Nelson Manganaan Quinto

Management System Procedure LEASS -Quality Management System Manual LEASS-QMS Doc # LEASS- QMS-001 January 1, 2025 Version 1.0 Lead Al Assemah Machine Shop and Metal Works Industrial Area (Sinaiyah) Mahasen Al Ahsa Saudi Arabia X Master Copy X Prepared by Name Engr Nelson M Quinto Designation Technical Services Engineer, API Compliance December 28, 2024 Date Signature Controlled Copy Reviewed by Uncontrolled Printed Copies Approved by Mohammed Al Yami General Manager December 31, 2024 202 The signature above certify that this procedure has been reviewed and accepted, and demonstrates that the signatories are aware of all the requirements contained herein and are committed to ensuring their provision Controlled Document Register: © LEASS 2025. All Rights Reserved “Printed copies of this document are considered “ UNCONTROLLED”, unless indicated otherwise” P a g e |1 Version:0.00 Date: Revisions and Amendment Record This QMS Manual is reviewed to ensure its continuing relevance to the system and process that describes. A record of contextual additions or omissions is given below: Date Revision Context Page December 31, 2024 Version 1.0 Compliance with API Q1 10th Edition All Pages Controlled Document Register: © LEASS 2025. All Rights Reserved “Printed copies of this document are considered “ UNCONTROLLED”, unless indicated otherwise” P a g e |2 Version:0.00 Date: Table of Contents Contents 1.0 Company Introduction ........................................................................................................................ 5 2.0 Scope ...................................................................................................................................................... 6 3.0 Terms, Definition, and Abbreviation ................................................................................................. 6 3.1 Terms and Definitions ..................................................................................................................... 7 3.2 Abbreviations .................................................................................................................................... 9 3.3 References ......................................................................................................................................... 9 4.0 Quality Management System Requirement .................................................................................... 9 4.1 Quality Management System ......................................................................................................... 9 4.2 Management Responsibility ......................................................................................................... 11 4.3 Organization Capability ................................................................................................................. 12 4.4 Documentation Requirements ..................................................................................................... 13 4.5 Control of Records .......................................................................................................................... 14 5.0 Product Realization ............................................................................................................................ 15 5.1 Contract Review ............................................................................................................................. 15 5.2 Planning ........................................................................................................................................... 15 5.3 Risk Management ........................................................................................................................... 16 5.4 Design ............................................................................................................................................... 17 5.5 Purchasing ....................................................................................................................................... 17 5.6 Control of Product Realization ..................................................................................................... 20 5.7 Product Release .............................................................................................................................. 25 5.8 Testing, Measuring, Monitoring, and Detection Equipment (TMMDE) ................................ 25 5.9 Control of Nonconforming Product ............................................................................................. 26 5.10 Management of Change (MOC) ...................................................................................................... 28 6.0 Quality Management System Monitoring, Measurement, Analysis, and Improvement ....... 28 6.1 General ............................................................................................................................................. 28 6.2 Monitoring, Measuring, and Improving ..................................................................................... 28 6.3 Analysis of Data .............................................................................................................................. 29 6.4 Improvement .................................................................................................................................. 30 6.5 Management Review ..................................................................................................................... 31 7.0 7.1 API Monogram Program ................................................................................................................... 32 Control of the Application and Removal of API Monogram ................................................... 32 Controlled Document Register: © LEASS 2025. All Rights Reserved “Printed copies of this document are considered “ UNCONTROLLED”, unless indicated otherwise” P a g e |3 Version:0.00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 Issued Date Version No. : 7.2 Product Marking Requirements ................................................................................................... 32 7.3 API Monogram Program – Nonconformance Reporting ......................................................... 33 8.0 Annex A: Quality Policy ..................................................................................................................... 35 9.0 Annex B: Quality Objective............................................................................................................... 35 10.0 Annex C: Sequence and Interaction of Processes .......................................................................... 36 11.0 Annex D: Organization Chart .............................................................................................................. 37 12.0 Annex E: Context of Organization...................................................................................................... 38 13.0 Annex F: Communication Plan ............................................................................................................ 39 Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e |4 Version:00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 1.0 Issued Date Version No. : Company Introduction Lead Al Assemah Machine Shop and Metal Works (LEASS) is a precision metal manufacturer and a mechanical engineering company that is based in Al Ahsa Industrial Area , Mubarraz Al Saudi Arabia will cover all our corporate and individual customers. that offers its services since it was established 20 years which are mainly in machine shop operations, automotive metal components manufacturing, and accuracy repairs, which includes engine refurbishment and machining, hydraulic equipment retrofitting and diesel fuel injection pumps calibration and measurement of its performance. LEASS since it was established in 2004 had taken its vision by consideration to aligned with the kingdom‟s development track and the company had considered the market‟s demand to provide all the industrial need by providing and utilizing advance equipment related to machinery maintenance and manufacturing, of its related metal parts and components. Thus, it had been reflected on the company‟s capability of delivering customer‟s demands, in terms of executing all manufacturing stages, in an efficient and précised manner and on time product and services deliveries. Main Office and Manufacturing Facility Address: Al Ahsa Industrial Area (Sinaiyah) Mubarraz Al Ahsa Saudi Arabia Contact Information: - - - - Email:-//- Number of Employees: 30 Professionals and Skilled Personnel Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e |5 Version:00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 2.0 Issued Date Version No. : Scope A documented Quality Management System (QMS) is established, and maintained that  LEASS identifies the processes needed for the quality management system and its applications throughout the organization such as management activities, provision of resources, determines the sequence and interaction of these processes, determines criteria and methods needed to ensure the availability of resources and information necessary to support the operations and monitoring of this process, monitors, measures and analyzes these processes and implements necessary actions to achieve planned results and continual improvement of these processes which stated in related procedures.  These processes are properly managed by LEASS in accordance with the requirements of API Spec Q1 Latest Edition and API Specification 7-1 and API Specification 7-2.  When LEASS chooses to outsource any process that affects service conformity with requirements, LEASS ensures control over such process (such as receiving measurement and /or monitoring). Control of such processes is identified with in the QMS (if any).  Documented procedures established for the QMS, or reference to them and,  Descriptions of interactions between the processes of the QMS. The interaction between the processes is identified in Annex C- Sequence and Interaction of Processes, the QMS manual will address process needed for the management of activities provision ofresources, product realizations, measurement and continual improvement as per API Q1 Latest Edition and API Specification 7-1 and API Specification 7-2. A documented system is established to define the controls needed to approve documents foradequacy prior to issue, to review and update as necessary and re-approve documents andto ensure that documents remain legible and readily identifiable. Scope of Work Manufacturing of Drill Stem Subs, Drill Collars and Rotary Shouldered Connections and repair of Oil and Gas Products. Product Range for API Monogram    Drill Stem Subs Drill Collar Threading for Rotary Shouldered Connections Applicable when API Spec 7-1 and API Spec 7-2 monogram license award by API. Exclusion API Advisory-6 notifies LEASS of API monogram able products that do not have auditable design requirements. 3.0 Terms, Definition, and Abbreviation Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e |6 Version:00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 Issued Date Version No. : 3.1 Terms and Definitions 1. Acceptance criteria: Specified requirements of acceptability applied to product or process characteristics. 2. Acceptance inspection: Demonstration through monitoring or measurement that the product conforms to specified requirements. 3. Calibration: Process of comparison to a standard of known accuracy, comparison of results against TMMDE (testing, measuring, monitoring, and detection equipment) acceptance criteria, and, if applicable, making needed adjustment(s). 4. Compliance: Act of satisfying (verb) or the status of having satisfied (noun) legal requirements. 5. Critical: Deemed by the organization, product specification, or customer to be of significant importance and requiring specific action. 6. Delivery: Point in time at which the agreed transfer of ownership takes place. 7. Design Acceptance Criteria (DAC) Requirements applied to characteristics or combinations of those characteristics, of materials, products, or components to achieve conformity to the specified design requirements and/or required design performance. 8. Design validation: Process of proving a design by testing to demonstrate that the product conforms to design requirements and performs as intended. 9. Design verification: Process of examining design outputs to determine conformity with specified requirements. 10. Key Performance Indicator (KPI): Quantifiable measure that an organization uses to gauge or compare performance. 11. Legal requirement: Statutory or regulatory requirements. 12. Management: A person or group of persons with authority and responsibility for the conduct and control of all or part of an organization. Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e |7 Version:00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 Issued Date Version No. : 13. Manufacturing Acceptance criteria (MAC): Requirements applied to characteristics or combinations of those characteristics, of materials, products, or components to achieve conformity to DAC and other product manufacturing requirements. 14. Outsourced activity: Function or process that is performed by an external supplier on behalf of the organization. 15. Preventive maintenance: Systematic servicing of equipment, machines, and/or facilities for the purpose of maintaining a satisfactory operating condition. 16. Procedure: Organization‟s documented method for performing an activity under controlled conditions to achieve conformity to specified requirements. 17. Product: Output of an organization intended to be provided to a customer. 18. Product realization: Set of interrelated or interacting activities (processes) necessary to provide product. 19. Remote assessment: Assessment conducted by person(s) not physically present at the location being assessed. 20. Risk: A situation or circumstance that has both a probability of occurring and a potentially negative consequence. 21. Servicing: Maintenance, adjustment, and/or repair performed on a product after delivery and/or on-site installation. 22. Supply chain: Suppliers and associated sub-supplier(s) required for product realization. 23.API monogram able product Product that has been newly manufactured by an API Licensee utilizing a fully implemented API Spec Q1 compliant quality management system and that meets all the API-specified requirements of the applicable API product specification(s) and/or standard(s). 23. 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 Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e |8 Version:00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 Issued Date Version No. : measurement of quality and quantity with respect to materials; products, processes, services, and/or practices. 25.API-Specified requirements Requirements, including performance and Licensee-specified requirements, set forth in API Spec Q1 and the applicable API product specification(s) and/or standard(s). 26.Licensee Organization that has successfully completed the application and audit process and has been issued a license by API to use the API Monogram Mark. 3.2 Abbreviations DAC ITP KPI LEASS MAC MOC MPS PCP QAP QMS QP TMMDE Design Acceptance Criteria Inspection Test Plan Key Performance Indicator Lead Al-Assemah Machine Shop & Metal Works Manufacturing Acceptance Criteria Management of Change Manufacturing Process Specification Process Control Plan Quality Activity Plan Quality Management System Quality Plan Testing, Measuring, Monitoring, and Detection Equipment 3.3 References API Specification Q1 10th Edition, September 2023 API Specification 7-1 2nd Edition, February 2023 API Specification 7-2 2nd Edition, January 2017 4.0 Quality Management System Requirement 4.1 Quality Management System 4.1.1 General LEASS shall plan, establish, document, implement, and maintain at all times quality management system in accordance with the requirements of API Specification Q1 latest edition for the products provided within the scope defined by LEASS. LEASS shall measure and improve the effectiveness of quality management system. Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e |9 Version:00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 4.1.2 Issued Date Version No. : Quality Policy LEASS‟s quality policy for its commitment to quality shall be defined, documented, reviewed, and approved by top management. The quality policy shall:      4.1.3 appropriate to LEASS and support strategic direction. basis for the development of quality objectives. communicated, understood, implemented, and maintained within LEASS. available to relevant interested parties, as specified by LEASS. include commitment to conform to the requirements and continually improve the effectiveness of quality management system. Quality Objectives Quality objectives, including those needed to meet product and customer requirements, shall established at relevant functions and levels within LEASS by management with approval from top management. The quality objectives shall be measurable, communicated, and consistent with the quality policy. 4.1.4 Planning the Quality Management System 4.1.4.1 General Planning of the quality management system shall be performed. LEASS shall:          4.1.4.2 defined the scope of the quality management system, that identifies products(s) and includes any limitations and exclusions in Section 2.0 Scope of Quality Management System Manual; identified external and internal issues relevant to LEASS‟s long term and or overall objectives and goals in Annex E-Context of Organization; Determined relevant interested parties and their requirements for the quality management system in Annex E-Context of Organization; Determined the sequence and interaction between the processes of the quality management in Annex C- Sequence and Interaction of Processes; Determined and managed the criteria and methods needed for effective operation and control of quality management system processes; Identified quality objectives, including actions, resources, responsibilities, timeframe, and how results are monitored and evaluated; Addressed identified risks; Addressed identified opportunities for improvements; and Identified key personnel in Annex D- Organization Chart. Exclusions If LEASS performs activities addressed in API Specification Q1 latest edition, including activities which are outsourced, no claim to exclusion of those activities shall be permitted. Excluded activities shall not affect LEASS‟s ability, or responsibility, to provideproduct that satisfies customer and legal requirements. Where exclusions are claimed, the justification shall be documented. Allowable exclusions shall be limited to the following sections of API Specification Q1 10th edition: 5.4 Design Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e | 10 Version:00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 Issued Date Version No. : 5.6.4 Validation of Processes 5.6.7 Externally Owned Property 5.8 Testing, Measuring, Monitoring, and Detection Equipment (TMMDE) Design is excluded as per API Advisory 6.Design Exclusion under the API Monogram Program. 4.1.5 Communication 4.1.5.1 Internal LEASS shall establish internal communication processes. The processes shall include communicating at relevant level and functions within the LEASS:   the importance of satisfying customer, legal, and other applicable requirements; and the results of analysis of data. 4.1.5.2 External LEASS shall establish and implement a process for communicating with external organizations, including customersin Annex F- Communication Plan The process shall address: a. executionof inquiries, contracts, or order handling and amendments b. determining and understanding requirements throughout contract execution and product realization c. provision of product information, including nonconformities d. feedback and customer complaints e. communications of quality plans including subsequent changes; and f. communicating changes and associated risks 4.2 Management Responsibility 4.2.1 General Top management shall demonstrate leadership and commitment to the establishment, implementation, maintenance, and improvement of the quality management system by: a. approving establishment of quality objectives at relevant functions and levels within LEASS; b. providing resources needed for the quality management system; NOTE: Resources can include human resources and specialized skills, organizational infrastructure, financial resources, and technology c. engaging and supporting personnel in the implementation and maintenance of the quality management system; and d. assigning responsibilities and authorities for ensuring the processes achieve intended outputs. 4.2.2 Responsibility and Authority Responsibilities, authorities, and accountabilities of personnel within the scope of LEASS‟s quality management system shall be defined, documented, and communicated throughout LEASS. 4.2.3 Management Representative Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e | 11 Version:00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 Issued Date Version No. : Top management shall appoint and maintain a member of LEASS‟s management who, irrespective of other responsibilities, shall have responsibility and authority that includes: a. ensuring that the quality management system conforms to the requirements of API Specification Q1 10th edition b. ensuring that processes needed for the quality management system are established, implemented, and maintained; c. reporting to top management on the performance of the quality management system and any need for improvement; d. ensuring initiation of action(s) to address nonconformities; and e. ensuring the promotion of awareness of customer requirements throughout LEASS. 4.3 Organization Capability 4.3.1 Resources and Knowledge 4.3.1.1 Resources LEASS shall determine and allocate the resources needed to implement, maintain, and improve the effectiveness of the quality management system. 4.3.1.2 Knowledge LEASS shall determine the knowledge needed to provide continued operation of its processes and achieve ongoing conformity of products. This knowledge shall be maintained and made available as determined by LEASS. NOTE: Knowledge can be acquired through experience, study, training, lessons learned, best practices or other sources. 4.3.2 Human Resources 4.3.2.1 Personnel Competence LEASS‟s personnels whose responsibilities fall within the scope of the quality management system shall competent. LEASS shall maintain a documented procedure addressing personnel competence. The procedure shall address: a. how required competencies are identified and documented; b. how the required education, training, experience or other actions to achieve competence are identified; c. evaluation of effectiveness of actions taken to acquire competencies; d. criteria and methods for assessing, maintaining and re-assessing competencies; and e. personnel responsible for assessing competency. Records of personnel competence shall be maintained. Reference:Procedure for Personnel Competency & Training 4.3.2.2 Training LEASS shall develop and maintain a procedure for training that shall address: a. identification of the content and frequency of training required; b. provision of quality management system training; Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e | 12 Version:00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 Issued Date Version No. : c. provision of job training including personnel awareness of the relevance and importance of their activities and how they contribute to the achievement of LEASS‟s quality objectives; d. provision of customer specified training and/or customer provided training, when required; e. evaluation of effectiveness of training; and f. identification of required training records. Records of personnel training shall be maintained. Reference: Procedure for Personnel Competency & Training 4.3.3 Work Environment LEASS shall determine, provide, manage, and maintain the work environment needed to achieve conformity of the product. Work environment shall include: a. b. c. d. building, workspace, and associated utilities; process equipment (both hardware and software); supporting services (e.g.: transport, communication, information systems); and conditions under which work is performed such as physical, environmental, or other factors. 4.4 Documentation Requirements 4.4.1 General The quality management system documentation shall include: a. the scope of the quality management system that identifies product(s) covered and includes justification for any exclusions b. statements of quality policy and quality objectives c. identification of legal and other applicable requirements to which LEASS claims compliance that are needed to achieve product conformity; d. identification of how the quality management system addresses each requirement of API Specification Q1 latest edition; e. identification of processes that requires validation; and f. procedures, documents, and records necessary for the planning, operation, and control of its processes and conformance with specified requirements. NOTE: Some of the above documentations have been traditionally included as part of a quality manual but can be many different formats and can be either a single document or multiple documents. 4.4.2 Procedure All procedures required by API Specification Q1 latest edition shall describe LEASS‟s method for performing an activity and shall be documented, implemented, and maintained for continued sustainability. NOTE: As ingle procedure can address the requirements for one or more documented procedures. Any requirements for a documented procedure can be satisfied by more than one procedure. 4.4.3 Control of Internal Documents Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e | 13 Version:00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 Issued Date Version No. : LEASS shall maintain a documented procedure for the identification, distribution, and control of internal documents required by the quality management system and API Specification Q1 latest edition, including revisions, translations, and updates. The procedure shall address: a. responsibilities for approval and re- approval; b. review and approval for adequacy prior to issue and use; c. reviews for continued suitability and revision(s) as necessary d. identification of changes and current revision status; e. legibility and identification of documents; and f. availability where the activity is being performed. Obsolete documents shall be removed from all points of issue or use, or otherwise identified to prevent unintended use if they are retained for any purpose. Procedures, work instructions, and forms required by the quality management system shall be controlled. Reference: Control of Document Procedure 4.4.4 Control and Use of External Documents LEASS shall maintain a documented procedure for the control of documents of external origin required for product realization and used by LEASS, including API or other external specification. The procedure shall address a. identification and documentation of required documents; b. access and distribution of required documents, including relevant versions; c. integration of requirements into product realization and any other affected processes; d. process for identifying when changes to required documents have occurred, including addenda, errata, and updates; e. assessment of impact of changes; and f. integration of applicable changes. NOTE: Normative references that are identified within API product or other external specifications and are required during product realization can also be considered an external document. Reference: Control of Document Procedure 4.5 Control of Records Records, including those originating from outsourced activities shall be established and controlled to provide evidence of conformity to requirements and LEASS‟s quality management system. LEASS shall maintain a documented procedure to identify the controls and responsibilities for records. The procedure shall address records: a. identification; b. collection; c. legibility; d. correction; e. storage; f. protection from unintended alteration, damage, or loss; g. retrieval; h. retention period; and i. disposition Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e | 14 Version:00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 Issued Date Version No. : Records shall be retained for a minimum of ten years or as by customer, legal, and other applicable requirements, whichever is longer. Reference: Control of Record Procedure 5.0 Product Realization 5.1 Contract Review 5.1.1 General LEASS shall maintain a documented procedure for the review of requirements related to provision of product. The procedure shall address: a. determination of requirements; b. review of requirements; and c. changes to requirements. Reference: Procedure for Contract Review 5.1.2 Determination of Requirements LEASS shall determine: a. requirements specified by the customer; b. legal and other applicable requirements; and c. requirements not stated by the customer but considered necessary by LEASS for the provision of products. Where the customer provides no documented statement of requirements, the customer requirements shall be confirmed by LEASS and records maintained. 5.1.3 Review of Requirements LEASS shall review the requirements related to provision of product. This review shall be conducted prior to LEASS‟s commitment to deliver product to the customer and shall confirm that: a. requirements are identified and documented; b. requirements differing from those previously identified are resolved; and c. LEASS has the capability to meet the documented requirements. Where contract requirements are changed, LEASS shall amend the relevant documents and make relevant personnel aware of the changed requirements. Records of the results of the review, including resulting actions, shall be maintained. 5.2 Planning LEASS shall identify and plan the processes and documents needed for product realization. In planning LEASS shall address the following: a. required resources and work environment management b. product and customer- specified requirements c. legal and other applicable requirements Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e | 15 Version:00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 Issued Date Version No. : d. design requirements e. contingency planning f. required verification, validation, monitoring, measurements, inspection, and test activitiesspecific to the product and the criteria for acceptance; g. management of change (MOC); and h. records needed to provide evidence that product realization conforms to requirements. The output of planning shall be documented and updated as changes occur. The plans shall be maintained in a suitable for LEASS‟s method of operations. 5.3 Risk Management 5.3.1 General LEASS shall maintain a documented procedure to identify and control risk associated with product delivery and product quality. The procedure shall address: a. b. c. d. e. f. risk identification and assessment technique; risk assessment tools and their application; criteria to determine risk severity including potential consequences of product failure; risk mitigation actions; assessment of remaining risk; and contingency planning, including when a contingency plan is required based on assessment of remaining risks. NOTE 1: Risk assessment can include consideration of severity, probability of occurrence, and detectability. NOTE 2: Risk assessment can be an activity associated with corrective action. Reference: Procedure for Risk Management- Risk Assessment Product Delivery Risk assessment associated with product delivery shall include: a. facility/equipment availability including maintenance; and b. supplier delivery performance and material availability/supply. 5.3.2.2 Product Quality Risk assessment associated with product quality shall include: a. delivery of nonconforming products; and b. availability of competent personnel. 5.3.2.3 Changes Impacting Product Quality If any of the following changes can negatively impact the quality of product, risk assessment associated with product quality shall be performed: Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e | 16 Version:00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 a. b. c. d. e. changes changes changes changes changes Issued Date Version No. : in LEASS‟s organizational structure; in key personnel; in the supply chainof critical products, components, or activities; to the management system scope or procedures; and to LEASS‟s capability to perform the process (es) required for product realization. NOTE: Changes can be of internal or external origin. 5.3.3 Contingency Planning When LEASS determines, a contingency plan is required based on assessed risk, the contingency plan shall include, at a minimum: a. actions required to reduce effects of disruptive incidents; b. identification and assignments of responsibilities and authorities; and c. internal and external communication controls The contingency plan(s) shall be documented, communicated to the relevant personnel, and updated as needed. 5.3.4 Records Records of risk assessment and management including actions taken shall be maintained. 5.4 Design LEASS is not responsible for design of product, the requirements of 5.4 Design of API Specification Q1 10th edition. 5.5 Purchasing 5.5.1 Purchasing Control 5.5.1.1 Procedure LEASS shall maintain a documented procedure for the purchase for the purchase of products, components, and/or activities required for product realization. The procedure shall address: a. determination of critical products, components, and/or activities; b. initial evaluation and selection of suppliers; c. use of identified risk to determine initial assessment method of supplier‟s capability for critical purchases; d. type and extent of control applied to the supply chain for critical products, components, or activities; e. criteria, scope, frequency, and methods for re-evaluation of suppliers; f. identification of approved suppliers and scope of approval; and g. identification of customer specified suppliers and suppliers limited by proprietary, and/or legal requirements when 5.5.1.3 of API specification Q1 tenth edition. Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e | 17 Version:00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 Issued Date Version No. : Reference: Procedure for Purchase Control and Supplier Management 5.5.1.2 Initial Supplier Evaluation- Critical Purchases For the purchase of critical products, components or activities, the initial evaluation of suppliers (not previously approved) shall address the scope of supply, be site- specific for each supplier and include following: a. verification of the supplier‟s quality management system implementation and conformity to the quality system requirements specified for suppliers by LEASS. b. verification of the type and extend of control applied by the supplier, internally and to their supply chain, to meet LEASS‟s requirements; c. assessment of the supplier‟s capability to meetLEASS‟s specified requirements by one or more of the following based on identified risk 1. performing an on-site assessment to verify that relevant product realization processes are being performed in accordance with process controls, and are effective in achieving conformity to requirements, 2. performing a remote assessment to verify that relevant product realization processes are being performed in accordance with process controls and are effective in achieving conformity to requirements. 3. performing inspection, testing, or verification of relevant characteristics of a received product. For suppliers of critical purchases with high-risk severity items identified by LEASS for which an on-site assessment as per 5.5.1.2 item c) 1) is not performed, the assessment of the supplier‟s capability shall include performing a remote assessment per 5.5.1.2 Item c) 2) and performing inspection, testing, or verification per 5.5.1.2 Item c) 3). When performed, remote assessment shall include verification of objective evidence through real -time audio/ video observation of required activities and documentation using information and communication technology. Evaluation of a supplier shall also be performed in accordance with the requirements of API Specification Q1 10th edition 5.5.1.2 for any additions to a supplier‟s scope of approval or change from an approved site to a new site of supply. 5.5.1.3 Initial Supplier Evaluation- Critical Purchases- Customer Specified, Proprietary, and/ or Legal Limited For the purchase of critical products, components, or activities where the supplier is specified by the customer or involves proprietary and/ or legal requirements that limit application of 5.5.1.2, the initial evaluation shall include the following: a. verification of the supplier‟s quality management system implementation and conformity to quality system requirements specified for suppliers by LEASS and/ or the customer requirements; and b. identifying how the supplied products, component or activity conforms to specified requirements. Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e | 18 Version:00 Date: LEAD AL ASSEMAH MACHINE SHOP & METAL WORKS ‫مخرطة العاصمة الرئدة للمعادن‬ Quality Management System Manual Doc # LEASS-QP-001 Issued Date Version No. : The scope of approval for customer- specified suppliers shall be limited to the relevant customer contract when assessment per 5.5.1.2, Item c) has not been performed. 5.5.1.4 Initial Supplier Evaluation- Noncritical Purchases For the purchase of noncritical products, components, or activities that impact product realization or final product, the criteria for evaluation of suppliers by LEASS shall meet the requirement of 5.5.1.2 or satisfy one or more of the following: a. verification that the supplier‟s quality management system conforms to the quality system requirements specified for suppliers by LEASS; b. assessment of the supplier to meet LEASS‟s purchasing requirements; c. assessment of the product or component upon delivery, or activity upon completion. 5.5.1.5 Supplier Reevaluation For previously approved suppliers of products, components or activities LEASS shall determine the supplier reevaluation frequency based on identified risks and supplier quality performance. For the re-evaluation of suppliers of critical products, components or activities, the requirements of 5.5.1.2 shall apply. For the re- evaluation of suppliers of critical products, components or activities for customer specified suppliers and suppliers limited by proprietary, and/ or legal requirements, the requirements of 5.5.1.3 shall apply. For the re- evaluation of suppliers of noncritical products, components, or activities that impact product realization or the final product, the requirements of 5.5.1.4 shall apply. 5.5.1.6 Records Records of the results of evaluations including objective evidence and any necessary actions arising from the evaluations shall be maintained. Records of identification of approved suppliers, customer specified suppliers, and suppliers limited by proprietary, and/or legal requirements shall be maintained. 5.5.1.7 Outsourcing When LEASS chooses to outsource a process or activity of its quality management system, LEASS shall verify that the supplier satisfies the applicable requirements of LEASS‟s quality management system. When LEASS choose to outsource a product realization process or activity, LEASS shall maintain responsibility for product conformance to specified requirements, including applicable API or other external specifications. Records of outsourced activities shall be maintained and shall include evidence of conformity. 5.5.2 Purchasing Information LEASS shall ensure the adequacy of specified purchasing information prior to communication to the supplier. Purchasing information provided to the suppliers shall be documented and describe the product, component, or activity to be purchased, including applicable: Controlled Document Register: © LEASS 2024. All Rights Reserved “Paper copies of this document are UNCONTROLLED, unless indicated otherwise” P a g e | 19 Version:00 Date: