, operation, and control of its processes and compliance with specified requirements
- record of customer requirement, when customer provides no documented statement of requirements
- Records of contract review including resulting actions
- records needed to provide evidence that the product realization processes meet requirements (for eg inspection record)
- Records of risk assessment and management including actions taken
- Contingency plan
- Records of design inputs
- Records of design outputs
- Records of design review
- Records of design and development verification and the final review
- Records of the design and development validation, approval, and any necessary actions
- Records of design and development changes,
- Records of supplier evaluation
- Records of outsourced activities
- Records of verification of Purchased Products or Activities
- Records of product realization plan
- records of review/verification, validation, monitoring, measurement, inspection, and test activities, including criteria for product acceptance
- Records of validation of Processes for Production and Servicing
- Records of identification and traceability
- Records for the control and disposition of customer-supplied property
- Records of the results of assessments of product kept in storage
- Records of required inspection and testing
- Records of preventive maintenance
- Records of assessment of the validity of previous measurements and actions to be taken on the equipment and product, when the equipment is found to be out of calibration.
- Records of the results of calibration and verification
- Records shall be maintained to enable identification of the individual releasing the product
- Records of notification to customers of product not conforming to DAC or contract requirements
- Records of nature of nonconformities of non conforming product and any any subsequent actions taken
- Records of MOC activities
- Records of customer satisfaction
- Records of internal audit
- Records of the Corrective action
- Records of the preventive action
- Records of Management Review