ISO 29001:2020 Internal Audit checklist

ISO 29001:2020 Audit checklist

The following checklist can be used for both internal audits as well as Gap Analysis tools.

ISO 29001:2020 Checklist
Clause 4: Context of the organization
4.1 Understanding the organization and its context
1Has the organization determined the external and internal issues relevant to the Purpose & strategic direction of its QMS and that can affect its ability to achieve the intended results?
2Does the organization monitor and review information about these external and internal issues?
3While determining the internal and external issues has the organization considered positive and negative factors or conditions?
4Was the understanding of the external context facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local?
5Was the understanding of the internal context facilitated by considering issues arising from values, culture, knowledge and performance of the organization?
6Does the organization retains documented information that demonstrates the understanding of its context?
4.2 Understanding the needs and expectations of interested parties
1Has the organization determined the interested parties that are relevant to the QMS?
2Has the organization determined the requirements of these interested parties relevant to the QMS?
3Does the organization monitor and review the information about these interested parties and their relevant requirement?
4Does the organization retains documented information that demonstrates the understanding of the needs and expectations of interested parties?
4.3Determining the scope of the quality management system
1Has the organization established the scope of its QMS?
2Has the organization determined the boundaries and applicability of the QMS?
3While determining the scope, has the organization determined the external and internal issues, requirements of relevant interested parties, product and services of the organization?
4While determining Applicability, does the organization determine if it affects its ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction?
5Does the scope state the types of products and services covered?
6Does the scope give justification for any requirements that the organization determines and is not applicable to the scope of its QMS?
7Is the organization’s scope made available and maintained as a Documented Information?
8When requested, does the organization advises interested parties of any requirements of this document that the organization determines are not applicable to the scope of its quality management system?
4.4 Quality management system and its processes
1Has the organization established, implemented, maintained and continually improved its QMS?
4.4.1
1Has the organization determined the processes needed for the QMS?
2Has the organization determined the application of these process throughout the organization?
3Has the organization determined the sequence and the interaction of these process?
4Has the organization determined and applied the criteria and methods needed to ensure the effective operation and control of these processes?
5Do these methods include the monitoring, measurement and related performance indicator?
6Has the organization determined the resources needed for the organization?
7Has the organization ensured the availability of the resources needed for these processes?
8Has the organization assigned the responsibilities and authorities for these processes?
9Has the organization addressed the risk and opportunities associated with these processes?
10Has the organization evaluated these processes and implemented any changes needed to ensure that these processes achieve its intended results?
11Has the organization made improvement in its processes and its QMS?
4.4.2 
1Has the organization maintained documented information to support the operation of its processes?
2Do the organization retain documented information as evidence that the processes have been carried out as planned?
4.4.3
1Has the organization defined the extent of documented information required to meet relevant
interested parties’ requirements?
Clause 5Leadership
5.1Leadership and commitment
5.1.1General
1Does the top management demonstrate leadership and commitment by taking accountability for the effectiveness of its QMS?
2Has the top management ensured that the quality policy and quality objective are established?
3Is the quality policy and quality objective compatible with the context and strategic direction of the organization?
4Has the organization integrated the requirements of QMS with the business processes?
5Is the organization promoting the use of process approach and risk-based thinking throughout the organization?
6Is the top management ensuring that the resources needed for the QMS are available?
7Is the importance of the effectiveness of QMS and meeting QMS requirements communicated?
8Does the top management ensure that the QMS is achieving its intended results?
9Does Top Management engage, directs and supports the persons required to contribute to the effectiveness of the QMS requirements?
10Is Top Management promoting improvements?
11Is Top Management supporting other relevant management roles to demonstrate their leadership as it applies to their area of responsibilities?
5.1.2Customer Focus
1Does the Top Management demonstrate leadership and commitment by ensuring that customer and applicable statutory and regulatory requirements are determined, understood and are consistently meeting the requirements?
2Are the risks and opportunities that can affect the conformity of products and services and the ability to enhance customer satisfaction are determined and addressed?
3Is the focus of enhancing customer satisfaction maintained?
5.2Policy
5.2.1Establishing the Quality policy
1Has the Top Management established, implemented and maintained a quality policy?
2Is quality policy appropriate to the purpose and context of the organization and does it supports its strategic directions?
3Does the Quality policy provide the framework for setting quality objective?
4Does the Quality policy include the commitment to satisfy applicable requirements and to continually improvement of the QMS?
5.2.2Communicating the quality policy
1Is Quality policy maintained as documented information?
2Is Quality policy communicated, understood and applied within the organization?
3Is Quality policy appropriate and made available to the relevant interested parties?
5.3Organizational roles, responsibilities and authorities
1Has the Top management ensured that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization?
2While assigning the responsibilities and authorities, do the top management ensure that the processes are meeting their intended results?
4While assigning the responsibilities and authorities, do the top management ensure that there is the promotion of customer focus throughout the organization?
5While assigning the responsibilities and authorities, do the top management ensure that performance of its QMS and opportunities for improvement are reported to them?
6While assigning the responsibilities and authorities, do the top management ensure that integrity of QMS is maintained when changes to the QMS are planned and maintained?
7Has the organization defined the relevant roles?
8Has the organization maintained and retained documented information (record and procedure) covering responsibilities and authorities for these roles?
Clause 6Planning
6.1Actions to address risks and opportunities
1While planning for QMS, does the organization considers the issues referred to in clause 4.1 and requirement referred to in clause 4.2?
6.1.1
1Has the organization determined the risks and opportunities that have to be addressed so that QMS can achieve its intended results, enhance desirable effects, prevent, or reduce undesired effects and achieve improvement?
6.1.2
1Has the organization planned actions to address these risks and opportunities?
2Have these actions implemented and integrated into its QMS processes?
3Has the organization evaluated the effectiveness of these actions?
4Is the action proportionate to the potential impact on the conformity of product and services?
6.1.3
1For managing risks and opportunities has the organization defined techniques, tools and their application for identification and assessment of risks and opportunities, and prevention and mitigation of risks?
2For managing risks and opportunities has the organization identified relevant interested parties?
3For managing risks and opportunities has the organization identified sources of risk and opportunity, areas of impacts, events and their causes, and their potential consequences?
4For managing risks and opportunities has the organization analysed potential risk and opportunity by determining consequences and their likelihood?
5For managing risks and opportunities has the organization evaluated risk and opportunity and develop controls for them?
6For managing risks and opportunities has the organization applied appropriate risk treatments and opportunity realization plans?
7Has the organization maintained and retained documented information (records and procedure) to support and demonstrate the management of risks and opportunities?
6.2Quality objectives and planning to achieve them
6.2.1
1Has the organization established quality objectives at relevant functions, levels and process needed for the QMS?
2Are the quality objectives consistent with the quality policy?
3Does the organization have quality objectives which are relevant to the conformity of product and services and enhancement of customer satisfaction?
4Are the quality objective measurable and do they take account of applicable requirements?
5Are the quality objectives monitored, communicated and updated as required?
6Does the organization maintain documented information on the quality objectives?
6.2.2
1For achieving quality objectives do the organization determines what will be done, what resources are required, who will be responsible, when will it be completed and how are the result to be evaluated?
6.3Planning for change
1While determining changes for the QMS, are changes carried out in a planned manner?
2While planning for change, does the organization consider the purpose of the change and their potential consequence; the integrity of the QMS; the availability of resources; and allocation and reallocation of responsibilities and authorities?
3How does the organization manage risks and opportunities associated with proposed changes?
4Has the organization maintained and retained documented information (records and procedure) to manage the process of change?
7Support
7.1Resources
7.1.1General
1Has the organization determined and provided the resources needed for the establishment, implementing, maintaining and continually improvement of the QMS?
2Has the organization considered the capabilities and constraints of existing internal resources?
3Has the organization considered what needs to be obtained from external providers?
7.1.2People
1Has the organization determined and provided the persons required for effective maintenance of QMS and for operation and control of its processes?
7.1.3Infrastructure
1Has the organization determined and maintained the infrastructure needed for the operation of its processes and to achieve conformity of product and services?
7.1.3.1
1Does the organization maintains and retains documented information of the processes for the
determination and usage of its infrastructure to achieve conformity of products and services?
2Does the documented Information addresses infrastructure to be maintained?
3Does the documented Information addresses method of maintaining the infrastructure, including frequency and monitoring, that ensure infrastructure integrity to performance requirements?
4Does the documented Information addresses outcome of maintenance, including applicable testing methods and acceptance criteria?
5Does the documented Information addresses responsible personnel?
7.1.3.2
1For service-related infrastructure, does the documented information addresses usage history, repairs or redress, modifications, remanufacturing, inspection, and test activities that allow direct verification for reuse of infrastructure?
2For service-related infrastructure, does the documented information addresses list of critical spare parts required by the customer and/or technical requirements including those
recommended by the original equipment manufacturer?
7.1.3.3
1Does the organization applies risk-based maintenance which typically includes the concepts of preventive and predictive maintenance and /or reliability centred maintenance and /or mean time between failures and /or system, design and process failure mode and effects analysis and /or failure mode and criticality effects analysis and /or process control plans and/or others that are in context of the organization and its risks.
7.1.4Environment for the operation of processes
1 Has the organization determined, provided and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services?
7.1.5Monitoring and measuring resources
7.1.5.1General
1Has the organization determined and provided the necessary resources needed when monitoring and measuring are used to verify conformity to product and service requirement?
2Are resources suitable for the type of monitoring and measurement activities undertaken?
3Are resources maintained to ensure their continuing fitness?
4Does the organization retains appropriate documented information (record) as evidence of fitness for the purpose of the monitoring and measurement resources?
5Does the organization maintains documented information that defines the processes and controls employed to manage monitoring and measurement resources that meet the requirements?
7.1.5.2Measurement traceability
1Is there a requirement for measurement traceability?
2Where measurement traceability is a requirement, is measurement equipment calibrated or verified at a specified interval or prior to use?
3Is the calibration or done against measurements standards traceable to national or international standards?
4Where no such standard is existing, are documented information retained for the basis used for calibration or verification?
5Are the measuring equipment identified in order to determine their status?
6Are the measuring equipment safeguarded from adjustments, damage or deteriorated that would invalidate the calibration and subsequent measurement results?
7Does the organization maintains and retains documented information (records and procedure )demonstrating the conformance and measurement traceability of the measuring equipment used to determine product conformity to requirements? Does it includes some of the Common practice like a measuring equipment register?
8Does documented information includes a unique identification, specific to each piece of equipment?
9Does the organization determine and take appropriate action if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose?
10Does the organization shall retain documented information of the action taken and of customer notification, if product(s) or services have been delivered?
7.1.6Organizational knowledge
1Does the organization determine the knowledge necessary for the operation of its processes and to achieve conformity of product and services?
2Does the organization maintain this knowledge and make it available to the extent necessary?
3While addressing changing needs and trends, does the organization considers its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates?
7.2Competence
1Does the organization determine the necessary competence of its employees whose work affects the performance and effectiveness of the QMS?
2Does the organization ensure that its employees are competent on basis of appropriate education, training or experience?
3Does the organization take applicable actions to acquire the necessary competence and evaluate the effectiveness of action taken?
4Does the organization retain the appropriate documented information as evidence of competence?
7.2.1
1Does the organization validates the competence to the risk level associated with the task?
2Does the organization maintains documented information that defines the practices employed to manage competence requirements of personnel whose responsibilities influence the achievement of quality objectives?
 
3Does it includes developing a competence model that defines a competence catalogue, proficiency levels, criteria for attaining and maintaining proficiency, and resulting competence profiles which can include technical interviews, assessments and online training.
7.3Awareness
1Does the organization ensure that the persons doing work under the organization’s control are aware of its quality policy, relevant quality objectives, their contribution to the effectiveness of QMS including the benefits of improved performance and the implications of not meeting QMS requirements?
2How does the organization ensures that persons doing work under the organization’s control, including external provider’s personnel, are aware of specified regulated and customer quality requirements, risk mitigations and conformity assessment requirements related to their work.?
7.4Communication
1Does the organization determine the internal and external communication relevant to the QMS including on what it will communicate, when to communicate, with whom to communicate, how to communicate, and who communicates?
7.5Documented Information
7.5.1General
1Does the organization’s QMS include documents required by ISO 9001:2015 and documents determined by the organization necessary for the effectiveness of the QMS?
7.5.2Creating and updating
1While creating and updating documented information, does the organization ensure it is appropriate in terms of identification descriptions?
2While creating and updating documented information does the organization ensure that it is in proper format and in the correct media?
3While creating and updating documented information, does the organization ensure that there are appropriate review and approval for suitability and adequacy?
7.5.3Control of documented information
7.5.3.1
1Does the organization control its documented information to ensure that it is available and suitable for use, whenever it is needed?
2Is the documented information adequately protected?
7.5.3.2
1Is the distribution, access, retrieval and use of documented information adequately controlled?
2Is the documented properly stored and adequately preserved and it is legible?
3Is there control of changes (e.g. version control)?
4Are their adequate control in place for retention and disposition?
5Is external origin documented information necessary for planning and operation of QMS appropriately identified and controlled?
6Are records protected for unintended alterations?
7.5.3.3
1The organization shall maintain documented information (Procedure) that defines the processes and controls used to meet the requirements of control of Documented Information?
2When external specification requirements, including addenda, errata, and updates, are used in the design or manufacture of a product or service, does the organization maintain and retain documented information for the practices employed for the integration of these requirements into the related operating processes?
Clause 8Operations
1Does the organization plan, implement and control the processes needed to meet the requirement for the provision of product and services and to implement the action determined in clause 6?
8.1Operation planning and control
1Does the organization determine the requirements for the products and services?
2Has the organization established criteria for the processes and acceptance of products and services?
3How does the organization determine the resources needed to achieve conformity to the product and service requirements?
4How does the organization implement controls of the processes in according with the criteria?
5How does the organization determine, maintain and retain necessary documented information to have confidence that the processes have been carried out as planned and to demonstrate the conformity of products and services?
6How does the organization control its planned changes and review the consequences of unintended changes?
7How does the organization take action to mitigate any adverse effects of its unintended changes?
8How does the organization ensure that outsourced processes are controlled?
9When determining the requirements for the products and services, how does the organization take into account the customer’s scope?
10Do the organization have documented information specifying the processes of the quality management system and the resources to be applied to a specific product, service, project or contract such as a quality plan, service quality plan or inspection and test plan?
11How do the organization maintain documented information as the basis for operational process control and retain documented information to demonstrate conformance has established the controls?
12How does the organization apply change management processes in respect to risks to the achievement of specified requirements and to the realization of improvement opportunities when planning the operations?
13Has the organization established contingency plans as a risk treatment and in case it has does it include roles and responsibility for response, communication, immediate actions?
8.2Requirements for products and services
8.2.1Customer communication
1Does the organization communicate with customers to provide information relating to products and services, handling enquiries, contracts or orders (including any changes)?
2Does the organization obtain customer feedback relating to products and services including customer complaint?
3Does the organization communicate with the customers relating to handling or controlling customer property?
4Has the organization established requirements for contingency action, where required?
8.2.2Determining the requirements for products and services
1Has the organization determined the requirements for product and services to be offered the customer?
2Are the requirements defined and does it includes applicable statutory regulatory requirements and those considered necessary by the organization?
3Can the organization meet the claims for the product and services it offers?
8.2.3Review of the requirements for products and services
8.2.3.1
1Has the organization ensured that it has the ability to meet the requirements for products and services?
2Has the organization conducted a review before committing to supply product and services?
3Has the organization reviewed the requirements specified by the customer, including the requirements for delivery and post-delivery activities?
4Has the organization reviewed the requirements not stated by the customers but necessary for the specified or intended use when know?
5Has the organization reviewed the statutory & regulatory requirements applicable to the product and services and requirements specified by the organization?
6Have the organization reviewed and resolved contract or order requirements differing for those previously defined?
7When the customer does not provide a documented statement of their requirement, does the organization conform to the customer’s requirements before acceptance?
8.2.3.1.1
1Does the organization maintain documented information (Procedure )that defines the process for the review of requirements related to the provision of products or services?
8.2.3.2
1Does the organization retain documented information on the results of the review and on any new requirements for the products and services?
8.2.4Changes to requirements for products and services
1Does the organization ensure that the relevant documented information is amended and the relevant persons are made aware of the changed requirements when the requirements for the products and services are changed?
8.3Design and development of products and services
8.3.1General
1 Has the organization established, implemented and maintain a D&D process that is appropriate to the subsequent provision of product and services?
8.3.2Design and development planning
1In determining the stages and controls for D&D, has the organization is taken into consideration the nature, duration and complexity of D&D activities?
2In determining the stages and controls for D&D, has the organization taken into consideration the required process stages including D&D reviews?
3In determining the stages and controls for D&D, has the organization taken into consideration the D& D verification and validation activities?
4In determining the stages and controls for D&D, has the organization taken into consideration the responsibilities and authorities involved in the D&D process?
5In determining the stages and controls for D&D, has the organization taken into consideration the external and internal resources needed?
6In determining the stages and controls for D&D, has the organization taken into consideration the need to control interfaces between persons involved in D&D?
7In determining the stages and controls for D&D, has the organization taken into consideration the need for involvement of customer and user?
8In determining the stages and controls for D&D, has the organization taken into consideration the requirements of the subsequent provision of product and services?
9In determining the stages and controls for D&D, has the organization taken into consideration the level of the control expected for the D&D by customers and other relevant interested parties?
10In determining the stages and controls for D&D, has the organization taken into consideration the documented information needed to demonstrate that design and development requirement has been met?
11How does the organization ensures that ensure that the required activities for managing risks and opportunities are incorporated in the design development process?
12Has the organization maintained documented information (Procedure) that defines the processes used to plan and control design and development activities of products and/or services?
8.3.3Design and Development inputs
1Has the organization determined the essential requirements for the specific types of products and services to be designed and developed?
2Does the organization consider the following functional and performance requirements; statutory and regulatory requirements; standards or code of practices that the organization has committed to implement; information derived from previous design and development activities; potential consequences of failure due to the nature of the product and services?
3Does the organization ensure that the inputs are adequate for D&D purpose, complete and unambiguous?
4Does the organization resolve the conflicting D&D inputs?
5Are documented information for D&D inputs retained?
6Has the organization included environmental and safety conditions as the Performance requirements?
7Has the organization considered outputs of process of managing risks and opportunities?
8.3.4Design and development controls
1Has the organization applied the necessary controls to D & D processes to ensure that the result to be achieved are defined?
2Has the organization conducted a review to evaluate the ability of the results of D& D to meet the requirements?
3Has the organization conducted the verification to ensure that D&D meet input requirements?
4Has the organization conducted the validation to ensure that the resulting product and service meet the requirements of the specified application or intended use?
5Has the organization taken necessary action on the problems determined during reviews, verification or validation activities?
6Has the organization retained documented information on the above-mentioned activities?
8.3.5Design and Development outputs
1Does the organization ensure that D&D outputs meet the input requirements?
2Does the organization ensure that D&D outputs are adequate for the subsequent processes for the provision of product and services?
3Does the organization ensure that D&D outputs include (or has reference) monitoring and measuring requirements and acceptance criteria?
4Does the organization ensure that D&D outputs specify the characteristics of the products and services that are essential for their intended use?
8.3.6Design and Development changes
1Has the organization identified, reviewed and controlled changes made during, or subsequent to the D & D of the product and services to ensure that there is no averse to the impact on conformity to requirement?
2Has the organization retained the documented information on D&D changes, the result of reviews, authorization of the changes and the action taken to prevent adverse impact?
8.4Control of externally provided processes, products and services
8.4.1General
1Does the organization ensure that the externally provided processes, products and services conform to the requirements?
2Does the organization determine the controls needed when the product and services from the external providers are incorporated into their own product and services?
3Does the organization determine the controls needed when the product and services from the external providers are provided directly to the customer by external providers?
4Does the organization determine the controls needed when the process or part of the process is provided by the external providers?
5Has the organization determined and applied the criteria for selection, evaluation, monitoring of performance and re-evaluation of external providers?
6Has the organization retained the documented information of these activities and any action arising out or evaluation/re-evaluation?
8.4.2Type and extent of control
1Does the organization ensure that the externally provided processes, product and services do not adversely affect its ability to consistently deliver conforming products and services to the customers?
2Does the organization ensure that the externally provided process remains within the control of its QMS?
3Has the organization defined the controls to be applied to an external provider and its resulting outputs?
4Has the organization taken into consideration the potential impact of the organization’s ability to consistently meet customer and applicable statutory and regulatory requirement?
5Has the organization taken into consideration the effectiveness of the controls applied by the external providers?
6Has the organization determined the verification or other activities, necessary to ensure that the externally provided processes, products and services meet requirements?
8.4.2.1
1How does the organization assess external provider performance at planned intervals, and adjust the type and extent of controls to manage associated risks and opportunities?
2Has the organization maintained documented Information (procedure ) that defines how the requirements of type and extent of control of externally provided processes, products and services are met?
3 How does the organization addresses the determination of the risks to the achievement of specified requirements and to the realization of improvement opportunities for the products and/or services to conformance to specified requirements?
4Has the organization retained documented information (records) that demonstrates the effectiveness of verification, or other activities, necessary to ensure that the externally provided
processes, products and services meet requirements?
8.4.3Information for external providers
1Does the organization ensure the adequacy of requirements prior to their communication to the external provider?
2Does the organization communicate to the external providers its requirements for the processes, products and services required?
3Does the organization communicate to the external providers its requirements for the approval of the product and services; methods, processes and equipment; the release of product and services?
4Does the organization communicate to the external providers its requirements for competence including any qualification of persons?
5Does the organization communicate to the external providers its requirements for external provider’s interactions with the organizations?
6Does the organization communicate to the external providers its requirements for control and monitoring of the external providers’ performance to be applied by the organization?
7Does the organization communicate to the external providers its requirements for verification or validation activities that the organization or its customer intends to perform at the external providers’ premises?
8.5Production and Service provision
8.5.1Control of production and service provision
1Has the organization implemented production and service provision under controlled conditions?
2 Are there any documented information available that defines the characteristics of the product, services or activities to be performed and the results to be achieved?
3Are any suitable monitoring and measuring resources available? Are they being used?
4Are monitoring and measuring activities being performed at appropriate stages?
5Are competent persons (including qualification) being appointed?
6Is the infrastructure and environment being used suitable for operation of processes?
7Has the organization implemented any actions to prevent human error?
8Has the organization implemented any release, delivery and post-delivery activities?
9Where resulting output cannot be verified by subsequent monitoring or measurement, has the organization conducted validation and periodic revalidation of the process for production and service provision?
8.5.1.1
1For the validation and periodic revalidation has the organization considered required equipment, competence of personnel, use of specific methods, including identified operating parameters, identification of acceptance criteria and revalidation.
2How does the organization maintains documented information that defines the controls used to meet the requirements of Control of production and service provision?
3How does the organization retain documented information (records) to demonstrate the control effectiveness?
8.5.2Identification and traceability
1Has the organization used any suitable means to identify output when it is necessary to ensure the conformity of products and services?
2Has the status of outputs with respect to monitoring and measuring requirements throughout the production and service provision being identified by the organization?
3Has the organization controlled the unique identification of the outputs when traceability is a requirement?
4Has the organization retain the documented information necessary to enable traceability, when traceability is a requirement?
8.5.2.1
1How does the organization maintains documented information that defines the processes used to meet the requirements of Identification and traceability?
8.5.3Property belonging to customers or external providers
1When property belonging to customers or external providers is under the organization’s control or being used by the organization, does the organization exercise adequate care?
2Does the organization identify, verify, protect and safeguard customers’ or external providers’ property?
3When the property or the customer or external provider is lost, damaged or otherwise, fount to be unsuitable for use, does the organization report this to the customer or external provider? Does the organization retain documented information on what has occurred?
8.5.3.1
1How does the organization maintains documented information that defines the processes that are used to meet the requirements of Property belonging to customers or external providers?
8.5.4Preservation
1Does the organization preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements?
2Does the organization maintains documented information (Procedure ) for risk-based preservation?
3Does the documented information defines the methods used to preserve products, including environment controls , and constituent parts throughout operations, delivery to the intended destination, and/or service delivery, in order to maintain conformity to requirements?
Does the documented information defines the storage areas designated to prevent damage or deterioration of product and constituent parts, pending use or delivery?
4Does the documented information defines the type and frequency of assessment, appropriate to the product being assessed, to detect deterioration?
5Does the documented information defines the identification and traceability marks, transportation, handling, packaging, and protection requirements, as applicable?
Post-delivery activities
8.5.5
1Does the organization meet requirements for post-delivery activities associated with the product and services?
2In determining the extent of post-delivery activities does the organization considers the statutory & regulatory requirements; the potential undesired consequences associated with its product and services; customer requirement & feedback; nature, use and intended lifetime of its product and services?
8.5.6Control of change
1Do the organization conduct review and control changes for production or service provision to ensure continuing conformity with requirements? The changes for production or service provision includes
a) the organizational structure;
b) key or essential personnel;
c) critical providers;
d) design;
e) the management system.
2How does the organization notify customers where changes impact product and/or services to be delivered to the customer?
3Does the organization retain documented information describing the results of the review of changes, the person(s) authorizing the change and any necessary actions arising from the review?
4How does the organization reviews changes resulting from assessments of risks and opportunities and corrective actions?
5When specified how does the the organization notifies the customer of the effect of changes on residual or new risks?
8.6Release of products and services
1Has the organization implemented planned arrangements, at appropriate stages, to verify that the product and service requirements have been met?
2Does the organization ensure that the release of product and service proceed only after the planned arrangement is satisfactorily completed or approved by the relevant authority and as applicable by the customer?
3Does the organization retain the documented information on the release of products and services and it includes information relating to the evidence of conformity with the acceptance criteria; traceability of the person authorizing the release?
4How does the organization maintains documented information that defines the processes that are used to meet the requirements of Release of products and services?
8.7Control of nonconforming outputs
8.7.1
8.7.1
1Does the organization ensure that the outputs which do not conform to their requirements are identified and controlled to prevent their unintended use or delivery?
2Is the action appropriate to the nature of the nonconformity and its effect on the conformity of products and services?
3Do the organization also consider nonconforming product and services detected after delivery of products, during and after the provision of services?
4When non-conforming products and services are detected does the organization take correction action and/or segregation, containment, return, or suspension of the provision of product & services and/or informing the customer and/or obtaining authorization for acceptance under concession?
5How are the Conformity to the requirements shall be verified when nonconforming outputs are corrected?
8.7.1.1
1How does the organization maintains documented information that defines the processes that are used to meet the requirements of Control of nonconforming outputs?
8.7.2
1Does the organization retain documented information that describes the nonconformity; describes the actions taken; describes any concession obtained; identifies the authority deciding the action in respect of the nonconformity?
Clause 9Performance evaluation
9.1Monitoring, measurement, analysis, and evaluation
9.1.1General
1Did the organization plan how to monitor, measure, analyze, and evaluate its QMS?
2Did the organization plan how to monitor QMS performance and effectiveness?
3Did the organization figure out what needs to be monitored and select methods?
4Did the organization determine its QMS monitoring requirements?
5Does the organization select monitoring methods that can produce valid results?
6Did the organization establish when monitoring should be done and who should do it?
7Did the organization plan how to measure QMS performance and effectiveness?
8Did the organization figure out what needs to be measured and did the organization select methods?
9Did the organization determine its QMS measurement requirements?
10Does the organization select measurement methods that can produce valid results?
11Did the organization establish when measuring should be done and who should do it?
12Did the organization plan how to analyze QMS performance and effectiveness?
13Did the organization select analytical methods that are capable of producing valid results?
14Did the organization decide when monitoring and measurement results are analyzed?
15Did the organization plan how to evaluate QMS performance and effectiveness?
16Did the organization select evaluation methods that are capable of producing valid results?
17Did the organization decide when monitoring and measurement results are evaluated?
18Do the organization monitor, measure, analyze, and evaluate the organization’s QMS?
19Does the organization monitor the performance and effectiveness of the organization’s QMS?
20Do the organization record monitoring results and does the organization retain and control these records?
21Does the organization measure the performance and effectiveness of the organization’s   QMS?
22Do the organization record measurement results and does the organization retain and control these records?
23Does the organization analyze the performance and effectiveness of its   QMS?
24Do the organization record analytical results and does the organization retain and control these records?
25Does the organization evaluate the performance and effectiveness of its QMS?
26Do the organization record evaluation results and does the organization retain and control these records?
9.1.2Customer satisfaction
1Does the organization establish methods that the organization can use to monitor customer perceptions?
2Does the organization figure out how the organization is going to obtain information about how customers feel about how well it is meeting their needs and expectations?
3Does the organization figure out how the organization is going to review information about how customers feel about how well it is meeting their needs and expectations?
4Do the organization monitor how well customer needs and expectations are being fulfilled?
5Do the organization monitor how the organization’s customers feel about how well the organization is meeting their needs and expectations (do the organization monitor the organization’s customers’ perceptions)?
6How does the organization maintains documented information that defines the process employed to measure customer satisfaction?
9.1.3Analysis and evaluation
1Does the organization analyze its monitoring and measurement results?
2Does the organization analyze and evaluate appropriate data and information?
3Does the organization use its analytical results to evaluate performance?
4Does the organization evaluate the performance of its QMS?
5Does the organization determine if it needs to improve its performance?
6Does the organization evaluate the performance of its external providers?
7Does the organization use its analytical results to evaluate effectiveness?
8Does the organization evaluate the effectiveness of its QMS?
9Does the organization determine if it needs to improve its effectiveness?
10Does the organization evaluate the effectiveness of its planning?
11Does the organization determine if its plans were effectively implemented?
12Does the organization evaluate the effectiveness of its actions?
13Does the organization evaluate the effectiveness of actions taken to address risks?
14Does the organization evaluate the effectiveness of actions taken to address opportunities?
15Does the organization use its analytical results to evaluate conformity?
16Does the organization evaluate the conformity of products and services?
17Does the organization use its analytical results to evaluate satisfaction?
18Does the organization evaluate the degree of customer satisfaction?
19How does the organization maintain documented information that defines the process for the identification, collection and analysis of data to demonstrate the suitability and effectiveness of the quality management system?
20Does the analysis includes include data generated from monitoring and measurement,
internal audits, management reviews, and other relevant sources?
9.2Internal Audit
9.2.1
1Does the organization conduct internal audits at planned intervals?
2Did the organization plan a program that can find out if QMS meets the Organization’s own requirement and ISO 9001:2015 requirements?
3Did the organization plan a program that can find out if QMS is effectively implemented and maintained?
9.2.2
1Did the organization plan, establish, implement, and maintain an audit program?
2Did the audit program include the frequency, methods, responsibilities, planning requirements, and reporting?
3Does the audit program take into consideration the importance of the process concerned, changes affecting the organization, and the results of previous audits?
4Did the organization define the audit criteria and scope of each audit?
5Does the organization ensure that the audit is conducted by the auditors to ensure objectivity and impartiality of the audit process?
6Does the organization ensure that the results of the audits are reported to relevant management?
7Does the organization take appropriate correction and corrective action without undue delays?
8Does the retain documented information as evidence of the implementation of the audit program and the audit results?
9.2.3
1How does the planned intervals of internal audits takes into consideration the risks and
opportunities associated with the process of Operational planning and control and the results of performance evaluation?
9.3Management review
9.3.1General
1Does the Top Management review the organization QMS at planned intervals?
2Does the review ensure QMS’s continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization?
9.3.2Management review inputs
1Does the review take into consideration the status of actions from previous management reviews?
2Are the changes in external and internal issues relevant to QMS considered?
3Does the review take into consideration information on the performance and effectiveness of the QMS?
4Does the review take into consideration customer satisfaction and feedback from relevant interested parties?
5Does the review take into consideration the extent to which the quality objectives have been met?
6Does the review take into consideration the process performance and conformity of products and services?
7Does the review take into consideration nonconformities and corrective actions?
8Does the review take into consideration monitoring and measuring results?
9Does the review take into consideration audit results?
10Does the review take into consideration the performance of external providers?
11Does the review take into consideration the adequacy of resources?
12Does the review take into consideration the effectiveness of actions taken to address risks and opportunities?
13Does the review take into consideration the opportunities for improvement?
9.3.3Management review outputs
1Do the outputs of the Management review include decisions and actions related to the opportunities for improvement; any need for changes to the QMS; and resources needed?
2Does the organization retain documented information as evidence of the result of the management review?
Clause 10Improvement
10.1General
1Has the organization determine and select opportunities for improvement?
2Has the organization implemented any necessary action to meet customer requirements and enhance satisfaction?
3Has the organization taken action for improving products & services to meet requirements as well as to address future needs and expectations?
4Has the organization taken action for correcting, preventing, or reducing undesired effects?
5Has the organization taken action for improving the performance and effectiveness of the QMS?
10.2Nonconformity and corrective action
1When any nonconformity (including complaints) occurs, does the organization take action to control and correct it and deal with the consequences?
2When any nonconformity (including complaints) occurs, does the organization evaluate the need for action to eliminate the causes of the nonconformity?
3Does the organization reviews and analyzes the nonconformity?
4Does the organization determine the causes of the nonconformity?
5Does the organization determine similar nonconformity exist or could potentially occur?
6Has the organization implemented any action needed?
7Has the organization reviewed the effectiveness of the corrective action taken?
8Has the organization updated risk and opportunities determined during planning if necessary?
9Has the organization made changes to the QMS if necessary?
10Are the corrective actions appropriate to the effects of the nonconformities encountered?
10.2.2
1Does the organization retain documented information on the nature of the nonconformities and any subsequent actions taken; and the result of any corrective action?
2How does the organization maintains documented information that defines the processes that are used to meet the requirements of Nonconformity and corrective action?
10.3Continual improvement
1Does the organization continually improve the suitability, adequacy, and effectiveness of the QMS?
2Does the organization consider the results of analysis and evaluation, and output from management review to determine if there are needs or opportunities to be addressed as part of continual improvement?
10.3.1
1Does the implementation of improvements shall be subject to management of change processes in accordance with planning of change?
2How does the organization maintains documented information that defines the processes that are used to meet the requirements of Continual improvement?
3Does the organization retains documented information to demonstrate its effectiveness?

Example of Quality Manual based on API Q1 and/ or ISO 29001:2020

0. Introduction

0.1 The Company

// Include your company profile

 0.2 Products & Services

// Include your company’s product and services

1.0 Scope

1.0 Scope for ISO 29001:2020

1.0 Scope for API Q1

      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 on the basis of 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, in accordance with 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

2.0 Normative References for ISO 29001:2020

2.0 Normative References for API Q1

1. ISO 29001: 2020                   Petroleum, petrochemical and natural gas industries

— Sector-specific quality management systems

— Requirements for product and service supply organizations.

2. ISO 9000: 2015                     Quality management systems – Fundamentals and Vocabulary

3. ISO 19011:2011                 Guidelines for auditing Management System.

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

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

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

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

3.0 Terms & Definitions.

3.0 Terms & Definitions for ISO 29001:2020

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

That deemed by the XXX, product specification, 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

Representative sample of a product, component, or output from a process 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

Obligation 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 installation is required by applicable product specifications

4.0 QUALITY MANAGEMENT SYSTEM – REQUIREMENTS

4.0 Quality Management System – Requirements for API Q1

4.0 Context of the Organization 

4.0 Context of the Organization  for ISO 29001:2020

  1. 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 prior to issue; and are identified with respect to their revision level.
  2. 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.
  3. Quality Records are retained for a minimum period of 5 Years as required by the customer/API product specifications.

4.1 QUALITY MANAGEMENT SYSTEM

4.1 Quality Management System for API Q1

4.1.1 General

4.1.1 General for API Q1

4.4 Quality management system and its processes for ISO 29001:2020

XXX has established, documented, implemented, and maintained at all times a Quality Management System for all products and service provided for use in the petroleum and natural gas industry. XXX measures the effectiveness and improves upon the Quality Management System in accordance with the requirements of API Spec Q1, 9th Edition & ISO 9001:2015. Processes for XXX with inputs, outputs and sequences are given in Annexure-II & III. Processes include:

  1. Trading of items (Procurement from Agents / Principals & supply to customers)
  2. Repair & refurbishment of static & rotating equipment at Workshop
  3. IT department (Maintenance of systems & support of software and hardware for departments)
  4. HR & Administration (Recruitment & Recording employee attendance, Leaves, Plan for training and renewal of licenses)

Outsourced processes:  Calibration of equipment is outsourced to external calibration agency. Transportation / delivery of products are often outsourced if necessary. The performance of the outsourced agencies are monitored and controlled. Necessary resources for the processes are provided by the management 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 InformationRef. no
Overall Process Map   Annexure – II
Process Maps : for processes   Annexure – III

4.1.2 Quality Policy

4.1.2 Quality Policy for API Q1

5.2 Policy For ISO 29001:2020

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 commitment to satisfy applicable requirements and continual improvements of the Quality Management system.

Documented Quality Policy is shown in 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 it’s Objectives (Refer 4.1.3), and is communicated, understood, implemented, and maintained at all relevant functions and levels within the XXX. The policy includes a commitment to the company with requirements and continually improves the effectiveness of the quality management system in accordance with specifications API Q1 and ISO 29001:2022.

Authority 

Quality policy is established by the top management and is approved by the Chairman. Any changes to the policy must be approved by the General Manager.

Role of the policy

The main role of the Quality policy is to communicate the company’s commitments and aspirations with regard to 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 in Refer 4.1.3.

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 on 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 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

4.1.3 Quality Objectives for API Q1

6.2 Quality objectives and planning to achieve them for ISO 29001:2020

Quality objectives for all processes are defined and are available with the respective department heads. These are consistent with the quality policy and measurable. Quality Objectives are defined with focus on achieving products and service conformity and enhancing customer satisfaction. Objectives are monitored and communicated. Documented information of Quality Objectives are 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 achievements of the Objectives is done covering the action plan, resources responsibility and time period. The performance is measured and monitored by the relevant Departments and Management Representative.

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 in 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 Planning of API Q1

Management ensures that:

a) Criteria and methods needed for the operation and control of all Quality Management System processes are determined, managed, and effective; and

b) Planning of the Quality Management System is carried out in order to meet the requirements of this specification.

4.4.1.1  Understanding the organization and its context

4.1 Understanding the organization and its context of ISO 29001:2020

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 meets the intended result(s) of the Quality Management System. Organization contexts related to internal & external issues that are relevant and can affect its ability to achieve intended results of the QMS are identified and documented by the respective departments with proposed actions. Information about these external and internal issues are regularly monitored and reviewed.

4.4.4.2  Understanding the needs and expectations of interested parties

4.2 Understanding the needs and expectations of interested parties of ISO 29001:2020

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, Government / Regulatory Bodies. The needs and expectations of interested parties are identified and taken care by the departments. Management of XXX is always committed to fulfill the needs and expectations of all interested parties. The main needs and expectations of the interested parties are given below.

4.1.5 Communication

4.1.5 Communication of API Q1

7.4 Communication of ISO 29001:2020

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 process to ensure that:

a) Importance of meeting customer, legal, and other applicable requirements is communicated at relevant functions within the XXX; and

b) Results of analysis of data are communicated at relevant levels and functions within XXX.

c)  Internal communications in XXX are done by internal memo, e-mail communication, phone calls, meetings, trainings and tool box meetings.

4.1.5.2 External

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

a) Execution of inquiries, contracts, or order handling and amendments

b) Provision of product information, including product nonconformities identified after delivery to the customer (Refer 5.10.4);

c)  Feedback and customer complaints (Refer 6.2.1),

d) When required by contract, providing information required by product quality plans and subsequent changes to those plans (Refer 5.7.2).

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

The point of contact for 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 Machine shop Manager & Quality Systems Manager.

4.2 MANAGEMENT RESPONSIBILITY

4.2 Management Responsibility of API Q1

4.2.1 General

4.2.1 General of API Q1

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:

a) Ensuring that Quality Objectives are established including key performance indicators for use in data analysis; and

b) Conducting Management Reviews (Refers 6.5).

4.2.1.1 Leadership and commitment

5.1 Leadership and commitment of ISO 29001:2020

 XXX’s Management has demonstrated leadership and commitment with respect to the quality management system through

  1. Taking accountability for the effectiveness of the quality management system by periodical review of quality management system through management review meeting, Quality objectives review and providing necessary resources.
  2. 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.
  3. Management has determined the organizational processes and integrated with the quality management system requirement through process map & Interaction this can be demonstrated.
  4. The established procedure for promoting the use of the process approach and risk-based thinking.
  5. Ensuring that the resources needed for the quality management system are available, this is being periodically reviewed through management review meeting.
  6. Communicating the importance of effective quality management and of conforming to the quality management system requirements
  7. Ensuring that the quality management system achieves its intended results
  8. Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system by providing training, conducting awareness programs and
  9. Promoting improvement by introducing the suggestion scheme, Kaizens and conducting meetings.
  10. Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

4.2.1.2 Customer focus

5.1.2 Customer focus of ISO 29001:2020

Xxx management has demonstrated leadership and commitment with respect to customer focus by ensuring that:

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

4.2.2 Responsibility and Authority

4.2.2 Responsibility and Authority of API Q1

5.3 Organizational roles, responsibilities and authorities of ISO 29001:2020

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

  1. The quality management system conforms to the requirements of this API Q1 and/or ISO 29001:2020 standard.
  2. The processes are delivering their intended outputs
  3. Reporting on the performance of the quality management system and on opportunities for improvement, in particular, to top management
  4. The promotion of customer focus throughout the organization
  5. 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

4.2.3 Management Representative of API Q1

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

  1. Ensuring that processes needed for the Quality Management System are established, implemented, and maintained;
  2. Reporting to top management on the performance of the Quality Management System and any need for improvement;
  3. Ensuring initiation of action(s) to minimize the likelihood of the occurrence of nonconformities (Refer 6.4.3); and
  4. Ensuring the promotion of awareness of customer requirements throughout XXX.

4.3 ORGANIZATION CAPABILITY

4.3 Organization Capability of API Q1

4.3.1 Provision of Resources

4.3.1 Provision of Resources of API Q1

7.1 Resources of ISO 29001:2020

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.  For determining the resources, capabilities and constraints of internal resources and required competency are considered.

4.3.1.1 People & Infrastructure

7.1.2 People and 7.1.3 Infrastructure of ISO 29001:2020

Requirement 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 workshop
  • Information and communication technology

 4.3.1.2 Organizational Knowledge

7.1.6 Organizational knowledge of ISO 29001:2020

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 are documented and shared. Service related information (e.g. discrepancies, customer grievances) are documented and shared. Whenever there is a changing requirements, acquiring or access of additional knowledge or updates are done and documented by concerned department.

4.3.2 Human Resources

4.3.2 Human Resources of API Q1

4.3.2.1 General       

4.3.2.1 General of API Q1       

7.1.2 People of ISO 29001:2020

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 provision for determining and documenting the effectiveness of the training or other actions taken toward the achievement of required competency.

4.3.2.2 Personnel Competence

4.3.2.2 Personnel Competence of API Q1

7.2 Competence of ISO 29001:2020

Management ensures that the personnel performing work which affects conformity to service requirements are competent on the basis of 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 and Awareness

4.3.2.3 Training and Awareness of API Q1

7.3 Awareness of ISO 29001:2020

Personnel of each department are made aware of quality policy, and objectives for the department and their contribution to effective Quality management System. Effect of non-conformity in their work are also made aware of. XXX

  1. Provides Quality Management System training and job training;
  2. Ensures that customer-specified training and/or customer-provided training, when required, is included in the training program;
  3. Ensures that the frequency and content of training is identified;
  4. 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
  5. Maintains appropriate records of education, training, skills, and experience

4.3.3 Work Environment

4.3.3 Work Environment of API Q1

7.1.4 Environment for the operation of processes of ISO 29001:2020

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

  1. Buildings, workspace, and associated utilities;
  2. Process equipment and its maintenance (both hardware and software) (Refer 5.7.8);
  3. Supporting services (e.g. transport, communication, information systems); and
  4. Conditions under which work is performed such as physical, environmental, or other factors.

4.4 DOCUMENTATION REQUIREMENTS

4.4 Documentation Requirements of API Q1

7.5 Documented information of ISO 29001:2020

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

4.4.1 General

4.4.1 General of API Q1

The Quality Management System documentation includes:

  1. Statements of Quality Policy and Quality Objectives;
  2. A Quality Manual that addresses the requirements specified in the standards API Q1 & ISO 29001:2020
    • The scope of the Quality Management System, including justification for any exclusion to specific Quality Management System elements (Refer 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 (Refer 5.7.1.5); 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

4.4.2 Procedures of API Q1

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

4.4.2.1 Creating & updating documentation

7.5.2 Creating and updating of ISO 29001:2020

Following are ensured while creating & updating documentation.

  1. Identification & description (title, date, reference no)
  2. Format is maintained in system or as hard copy.
  3. Reviewed and approved by authorized person (department head or by MR, as applicable).  

4.4.3 Control of Documents

4.4.3 Control of Documents of API Q1

7.5.3 Control of documented information of ISO 29001:2020

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 Use of External Documents in Product Realization

4.4.4 Use of External Documents in Product Realization of API Q1

7.5.3 Control of documented information of ISO 29001:2020

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.

4.5 CONTROL OF RECORDS

4.5 Control Of Records of API Q1

7.5.3 Control of documented information of ISO 29001:2020

XXX maintains a documented procedure to identify the controls and responsibilities needed for the identification, collection, storage, protection, 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 five years or as required by customer, legal, and other applicable requirements, whichever is longer.

5.0 PRODUCT REALIZATION

5.0 Product Realization of API Q1

8 Operation of ISO 29001:2020

Planning of 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 requirement 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 requirement for records necessary to demonstrate process and product conformity.

5.1 CONTRACT REVIEW

5.1 Contract Review of API Q1

8.2 Requirements for products and services of ISO 29001:2020

5.1.1 General

5.1.1 General of API Q1

8.2.3 Review of the requirements for products and services of ISO 29001:2020

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

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

  Record is maintained for the results of review of contracts.

 5.1.1.1 Customer communication

8.2.1 Customer communication of ISO 29001:2020

Communication with customers is include

  1. Providing information relating to products and services
  2. Handling inquiries, contracts or orders, including changes
  3. Obtaining customer feedback relating to products and services, including customer complaints
  4. Handling or controlling customer property
  5. 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.

5.1.2 Determination of Requirements

5.1.2 Determination of Requirements of API Q1

8.2.2 Determining the requirements for products and services for ISO 29001:2020

XXX determines:

  1. Requirements specified by the customer;
  2. Legal and other applicable requirements; and
  3. 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 maintained.

5.1.3 Review of Requirements

5.1.3 Review of Requirements of API Q1

8.2.3 Review of the requirements for products and services of ISO 29001:2020

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:

  1. Requirements are identified and documented;
  2. Requirements differing from those previously identified are resolved; and
  3. 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

5.2 Planning of API Q1

8.1 Operational planning and control of ISO 29001:2020

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

  • 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

Schedule for delivery is prepared at the quotation stage including service requirements if any. The schedule for delivery and services are monitored for identifies and plans 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:

  1. Required resources and work environment management (Refer 4.3);
  2. Product and customer-specified requirements (Refer 5.1);
  3. Legal and other applicable requirements;
  4. Contingencies based on risk assessment (Refer Risk Assessment and Management) and (Refer Contingency Plan);
  5. Design and development requirements (Refer Design & Development);
  6. Required verification, validation, monitoring, measurement, inspection, and test activities specific to the product and the criteria for product acceptance;
  7. Management of change (MOC) (Refer Management of Change) and
  8. 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:

  1. Definition and evaluation of manufacturing operations and process
  2. Development of adequate and capable process
  3. Identification of special process
  4. Consideration of associated risks and consequences
  5. Establishment and implementation of appropriate process control measures
  6. Development of instructions and training for process operators, and
  7. Requirements for records necessary to demonstrate process conformity
  8. 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.,
  9. QMS Procedures related to Control of Production, 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:

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

5.3 RISK ASSESSMENT AND MANAGEMENT

5.3 Risk Assessment and Management of API Q1

6.1 Actions to address risks and opportunities of ISO 29001:2020

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 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 risks, issues and the controls thereof are maintained as Documented Information by the department heads.  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 risk associated with impact on delivery and quality of product. The procedure identifies the techniques, tools and their application for risk identification, assessment, and mitigation.

Risk assessment associated with product delivery includes:

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

Risk assessment associated with product quality includes, as applicable:

  • Delivery of nonconforming product (Refer 5.10.1);
  • Availability of competent personnel.

Records of risk assessment and management including actions taken and maintained

5.4 DESIGN AND DEVELOPMENT

5.4 Design and Development of API Q1

8.3 Design and development of products and services of ISO 29001:2020

5.4.1 Design and Development Planning

5.4.1 Design and Development Planning of API Q1

8.3.1 General and 8.3.2 Design and development planning of ISO 29001:2020

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

  1. The plan(s), including plan updates, used for design development;
  2. The design and development stages;
  3. The resources, responsibilities, authorities, and their interfaces to ensure effective communication;
  4. The review, verification, and validation activities necessary to complete each design and development stage; and
  5. The requirements for a final review of the design (Refer 5.4.5).

When design and development activities are performed at different locations within XXX, The procedures identify the controls required to ensure that the designs meet the requirements of (Refer Design and Development). When design and development are outsourced, XXX ensures the supplier meets the requirements of (Refer 5.6.1.6).

5.4.2 Design and Development Inputs

5.4.2 Design and Development Inputs of API Q1

8.3.3 Design and development inputs of ISO 29001:2020

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

  1. Customer-specified requirements (Refer 5.1);
  2. Requirements provided from external sources, including API product specifications;
  3. Environmental and operational conditions;
  4. Methodology, assumptions, and formulae documentation;
  5. Historical performance and other information derived from previous similar designs;
  6. Legal requirements; and
  7. Results from risk assessments (Risk Assessment and Management).

Records of design inputs are maintained.

5.4.3 Design and Development Outputs

5.4.3 Design and Development Outputs of API Q1

8.3.5 Design and development outputs of ISO 29001:2020

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

Outputs:

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

Records of design outputs are maintained.

5.4.4 Design and Development Review

5.4.4 Design and Development Review of API Q1

8.3.4 Design and development controls of ISO 29001:2020

At suitable stages, review(s) performed:

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

Participants in such review(s) include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the review(s) and any necessary actions are maintained.

5.4.5 Design and Development Verification and Final Review

5.4.5 Design and Development Verification and Final Review of API Q1

8.3.4 Design and development controls of ISO 29001:2020

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

5.4.6 Design and Development Validation and Approval

5.4.6 Design and Development Validation and Approval of API Q1

8.3.4 Design and development controls of ISO 29001:2020

Design and development validation is performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the specified requirements. Validation is completed prior to the delivery of the product, when possible. The completed design is approved after validation. Competent individual(s) other than the person or persons, who developed the design, approve the final design. Records of the design and development validation, approval, and any necessary actions are maintained

5.4.7 Design and Development Changes

5.4.7 Design and Development Changes of API Q1

8.3.6 Design and development changes of API Q1

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

5.5 CONTINGENCY PLAN

5.5 Contingency plan of API Q1

8.1 Operational planning and control of ISO 29001:2020

5.5.1 General

XXX maintains a documented procedure for Contingency Planning and needed to address Risk associated with impact on delivery and quality of product. Contingency planning is based on assessed risks, and output is documented and communicated to the relevant personnel and updated as required.

5.5.2 Planning Output   

The contingency plan includes, at a minimum:

  1. Actions required in response to significant risk scenarios to mitigate effects of disruptive incidents;
  2. Identification and assignment of responsibilities and authorities; and
  3. Internal and external communication controls (Refer 4.1.5).

5.6 PURCHASING

5.6 Purchasing of API Q1

8.4 Control of externally provided processes, products and services of ISO 29001:2020

5.6.1 Purchasing Control

5.6.1 Purchasing Control of API Q1

8.4.1 General of ISO 29001:2020

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 IT department based on credentials and past experience  

5.6.1.1 Procedure

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

The procedure address:

  1. Identification of critical products, components or activities;
  2. Initial evaluation and selection of suppliers based on their ability to supply products, components or activities in accordance with the XXX requirements (Refer 5.6.1.2 and 5.6.1.3);
  3. Type and extent of control applied to the supply chain for critical products, components or activities;
  4. Criteria, scope, frequency, and methods for reassessment of suppliers;
  5. Maintaining a list of approved suppliers and scope of approval; and
  6. Type and extent of control to be applied to outsourced activities (Refer 5.6.1.6).

5.6.1.2 Initial Supplier Evaluation – Critical Purchases

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

  1. Verification that the supplier’s Quality Management System conforms to the quality system requirements specified for suppliers by XXX; and
  2. Verification of the type and extent of control applied by the supplier, internally and to their supply chain, in order to meet XXX requirements; and
  3. 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.

5.6.1.3 Initial Supplier Evaluation – Noncritical Purchases

For 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 5.6.1.2 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.

5.6.1.4 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 5.6.1.2 is apply. For the re-evaluation of suppliers of non-critical products, components or activities, the requirements of Refer 5.6.1.3 is apply.

5.6.1.5 Supplier Evaluation – Records

Records of the results of all evaluations and any necessary actions arising from the evaluations will be maintained.

5.6.1.6 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 workshop, calibration of equipment is outsourced to external calibration agency. Transportation / delivery of products are often outsourced if necessary. The performance of the outsourced agencies are monitored and controlled. Records of outsourced activities are maintained.

5.6.2 Purchasing Information

5.6.2 Purchasing Information of API Q1

8.4.3 Information for external providers of ISO 29001:2020         

After confirmation of orders by 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 prior to their communication to the supplier. Purchasing information provided to the supplier documented and adequately describe the product or activity to be purchased, including acceptance criteria, and where appropriate:

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

5.6.3 Verification of Purchased Products or Activities

5.6.3 Verification of Purchased Products or Activities of API Q1

8.4.2 Type and extent of control of ISO 29001:2020

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

  1. External Providers are selected on the basis of their credentials, capability to meet the requirements of the concerned products / services and their past record of supply.
  2. Performance of external providers is monitored on the basis of quality of the product & services supplied and delivery commitments. Records of their evaluations are maintained.
  3. Verification / inspection of products & services are 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. For critical products, components or activities, the procedure addresses the following:

  1. Review of XXX required documentation from the supplier; and
  2. Verification that the applicable versions were used when specifications, drawings, process requirements, inspection instructions, traceability, and other relevant technical data are specified per 5.6.2 b).

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 evidences that purchased products and activities conform to specified requirements. XXX maintains records of verification activities.

5.7 PRODUCTION AND SERVICING PROVISION

5.7 Production and service provision of API Q1

8.5 Production and service provision of ISO 29001:2020

5.7.1 Control of Production and Servicing

5.7.1 Control of Production and Servicing of API Q1

8.5.1 Control of production and service provision of ISO 29001:2020

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.

5.7.1.1 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 (Refer 5.7.2);
  • 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 (Refer 5.7.1.3);
  • Implementation of monitoring and measurement activities; and
  • Implementation of product releases, including applicable delivery and post-delivery activities.

5.7.1.2 Servicing

XXX maintains a documented procedure (Control of Servicing) that describes controls associated with the Servicing (Refer 3.1.21) of products. The procedures address the following:

  1. Review and implementation of the XXX customer-specific, product servicing, and other servicing requirements;
  2. The availability and use of suitable Servicing, testing, monitoring, and measurement equipment;
  3. The availability of work instructions, when applicable;
  4. Ensuring identification and traceability requirements are maintained throughout the Service process;
  5. The implementation of monitoring and measurement activities;
  6. Process control documents (Refer 5.7.1.3); and
  7. Requirements for release of the product that was serviced.

5.7.1.3 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 product quality plans (Refer 5.7.2), API product specifications, customer requirements, and/or other applicable product standards/codes. The process control documents include, reference instructions and acceptance criteria for process, tests, inspections, and required customer’s inspection hold or witness points.

5.7.1.4 Product Realization Capability Documentation

XXX develops and maintains the documentation that includes but is not limited to product realization plans (Refer 5.2) 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.

5.7.1.5 Validation of Processes for Production and Servicing

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 (Refer 5.6.1.6).

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

  1. Required equipment;
  2. Qualification of personnel;
  3. Use of specific methods, including identified operating parameters;
  4. Identification of acceptance criteria;
  5. Requirements for records; and
  6. 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;

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

5.7.2 Product Quality Plans

5.7.2 Product Quality Plans of API Q1

8.1 Operational planning and control of ISO 29001:2020

When required by contract, XXX develops a product 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 product Quality Plan required by contract is address each of the following as a minimum:

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

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

5.7.3 Identification and Traceability

5.7.3 Identification and Traceability of API Q1

8.5.2 Identification and traceability of ISO 29001:2020

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.

5.7.4 Product Inspection/Test Status

5.7.4 Product Inspection/Test Status of API Q1

8.5.1 Control of production and service provision of ISO 29001:2020

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.

5.7.5 Customer-supplied Property

5.7.5 Customer-supplied Property of API Q1

8.5.3 Property belonging to customers or external providers of ISO 29001:2020

XXX is committed to protect the customer and external providers property while it is under custody of XXX or in use.  Such properties include : 

  1. Products supplied by customers for repair / servicing. Log is maintained for the products.
  2. Customer drawings / sketches , specifications etc. These are kept in safe custody . Soft copies if any are maintained with appropriate access controls.
  3. Manuals provided by equipment suppliers. These are kept in cabinets for references.
  4. 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 providers 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 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 control of the XXX. The procedures include requirements for reporting to the customer any loss, damage, or unsuitability for use of customer-supplied property. Records for the control and disposition of customer-supplied property maintained.

5.7.6 Preservation of Product

5.7.6 Preservation of Product of API Q1

8.5.4 Preservation of ISO 29001:2020

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

5.7.6.1 General

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

5.7.6.2 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 product, pending use or delivery. In order to detect deterioration, the condition of product or constituent parts in stock 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.

5.7.7 Inspection and Testing

5.7.7 Inspection and Testing of API Q1

8.5.1 Control of production and service provision of ISO 29001:2020

5.7.7.1 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 and final inspection and testing. Records of required inspection and testing maintained per documented procedures.

5.7.7.2 In-process Inspection and Testing

XXX inspects and tests the product at planned stages as required by the product Quality Plan (Refer 5.7.2), process control documents (Refer 5.7.1.3), and/or documented procedures. Evidence of conformity with the acceptance criteria is maintained.

5.7.7.3 Final Inspection and Testing

XXX performs all final inspection and testing in accordance with the product Quality Plan (Refer 5.7.2) and/or documented procedures to validate and document conformity of the finished product 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.

5.7.8 Preventive Maintenance

5.7.8 Preventive Maintenance of API Q1

7.1.3 Infrastructure of ISO 29001:2020

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

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

Records of preventive maintenance are maintained.

5.8 CONTROL OF TESTING, MEASURING AND MONITORING EQUIPMENT

5.8 Control Of Testing, Measuring And Monitoring Equipment of API Q1

7.1.5 Monitoring and measuring resources of ISO 29001:2020

XXX determines the testing, monitoring, and measurement requirements and the associated equipment needed to provide evidence of conformity to those requirements. 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:

  1. Unique identifier;
  2. Calibration status;
  3. Equipment traceability to international or national measurement standards; where no such standards exist, the basis used for calibration or verification is recorded
  4. Frequency of calibration, at specific intervals or prior to use;
  5. Calibration or verification method, including adjustments and readjustments, as necessary;
  6. Acceptance criteria;
  7. Control of equipment identified as out-of-calibration in order to prevent unintended use; and
  8. 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 (Refer 4.1.5.2) if suspect product has been shipped.

Testing, measuring, and monitoring equipment:

  1. Are calibrated or verified, or both, against measurement standards;
  2. Have the calibration status identifiable by the user for the activities being performed at all times;
  3. Are safeguarded from adjustments that would invalidate the measurement result or the calibration status;
  4. Are protected from damage and deterioration during handling, maintenance, and storage; and
  5. 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. 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. Records of the results of calibration and verification are maintained.

5.9 PRODUCT RELEASE

5.9 Product Release of API Q1

8.6 Release of products and services of ISO 29001:2020

XXX maintains a documented procedure (Refer Product Release) to ensure release of product to the customer does not proceed until the planned arrangements (Refer 5.7) 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.

5.9.1 Post-delivery activities

8.5.5 Post-delivery activities of ISO 29001:2020

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 warranty period.  Services are carried out by the equipment suppliers except for some battery and UPS for which services are done by XXX internally.  All services are monitored by the concerned dept. and service records are kept with feedbacks from customers. After servicing / repairs of equipment at workshop, periodic maintenance or servicing ( in warranty period) are done if required in the contract . Record of services is maintained.

5.10 CONTROL OF NONCONFORMING PRODUCT

5.10 Control of nonconforming products of API Q1

8.7 Control of nonconforming outputs of ISO 29001:2020

XXX identifies and controls the nonconforming products and services to prevent their unintended use or delivery. It is applicable also if non-conforming product/services is detected after delivery.  Non-conforming outputs are dealt in one or more of the following ways:

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

Corrective actions are taken to prevent 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. 

5.10.1 General

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

  1. Product identification to prevent unintended use or delivery;
  2. Addressing the detected nonconformity (Refer 5.10.2);
  3. Taking action to preclude its original intended use or delivery; and
  4. Authorizing its use, release, or acceptance under concession by relevant authority and, where applicable, by the customer (Refer 5.10.3).

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

  • Identifying, documenting, and reporting non-conformances or product failure 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 nonconforming product is detected after delivery.

5.10.2 Nonconforming Product

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

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

5.10.3 Release of Nonconforming Product under Concession

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

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

5.10.4 Customer Notification

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

5.10.5 Records

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

5.11 MANAGEMENT OF CHANGE (MOC)

5.11 Management of Change (MOC) of API Q1

8.5.6 Control of changes of ISO 29001:2020

Changes in the product/ service requirements if any are reviewed by the concerned department. Results of review and any actions needed are recorded and approved by the department head ensuring conformity with the requirements.

5.11.1 General

XXX maintains a process (Refer 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 Control of Records).

5.11.2 MOC Implementation

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

  1. Changes in the organizational structure (Refer 4.2.2);
  2. Changes in key or essential personnel (Refer 4.3.2);
  3. Changes in suppliers of critical products, components or activities (Refer 5.6.1.1); and/or
  4. 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

6.0 Quality Management System Monitoring, Measurement, Analysis and Improvement of API Q1

9 Performance evaluation and 10 Improvement of ISO 29001:2020

6.1 GENERAL

6.1 General of API Q1

9.1 Monitoring, measurement, analysis and evaluation of ISO 29001:2020

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

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

Documented information are maintained  for monitoring , measurement , analysis and evaluation , which includes customer satisfaction, meeting the planned time frame for services, complaints, effectiveness of the actions taken on risks & opportunities, performance of external providers. Measurement and analysis are performed at least once in 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 determination of applicable methods, including techniques for the analysis of data, and the extent of their use.

6.2 MONITORING, MEASURING, AND IMPROVING

6.2.1 Customer Satisfaction

6.2.1 Customer satisfaction of API Q1

9.1.2 Customer satisfaction of ISO 29001:2020

As one of the performance of quality management system, the Organization monitors information relating to customer perception as to whether the Organization has met customer requirements. XXX is performing regular customer survey by using customer feedback form. Customer feedbacks are reviewed by GM and analysis on 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 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 address the frequency of measurement, obtaining customer feedback, key performance indicators (KPIs), and other information that XXX uses to determine whether the 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 Internal audit of API Q1

9.2 Internal audit of ISO 29001:2020

The organization conducts internal audits at planned intervals to determine 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 Management Representative as evidence of implementation of audit programs and audit results. Results of internal audits are reported to the higher management in review meetings

6.2.2.1 General

XXX maintains a documented procedure (Refer 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 criticality of the process being audited. XXX identifies the audit criteria, scope, frequency, and methods to ensure that all process 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 included as part of the internal audit of the XXX.

6.2.2.2 Performance of Internal Audit

Audits performed by competent personnel (Refer 4.3.2.2) 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 process of the Quality Management System required meeting this specification audited prior to 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 (Refer 6.4.2). The results of internal audits and the status of corrective actions are reported in the management review (Refer 6.5). Records of internal audits are maintained.

6.2.3 Process Evaluation

6.2.3 Process Evaluation of API Q1

9.1.3 Analysis and evaluation of ISO 29001:2020

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 (Refer 6.4.2), as appropriate

6.3 Analysis of data

6.3 Analysis of data of API Q1

9.1.3 Analysis and evaluation of ISO 29001:2020

Individual department heads analyse and evaluate data and information generated from customer feedbacks, 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 (Refer 6.2.2), management reviews, and other relevant sources.

The data analysis output provides information relating to:

  1. Customer satisfaction (Refer 6.2.1);
  2. Conformity to product requirements;
  3. Nonconformities and product failures identified after delivery or use, provided the product or documented evidence is available to facilitate the determination of the cause (Refer 05.10);
  4. Characteristics and trends of processes and products including opportunities for preventive action (Refer 6.4.3);
  5. Supplier Performance (Refer 5.6); and
  6. Quality Objectives (Refer 4.1.3).

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

6.4 IMPROVEMENT

6.4 Improvement of API Q1

10 Improvement of ISO 29001:2020

6.4.1 General

6.4.1 General of API Q1

10.1 General of ISO 29001:2020

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.

6.4.1.1 Continual Improvements

10.3 Continual improvement of ISO 29001:2020

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

6.4.2 Corrective Actions of API Q1

10.2 Nonconformity and corrective action of ISO 29001:2020

XXX takes actions to eliminate the causes of non-conformities including complaints in order 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 in order to minimize the likelihood of its recurrence. Corrective actions are appropriate to the effect(s) of the nonconformity encountered. The procedures identify requirements for:

  1. Reviewing a process nonconformity (including customer complaints);
  2. Determining and implementing corrections;
  3. Identifying the root cause of the nonconformity and evaluating the need for corrective actions;
  4. Implementing corrective action to reduce the likelihood that nonconformity recurs;
  5. Identifying the timeframe and responsible person(s) for addressing corrections and corrective action;
  6. Verification of the effectiveness of the corrections and corrective action taken; and
  7. 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 effectiveness of the corrective actions taken.

6.4.3 Preventive Action

6.4.3 Preventive Action of API Q1

XXX maintains a documented procedure (Refer Preventive Action) to determine and implement preventive actions, both internally and with suppliers, to eliminate the causes of potential nonconformities in order to minimize the likelihood of their occurrence. Preventive actions are appropriate to the effect(s) of the potential problems. The procedures identify requirements for:

  1. Identifying opportunities for improvements;
  2. Identifying a potential nonconformity and its potential cause(s);
  3. Evaluating the need for preventive action, including any immediate or short-term action required, to prevent occurrence of nonconformity;
  4. Identifying the time-frame and responsible person(s) for implementing a preventive action;
  5. Reviewing the effectiveness of the preventive action taken; and
  6. MOC, (Refer 5.11) when the preventive actions require new or changed controls within the Quality Management System.

Records of the activities for control of potential process nonconformities are maintained

6.5 MANAGEMENT REVIEW

6.5 Management Review of API Q1

5.3 Management Review of ISO 29001:2020

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.

6.5.1 General

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 QHSE Policy and Quality Objectives (Refer Management Review).

6.5.2 Input Requirements

The input to Management Review includes, as a minimum:

  1. Effectiveness of actions resulting from previous management reviews;
  2. Results of audits (Refer 6.2.2);
  3. Changes that could affect the Quality Management System, including changes to legal and other applicable requirements (such as industry standards);
  4. Analysis of customer satisfaction, including customer feedback (Refer 6.2.1);
  5. Process performance (Refer 6.2.3) and (Refer Analysis of Data)
  6. Results of Risk Assessment (Refer Risk Assessment and Management)
  7. Status of corrective and preventive actions (Refer 6.4.2 and 6.4.3);
  8. Analysis of supplier performance;
  9. Review of the analysis of product conformity, including nonconformities identified after delivery or use (Refer Control of Nonconforming Products) and
  10. 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 (Refer 5.11) 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.

 ( The following section is for API Q1 only and not for ISO 29001:2020)

7.0 API MONOGRAM PROGRAM REQUIREMENTS

ANNEX A – API Spec Q1, 9TH EDITION

XXX, an API Licensed organization provides, API monogrammed products, in conformance with API Spec ….., API Spec …., API Spec …., API Spec ….& API Spec …. monogram requirements

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 in order 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, set forth 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:

  1. Products that do not conform to API-specified requirements shall not bear the API Monogram.
  2. 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.
  3. Only an API Licensee shall apply the API Monogram and its designated license number to API monogrammable products.
  4. 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.
  5. 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.

Example of Procedure for management of change

1.0 PURPOSE

The purpose of the procedure is to maintain a process for management of change (MOC).  XXX ensure that quality management system is maintained when changes to the quality management system are planned and implemented. The potential risks associated with the change and any required approvals prior to the introduction of such changes are identified and addressed.

2.0 SCOPE

This procedure is applicable to all the following systems and standards

  • ISO 29001: 2020/ API Spec Q1, 9th edition
  • API Spec …
  • API Spec ….
  • API Spec ….
  • API Spec …..
  • API Spec …..

3.0 RESPONSIBILITY

  1. Management Representative
  2. Quality Systems Manager
  3. All concerned process heads

4.0 INPUT:

Management of Change note, Corrective actions report

5.0 RESOURCES

Competent Manpower, Computers, Printer & Internet connection, XXX Procedures          

6.0 DESCRIPTION

All members of the XXX, including Company, contractors and vendors are responsible for identification, communication and management of change. The changes that might affect quality of the product:

  1. Changes in the organizational structure,
  2. Changes in key or essential personnel,
  3. Changes in crucial suppliers,
  4. Changes to the management system procedures, including changes resulting from corrective and preventive action

It is important when reviewing a potential change, that each of the above ‘Key Areas’ is considered, as each one could be influenced by, and in turn affect, others. Also, the potential changes should be circulated around the company in an expeditious manner so that a positive and prompt response can be issued to the initiator of the change notice.

7.0 PROCEDURE

The early identification, communication of management of change are the responsibility of all members of XXX. The management of change review process is illustrated Figure 1. Once a potential change is identified, the initiator who can be an individual or department shall inform the MR and raise a management of change request form.

7.1 CHANGES TO PROCESSES

  1. Management system processes will undergo changes, typically when:
    • Improvement opportunities have been identified, typically to improve process effectiveness
    • Nonconformities within a process are identified and require corrective action
    • Conditions in the industry or company change, requiring a process to be updated
    • New processes are added which impact on existing processes, requiring changes
    • Customer requirements result in a need to change processes
    • Any other reason determined by management
  2. In such cases, the process must be changed in a controlled manner to ensure proper authorization and implementation of the changes.
  3. At a minimum, process changes shall include the steps herein:
    • The request for a process change shall be documented, in Management of change format XXX/MR/16. The justification for the change shall be recorded.
    • The change shall be reviewed by appropriate management, including the senior most manager responsible for the process. Changes must be approved prior to implementation.
    • The appropriate process will be updated to reflect the change. This document will undergo review and approval per the procedure of Control of Document
    • The follow-up verification step of the CAR process shall seek to ensure the change has had the intended effect, and/or has improved the process. If not, the change may be rolled back or a new change made to correct any new issues that arise as a result of the change.

7.2 CHANGES TO PROCESS OUTPUTS

  1. Where a process output is a document, the rules for changing documents above shall apply.
  2. Formal changes to process outputs will be used when the change is significant. Minor changes may be made without formal control, however the decision on what constitutes a significant vs minor change must be agreed upon by those involved in the change. If a customer indicates a change is significant, this will trump any internal decision.

7.3 CHANGES TO DOCUMENTATION

  1. Management system documents undergo changes when there is a need to revise them.
  2. Changes to documentation are done in accordance with the procedure of Control of Document

7.4 CHANGES TO ORDERS OR CONTRACTS

  • Changes to active orders or contracts may occur when the customer changes the requirements after the work has begun, or may be initiated by XXX when unforeseen circumstances are encountered.
  • When changes are initiated by the customer, the new requirements will undergo the same review and acceptance per the procedure for Contract review. If the changes cannot be accepted by XXX a satisfactory solution will be negotiated with the customer.
  • When changes are initiated by XXX the Machine shop Manager will notify the customer and negotiate a resolution.

7.0 OUTPUT:

Management of change form, training plan, related actions

8.0 KEY PERFORMANCE INDICATOR:

Management of change by taking actions.

9.0 ASSOCIATED DOCUMENTS & RECORDS

DESCRIPTIONFORMAT NUMBERRESPONSIBILITY
Record of Management of ChangeXXX / MR / 16MR

Example of procedure for Preventive Action

1.0 PURPOSE

The purpose of the procedure is:

  • To determine and implement preventive actions, both internally and within the supply chain.
  • To eliminate the causes of non-conformities in-order to minimize the likelihood of its recurrence.

2.0 SCOPE

This procedure is applicable to all the following systems and standards

  • ISO 29001:2020/ API Spec Q1, 9th edition
  • API Spec …..
  • API Spec …..
  • API Spec …..
  • API Spec …..
  • API Spec …..

3.0 RESPONSIBILITY

  • Management representative
  • All concerned process owners

4.0 PROCEDURE

  1. The Management determines action to eliminate the causes to potential nonconformities in order to prevent their occurrence.
  2. Preventive Actions are appropriate to the effects of the potential problems.
  3. The preventive action requires the following:
    • Identifying the areas of improvement.
    • The effective handling of customer complaints and reports of actual non-conformances.
    • Reviewing of nonconformities including customer complaints.
    • Determining potential nonconformities and their causes.
    • Evaluating the need for action to prevent occurrence of nonconformities.
    • Determining and implementing action needed.
    • Identifying the timeframe and responsible person(s) for implementing a preventive action.
    • Preventive actions are implemented to prevent and eliminate non-conformance to a degree, appropriate to the magnitude of problems and commensurate to the risks encountered.
    • Records of the results of action taken.
    • Reviewing the effectiveness of preventive action taken.
    • MOC when the preventive actions require new or changed controls within the Quality Management System.
  4. Preventive actions which are implemented are monitored and audited by the Management Representative & Quality Systems Manager to assess the effectiveness of the action taken.
  5. Records of Preventive Actions taken are maintained and retained for five years.

4.1 Effectiveness Review on Preventive Action:

  1. In XXX, effectiveness of the Preventive action taken is reviewed through a NC closure verification checklist.
  2. Management Representative reviews effectively and may insist for more action, if required. This activity is subject to further evaluation at the time of the Management Review.

4.2 Areas of responsibility:

  1. The management and all employee of the respective location are responsible for introducing preventive action in the company
  2. All employees in departments, which influence product quality are obliged to:
    • Identify and eliminate potential non conformities
    • Introduce effective preventive measures and show that these are effective

4.3 Source of information:

  1. It is necessary for appropriate sources of information to be checked so that potential cause of discrepancy can be recognised, analysed and eliminated.
  2. Such sources are:
    • Quality data from processes
    • Data and trends from goods inwards inspection
    • Data on scrap material
    • Data on rework
    • Results of intermediary and final inspection and checking
    • Results of system, procedure and process audits
  3. The Management Representative/Quality Systems Managereither carry out these checks himself or organise and assess them
  4. Common problem solving methodologies like QC story, Fish-Bone diagrams are used to solve the problems.
  5. The results of the problem solving methodology are documented appropriately by concerned personnel and these documents are subject to verification during MRM.

    5.0 ASSOCIATED DOCUMENTS & RECORDS

    DESCRIPTIONFORMAT NUMBERRESPONSIBILITY
    Customer Complaint RecordXXX / QA / 14QA/QC Engineer
    Non conformance Product ReportXXX / QA / 42QA/QC Engineer
    Non conformance ReportXXX / MR / 09Management Representative
    Preventive Action RequestXXX / MR / 17Management Representative

    Example of Procedure for Analysis of Data

    1.0 PURPOSE

    The purpose of the procedure is to establish a system for the identification, collection, and analysis of data to demonstrate the suitability and effectiveness of the quality management system. At XXX, Data analysis includes data generated from monitoring and measurement, internal audits, management reviews, and other relevant sources.

    2.0 SCOPE

    This procedure is applicable to all the following systems and standards

    • ISO 9001: 2020/ API Spec Q1, 9th edition
    • API Spec ….
    • API Spec …..
    • API Spec …..
    • API Spec …..
    • API Spec ….

    3.0 RESPONSIBILITY

    • Management Representative
    • Quality Systems Manager
    • All concerned process heads

    4.0 INPUT

    • Customer satisfaction Feedback
    • Customer Complaints
    • Audit Results
    • Conformity to product requirements.
    • Nonconformities and product failures identified after delivery or use.
    • External provider/Suppliers Performance
    • Quality objectives

    5.0 RESOURCES

    Competent Manpower, Computers, Printer & Internet connection, Stationaries, XXX Procedures

    6.0 PROCEDURE

    • Management Representative reviews the data collected like customer complaints and identifies the statistical techniques for establishing, controlling and verifying process capability, product characteristics.
    • As soon as suitable technique is identified, it is used in the relevant area.
    • The analysis of data provides information relating to;
      • Customer satisfaction
      • Customer Complaints
      • Self – Assessment
      • Audit Results
      • 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 process and products including opportunities for preventive action.
      • Suppliers Performance
      • Information on Quality objectives
    • Corrective actions taken are to ensure their effectives.
    • The Data Analysis record is maintained.
    • The data from the above is analyzed periodically (at least once in 3 months) and statistical report is prepared and submitted to the top management (CHAIRMAN) for information and necessary follow-up for the corrective action and continual improvement of the system/area. 
    • Summary of the statistical analysis is produced in the Management Review Meeting.

    6.1 CUSTOMER FEED BACK

    Customer Satisfaction is detailed in procedure for Customer Satisfaction

    6.2 CUSTOMER COMPLAINT

    1. All customer complaints received within XXX are recorded in the customer complaint Record.
    2. It is the responsibility of all managers and staff to report in case of receipt of any customer complaints to the Quality Systems Manager and Management Representative by forwarding such written complaints received from the client. In case of verbal complaints the concerned personnel records such complaint in the customer complaint Record or send a written note to the Management Representative.
    3. The customer complaint is used as a tool for the verification of customer satisfaction. All customer complaints within XXX are logged in the customer complaint record and are subject to the verification of Management Representative, and a review of customer complaints is carried out periodically.
    4. All personnel in XXX have the responsibility to inform the Management for any customer complaints reported verbally or in written format.
    5. Each customer complaint is treated as Non-conformities within XXX and necessary corrective and preventive actions taken accordingly.
    6. No of customer complaints/ or the frequency of customer complaints are monitored in weekly basis and the trend of NCs are reviewed accordingly.
    7. Management Representative summarizes the above with the status of corrective and preventive action and furnish the same for the Management Review.

    6.3 VERIFICATION OF CONFORMITY TO PRODUCT REQUIREMENT

    1. XXX realize that the product conformance are the results of using right personnel on right job, using right material, machinery, tools etc., and well understanding of customer requirements. All personnel performing product manufacturing or providing services are trained to carry out their task in order to meet the product service requirements.
    2. This requirement is being monitored during various stages of the manufacturing process or service by the supervisors and Inspection personnel.
    3. Training needs and records are verified during Management Review Meetings once in 12 months.
    4. All production equipments are checked periodically and monitored for its fitness for the intended use. All measuring equipments are calibrated, validated and checked prior to use. Records are maintained for historical review.
    5. Deviations and non-conformities, trends of NCs, reasons, occurrence and recurrence are recorded and verified periodically, and necessary corrective action and opportunities for preventive measures are verified accordingly.

    6.4 SUPPLIER OR SUB-CONTRACTOR VERIFICATION

    1. In order to maintain the product/service quality, XXX has to be aware of the performance of the vendor/supplier/ sub-contractor that can be managed within this Quality Management System.
    2. XXX follows an approved vendor/subcontractor list and the suppliers and sub-contractors are reviewed once in 12 months.
    3. Data pertaining to each supplier or subcontractor are maintained in the Procurement Department.

    7.0 OUTPUT

    Analysis of Customer feedback, analysis of Supplier performance, Quality objectives status, Analysis of Audit Results, Conformity to product requirements.

    8.0 KEY PERFORMANCE INDICATOR

    All analysis done and related action plans & corrective actions

    9.0 ASSOCIATED DOCUMENTS & RECORDS

    DESCRIPTIONFORMAT NUMBERRESPONSIBILITY
    Master List of Quality ObjectivesXXX / MR / D07Management Representative
    Nonconformance ReportXXX / MR / 09Management Representative
    QHSE Performance AnalysisXXX / MR / 22Management Representative
    Customer feedback formXXX / COM / 04Commercial Officer
    Annual Customer EvaluationXXX / COM / 09Commercial Officer
    Production Monitoring & Delivery StatusXXX / COM / 10Commercial Officer
    Supplier Evaluation FormXXX / PRO / 04Procurement Engineer
    Vendor RatingXXX / PRO / 06Procurement Engineer
    Customer Complaint RecordXXX / QA / 14QA/QC Engineer
    Nonconformance Product ReportXXX / QA / 42QA/QC Engineer

    Example of Procedure for Control Of Non Conforming Products

    1.0 PURPOSE

    The purpose of this procedure is

    • To identify the controls and related responsibilities and authorities for addressing non-conforming product
    • To address detected non-conformities
    • To take action to preclude its original intended use or delivery
    • To authorize its use, release, or acceptance under concession by relevant authorities.

    2.0 SCOPE

    This procedure is applicable to all the following systems and standards

    • ISO 29001: 2020/ API Spec Q1, 9th edition
    • API Spec 6A
    • API Spec 16A
    • API Spec 5CT
    • API Spec 5DP
    • API Spec 7-1

    3.0 RESPONSIBILITY

    • Management Representative
    • QA/QC Engineer
    • All concerned process owners

    4.0 INPUTS

    Final Product/output inspection

    5.0 RESOURCES

    ALL MMEs, trained man power Computers, Printer & net connection, XXX Procedures/QIPs/ Work instructions

    PROCEDURE

    1. The nonconforming Materials during receiving, in-process and final inspection are identified and corrective actions are taken as appropriate.
    2. The nonconforming Materials are dealt with and reviewed by QA/QC Engineer.
    3. The review includes the following.
      • By taking action to eliminate the detected nonconformity.
      • By authorizing its use, release or acceptance under concession by a relevant authority and where applicable, by customer.
      • By taking action to preclude its original intended use or applicable.
      • By taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product/output is detected after delivery or use has started.
    4. Non-conforming product are identified, by means of attachment of a yellow sticker, documented and after evaluation are segregated, to ensure un-authorised use is not permitted prior to disposition action.
    5. Disposition of non-conforming material is made at inspection level, which ensures that where notification to functions affected is required and it can be achieved.
    6. When nonconforming product/output is corrected, that product/output is subjected to re-verification to demonstrate conformity to the requirements.
    7. Records of the nature of nonconformities and any subsequent actions taken including concessions obtained are maintained.
    8. The product/output that does not satisfy the original customer acceptance criteria satisfies that changes / new customer acceptance criteria.
    9. The details of nonconformity and repairs are recorded and maintained.
    10. The repaired or reworked product/output is re-inspected and records are maintained.

    6.1 Responsibility

    1. All department managers and their staff are responsible to implement this procedure in order to attain its objective.
    2. It is the responsibility of QA/QC personnel to identify the non-conforming material immediately after inspection and notifying to the concerned personnel (production/or store).
    3. Production personnel are responsible for segregating or where segregation is not possible, clearly identified and stopped for further processing unless the procedure for disposition action being established. (Refer: Master List of Independent Inspection Personnel)
    4. Storekeeper is responsible for segregating, where possible and following with the concerned supplier/or procurement for disposition action.
    5. The QA/QC Engineer is the final authority of XXX to accept any non-conforming material based on the application and design/product acceptance criteria. The QA/QC Manager may contact the concerned authority (customer/design engineer) for acceptance of such, when required.

    6.2 Non Conformance after product delivery:

     The procedure for addressing non-conformance after delivery of product includes:

    1. Identification of customer complaints otherwise referred as field non-conformances.  .
    2. The customers are notified in the event that product/output not conforming to customer acceptance criteria has been delivered and such notification records are maintained.
    3. The customer complaints are handled by Manager QA/QC and records are maintained. (Refer :Customer Complaint Record – XXX/QA/14)
    4. If the product is under the warranty period, based on the nature of complaint, the course of action towards the satisfactory completion of the complaint is initiated.
    5. The customer is informed in writing about the course of action and if required suitable person is deputed to the customer’s site to attend the complaint.
    6. The customer’s complaint and root cause of nonconformance is analyzed and corrective action is taken suitably to minimize recurrence of similar problems in future.

    6.3 IDENTIFICATION

    1. All non-conforming materials are identified in accordance with this procedure and are recorded in the NCR.
    2. Non-conforming materials awaiting disposition action are identified by yellow sticker (“NON-CONFORMING”) or attached with a round yellow sticker on the material identification card.
    3. Non-conforming material, which cannot be rectified or utilised within the system is identified by red sticker (“REJECTED”) or attached with a round red sticker on the material identification card.
    4. All non-conformance materials are to have non-conformance report filled with disposition action and are followed accordingly.

    6.4 REVIEW AND DISPOSITION OF NON-CONFORMING PRODUCT/OUTPUT

    1. The QA/QC Engineer is responsible for the review of non-conformity of the product/service or the quality system. On behalf of the Chairman, the QA/QC Engineer has the authority and organizational freedom for the disposition action.
    2. All non-conforming product are reviewed in accordance with this Procedure/Contract Technical requirement/or the product/output manufacturing specification (including API-specification and standards).
    3. Where the disposition action established is either repaired or re-work, acceptance with or without repair by concession, the product/output is regarded for alternative applications, or rejected/scrapped.
    4. The QA/ QC Engineer have to agree on disposition, concession or uplift of the non-conforming product/output or return of the non-conforming product/ output to the supplier or company stores. Details of the disposition action taken are recorded on the relevant inspection reports and/or NCR.
    5. Where required by the contract, the proposed use or repair of product/output which does not conform to specific requirement is reported for concession to the customer or customer’s representative. The description of non-conformity that has been accepted and of repair is recorded to denote the actual condition. All such records are maintained in accordance to Manual.
    6. Repair and/or reworked product are re-inspected in accordance with the quality plan and/or documented procedure.

    6.5 Records

    XXX has maintained the records of non-conformities and any subsequent action taken, including concessions obtained in the Non-conformance Product Report.

    7.0 OUTPUTS

    Non conforming output records.

    8.0 KEY PERFORMANCE INDICATOR

    Zero non conforming product

    9.0 ASSOCIATED DOCUMENTS & RECORDS

    DESCRIPTIONFORMAT NUMBERRESPONSIBILITY
    Customer Complaint RecordXXX/QA/14QA/QC Engineer
    Non Conformity Product ReportXXX/MR/42QA/QC Engineer

    Example of Procedure for Product Release

    1.0 PURPOSE

    The purpose of this procedure is

    • To ensure release of product to the customer  not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority
    • To provide guidelines and establish the process of product release to determine and ensure conformity to requirements specified.

    2.0 SCOPE

    This procedure is applicable to all the following systems and standards

    • ISO 29001: 2022/ API Spec Q1, 9th edition
    • API Spec …..
    • API Spec ……
    • API Spec …..
    • API Spec ……
    • API Spec …..

    3.0 RESPONSIBILITY

    1. Management representative
    2. QA/QC Engineer
    3. All concerned process owners

    4.0 INPUT

    • All inspection report, Completed production & quality plan
    • All process documents (Quality, Commercial, Marking, Logistic)

    5.0 RESOURCES

    Trained manpower, Computers, Printer & net connection, XXX Procedures/QIPs/ Work instructions

    6.0 PROCEDURE

    Product Release to customer is planned as per following way.

    1. Ensure all applicable inspection done on the product.
    2. Ensure all customer requirements are considered.
    3. Ensure all applicable testing is done.
    4. Any customer specific requirement regarding packing, marking is to be considered.
    5. Finally all process documents (Quality, Commercial, Marking, Logistic) are checked and verified according to Final Inspection Report or Workshop Report XXX/QA/41.
    6. Ensure release of product to the customer has not proceed until the planned arrangements have been satisfactory completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. The authority for final release of product lies with QC Manager.
    7. Customer needed docs Final test certificate, Packing list, Delivery  Note & Invoice are to be send (where applicable) during releasing the product to customer.
    8. If any API monogramming is applicable, final permissions are sought from the Management Representative who may authorize the marking if all production, process controls, inspection, testing and documentations meet the standards requirements and are documented in the Equipment/Product Specification Record XXX/QA/40.
    9. Records are maintained to enable identification of the individual releasing the product.
    10. Release of product to customer is finally approved by QC Manager.

    7.0 OUTPUTS

     Release for dispatch note

    8.0 KEY PERFORMANCE INDICATOR

     All testing done as per plan, No rejections

    ASSOCIATED DOCUMENTS & RECORDS

    DESCRIPTIONFORMAT NUMBERRESPONSIBILITY
    Production & quality planXXX / QA / 01QA
    Inspection Release NoteXXX / QA / 41QA
    Equipment/Product Specification RecordXXX / QA / 40QC

    Example of procedure for Control of Testing , Measuring and Monitoring Equipment

    1.0 PURPOSE

    The purpose of this procedure is

    • To determine testing, monitoring, measuring requirements and the equipments needed to provide evidence of conformity.
    • 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.
    • To establish the criteria to calibrate process control instruments, weighing equipments, laboratory equipments and calibration equipments in accordance with the relevant specifications and national / international standards.

    2.0 SCOPE

    This procedure is applicable to all the following systems and standards

    • ISO 29001: 2020/ API Spec Q1, 9th edition
    • API Spec ….
    • API Spec …..
    • API Spec …..
    • API Spec …..
    • API Spec ……

    Applies to all processes which has an influence on product quality.

    • RESPONSIBILITY
    • QA/QC Engineer
    • All concerned Personnel

    2.0 INPUT

    1. All MMEs
    2. Calibration procedure & Specifications,
    3. Calibration schedule/ Calibration methods   

    3.0 RESOURCES

    • Competent & Experience Manpower, XXX Procedures/QIPs/ Work instructions
    • Advance Instruments / equipment for carrying out Inspection & Testing,
    • In-house Masters for Internal calibration

    4.0 PROCEDURE

    • It is the responsibility of the QA/ QC Engineer to ensure that all test equipments are adequately calibrated traceable to National/International Standards.
    • It is the policy of XXX to maintain the accuracy and reliability of its inspection and measuring equipment/ tools at a level acceptable within the calibration appropriate to their tolerances by calibrating them as scheduled.

    4.1 CALIBRATION PLAN

    1. QA/QC Engineer verifies the Master list of Monitoring and Measuring Instruments to ensure the frequency, date of calibration, due date of calibration and status of all the equipments requiring calibration.
    2. Calibration interval is identified for all the measuring equipments as per the international standard requirements.
    Sl. No.Equipment/or InstrumentCalibration IntervalMode of Calibration
    1Vernier CaliperEvery six monthsInternal
    2External MicrometerEvery six monthsInternal
    3Internal MicrometerEvery six monthsInternal
    4Depth MicrometerEvery six monthsInternal
    5Vernier Height GaugesEvery six monthsInternal
    6Dial IndicatorEvery six monthsInternal
    7Surface TableEvery six monthsInternal
    8Engineer’s LevelEvery six monthsInternal
    9Electrode OvenEvery six monthsInternal
    10Slip GaugesEvery One yearExternal
    11Pressure Gauges and RecorderEvery three months or before useExternal/Internal
    12Temperature RecordersEvery three months or before useExternal
    13API Thread Ring & Plug GaugesFirst Re-calibration after 1000 engagements and subsequent every after 500 engagementsInternal/External
    14API Thread Plug GaugesFirst Re-calibration after 1000 engagements and subsequent every after 500 engagementsInternal/External
    15Tong TesterEvery One yearExternal
    16Precision LevelEvery six monthsInternal
    17Bore GaugeEvery six monthsExternal
    18Ball Trammel GaugeEvery six monthsInternal
    19MPI YokeEvery six monthsInternal
    20Noise MeterEvery One yearExternal
    21PWHT Temperature Controller K-TypeEvery Three MonthsExternal
    22Snap GaugeEvery One yearExternal
    23Bevel ProtractorEvery six monthsExternal
    24Hilo GaugeEvery One yearExternal
    25Weld GaugeEvery One yearExternal
    26Dew Point MeterEvery One yearExternal
    27Infrared ThermometerEvery One yearExternal
    28Hardness TesterEvery One yearExternal
    29Lux MeterEvery One yearExternal
    30Measuring TapeEvery One yearExternal
    31Welding RectifierEvery six monthsInternal
    32PWHT FurnaceEvery One yearInternal
    33Yoke Calibration BlockEvery One yearExternal
    34Digital ThermometerEvery One yearExternal
    35Digital ThermocoupleEvery One yearExternal
    36Step BlockEvery One yearExternal
    37Humidity MeterEvery One yearExternal
    38Micrometer Setting RodEvery One yearExternal
    39Ultrasonic Thickness GaugeEvery One yearExternal
    40DriftEvery six monthsInternal
    41Dial CaliperEvery six monthsInternal
    42Paint/Foil thickness GaugeBefore useInternal
    43API Taper GaugesEvery after 1000 engagementsInternal
    44Master Gauges Plug and RingEvery after 250 engagementsExternal
    45External Dial CaliperEvery six monthsInternal
    46Internal Dial CaliperEvery six monthsInternal
    47API Profile GaugesEvery after 1000 ConnectionsInternal

    As per API Spec. 7-2 Sec.10.3.1.5.2 – Regional and reference master gauges are retested for mating and interchange standoff at least once each seven years, and certified on a certificate of retest as being acceptable for further use. API working gauges setting rods and others shall be segregated into adjustable and non-adjustable as per API 5CT clause 8.2 para 4.

    4.2 GENERAL CALIBRATION REQUIREMENTS:

    1. Unless, otherwise specified, monitoring and measuring equipment is calibrated to manufacturer’s specifications. If no specifications are available, the equipment is calibrated based on intended use.
    2. The specifications for calibration must be reviewed, planned and validated by QA/QC Engineer.
    3. Environmental Condition to be maintain as per requirement.
      • Temperature Range: 23°C±5°C
      • Humidity Range: 20 to 80 % RH
    4. Calibration requirements are documented in the calibration certificates for the individual instrument / instrument type.

      4.3 INSTRUMENT RECEIPT:

      1. All monitoring and measuring equipment must be received, reviewed, verified, and approved by QA/QC Engineer before it can be used in production or inspection reject/accept decisions.

      4.4 INSTRUMENT IDENTIFICATION:

      1. All inspection, measuring and test equipment are have a unique identification number and details relating to each piece of equipment is recorded in the Master list of Monitoring and Measuring Equipment.
      2. All master equipment for calibration also has a unique Identification Number and has the calibration traceable to National/ International Standard (e.g. NAMAS). Calibration reports of master equipment are maintained separately with the list of Monitoring and Measuring Instruments.
      3. Identification is made either by engraving the unique identification on the equipment or by labeling (fixing the identification number by a label/sticker).
      4. Upon completion of the calibration, the status of calibration is identified by fixing a calibration sticker. Calibration sticker has the date of calibration, calibration due and certificate number.
      5. All non-conforming instrument/equipment is identified by red sticker and is segregated.
      6. In order to identify the Product inspected by a particular Equipment/instrument, that equipment/instrument is logged in a register with  the following information:
        • Date of use
        • Job/contract number
        • Operator Name
      7. All instruments (not fitted with equipment/machines) are stored in the gauge room and the calibrated equipment/instruments are stored separately without mixing with the instruments not calibrated.

      4.5 HANDLING & STORAGE:

      • Personnel handling, transporting, or storing monitoring and measuring equipment must ensure that care is taken to prevent damage or deterioration to the equipment. If personnel are not familiar with the use or application of equipment, they are responsible for asking their supervisor and/or QA personnel for training.
      • In case the QA personnel not available, the users should follow the user manual provided with the equipment for doing monitoring and measurement activities.

      4.6 OUTSIDE SUPPLIERS:

      • For calibration preference of suppliers is to those who hold ISO/IEC 17025 certification, but is made based on their technical competence. QA/QC Engineer is responsible for ensuring that outside calibration service providers are on Approved Supplier List.

      4.7 CALIBRATION PROCEDURE (Internal)

      1. All measuring and test equipment which can be calibrated internally (within XXX) have calibration procedure and is demonstrated accordingly (Level III – Quality Internal Procedures).
      2. Trained/Qualified personnel are conducted the calibration to safe guard the inspection, measuring and test facilities from adjustments, which would invalidate the calibration setting.
      3. XXX operates detailed Level III procedures, which specifies the process employed for the calibration of inspection, measuring and test equipment including detail of equipment type unique identification, location, frequency of checks, check method, acceptance criteria and the action to be taken when results are unsatisfactory.

      4.8 CALIBRATION PROCEDURE (External)

      1. On receipt of the calibration recall instruction from the Quality System Manager, the QC Engineer checks the calibration status of the all measuring and monitoring devices.
      2.  A list to be prepared for devices which are due for calibration by the QC Engineer and the measuring and monitoring devices are collected and delivery note is prepared by the store keeper. The physical condition of the measuring and monitoring devices to be checked by QC Engineer before sending them for calibration.
      3.  The measuring and monitoring devices is sent to the approved calibration providers through Machine shop driver.
      4. The driver is responsible for delivering the measuring and monitoring devices to the calibration provider and bring acknowledgement of the same.
      5.  Once the measuring and monitoring devices are calibrated, it is collected by the driver along with original invoice.
      6. The driver is responsible for delivering the measuring and monitoring devices and their calibration certificates to the QC Engineer.
      7. It is the responsibility of QC Engineer to check the accuracy and correctness of the calibration certificates and if any deviations report immediately to the service provider. Also the QC Engineer will examine the physical condition of the measuring and monitoring devices once it is back from calibration.
      8. Original calibration certificates are to be filed in the calibration certificates files and a copy to be maintained with the QC Engineer. Accordingly the master list of measuring and monitoring instruments to be updated by the QC Engineer.
      9.  Then the measuring and monitoring devices is send to the production with calibration sticker.
      10.  The same methodology is followed for customer provided measuring and monitoring devices.

      4.9 CALIBRATION RECORDS:

      1. All calibrated instruments (externally or internally) have a calibration certificate issued by the authority (internal or external). In house calibration is recorded in the in-house calibration certificate. (Refer XXX / QA / 16).
      2.  Calibration certificate have the following:
        • Date of calibration
        • Equipment details
        • Reference procedure with issue and revision status
        • Master equipment used/traceability (measurement standard)
        • Environmental Condition.
        • Calibration data (any out of specification reading as received for calibration/verification and an assessment of the impact of out of specification)
        • Name and Signature of the calibration performed
      3. Status of calibration is recorded in the Master list of Monitoring and Measuring Instruments.
      4. Where inspection measuring and test equipment is found to be nonconforming but still within its calibration period, the equipment is labeled with ‘Red sticker’ and held as segregated.
      5. An assessment of the equipment is undertaken and appropriate rectification is taken
        • Any inspection, measuring and test equipment found to be suspected, the suspected equipment is automatically segregated and re-inspected to re-establish conformance in accordance to the inspection requirements
        • It is the responsibility of the QA/ QC Engineer or his Designated Engineer to arrange recall of the units due for calibration.
      6. All calibration records are maintained with Quality Assurance Department.
      7. All calibration records of monitoring and measuring equipment is maintained by the QA/QC Engineer and retained for a minimum of 5 years.

      4.10 OUT OF TOLERANCE CONDITIONS:

      1. If any monitoring and measuring equipment is found to be out of tolerance during calibration, the monitoring and measuring equipment is reviewed for possible impact on measured product since the equipment’s last known acceptable calibration/verification.
      2. The QA/QC Engineer, or delegate, must make a determination as to the appropriate action required concerning use of the equipment and any product potentially affected by its prior use (use as it is, scrap, recall, etc.)
      3. A notation of actions taken on equipment and product is maintained in the calibration files.
      4. The QA/QC Engineer must provide a copy of the equipment’s calibration history at the time of review.
      5. Equipments which are considered as out of calibration/damaged/lost will be recorded in the Non-calibrated / Scrap equipment Record.

      4.11 NON-CONFORMING MEASURING EQUIPMENT:

      1. Any confirmed measuring equipment that is suspected or known to be damaged, malfunctioning in such a way to invalidate its intended use, producing incorrect measurement results, safeguard broken or damaged, or otherwise considered unfit for use must be removed from service and segregated or identified in such a way to prevent its use.
      2. This is done by performing the following:
        • By marking the instruments inactive in the calibration files.
        • Record the date, reason for defect, replacement status, and whether any product has been affected and why.
        • Place a Not in Use on the non-conforming equipment until disposition.
      3. Equipment cannot be returned to service until the reasons for its nonconformity have been eliminated and its full function has been confirmed, or it is designated for ‘limited use’ only. If the instrument is sent out for repair, the supplier also calibrates the equipment.
      4. Accompanying documents is reviewed upon its receipt to ensure that calibration was completed.
      5. If the instrument is replaced, a new entry with a new instrument number is created in the calibration list. The nonconforming instrument remains inactive.

      4.12 LIMITED USE:

      1. If any equipment is not functioning to its full capabilities, but is acceptable for limited or other use, this information must be clearly identified and apparent for the operator/user. For example, this could be used for ‘reference only’ measurements.

      4.13 LOST INSTRUMENTS:

      1. Any instrument that cannot be located at the calibration due date require the notification of the process In-charges. Instruments that cannot be located for a period exceeding 2 months requires notification of the QA/QC Engineer.

      4.14 TRACEABILITY:

      All calibrations are traceable to the International Standards.

      1. Master list of all Monitoring and Measuring Equipment’s (MMEs) is established containing the following:
        • Equipment Description
        • Identification Number
        • Range
        • Acceptance Criteria
        • Adjustable/Non-Adjustable
        • Location
        • Interval of Calibration/verification
        • Calibration/verification responsibility (External or In-house)
      2. The interval of calibration/verification is determined based on the type of MME and frequency of usage.
      3. The MMEs are calibrated either in-house or by the approved external laboratories. In case of in-house calibration/verification, the calibration/ verification is carried out as per work instructions.
      4. All newly procured MMEs are submitted to QA/QC Engineer for registering in the Master list. The QA/QC Engineer ensures the availability of the calibration certificate for the new MME or otherwise ensures issuance only after calibration
      5. If the deviation of the measurement is affecting the product quality, the components produced using this MME are traced and is re-inspected. In case the components/ products are already dispatched, the customer is intimated regarding the same and the necessary action is taken.

      4.15 MONITORING AND MEASUREMENT OF THE PROCESS

      1. The QA/QC Engineer verifies timeliness of re-calibration / verification to check the process effectiveness.
      2. When the equipment is provided from a source external, including third-party, proprietary, employee and customer-owned equipment, XXX / QC verifies that the equipment is suitable and provides evidence of conformity to the requirements of this section.
      3. XXX maintains a registry of Monitoring and Measuring Equipment of the required testing, measurement and monitoring equipment used to determine product conformity to requirements

      5.0 Outputs:

      • Calibration certificates file (Internal/External)
      • Calibration history card
      • Calibration Sticker

      6.0 KEY PERFORMANCE INDICATOR:

      Completion of calibration as per schedule  

      7.0 ASSOCIATED DOCUMENTS & RECORDS

      DESCRIPTIONFORMAT NUMBERRESPONSIBILITY
      Master list of Monitoring & Measuring InstrumentsXXX / QA / D02QA/QC Engineer
      In-House Calibration CertificateXXX / QA / 16QA/QC Engineer
      In-House Calibration Certificate (Pressure Gauges)XXX / QA / 35QA/QC Engineer
      Calibration History CardXXX / QA / 36QA/QC Engineer
      Yoke In-house Calibration CertificateXXX / QA / 37QA/QC Engineer
      Non-calibrated/Scrap equipment RecordXXX / QA / 43QA/QC Engineer

      Example for procedure for preventive maintenance

      1. PURPOSE

      The purpose of this procedure is to outline the methodology for the establishment of preventive maintenance for equipment used in product realization and also to be followed for attending any maintenance activities on key process equipment / machinery at XXX.

      2. SCOPE

      This procedure is applicable to all the following systems and standards

      • ISO 29001: 2022/ API Spec Q1, 9th edition
      • API Spec ….
      • API Spec ….
      • API Spec …..
      • API Spec …..
      • API Spec …..

      Applies to all processes which has an influence on product quality

      2.0 RESPONSIBILITY

      • Machine shop Manager
      • Machine shop Supervisor/Foreman
      • All concerned process owners

      3.0 INPUT

      Preventive maintenance plan, Break downs

      4.0 RESOURCES

      Trained Manpower, Critical & Regular spares, Consumables, AMCs & Maintenance contracts and Measuring Instruments

      5.0 PROCEDURE

      1. The Preventive Maintenance of equipment and machinery is carried out to ensure the continuing process capability.
      2. Machinery is classified as product machinery and Utilities.
      3. Annual Preventive Maintenance Plan has been prepared for product machinery and addressed for all the machines, specified in the Master list of Machines, with requirements for type of equipment is maintained
      4. Machine shop Supervisor/Foreman assigns the work and carries out preventive maintenance as per Preventive maintenance schedule of all machines.
      5. Daily / weekly / monthly / quarterly / half-yearly and annual Maintenance checklist is prepared for all the Machines specified in the Master list of Machines.
      6. Using Preventive Maintenance Checking Parameters, all the parameters to be checked, reviewed and approved by concern personnel and are then specified in the Preventive Maintenance checklist.
      7. It should be considered the manufacturer’s recommendations susceptible failures gathered from work experience of the machine.
      8. Breakdown Maintenance to be carried out as per QMS. Breakdown related to critical issue and/or in certain cases where Top Management involvement is required then Breakdown maintenance report to be prepared by Supervisor/Foreman, reviewed by Machine shop Manager and approved by Chairman
      9. Minor breakdowns shall be recorded in the Breakdown Register.
      10. Records of preventive maintenance are maintained minimum of 5 Years.

      Preventive maintenance is performed based on Machine Manual, risk, system reliability, usage history, experience, industry recommended practices, relevant codes and standards, original equipment manufacturer’s guidelines, or other applicable requirements.

      6.0 Output:

      • Updated Annual Preventive Maintenance Plan
      • Updated Preventive Maintenance Checklist.
      • Breakdown Maintenance report & register

      7.0 ASSOCIATED DOCUMENTS & RECORDS

      DESCRIPTIONFORMAT NUMBERRESPONSIBILITY
      Master list of MachinesXXX / MNT / D 01Machine shop Supervisor/Foreman
      Master list of Handling EquipmentXXX / MNT / D 02Machine shop Supervisor/Foreman
      Master list of Preventive Maintenance ChecklistsXXX / MNT / D 03Machine shop Supervisor/Foreman
      Master list of PumpsXXX / MNT / D 04Machine shop Supervisor/Foreman
      Master list of Test StumpsXXX / MNT / D 05Machine shop Supervisor/Foreman
      Master list of Blind FlangesXXX / MNT / D 06Machine shop Supervisor/Foreman
      Master list of DriftsXXX / MNT / D 07Machine shop Supervisor/Foreman
      Master list of MandrelXXX / MNT / D 08Machine shop Supervisor/Foreman
      Preventive Maintenance Checking ParametersXXX / MNT / 01Machine shop Supervisor/Foreman
      Breakdown Maintenance ReportXXX / MNT / 02Machine shop Supervisor/Foreman
      Breakdown Maintenance RegisterXXX / MNT / 03Machine shop Supervisor/Foreman
      Preventive Maintenance ChecklistXXX / MNT / 04Machine shop Supervisor/Foreman
      Annual Preventive Maintenance PlanXXX / MNT / 05Machine shop Supervisor/Foreman

      Example of Procedure for Inspection & Testing

      1.0 PURPOSE

      The purpose of this procedure is:

      • To verify that product requirements have been met.
      • To describes the requirements for in-process and final inspection and testing.
      • To define in detail the various steps to be initiated for the inspection and testing of raw materials and finished products for achieving process control and optimum quality Control.

      2.0 SCOPE

      This procedure is applicable to all the following systems and standards

      • ISO 29001: 2020/ API Spec Q1, 9th edition
      • API Spec ….
      • API Spec …..
      • API Spec …..
      • API Spec …..
      • API Spec ….

      Applies to all processes which has an influence on product quality

      3.0 RESPONSIBILITY

      1. QA/QC Engineer
      2. Operations Engineer
      3. Machine Shop Manager
      4. All concerned process owners

      4.0 INPUT

      • Requirements for in-process and final inspection and testing
      • Production & Quality plan
      • Inspection & Test plan

      5.0 RESOURCES

      All MMEs, Trained Manpower, Computers, Printer & net connection, XXX Procedures/QIPs/ Work instructions

      6.0 PROCEDURE

      XXX maintains a documented procedure for inspection and testing to verify that product had met the requirements.

      6.1 IN-PROCESS INSPECTION AND TESTING

      1. Production & Quality Plans or written instructions/route sheet identify all ‘hold’ points during the production process where inspection, testing and identification is required. This is accomplished through inspection and testing, process monitoring or sampling to a specified sampling plan.
      2. Acceptance of the above, are identified by signing the document by the concerned inspection authority. (QA/QC Engineer)
      3. No material is moved to the next process station until the above verification is completed unless under a ‘positive recall’ method.
      4. Non-conforming ‘in-process’ material are identified as above and the material is quarantined awaiting disposition, in accordance with this quality procedure.
      5. In case of site operation the in process inspection may be managed by an Inspection Release Note or other release note or inspection clearance acceptable to the customer.

      6.2 FINAL INSPECTION AND TESTING

      1. All product manufactured by XXX have a final inspection and testing to validate the conformance of the product to the manufacturing specification requirement and customer specification in accordance with the product quality plans.
      2. Personnel other than those who performed or directly supervised the production of the product is (i.e. QA/QC Engineer) to perform the final acceptance inspection at planned stages of the product realization process.

      6.3 HARNESS SURVEY

      6.3.1 REQUIREMENTS FOR HARDNESS SURVEY

      • The hardness inspector derives instructions from QA/QC department to conduct hardness inspection.
      • Hardness testing is done as per procedure.

      6.3.2 INSPECTION AND WITNESSING

      • The QA/QC Engineer is responsible to identify and mark up punch location of the equipment.
      • QA/QC Engineer obtains current version RRIR sheet from QA/QC Engineer and/or Production In charge.
      • QA/QC Engineer is required to witness all punches, record them into   RRIR sheet after conversion by using Brinell Hardness Chart and endorse them with his signature and date.
      • There should not be any form/register for recording hardness readings.
      • The reading recorded along the punch is not taken into consideration.
      • RRIR sheets, once endorsed by QA/QC Engineer are filed back in the job folder.
      • Readings are subject to final approval from QA/QC Manager/Operations Manager.

      6.3.3 EQUIPMENT

      • Hardness Testing is conducted using XXX hardness tester and a hammer of more than Kg 1 is used.
      • Equipment should be cleaned prior to and after its use
      • Periodic Inspection of the equipment is done by QA/QC dept. to ensure validity of the results obtained.
      • Equipment is stored in the gauge room, at a secure place
      • Hardness pins (carbide pin) is reordered by writing a material requisition to the stores in charge.

      6.3.4 HEALTH, SAFETY AND ENVIRONMENT

      • Refer to XXX HSE manual.

      6.3.5 PERSONNEL

      • Only qualified personnel are given the responsibility of hardness test.
      • Personnel qualification is done by QA/QC Engineer by training and examination.
      • Requalification of personnel is due every 365 days of the last qualification.
      • Records are maintained.

      6.3.6 NON-CONFORMANCES

      • Initial and final hardness reading recorded is checked for compliance with Hydril/GE acceptable ranges.           
      • In case of deviations, Nonconformance report is raised, and communicated to all concerned including customer.
      • Equipment is marked/tagged red and moved to NC area with in machine shop until rework.

      6.4 INSPECTION RECORDS

      Inspection records are maintained to reflect the status of the product at all stages which include:-

      1. Records of Incoming Material (Material Receiving Inspection Report & Store Receipt Voucher)
      2. Records of In-process Inspection (Production & Quality Plan and Release Notes)
      3. Records of Final Inspection (Work Shop Report, Dimensional Report, Hardness Test Report, Pressure Test Reports, Liquid Penetrant Report) and when on Project/site operations this is replaced by “Completion Report”

      Inspection records are treated as quality records and are retained as per the L2 – 04 Control of Records.

      7.0 OUTPUT

      • All inspection & Test reports, MTCs,
      • Completed Production & quality plan and ITPs

      8.0 KEY PERFORMANCE

      No rejections

      9.0 ASSOCIATED DOCUMENTS & RECORDS

      DESCRIPTIONFORMAT NUMBERRESPONSIBILITY
      ML of Independent Inspection PersonnelXXX / QA / D03QA/QC Engineer
      ML of NDT Certified PersonnelXXX / QA / D04QA/QC Engineer
      Production & Quality PlanXXX / QA / 01QA/QC Engineer
      Dimensional ReportXXX / QA / 02QA/QC Engineer
      Hardness Test ReportXXX / QA / 03QA/QC Engineer
      Pressure  Test ReportXXX / QA / 04QA/QC Engineer
      Liquid Penetrant Examination (PT) ReportXXX / QA / 05QA/QC Engineer
      Magnetic Particle Examination (MT) ReportXXX / QA / 06QA/QC Engineer
      Ultrasonic Wall Thickness ReportXXX / QA / 07QA/QC Engineer
      Daily Blasting And Painting ReportXXX / QA / 08QA/QC Engineer
      Radiography Examination ReportXXX / QA / 09QA/QC Engineer
      Heat Treatment Instruction and ReportXXX / QA / 11QA/QC Engineer
      API Gauge Engagement RecordXXX / QA / 17QA/QC Engineer
      Certificate of ConformanceXXX / QA / 23QA/QC Engineer
      Visual Inspection ReportXXX / QA / 32QA/QC Engineer
      Goods Receiving & Inspection ReportXXX / QA / 33QA/QC Engineer
      Material Verification FormXXX / QA / 38QA/QC Engineer
      Process Validation RecordXXX / QA / 39QA/QC Engineer
      Equipment or Product Specification RecordXXX / QA / 40QA/QC Engineer
      Work Shop ReportXXX / QA / 41QA/QC Engineer
      Nonconformance Product ReportXXX / QA / 42QA/QC Engineer