Quality Management System Manual - Witco Inc
This Page 1 of 35 of the Quality Management System ManualIf issued as a controlled copy, the serial number of this copy isQualityManagementSystemManualRevision ECompliant with AS9100 Revision CPrinted copies of this manual or any page from this manual is considered uncontrolled for reference only unless accompanied by this serialized first page
Quality Management System ManualRevision EPage 2 of 35Table of ContentsTable of Contents. 21Introduction to the Quality Management System Manual . 51.1Quality Management System Scope . 51.2Quality Policy Statement . 51.3Exclusions from AS 9100, ISO 13485 or ISO 9001 and Justification for Exclusion . 61.4Approvals . 61.5Revision History . 62Process Sequence and Interaction . 72.1Interaction of Procedures with Processes . 72.1.1Document and Records Control. 72.1.2Internal Audit . 72.1.3Control of Nonconforming Product . 72.1.4Corrective and Preventive Action . 73Management Process . 83.1Management Process Objective(s) and Measurement(s) . 83.2Management Process Records . 83.3Management Process Rules . 83.4Management Process Instructions . 93.4.1Management Review . 93.5Use of the Issues Log . 103.6Resource Control . 103.6.1Human Resources . 103.6.2Infrastructure Resources . 114Contract Administration Process . 114.1Contract Administration Process Objective(s) and Measurement(s) . 114.2Contract Administration Process Records . 114.3Contract Administration Process Rules . 114.4Contract Administration Process Instructions . 124.4.1Contract Review Instruction . 124.4.2Risk Assessment . 124.4.3Risk Management . 124.4.4Configuration Management . 134.4.5Planning Instruction . 135Purchasing Process . 145.1Purchasing Process Objective(s) and Measurement(s) . 145.2Purchasing Process Records. 145.3Purchasing Process Rules . 145.4Purchasing Process Instructions . 165.4.1Order Preparation and Product Verification Instruction . 165.4.2Raw Material Control Instruction . 175.4.3Supplier Approval and Monitoring Instruction . 176Manufacturing Process . 196.1Manufacturing Process Objective(s) and Measurement(s) . 196.2Manufacturing Process Records . 196.3Manufacturing Process Rules . 196.4Manufacturing Process Instructions . 20Printed copies of this manual or any page from this manual is considered uncontrolled for reference only unless accompanied by a serialized first page
Quality Management System ManualRevision EPage 3 of 356.4.1Production Process Verification (First Article) . 206.4.2In-Process Inspections . 206.4.3Verification of Measuring Devices . 206.4.4Equipment Maintenance . 216.4.5Work Instructions . 216.4.6Sampling Inspection . 226.4.7Manufacturing Process Flow . 236.4.8Final Inspection . 247Storage and Shipping Process . 257.1Storage and Shipping Process Objective(s) and Measurement(s) . 257.2Storage and Shipping Process Records . 257.3Storage and Shipping Process Rules . 257.4Storage and Shipping Process Instructions . 251.1Shipping Process Flow. 258Document and Record Control Procedure . 268.1Scope. 268.1.1Documents . 268.1.2Records . 268.1.3Forms . 268.1.4Electronic Documents . 268.1.5Paper Documents. 261.2Control of Documents. 268.1.6Job Specific Documents . 278.1.7Externally Controlled Documents . 278.2Document Control . 278.2.1Approval, Review and Update . 278.2.2Availability and Maintenance . 278.2.3Obsolete Documents . 278.2.4Revision of Documents . 278.3Records Control . 288.3.1Rules for Quality Records. 288.3.2Records Control Matrix . 289Internal Auditing Procedure . 289.1Internal Audit Scope and Purpose . 289.2Internal Audit Responsibilities . 289.3Audit Planning . 299.3.1Process . 299.3.2Schedule . 299.3.3Management Representative . 299.3.4Auditor Selection . 299.3.5Outside Agency . 299.3.6Audit Preparation. 299.4Conducting the Audit . 299.4.1Observation. 299.4.2Document Review . 309.4.3Interview . 309.5Product Audits . 309.6Documentation . 30Printed copies of this manual or any page from this manual is considered uncontrolled for reference only unless accompanied by a serialized first page
Quality Management System ManualRevision EPage 4 of 359.6.1Audit Report. 309.6.2Audit Non-conformances . 309.6.3Follow Up . 3010 Procedure for the Control of Nonconforming Product . 3010.1 Non-Conforming Product Control Scope and Purpose . 3010.2 Identification. 3010.3 Segregation . 3110.3.1 Containment . 3110.4 Disposition . 3110.4.1 Scrap . 3110.4.2 Repair . 3110.4.3 Rework . 3110.4.4 Ok to Proceed . 3210.5 Customer Notification. 3210.6 Issues Log . 3210.7 Supplier Caused Nonconformity . 3210.8 Customer Returns . 3210.9 Internal Nonconformance . 3210.10Records . 3211 Corrective Action . 3311.1 Corrective Action Scope and Purpose . 3311.2 Corrective Action Responsibilities . 3311.3 Review Non-Conformances . 3311.4 Determine the Cause . 3311.4.1 Investigation . 3311.5 Prevent Recurrence . 3311.6 Corrective Action . 3411.7 Time Limits . 3411.8 Documentation . 3411.9 Review the Results of Actions Taken . 3412 Preventive Action . 3412.1 Scope. 3412.2 Evaluating the Need. 3412.3 Determining and Implementing Actions Needed . 3512.4 Review and Record . 35Printed copies of this manual or any page from this manual is considered uncontrolled for reference only unless accompanied by a serialized first page
Quality Management System ManualRevision EPage 5 of 351 Introduction to the Quality Management System ManualThis quality management system manual has been designed by Witco Inc. hereafter referred to as Witco, for theimplementation of customer supplier quality requirements and the requirements of AS 9100. This manual contains:The scope of Witco’s quality management systemThe sequence and interaction of the quality management system processesJustification for any exclusion from AS 9100, ISO 13485 or ISO 9001 in the quality management systemIncludes references to the following procedures which are required by AS 9100, ISO 13485 or ISO 9001:o Document Controlo Records Controlo Control of Nonconforming Producto Internal Auditingo Corrective Actiono Preventive ActionDescriptions of the processes in the quality management system including where applicable;o the objectives and measurables of the process;o the records required by the process;o rules that apply to users of the process;o process instructions necessary for the successful function of the processA list of the authorities approving this Quality Management System ManualA brief description of revisions made to this document throughout its lifetime1.1 Quality Management System ScopeThis Quality Manual provides guidance and establishes requirements for Witco Inc. to remain compliant to theAS9100 Quality Management System. Witco’s Quality Management System is tailored to meet the following AS9100requirements:Precision CNC Machining for Commercial and Aerospace IndustriesSituations where partial or no compliance is required will be exceptions and specifically designated in the contract orproduct work instruction.1.2 Quality Policy StatementThe mission of Witco Inc. is to provide complete customer satisfaction by successfully employing resources, strivingfor continuous improvement, and by utilizing our quality management system to assure a sustainable advantage overour competitors through our dedication, skill, and effort.Printed copies of this manual or any page from this manual is considered uncontrolled for reference only unless accompanied by a serialized first page
Quality Management System ManualRevision EPage 6 of 351.3 Exclusions from AS 9100, ISO 13485 or ISO 9001 and Justification for ExclusionClause fromStandardTopicJustification Statement7.3 of all 3StandardsDesignControlProduct design is not required by our customers and not performing this process doesnot adversely affect compliance with statutory or regulatory requirements. Customersatisfaction is unaffected by excluding the design control process.1.4 ApprovalsThe approvals indicated below are for the approval of this revision of the Quality Management System ManualNameTitleNameTitle1.5 Revision -10E07-02-10Brief DescriptionInitial Release of document for management review prior to implementationClarification revisions throughout, enhancement of risk assessment and configuration management sections, addition ofsection numbers to all headings, rewritten preventive action procedure. Enhancement of document control, nonconformingproduct and records control procedures. Record retention times increased to meet general aerospace requirements.Clarification of revisions throughout. Removed Risk Drivers Section, updated gages selection, and redefined the manner inwhich scrap will be handled.Update Quality Manual Scope, update process interaction with outsourced processes, clarify records retained at supplier,clarify OK to Proceed disposition, and clarify actions taken when CAR is not effective.Updated internal auditor competency requirements, defined individual having approval/disapproval authority for suppliers,and defined the process for approving personnel for dispositions of non-conforming material.Printed copies of this manual or any page from this manual is considered uncontrolled for reference only unless accompanied by a serialized first page
Quality Management System ManualRevision EPage 7 of 352 Process Sequence and InteractionThe management process is responsible for oversight of all processes, tracking and analyzing customer satisfaction,management review and the administration of the training process through the Human Resources department.The contract administration process is responsible for the preparation of quotations, contract review, procurementof materials and services and planning of product realization.The manufacturing process is responsible for producing and inspecting the product. They support these processeswith maintenance and calibration.The storage and shipping process is responsible for packaging product for inventory or immediate shipment.TrainingTraining, which is part of themanagement process, supportsall ManagementThe management processinteractswithandoversees all ringStorage/Shipping2.1 Interaction of Procedures with Processes2.1.1 Document and Records ControlDocument and Records Control procedures are applied to all processes and all procedures.2.1.2 Internal AuditThe internal audit procedure is applied to all primary processes and the supporting processes are audited as part ofthe primary process that they support. Internal audit results are reviewed in the management process. Themanagement process administrates the internal audit procedure.2.1.3 Control of Nonconforming ProductThe nonconforming product procedure applies primarily to the purchasing, manufacturing and shipping processes. Itprovides review data to the management process.2.1.4 Corrective and Preventive ActionThe corrective and preventive action procedures are administered by the management process and applied to otherprocesses as directed by the management process.Printed copies of this manual or any page from this manual is considered uncontrolled for reference only unless accompanied by a serialized first page
Quality Management System ManualRevision EPage 8 of 353 Management ProcessThis is the process by which Witco manages the quality management system to ensure that its various departmentsand employees remain focused on the customers.3.1 Management Process Objective(s) and Measurement(s)Customer Satisfaction – Customer satisfaction is measured by the number of customer complaints and by monitoringthe data that affects customer satisfaction; Delivery Performance and Customer NCM’s.Employee Competency – Employee competency is measured by monitoring the number of issues with a resolutionon the Issues Log of training or employee error.3.2 Management Process RecordsThe records listed below are those necessary for the management process and may not be an exhaustive list. Theserecords are controlled in accordance with the Records Control Procedure.Record TypeRecord FormatMinimum Retention TimeManagement ReviewEmployee TrainingIssues LogTraining Records & Training Matrix3 YearsLength of Employment 1 Year3.3 Management Process RulesMaintenanceResponsibilityManagement Rep.Office ManagerEstablish a ManagementQuality System1. Control all documents created by management and providing instruction per theDocument Control ProcedureEstablish a Quality Policy2. Communicate all relevant quality management system, customer, product,statutory and regulatory requirements to the appropriate departments andpersonnel within Witco and where appropriate, to customers and suppliersEstablish Objectives toSupport the Policy and3. Establish, communicate and maintain Witco’s quality policy in accordance withMeasure thesection 5.3 of the standardManagement QualitySystem4. Ensure that objectives, consistent with the quality policy, are established to ensurethe effectiveness of the quality management system processes and theconformance of products to their requirements.Assign a Management5. As a minimum, product conformity and on time delivery performance shall beTeam Member toenforce and oversee themeasured to give evidence of customer focus.System, Policy and6. Ensure that all process objectives are assigned target values that are consistentObjectiveswith the goals of Witco and will maintain customer satisfaction.7. Assign at least one member of the management team with the authority andProvide the Resourcesorganizational freedom to perform the duties outlined in sections 5.4.2 and 5.5.2needed to implementof the AS 9100 standard as the management representative for qualityand support the System,8. Establish and maintain an organization chart that identifies key managementPolicy and Objectivesfunctions within Witco, including the management representati
A list of the authorities approving this Quality Management System Manual A brief description of revisions made to this document throughout its lifetime 1.1 Quality Management System Scope This Quality Manual provides guidance and establishes requirements for Witco Inc. to remain compliant
DESCRIPTION OF THE VARIOUS ELECTROLESS NICKEL COATINGS Four male and four female specimen components were sent to Witco Corp. for electroless nickel plating. These coatings were supplied in either the as-coated or coated and heat treated conditions, as described below. 7.3.1. AS-COATED REVISION One of the electroless nickel coatings was applied .
3. Quality management system 12 3.1 Quality policy 12 3.1.1 Quality levels 12 3.1.1.1 Academic research 12 3.1.1.2 Cooperative research 13 3.1.1.3 Laboratory work of students 13 3.2 Purpose of the quality system 13 3.3 Responsibilities 13 3.4 Structure of the quality management system 13 3.4.1 Quality manual 14
QUALITY MANAGEMENT SYSTEM REQUIREMENTS General Requirements 1. Establishing and implementing a documented quality management system 2. Implementing a documented quality management system 3. Maintaining a documented quality management system 4. Continually improving the effectiveness of the QMS 5. Determining processes 6.
Quality management system 4 Quality management system A quality management system (QMS) can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management. Early systems emphasized predictable outcomes of an industrial product prod
QUALITY SYSTEM AUDIT SECTION 2 QUALITY MANAGEMENT (5.0 of ISO-9000 Requirements) 1. Has a Quality Manual been developed? (Critical) SAT UNSAT N/A CAR MINOR CAR MAJOR 2. Have the Processes/Procedures needed for the Quality Management System been identified and included or referenced in the Quality Manual? (Critical) SAT UNSAT N/A CAR MINOR
Pipeline Integrity Management System (PIMS) Facility Integrity Management System (FIMS) Structural Integrity Management System (SIMS) Environmental Management System (ISO 14000) Asset Management System (ISO 5500) Quality Management System (ISO 9000) Safety Management System (API RP 1173) Figure 1. Interrelation of an organization management system. This example is for a pipeline operating .
Management Systems are managed by the joint UoA – NHSG Quality Assurance Manager (QAM). 5.1 Quality Manual This Quality Manual is the statement by UoA of its documented Quality Management System which conforms with ISO/IEC 17025:2017. Conformance with the requirements stated in the Quality Manual and in the UoA IMS Standard Operating
CODE CASES: BOILERS AND PRESSURE VESSELS Supplement 4 The new andrevisedCases thatappear in thisSupplementwere approvedby theBoardon Pressure
