QTI AS9100 Standard Audit

MKS Instruments, Inc. INTERNAL AUDIT REPORT

• GENERAL INFORMATION

• DATE:

  Date

• SITE:

• LOCATION:
  Address

• AREA TO AUDIT:

  Select Design and Development; Engineering; Human Resources; Management; Manufacturing; Planning; Purchasing; Quality Assurance; Service and Repair;

  • Design and Development;
  • Engineering;
  • Human Resources;
  • Management;
  • Manufacturing;
  • Planning;
  • Purchasing;
  • Quality Assurance;
  • Service and Repair;

• AUDIT/DOCUMENT REPORT #:

• INVOLVED PERSONNEL:

• DOCUMENT PREPARED BY:

Personnel that was audited during the process

• Auditees:

Person

• Add signature

  Sign

Review of Previous Findings

• Are there Non-Conformances/Findings to review from previous audits (CPAR)?

  YES

  NO

• Non-Conformances/Findings Actions from previous audits (CAR):

Finding

• CAR Approved and Closed?

  YES

  NO

• What is the status of the CAR?

  Select Assigned Accepted In Process Monitoring Submitted for Approval Rejected Stopped

  • Assigned
  • Accepted
  • In Process
  • Monitoring
  • Submitted for Approval
  • Rejected
  • Stopped

• CAR assignee:

• Need to escalate?

  YES

  NO

• Escalate to whom?

• Are there observations from previous audits that need review?

  YES

  NO

• Observation from previous audit

Observation

• Was the observation still present during the assessment?

  YES

  NO

• Need to assign observation as a Non-Conformance/Finding?

  YES

  NO

• Non-Conformance

NC

• SECTION TO AUDIT:

  Select 4 - Quality Management System; 5 - Management Responsibility; 6 - Resource Management; 7 - Product Realization; 8 - Measurement, Analysis and Improvement; 2.1.6 - Cycle Time Improvement (CTI); 2.2 - Business Systems and Org. Capabilities; 2.3 - Statistical Methods; 3.1 - Software Quality;

  • 4 - Quality Management System;
  • 5 - Management Responsibility;
  • 6 - Resource Management;
  • 7 - Product Realization;
  • 8 - Measurement, Analysis and Improvement;
  • 2.1.6 - Cycle Time Improvement (CTI);
  • 2.2 - Business Systems and Org. Capabilities;
  • 2.3 - Statistical Methods;
  • 3.1 - Software Quality;

4 QUALITY MANAGEMENT SYSTEM

4.1 General & Documentation Requirements

• This sections assesses the organization's ability to document the quality management system.

• 1. What is your current ISO certification status?

  Certified

  Past Due

  Not Certified

• Certification expiry date:

• 1.1 Identify standards certified to:

• ISO 9001:2008

• 1.2 Identify scope of certification(s) (i.e. Any exclusions).

• Certification expiry date:

• Root Cause for being Past Due?

• Does the assessed have a estimated date for Re-Certification?

  YES

  NO

  N/A

• Scheduled Re-certification date:

  Date

• Need to escalate?

  YES

  NO

  N/A

• To whom?

• 1.1 Identify standards certified to:

• ISO 9001:2008

• AS9100

• 1.2 Identify scope of certification(s) (i.e. Any exclusions).

• 2. How are outsourced functions that affect product or service conformity identified and implemented with effective controls?

  Select Calibration; Manufacturing processes; Maintenance; Auditing; Inspection; Records management; Other services;

  • Calibration;
  • Manufacturing processes;
  • Maintenance;
  • Auditing;
  • Inspection;
  • Records management;
  • Other services;

• Describe actions selected above.

• 3. What is your process for your document control system (ISO 4.2.3, a-g).

• 3.1 Document control system includes:

• - Procedure for approval.

• Description of process:

• - Change or Revision control.

• Description of process:

• - Identification & legibility.

• Description of process:

• - Control for externally originated documents (i.e. Customer documents, specifications, industry standards, etc.).

• Description of process:

• - Obsoleting documents.

• Description of process:

• - Obsoleting documents.

• Description of process:

• - Ensure access to controlled documents when/where needed.

• Description of process:

• - Process is in place to periodically verify that the latest customer revisions are being used (Drawings & Specifications).

• Description of process:

• 4. How are your quality management system procedures defined, implemented and maintained? (ISO 4.2.1.b,c,d) (ISO 4.2.2.b).

• 4.1 ISO requires at a minimum documented and implemented procedures for the Control of Nonconforming Product, Corrective Action, and Preventive Action (do not have to be individual procedures - they can be combined).

  YES

  NO

  N/A

• 4.2 Level 2 procedures should be referenced in the form of an index.

  Compliant

  Non-Compliant

  N/A

• 4.3 Clear ownership of documents with process defined for regular review (look for evidence of revision changes).

  Compliant

  Non-Compliant

  N/A

• 4.4 Changes to the quality management system are effectively planned and communicated (to include training as applicable).

  Compliant

  Non-Compliant

  N/A

• 4.5 Process implemented for periodic review and update of documents per a defined frequency.

  Compliant

  Non-Compliant

  N/A

• 5. How do you demostrate integration/interaction of the Quality Management System business process? (ISO 4.2.2.c).

• 5.1 Quality manual has a disgram showing how all processes in the Quality Management System interact.

  Compliant

  Non-Compliant

  N/A

• 5.2 May also be shown on process maps such as SIPOCS (Supplier Input Process Outputs Customer).

  Compliant

  Non-Compliant

  N/A

• 5.3 Flowcharts on process documents may also show interaction with other processes.

  Compliant

  Non-Compliant

  N/A

• 6. How do you ensure quality records are identified and effectively managed? (ISO 4.2.1; 4.2.4).

• 6.1 Control of Records procedure is required that addresses identification of records, storage, protection, retrieval, retention and disposition.

  Ensure

  Does Not Ensure

• 6.2 Records requirements are clearly defined to include duration and location of storage (i.e. record retention matrix).

  Compliant

  Non-Compliant

  N/A

• 6.3 Records should demostrate operational effectiveness and conformity to requirements.

  Compliant

  Non-Compliant

  N/A

• 6.4 Sample several records to ensure that the process is being followed (this can often be sampled as other sections are being assessed.

  Compliant

  Non-Compliant

  N/A

• 6.5 Verify that records are legible, readily identifiable, and retrievable.

  Compliant

  Non-Compliant

  N/A

PREVIOUS SCORES

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VALIDATION SCORES

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

5 MANAGEMENT RESPONSIBILITY

• SUB-SECTION:

  Select 5.2 - Customer Focus; 5.3 - Quality Policy; 5.4 - Planning; 5.5 - Responsibility, Authority and Comunication; 5.6 - Management Review;

  • 5.2 - Customer Focus;
  • 5.3 - Quality Policy;
  • 5.4 - Planning;
  • 5.5 - Responsibility, Authority and Comunication;
  • 5.6 - Management Review;

5.2 Customer Focus

• This section assesses the organization's ability to focus on meeting customer requirements.

• 1. How do you determine your customers needs and requirements, monitor performance, and drive subsequent improvements? ( ISO 5.2, 8.2.1, 8.4)

• 1.1 Organization clearly defines who their internal and external customers are

  Compliant

  Non-Compliant

  N/A

• 1.2 Customer performance requirements and goals are established.

  Compliant

  Non-Compliant

  N/A

• ( Identify existing metrics on the "Metrics" worksheet - at minimum must include quality and delivery performance, must include AMAT supplier balanced scorecard when applicable)

• 1.3 Data is analyzed to determine top issues inhibiting the consistent achievement of defined goals.

  Compliant

  Non-Compliant

  N/A

• 1.4 Improvement actions are defined and implemented when goals are not being met.

  YES

  NO

  N/A

• 1.5 Performance trends are identified, trended, analyzed, and improved towards goals as appropriate.

  Compliant

  Non-Compliant

  N/A

• 2. How do you assess and improve your customers satisfaction levels?

• 2.1 Process defined for conducting customer satisfaction surveys on periodic basis (minimun yearly).

  Compliant

  Non-Compliant

  N/A

• 2.2 Survey results are analyzed and corresponding improvement plans are established towards achieving defined goals.

  Compliant

  Non-Compliant

  N/A

• 2.3 Improvement plan deployment is monitored.

  Compliant

  Non-Compliant

  N/A

• 2.4 Closed loop communication process with Customer on improvement plans and progress.

  Compliant

  Non-Compliant

  N/A

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VALIDATION SCORES

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

5.3 Quality Policy

• This section assesses the organization's quality policy.

• 1. How is your policy defined, approved and implemented? ( ISO 5.3)

• 1.1 Quality Policy defined and approved by top management.

  Compliant

  Non-Compliant

  N/A

• 1.2 Includes a commitment to "comply with requirements and continually improve the effectiveness of the quality management system".

  Compliant

  Non-Compliant

  N/A

• 1.3 Quality Policy is effectively communicated throughout the organization ( i.e. as part of new hire orientation, postings, badges, screen savers, etc.)

  Compliant

  Non-Compliant

  N/A

• 1.4 Personnel are aware of the quality policy, know how to access it, understand how it applies to their jobs.

  Compliant

  Non-Compliant

  N/A

• 1.5 Quality Policy is reviewed to ensure it continues to be suitable and appropriate for the organization.

  Compliant

  Non-Compliant

  N/A

• 1.6 Quality Policy provides a framework for the Quality Objectives (i.e. linkage between policy and how the quality objectives measure the deployment of the policy)

  Compliant

  Non-Compliant

  N/A

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VALIDATION SCORES

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

5.4 Planning

• This section assesses the organization's ability to establish strategic quality planning.

• 1. What is your process for the establishment and deployment of Quality Objectives. ( ISO 5.4.1)

• 1.1 Management reviews and defines Quality Objectives annually at a minimum.

  Compliant

  Non-Compliant

  N/A

• 1.2 Quality Objectives address at minimum supplier performance, internal quality performance and performance to customers.

  Compliant

  Non-Compliant

  N/A

• 1.3 Quality Objectives are translated into measurable metrics with goals established.

  Compliant

  Non-Compliant

  N/A

• ( Identify Quality objective metrics on the "Metrics" worksheet)

• 1.4 Goals are sufficientaly challenging and modified as required to drive continual improvement.

  Compliant

  Non-Compliant

  N/A

• 1.5 Quality Objectives are cascaded into " relevant" and "measurable" functional/department and individual employee objectives.

  Compliant

  Non-Compliant

  N/A

• 2. How do you provide for the monitoring, analysis and improvement of Quality Objectives?

• 2.1 Management regularly reviews progress per as defined frequency that is effective ( i.e. yearly is insufficient if goals are not being met).

  Compliant

  Non-Compliant

  N/A

• 2.2 Metrics are trended for performance monitoring towards goals.

  Compliant

  Non-Compliant

  N/A

• 2.3 Data is analyzed to determine top issues inhibiting the consistent achievement of defined goals.

  Compliant

  Non-Compliant

  N/A

• 2.4 Improvement actions are defined and implemented when goals are not being met.

  Compliant

  Non-Compliant

  N/A

• 2.5 Effective visual communications of Quality objectives and status throughout the organization ( i.e. top level status boards, department level status boards).

  Compliant

  Non-Compliant

  N/A

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VALIDATION SCORES

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

5.5 Responsibility, Authority and Comunication

• This section assesses the organization's ability to ensure that the responsabilities and authorities are defined and communicated within the organization.

• 1. How do you define and communicate responsabilities, authorities and their interrelation within the organization (ISO 5.5.1)

• 1.1 Top management ensures that the responsabilities and authorities are defined and communicated throughout the organization ( defined roles and responsabilities, organizational charts, responsability sections in procedures, etc.)

  Compliant

  Non-Compliant

  N/A

• 1.2 Personnel in the organization are aware of roles and responsabilities.

  Compliant

  Non-Compliant

  N/A

• 2. Do you designate a Quality Management System representative with defined responsabilities. ( ISO 5.5.2-3)

• 2.1 Quality Management System management representative has been appointed who, irrespective of other responsabilities shall have responsability and authority for the QMS.

  Compliant

  Non-Compliant

  N/A

• 2.2 Representative is part of the management team.

  Compliant

  Non-Compliant

  N/A

• 2.3 Representative reports to top management on the performance of the Quality Management System.

  YES

  NO

  N/A

• 2.4 Representative promotes awareness of customer requirements throughout the organization.

  YES

  NO

  N/A

• 2.5 Personnel throughout the organization are aware of who the QMS management representative.

  Compliant

  Non-Compliant

  N/A

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VALIDATION SCORES

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

5.6 Management Review

• This section assesses the organization's ability to review the organization's quality management system.

• 1. How do you ensure that the Quality Management System unerdgoes periodic management review to review progress and drive continual improvements? (ISO 5.6)

• 1.1 Management reviews are performed at a frequency necessary to drive continual improvements ( i.e. some topics may be reviewed yearly ( i.e. quality policy suitability) but some topics may require more frequent view ( i.e. audits, corrective actions, customer sat, performance metrics, open action items, etc.)

  Compliant

  Non-Compliant

  N/A

• 1.2 Records of management reviews are maintained per records retention requirements ( i.e. agenda, meeting minutes, action items).

  Compliant

  Non-Compliant

  N/A

• 1.3 Effective process in place for action item follow-up to ensure closure in a timely manner.

  Compliant

  Non-Compliant

  N/A

• 2. What are the key topics covered during the management review? At minimum, they should include the following; ( ISO 5.6)

• 2.1 Planned changes to the Quality Management System.

  YES

  NO

  N/A

• 2.2 Quality Policy review.

  YES

  NO

  N/A

• 2.3 Quality objectives review.

  YES

  NO

  N/A

• 2.4 Results of audits ( internal and external).

  YES

  NO

  N/A

• 2.5 Customer feedback ( performance metrics and satisfaction surveys).

  YES

  NO

  N/A

• 2.6 Process performance ( i.e. key manufacturing yields, key manufacturing process characteristics (Cpk's), metrics of key bussiness process, etc.).

  YES

  NO

  N/A

• 2.7 Product conformity ( i.e. supplier non-conformances, FAI yields, in-process inspection, final inspection, 1st piece checks, non-conforming materials data, scrap, Cost of Quality, etc.).

  YES

  NO

  N/A

• 2.8 Status of preventive and corrective actions.

  YES

  NO

  N/A

• 2.9 Follow-up action status from previous reviews.

  YES

  NO

  N/A

• 2.10 Recommended improvements to the Quality Management System.

  YES

  NO

  N/A

PREVIOUS SCORES

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VALIDATION SCORES

• Management Commitment (MC):

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

6 RESOURCE MANAGEMENT

• SUB-SECTION:

  Select 6.2 - Human Resources; 6.3 - Infrastructure; 6.4 - Work Environment;

  • 6.2 - Human Resources;
  • 6.3 - Infrastructure;
  • 6.4 - Work Environment;

6.2 - Human Resources

• This section assesses the organization's ability to improve itself using human resources.

• 1. How do you ensure that a training program is defined, implemented, monitored, effective, and continually improved? ( ISO 6.2)

• 1.1 Documented training requirements forvall job families that include general courses/skills and job family specific training requirements ( i.e. training matrixes, job family training curriculums).

  Compliant

  Non-Compliant

  N/A

• 1.2 Progress towards meeting training requirements is planned and monitored ( i.e. reports that show what has been completed and what is still needed).

  YES

  NO

  N/A

• 1.3 Training requirements are used for employee development planning ( i.e. Training plans exists for identified needs, Employee goals and objectives address needed training).

  Compliant

  Non-Compliant

  N/A

• 1.4 Managers/ Supervisors utilize training completion status to determine which personnel are certified and qualified to perform given tasks and responsabilities.

  Compliant

  Non-Compliant

  N/A

• 1.5 Training records are maintained.

  Compliant

  Non-Compliant

  N/A

• 1.6 Training metrics are identified, trended, analyzed, and improved towards goals as appropriate.

  Compliant

  Non-Compliant

  N/A

• ( Identify existing metrics on the "Metrics" worksheet - at minimum, there must be metrics or reports that show the organizations overall training completion rate for "all" training requirements, " continuous improvement methods/ tools" training, and " AMAT required" training).

• 2. What is your process for on the job certification for operators?

• 2.1 Documented process for on the job certification of manufacturing personnel ( not limited to specialized skills such as welding, soldering, assembly work).

  Compliant

  Non-Compliant

  N/A

• 2.2 Contains criteria for certification and defines training methodology ( i.e. qualified trainers assigned, observe work, be observed, approvals before independent work performed).

  Compliant

  Non-Compliant

  N/A

• 2.3 Considers Mastery levels where appropriate ( i.e. Certified to perform work, certified to teach others).

  Compliant

  Non-Compliant

  N/A

• 2.4 Contains requirements for periodic recertification and decertification when needed ( i.e. Job change, performance issues, away from job for a certain time period, etc.)

  Compliant

  Non-Compliant

  N/A

• 2.5 Certification status and plans are monitored by management ( i.e. Training matrix showing both employee certification status and plans to address gaps and employee development)

  Compliant

  Non-Compliant

  N/A

• 3. What is your process for Continual Improvement tools training?

• 3.1 Continual Improvement methods and improving tools course curriculum has been developed based on organizational needs analysis and strategic planning ( i.e. Lean / Six Sigma methodology, kaizen methodology, 8D methodology and all corresponding improvement tools needed to support improvement methodologies).

  Compliant

  Non-Compliant

  N/A

• 3.2 Curriculum has been integrated into all job family training requirements as applicable to each job family.

  Compliant

  Non-Compliant

  N/A

• 3.3 Curriculum identifies both the skills and the corresponding training courses ( can be internal and external courses).

  Compliant

  Non-Compliant

  N/A

• 3.4 Training materials are available in support of training courses.

  Compliant

  Non-Compliant

  N/A

• 3.5 Training completion metrics or reports are monitored by management.

  Compliant

  Non-Compliant

  N/A

• 4. What is your process to ensure relevant personnel undergo AMAT specific training?

• 4.1 Inventory of applicable customer requirements has been performed and requirements have been defined ( i.e. Copy Exact, workmanship standards, cosmetics, packaging/crating, product safety, 8D, FAI, PQP, CofC, FIR, DDD, SSQA, specifications listed on part drawings, etc.).

  Compliant

  Non-Compliant

  N/A

• 4.2 Training requirements have been integrated into the applicable job family training requirements/ curriculums.

  Compliant

  Non-Compliant

  N/A

• 4.3 Evidence that personnel working on AMAT orders have all completed required training before operating independently.

  Compliant

  Non-Compliant

  N/A

• 4.4 Refresher training requirements are defined and implemented ( i.e. Yearly CE training).

  Compliant

  Non-Compliant

  N/A

• 4.5 Training completion metrics or reports are monitored by management.

  Compliant

  Non-Compliant

  N/A

• 5. How do you ensure that training is effective?

• 5.1 Methods are defined to evaluate the effectiveness of training ( i.e. testing, internal/ external competency based certifications, observation & feedback, performance evaluations, defect mapping, overall training needs analysis, etc.).

  Compliant

  Non-Compliant

  N/A

• 5.2 Effectiveness of training is evaluated per the defined method.

  Compliant

  Non-Compliant

  N/A

• 5.3 Improvement actions defined and implemented forbtraining effectiveness gaps.

  Compliant

  Non-Compliant

  N/A

• 5.4 Management periodically reviews overall training program effectiveness and drives continual improvements to training program content and/ or methods for ensuring effectiveness of training ( i.e. Defect rates related to workmanship errors, processes not being followed, problem solving with inadequate root cause analysis, etc.).

  Compliant

  Non-Compliant

  N/A

• 6. How are organizational goals and objectives established and cascaded throughout the organization?

• 6.1 Management defines Goals and Objectives on a yearly basis.

  Compliant

  Non-Compliant

  N/A

• 6.2 Quality Objectives are included in and/ or aligned with Goals and Objectives.

  Compliant

  Non-Compliant

  N/A

• 6.3 Goals and Objectives are translated into measurable metric with goals established.

  YES

  NO

  N/A

• ( Identify top level goals and objectives metrics on the " Metrics" worksheet).

• 6.4 Goals are sufficiently challenging and modified as required to drive continual improvement.

  Compliant

  Non-Compliant

  N/A

• 6.5 Goals and Objectives are cascaded into "relevant" and "measurable" functional/department and individual employee objectives.

  Compliant

  Non-Compliant

  N/A

• 7. How are your goals and objectives monitored, analyzed, and improved?

• 7.1 Management regularly reviews progress per a defined frequency that is effective.

  Compliant

  Non-Compliant

  N/A

• 7.2 Metrics are trended for performance monitoring towards goals.

  Compliant

  Non-Compliant

  N/A

• 7.3 Data is analyzed to determine top issues inhibiting the consistent achievement of defined goals.

  YES

  NO

  N/A

• 7.4 Improvement actions are defined and implemented when goals are not being met.

  Compliant

  Non-Compliant

  N/A

• 7.5 Effective visual communications of Goals and Objectives and status throughout the organization ( i.e. Top level status boards, department level status boards).

  Compliant

  Non-Compliant

  N/A

• 8. How do you determine and improve employee satisfaction?

• 8.1 Process are in place for employee satisfaction surveys ( results analyzed, improved plans defined and implemented, and closed loop results monitored for employee satisfaction improvements).

  Compliant

  Non-Compliant

  N/A

PREVIOUS SCORES

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VALIDATION SCORES

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

6.3 - Infrastructure

• This section assesses the organization's ability to determine, provide and maintain appropriate infrastructure.

• 1. What is your process to determine, periodically review and fund the required infraestructure requirements to meet product/ process requirements? ( ISO 6.3) Includes;

• 1.1 Buildings, workspace and associated utilities.

  Compliant

  Non-Compliant

  N/A

• 1.2 Layout of equipment to improve workflow efficiency.

  YES

  NO

  N/A

• 1.3 Process equipment ( hardware and software). This requirement is also included in the new product introduction process.

  YES

  NO

  N/A

• 1.4 Supporting services ( e.g. Transportation, communication, IT, etc.).

  Compliant

  Non-Compliant

  N/A

PREVIOUS SCORES

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VALIDATION SCORES

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

6.4 - Work Environment

• This section assesses the organization's ability to determine and manage the work environment.

• 1. How do you determine and periodically review the work environment needed to meet product/ process requirements? ( ISO 6.4)

• 1.1 Safety and ergonomic requirements with the appropriate personal protective equipment. Audits are performed to check compliance.

  Compliant

  Non-Compliant

  N/A

• 1.2 Environmental controls are in place and monitored to meet production requirements ( e.g. Temperature, humidity, etc.).

  Compliant

  Non-Compliant

  N/A

• 2. If applicable, what ESD process controls been identified and implemented?

• 2.1 ESD controls, equipment, and training.

  Compliant

  Non-Compliant

  N/A

• 2.2 Audits are performed to ensure ESD compliance. Records are maintained.

  Compliant

  Non-Compliant

  N/A

• 3. If applicable, what cleanroom controls been identified and implemented?

• 3.1 Protocol requirements for people, equipment and material entering the cleanroom.

  Compliant

  Non-Compliant

  N/A

• 3.2 Effective particle monitoring program for all areas of the cleanroom.

  YES

  NO

  N/A

• 3.3 Cleaning requirements of the cleanroom.

  YES

  NO

  N/A

• 3.4 Periodic compliance audits.

  Compliant

  Non-Compliant

  N/A

• 4. How do you utilize 5S to continually improve the work environment?

• 4.1 Documented process for 5S and deployed throughout the organization.

  Compliant

  Non-Compliant

  N/A

• 4.2 Top management communicates their support of 5S to the organization.

  YES

  NO

  N/A

• 4.3 Required 5S training is identified and given to all applicable employees and included in their training records.

  YES

  NO

  N/A

• 4.4 5S area audits with goals are performed on a periodic basis and results are posted. Action items are taken if goals are not being met.

  YES

  NO

  N/A

• 4.5 Rewards and recognition are tied to 5S improvement.

  YES

  NO

  N/A

• 4.6 Evidence of logical and effective visual management ( i.e. defined locations for materials and equipment ( staging areas, kanbans), signage, tool shadow boards, organized work areas, general communication boards, work areas metrics/ action boards, etc.).

  Compliant

  Non-Compliant

  N/A

PREVIOUS SCORES

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VALIDATION SCORES

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

7 PRODUCT REALIZATION

• SUB-SECTION:

  Select 7.2 - Customer Related Process; 7.3a - Design and Development (OEM Suppliers Only); 7.3b - New Product Introduction (Non OEM Suppliers Only) 7.4 - Purchasing; 7.5 - Production and Service Provision; 7.6 - Control of Monitoring and Measuring Devices;

  • 7.2 - Customer Related Process;
  • 7.3a - Design and Development (OEM Suppliers Only);
  • 7.3b - New Product Introduction (Non OEM Suppliers Only)
  • 7.4 - Purchasing;
  • 7.5 - Production and Service Provision;
  • 7.6 - Control of Monitoring and Measuring Devices;

7.2 - Customer Related Process

• This section assesses the organization's ability to determine and review customer requirements and communication.

• 1. How does your contract review process meet the following requirements? ( ISO 7.2)

• 1.1 Defines customer requirements, including delivery and post-delivery activities ( e.g. Warranty, maintenance services, recycling, final disposal, etc.).

• 1.2 Defines non-specified requirements but necessary to satisfy the customer ( e.g. Reliability tests, functional tests, etc.).

• 1.2 Defines statutory and regulatory requirements.

• 1.3 Defines organization requirements ( e.g. Skillsets, equipment, etc.)

• 1.4 Records of the contract review including changes are maintained.

• 1.5 Contract review process metrics are identified, trended, analyzed, and improved towards goals as appropriate ( i.e. quote cycle times, quote win rates, customer feedback of contract review process, corrective SPS's etc.)

• NOTE: Identify existing metrics in the "Metrics" Section.

• Auditing Repair Suppliers?

  YES

  NO

• Controls to ensure that supplier is servicing to the latest revision levels of the OEM specifications).

  YES

  NO

  N/A

• 2. How are customers requirements reviewed for concurrance before commiting to supply product? ( ISO 7.2.2)

• 2.1 Appropriate functions review and approve the defined requirements to ensure they can be met.

  YES

  NO

  N/A

• 2.2 Any requirements that are not clear or cannot be met are documented and resolved with the customer.

  Compliant

  Non-Compliant

  N/A

• 2.3 Review process is supported by a checklist ( or equivalent) that clearly documents requirements, review and acceptance of requirements with appropriate stakeholders, and closed loop resolution of any gaps, questions, or discrepancies.

  YES

  NO

  N/A

• 3. When the contract is changed how does the organization identify what documents are affected and make the required changes? ( ISO 7.2.2)

• 3.1 Users are identified and made aware of the changes.

  YES

  NO

  N/A

• 4. How does the organization's customer contract (s) establish two-way communication with the customer? Communication topics include: (ISO 7.2.3)

• Product Information

• Describe process.

• Enquiries, contracts including changes

• Describe

• Customer feedback, including customer complaints.

• Describe

• 5. How do you meet the requirements of the Copy Exact Management process for AMAT?

• 5.1 Complete AMAT on-line CE training completion ( minimum one person from management, engineering, purchasing, manufacturing, within last year)

  YES

  NO

  N/A

• 5.2 All quality related personnel should complete AMAT on-line Copy Exact training.

  YES

  NO

  N/A

• 5.3 CE refresher training requirements defined and implemented internally and with the supply base ( evidence of implementation on a minimum yearly basis)

  YES

  NO

  N/A

• 5.4 Copy Exact controls are integrated into Internal change management processes and are systemic to the extent possible.

  YES

  NO

  N/A

• 5.5 CE training deployed to the supply base.

  YES

  NO

  N/A

• 5.6 A review of process of adherence gaps between sub-tier and AMAT requirements has been completed and actions established to bring requirements in line.

  YES

  NO

  N/A

• 6. How do you meet the requirements of the AMAT SPS and SNF change communication processes?

• 6.1 Appropriate personnel are trained in the use of the SPS and SNF communication tools via GMOX. Verify understanding via a log-in.

  YES

  NO

  N/A

• 6.2 Relevant personnel demonstrate understanding of the change requirements matrix.

  YES

  NO

  N/A

• 6.3 Evidence that 180 day advance notification to Applied Materials is being given for all product changes affecting design/ material/processing/mfg source/build locations changes.

  YES

  NO

  N/A

• 6.4 SPS's and SNF's are proactively monitored and managed for effectiveness ( i.e. Monir quantities, reasons for submission, cycle times to close, aging of open requests, open actions items, etc.)

  YES

  NO

  N/A

• 6.5 Effective Change Communication methods have been deployed to suppliers ( i.e. Frmal communication of changes, formal reviews/ approvals, spreadsheet/ database tracking of submissions, etc.)

  YES

  NO

  N/A

• 6.6 Need for SPS's are identified proactively vs. reactively ( i.e. During contract review versus after already in production)

  YES

  NO

  N/A

• 7. What is your process to ensure the requirements of the AMAT First Article Process are met?

• 7.1 Appropriate personnel are trained in FAI process requirements and usage of the FAI ACA tool on GMOX

  YES

  NO

  N/A

• 7.2 FAI acceptance rates are trended, data analyzed when goals are met, and improvement plans implemented.

  YES

  NO

  N/A

• 7.3 CCR's are submitted for BOM items on assemblies with internal FAI's maintained for the components.

  YES

  NO

  N/A

• Auditing Repair Suppliers?

  YES

  NO

• Ensure supplier is in compliance with FRI requirements ( First Repair Inspection).

  YES

  NO

  N/A

• Is section 5.2 part of the assessment scope?

  YES

  NO

• 8. How do you determine your customers' need and requirements, monitor performance, and drive subsequent improvements?

• 8.1 Customer performance requirements and goals are established.

  YES

  NO

  N/A

• ( Identify existing metrics on the "Metrics" worksheet - at a minimum must include quality and delivery performance, must include AMAT supplier balanced scorecard when applicable).

• 8.2 Data is analyzed to determine top issues inhibiting the consistent achievement of defined goals.

  YES

  NO

  N/A

• 8.3 Improvement actions are defined and implemented when goals are not being met.

  YES

  NO

  N/A

• 8.4 Performance trends are identified, trended, analyzed, and improved toward goals when applicable.

  YES

  NO

  N/A

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

7.3a - Design and Development (OEM Suppliers Only)

• This section assesses the organization's ability to control the design and development of product.

• 1. How does your documented design and development process adress the following requirements? ( ISO 7.3)

• 1.1 Defines key tasks, responsabilities, and deliverables.

  YES

  NO

  N/A

• 1.2 Tasks and deliverables should align with the requirements of all the questions below.

  Compliant

  Non-Compliant

  N/A

• 1.3 Contains defined stages ( e.g. alpha, beta, gamma, etc.) with design review, verification, validation, approvals, for each phase/ stage against defined exit criteria.

  YES

  NO

  N/A

• 1.4 Contains formal sign-off at gates with exceptions and risks documented.

  YES

  NO

  N/A

• 1.5 Senior Management provides design & development project oversight, utilizes cross functional teams, and customer involvement ( where applicable).

  YES

  NO

  N/A

• 1.6 Project Management techniques are in place to track deployment ( actions, owners, dates, status, metrics, etc.).

  YES

  NO

  N/A

• 1.7 Design and development standards and rules are for hardware, electrical, control systems, etc. are documented, controlled and used for all designs.

  YES

  NO

  N/A

• 1.8 Design factors include affordability, quality, reliability, EHS, maintainability, modularity, scalability, ease of troubleshooting, engineering revision, manufacturability, and design risk.

  YES

  NO

  N/A

• 1.9 Knowledge, use and alignment with international and industry standards ( e.g. SEMI S2, S8, S21, S23, SMEMA, etc.)

  YES

  NO

  N/A

• 1.10 Records retention requirements are defined.

  YES

  NO

  N/A

• 2. What metrics are in place to measure, monitor, analyze, and improve the Design and Development process? Examples of metrics:

  Select Effectiveness Efficiency

  • Effectiveness
  • Efficiency

• Effectiveness ( post release audit score, lagging quality, controlled build results, yields at approval stages, yields at key review and validation steps, corrective ECO's post release, actual vs. predictable reliability, warranty data, anual failure rates, internal/ external customer feedback).

  Select Post release audit Score; Lagging quality; Controlled build results; Yield at approval stages; Yield at key review and validation steps; Corrective ECO's post release; Actual vs. predicted reliability; Warranty data; Annual failure rates Internal/External customer feedback;

  • Post release audit Score;
  • Lagging quality;
  • Controlled build results;
  • Yield at approval stages;
  • Yield at key review and validation steps;
  • Corrective ECO's post release;
  • Actual vs. predicted reliability;
  • Warranty data;
  • Annual failure rates
  • Internal/External customer feedback;

• Describe metrics selected above

• NOTE: Identify existing metrics on the "Metrics" section.

• Efficiency ( performance to development schedule, performance to cost, development cycle times).

  Select Performance to development schedule; Performance to cost; Development cycle times; Other;

  • Performance to development schedule;
  • Performance to cost;
  • Development cycle times;
  • Other;

• Describe metrics selected above.

• NOTE: Identify existing metrics on the "Metrics" section.

• 3. How are inputs for product requirements identified, to include the following? ( ISO 7.3.2)

• 3.1 Product function or performance requirements.

• 3.2 Statutory and regulatory requirements.

• 3.3 Previous/ similar designs ( where applicable).

• 3.4 Other customer/ market specific requirements. Examples; Market requirements specification, Product performance specification, Customer/ statutory/ regulatory requirements, post mortem/ lessons learned reports from previous designs, etc.

• 3.5 Sample for evidence of records that supports inputs for product requirements.

• 4. How are outputs of product requirements identified, to include the following? (ISO 7.3.3)

• 4.1 Verification to design and development inputs.

• 4.2 Appropriate information for purchasing, production, and service provision.

• 4.3 Product acceptance criteria ( which includes functional testing).

• 4.4 Characteristics of the product that are essential for its safe and proper use. Examples; Design specification, Product specification sheet/ catalog, Test Specifications, Sourcing plan, BOM, Safety requirements, environmental requirements, etc.

• 4.5 Sample of evidence of records that support outputs for product requirements.

• 5. How is design verification performed in accordance with planned arrangements to ensure that the design outputs have met the design and development input requirements? ( ISO 7.3.5)

• 5.1 Planned verification is conducted , records kept, and reviewed and approved by appropriate parties.

  YES

  NO

  N/A

• 5.2 Deficiencies found during the verification are documented, reviewed and dispositioned accordingly.

  YES

  NO

  N/A

• NOTE: Verification is the process of determining whether the system is in compliance with its specifications ( design review, performance in simulated real world conditions, marathon testing, halt testing, etc.)

• 6. How is the design validation performed to confirm that the product is capable of meeting the requirements for the specified application or intended use? ( ISO 7.3.6)

• 6.1 Planned validation is conducted, records kept, and reviewed and approved by appropriate parties.

  YES

  NO

  N/A

• 6.2 Deficiencies found during the validation are documented, reviewed, and dispositioned accordingly

  YES

  NO

  N/A

• NOTE:
  Validation is the process of determining if the system works in real world applications ( customer confirmation in real world applications, beta test results (prototype at customer site), etc.)

• 7. How do you ensure the identification and qualification of necessary tools, production & test equipment needed for manufacturing?

• 7.1 Qualification plans are de<br>Fined and implemented for tools and equipment identified ( i.e. Mchine capabilities studies, test fixture qualifications, gage R & R, etc.)

  YES

  NO

  N/A

• 7.2 Tools and equipment are qualified before use for volume production.

  YES

  NO

  N/A

• 8. How do you ensurebthat product inspection and/ or test criteria is defined and implemented ( receiving, in-process and final)?

• 9. How do you identify critical to quality characteristics and ensure that the process capability ( Cp, Cpk) is assessed?

• 9.1 Evidence that process capabilities are determined, reviewed and appropriate actions are taken ( i.e. Risk mitigation actions and improvement projects for process capabilities < 1.33 before volume manufacturing release.

  YES

  NO

  N/A

• 10. How do you ensure operational routers ( traveler, job sequence) are developed and that the content is adequate to assure quality of product before moving to the next operation?

• 11. How does the design and development process ensure that FMECA ( Design and Process) is conducted?

• 11.1 Sould not be only for AMAT defined critical PQP parts.

  YES

  NO

  N/A

• 11.2 Cross-functional approach should be used.

  YES

  NO

  N/A

• 11.3 Personnel should be trained.

  YES

  NO

  N/A

• 11.4 Evidence that corrective actions are taken when RPN ratings do not meet defined requirements.

  YES

  NO

  N/A

• 11.5 Poka Yoke ( error proofing) is considered for the corrective actions to as required by high RPN's on FMEA's ( i.e. tools, fixtures, jigs, assembly aids, automated controls, software controls, etc.)

  YES

  NO

  N/A

• 11.6 Evidence that the granularity of the process FMEA's are sufficient to identify failure model risks ( i.e. Conducted a task level not just at overall process level, comprehensive evaluation that looks at potential failure modes related to man, methods, machines, materials, measurement, and mother nature ( environment))

  YES

  NO

  N/A

• 11.7 Documented evidence that process FMEA's are periodically re-evaluated for effectiveness based on on-going data review ( i.e. Process yields, internal defects, external defects, scrap, rework, etc.)

  YES

  NO

  N/A

• 12. How do you ensure that product-specific Process Control Plans are developed?

• 12.1 Should, not be only for AMAT defined critical PQP parts.

  YES

  NO

  N/A

• 12.2 Process FMEA's are utilized as inputs to process control plan development.

  YES

  NO

  N/A

• 12.3 Evidence that process control plans rely on more robust controls than just inspection ( i.e. error proofing, automation, SPC, etc.)

  YES

  NO

  N/A

• 12.4 Documented evidence that process control plans are periodically re-evaluated for effectiveness based on-going data review ( i.e. Process yields, internal defects, external defects, scrap, rework, etc.)

  YES

  NO

  N/A

• 13. When applicable, how are periodic reliability tests determined and implemented?

• 13.1 Results are monitored and analyzed, and improvements are implemented as needed ( i.e. weld strenghts, solder joint integrity, peel strenght, coupon testing, destructive tests, functional tests, etc.)

  YES

  NO

  N/A

• 14. How do you ensure that product goes through derating ( electronics), dimensioning, tolerancing and interchangeability assesments?

• 15. How do you ensure that a trouble shooting guide ( including fault tree analysis) is developed?

• 15.1 Troubleshooting guide is revision controlled.

  YES

  NO

  N/A

• 15.2 Troubleshooting guide is effectively communicated to users.

  YES

  NO

  N/A

• 15.3 Mechanisms are in place for user support and feedback.

  YES

  NO

  N/A

• 16. How do you ensure that a reliability assesment is conducted ( i.e. Reliability apportionment, MTBF prediction, reliability marathon testing)?

• 16.1 Actual performance is evaluated against established reliability targets.

  YES

  NO

  N/A

• 16.2 Evidence that improvement actions are taken when targets are not met.

  YES

  NO

  N/A

• 17. How do you ensure that highly accelerated life testing ( HALT) is performed to identify destructive operating limit of the design?

• 17.1 HALT outputs used to design controls ( i.e. design changes HASS / ESS / burn-in profile to screen infant mortality failures of production parts).

  YES

  NO

  N/A

• 18. How do you ensure transportation shock,mvibration, and drop testing is performed to validate that the packaging is sufficient?

• 19. How do you ensure a controlled build prior to release for volume manufacturing?

• 19.1 Controlled build validation requirements are defined and implemented ( i.e. first articles, meeting minimim process capabilities, meeting minimum FMEA RPN requirements, Gage R&R results, etc.)

  YES

  NO

  N/A

• 19.2 Results reviewed and approved prior to volume manufacturing.

  YES

  NO

  N/A

• 19.3 Evidence that controlled build results are used to improve the new product introduction process ( i.e. Integration of lessons learned into process / other products).

  YES

  NO

  N/A

• Product Improvement / Engineering Change

• 20. How does the change management process address the following requirements? ( ISO 7.3.7)

• 20.1 Design and development changes are identified and recorded.

  Addressed

  Not Addressed

• 20.2 Chenages are reviewed, verified, validated, and communicated internally and externally, as appropriate, and approved prior the implementation.

  Addressed

  Not Addressed

• 20.3 Reviews including evaluation of the effects of the changes on constituent parts and delivered products are performed.

  Addressed

  Not Addressed

• 20.4 Records are maintained and include results of the reviews and any necessary actions identified as a result of the change review process ( per Record Control process).

  Addressed

  Not Addressed

• 20.5 Change management process metric are identified, trended, analyzed, and improved toward goals as appropriate ( i.e. Open/closed, approvals aging, corrective vs. Improvement changes, etc.)

  Addressed

  Not Addressed

• NOTE : Identify existing metrics on the "Metrics" worksheet.

• 21. How does the change management process address the following requirements related to sub-tier suppliers? (ISO 7.3.7)

• 21.1 The process of how the organization will communicate and control changes of their process to their sub-tier suppliers is documented.

  YES

  NO

  N/A

• 21.2 The process of how a sub-tier supplier will communicate and control changes to their product to the organization is documented.

  YES

  NO

  N/A

• 21.3 These processes are communicated to all sub-tier suppliers and are repeated on a periodic basis. Evidence is available thst sub tiers suppliers comply with stated processes.

  YES

  NO

  N/A

• 21.4 Change Management controls are verified at subtier suppliers for adherence to he organization's stated policies.

  YES

  NO

  N/A

• 21.5 Evidence that sub tier suppliers are notifying the oreganization per established change control processes exits and is traceable.

  Compliant

  Non-Compliant

  N/A

PREVIOUS SCORES

• Management Commitment (MC):

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• Systems Approach (SA):

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• Results (R):

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VALIDATION SCORES

• Management Commitment (MC):

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• Systems Approach (SA):

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• Deployment (D):

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• Results (R):

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

7.3b - New Product Introduction (Non OEM Suppliers Only - OEM suppliers score as 'NA')

• This section assesses the organization's ability to control the design and development of product.

• DOCUMENTED PROCESS

• 1. Does the organization have a documented New Product Introduction (NPI) process? (ISO 7.3.1)

  YES

  NO

  N/A

• 1.1 Defined stage with design review, verification and validation.

  Compliant

  Non-Compliant

  N/A

• 1.2 Defines key tasks, responsibilities, and deliverables that align with all requirements of this section.

  Compliant

  Non-Compliant

  N/A

• 1.3 Defined exit criteria for each phase with formal sign-off gates with documented exceptions and risks.

  Compliant

  Non-Compliant

  N/A

• 1.4 Defined record requirements.

  Compliant

  Non-Compliant

  N/A

• 1.5 Tasks associated with Customer critical part PQP's are embedded in the new product introduction process.

  YES

  NO

  N/A

• PROJECT MANAGEMENT TECHNIQUES

• 2. Use of Project Management techniques:

• 2.1 Senior management provides project oversight and removes roadblocks.

  YES

  NO

  N/A

• 2.2 Detailed project pland developed.

  Compliant

  Non-Compliant

  N/A

• 2.3 Project plans updated for progress monitoring.

  Compliant

  Non-Compliant

  N/A

• 2.4 On-going evaluation of project risks.

  Compliant

  Non-Compliant

  N/A

• 2.5 Maintain action registers and monitor for closure.

  Compliant

  Non-Compliant

  N/A

• 2.6 Formal lessons learned analysis.

  Compliant

  Non-Compliant

  N/A

• PQP MANAGEMENT

• 3. If applicable, how do you manage your PQP program to meet the following requirements?

• 3.1 Critical Parts list is available and shows which parts require PQP's.

  Compliant

  Non-Compliant

  N/A

• 3.2 PQP completion status report is maintained and reviewed by management (e.g. inactive part, not started, in process, complete, waiting for Customer approval, Customer approved, etc.).

  Compliant

  Non-Compliant

  N/A

• 3.3 Clearly defined action plans (who, what, when) are in place for PQP's not yet completed or approved by Customers.

  Compliant

  Non-Compliant

  N/A

• 3.4 Bussiness processes exist with clear roles & responsibilities to meet Customers SPC requirements (i.e. establishing control limits, sampling frequency, measurement system, out-of-control action plans, etc.), projects to work on low CpK areas, metrics to monitor response times and empowered teams to shutdown for frequent out-of-control events.

  Compliant

  Non-Compliant

  N/A

• QUALITY PLANNING

• 4 Are key performance characteristics (KPC) identified?

  YES

  NO

  N/A

• 4.1 Criteria defined on what constitutes a KPC.

  Compliant

  Non-Compliant

  N/A

• 4.2 Internal and customer KPC's.

  Compliant

  Non-Compliant

  N/A

• 4.3 KPC's are identified in process documentation (e.g. prints, FMEA's, control plans, traveler, router, process documentation, etc.).

  Compliant

  Non-Compliant

  N/A

• 5. Is process capability assessed for KPC's?

  YES

  NO

  N/A

• 5.1 CpK goal >1.33 for sample sizes >30?

  YES

  NO

  N/A

• 5.2 CpK requirements for samples sizes are <30?

  Compliant

  Non-Compliant

  N/A

• 5.3 Action items defined in process capability is below goal before release to volume manufacturing.

  YES

  NO

  N/A

• 6. Are product inspection, test and acceptance criteria (i.e. receiving, in-process and final test) defined?

  YES

  NO

  N/A

• 7. How do you ensure test specification correlation between the supplier and the Customers Final Test activities is evalated for consistency?

  Compliant

  Non-Compliant

  N/A

• 7.1 If any gaps exist, they should be documented with closure actions taken to valume manufacturing.

  Compliant

  Non-Compliant

  N/A

• 8. Does the NPI output include the identification and qualification of the necessary tools, production, and test equipment needed for manufacturing?

  YES

  NO

  N/A

• 8.1 Qualification plans are defined and implemented for equipment and tooling (e.g. machine capability studies, test fixture qualification, etc.).

  Compliant

  Non-Compliant

  N/A

• 9. Are gage studies conducted on measuring equipment used to measure KPC characteristics?

  YES

  NO

  N/A

• 9.1 Goal >10%. 10%-30% in conditionally acceptable. >30% is not acceptable unless approved by top management.

  Compliant

  Non-Compliant

  N/A

• 10. Does the organization have a documented FMEA process?

  YES

  NO

  N/A

• 10.1 Use cross functional teams to create or revise FMEA's.

  Compliant

  Non-Compliant

  N/A

• 10.2 Threshold on when corrective actions are required (e.g. RPN>100, criticality>20).

  Compliant

  Non-Compliant

  N/A

• 10.3 Use of error proofing techniques (e.g. Poka-Yoke).

  Compliant

  Non-Compliant

  N/A

• 10.4 Requirements on when FMEA's need to be revised.

  YES

  NO

  N/A

• 10.5 FMEA training for team members.

  YES

  NO

  N/A

• 11. Are Process FMEA's created or revised during the design process?

  YES

  NO

  N/A

• 11.1 Process FMEA's are used as input for manufacturing documentation (e.g. Control plans, routers, inspection plans, OMS's, etc.).

  YES

  NO

  N/A

• 12. Are product specific control plans created or revised during the design process?

  YES

  NO

  N/A

• 12.1 List the controls used for the manufacturing process control.

  Compliant

  Non-Compliant

  N/A

• 12.2 Includes methods for monitoring of controlling KPC's.

  YES

  NO

  N/A

• 12.3 Include SPC control as part of manufacturing steps.

  Compliant

  Non-Compliant

  N/A

• 12.4 Develop out-of-control action plans (OCAP) when the process becomes unstable of not statistically capable.

  Compliant

  Non-Compliant

  N/A

• 12.5 Control plans are updated when any change accurs that affects product, manufacturing processes, measurement, logistics, supply source or FMEA's.

  YES

  NO

  N/A

• RELIABILITY PLANNING

• 13. Are reliability controls and improvements implemented as needed (e.g. cable pull tests, weld strengths, solder joint integrity, peel strength, coupon testing, destructive tests, functional tests, burn-in tests, etc.).

  YES

  NO

  N/A

• 14. Is product packaging performed (e.g. transportation shock, vibrations, and drop testing) to validate that the packaging is sufficient?

  YES

  NO

  N/A

• MANUFACTURING DOCUMENTATION

• 15. Does the NPI output include all required documentation to manufacture the product? (ISO 7.3.3)

  YES

  NO

  N/A

• 15.1 Specifications, drawings, process flow diagram.

  Compliant

  Non-Compliant

  N/A

• 15.2 Purchasing information for raw material (e.g. BOM's).

  Compliant

  Non-Compliant

  N/A

• 15.3 Manufacturing documentation (e.g. router, set-up instructions, traveler, work instructions, etc).

  Compliant

  Non-Compliant

  N/A

• 16. Is all manufacturing documentation validated prior to production release?

  YES

  NO

  N/A

• VALIDATION OF RESULTS

• 17. Is a controlled build required prior to release for volume manufacturing? (ISO 7.3.6)

  YES

  NO

  N/A

• 17.1 Validation requirements are defined and implemented (e.g. first article inspection, meeting minimum process capabilities, etc.).

  Compliant

  Non-Compliant

  N/A

• 17.2 Results are reviewed and approved prior to volume manufacturing.

  YES

  NO

  N/A

• 17.3 Results are used to improve the new product introduction process for other products.

  YES

  NO

  N/A

• 17.4 Records of the validation and any necessary actions are maintained.

  YES

  NO

  N/A

• 17.5 Control Build engineering issues / non-conformances are documented and tracked to full closure.

  YES

  NO

  N/A

• 18. When required by the customer, does the organization have a prototype program?

  YES

  NO

  N/A

• 18.1 Ensures that the same suppliers, tooling and manufacturing processes are used as will be used in production.

  Compliant

  Non-Compliant

  N/A

• 18.2 If any processes are outsourced, the organization provides technical leadership.

  YES

  NO

  N/A

• PROCESS, PRODUCT AND PROJECT PERFORMANCE METRICS

• 19. What metrics are in place to evaluate the effectiveness of the NPI process?

  Compliant

  Non-Compliant

  N/A

• 19.1 Validation that product meets customer expected performance requirements/targets (e.g. QPPM, CpK targets, FAI acceptance rates, etc.).

  Compliant

  Non-Compliant

  N/A

• 19.2 Validation that product meets internal Quality requirements/targets (i.e Internal defect rates, process capability levels, test yield, controlled build results, etc.).

  Compliant

  Non-Compliant

  N/A

• 19.3 Project Efficiency (Cost, Schedule, Cycle Time, etc.).

  Compliant

  Non-Compliant

  N/A

PREVIOUS SCORES

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VALIDATION SCORES

• Management Commitment (MC):

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• Deployment (D):

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• Results (R):

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

7.4 - Purchasing

• This section assesses the organization's ability to ensure that purchased product conforms to purchase requirements.

• Purchasing and Receiving Inspection.

• 1. How does the documented Purchasing and Receiving processes address the following? (ISO 7.4.1)

• 1.1 Purchased product must conform to specified purchased requirement.

  Compliant

  Non-Compliant

  N/A

• 1.2 Type and extent of supplier control on the purchased product is dependent upon the effect of the purchased product in subsequent steps of the final product.

  Compliant

  Non-Compliant

  N/A

• 2. How do you ensure that purchasing information describes the product to be purchased? (ISO 7.4.2)

• 2.1 Requirements for approval.

  Compliant

  Non-Compliant

  N/A

• 2.2 Requirement for qualification of personnel.

  Compliant

  Non-Compliant

  N/A

• 2.3 QMS requirements.

  Compliant

  Non-Compliant

  N/A

• 2.4 Purchased order is reviewed for adequacy prior to sumission to the supplier.

  Compliant

  Non-Compliant

  N/A

• 3. How does receiving ensure that purchased product meets specified purchased requirements? (ISO 7.4.3)

• 3.1 Defines verification process for incoming material ( e.g. Inspection, FAI, CofC, coupon sampling, independent lab test, etc.).

  Compliant

  Non-Compliant

  N/A

• 3.2 Defines how incoming material identified to indicate its status.

  Compliant

  Non-Compliant

  N/A

• 3.3 Defines how nonconforming incoming material is segregated from good material.

  Compliant

  Non-Compliant

  N/A

• 3.4 Defines how nonconforming incoming product is dispositioned.

  Compliant

  Non-Compliant

  N/A

• 3.5 If applicable, defines how statistically supported sampling plan are used for incoming material and is compliant with ANSI/ASQC or comparable method.

  Compliant

  Non-Compliant

  N/A

• Supplier Selection & Performance Management.

• 4. How does the documented supplier Selection and Performance Management process address the following? (ISO 7.4, 8.4)

• 4.1 Supplier evaluation and selection process is defined. Includes:

  YES

  NO

  N/A

• 4.2 Criteria for selection, evaluation and re-evaluation.

  YES

  NO

  N/A

• 4.3 Quantified criteria for approval to ASL.

  YES

  NO

  N/A

• 4.4 Defines when a supplier should be removed from the ASL.

  YES

  NO

  N/A

• 4.5 Supplier assessment process and plan ( e.g. On-site, survey, etc.).

  YES

  NO

  N/A

• 4.6 Scope includes special process suppliers.

  YES

  NO

  N/A

• 5. How does the organization ensure the following?

• 5.1 Maintains an ASL that includes the score of the approval.

  YES

  NO

  N/A

• 5.2 Performs supplier assessments according to the defined plan, progress is monitored.

  YES

  NO

  N/A

• 5.3 Reports results of supplier assessments according to the defined plan, progress is monitored.

  YES

  NO

  N/A

• 5.4 Assigns corrective actions when suppliers fail to meet requirements.

  YES

  NO

  N/A

• 5.5 Closes any known performance of capability gaps with suppliers.

  YES

  NO

  N/A

• 5.6 Defines responsabilities for who can approve and disapprove of a supplier.

  YES

  NO

  N/A

• 6. How are the results of supplier evaluations and any necessary actions arising from the evaluation maintained as records ( see Control of Records)?

• 7. How do you ensure the following special process supplier related requirements are addressed?

• 7.1 Use of special process suppliers when required by the customer is defined. Includes requirements for those suppliers (e.g. FAI, source inspection, etc.).

  YES

  NO

  N/A

• 7.2 Controls are adequate to ensure that when supplier is performing manufacturing that requires special processes, only Applied Materials approved those suppliers (e.g. FAI , source inspection, etc.).

  YES

  NO

  N/A

• 7.3 Purchasing personnel can demonstrate how to use GMoX to review Applied special processes and approved suppliers.

  YES

  NO

  N/A

• 8. How are supplier performance metrics tracked and used to improve supplier performance in the areas of quality and delivery ( including Special Process)? ( ISO 7.4, 8.4)

• 8.1 Supplier performance goals arebestablished and communicated to suppliers ( at minimum, quality and delivery requirements)

  Compliant

  Non-Compliant

  N/A

• 8.2 Regular performance reviews are held with suppliers warranted ( there should be logical criteria used to determine which suppliers undergo performance reviews - i.e. criticality, spend, performance, high risk, etc.).

  Compliant

  Non-Compliant

  N/A

• NOTE: Identify existing metrics on the "Metrics" worksheet.

PREVIOUS SCORES

• Management Commitment (MC):

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• Systems Approach (SA):

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• Results (R):

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VALIDATION SCORES

• Management Commitment (MC):

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• Systems Approach (SA):

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• Deployment (D):

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• Results (R):

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

7.5 - Production and Service Provision

• This section assesses the organization's ability to plan and carry out production and service provisions.

• 1. How do you ensure production documentation and approval requirements are identified? (ISO 7.5).

• 1.1 All process steps from incoming material through shipping have been identified (e.g. router, shop order, control plan, qualification plan, etc.).

  Compliant

  Non-Compliant

  N/A

• 1.2 Required documentation for each step of production is available of point of use (e.g. BOM's, prints, specifications, work instructions, set-up sheets, etc.).

  Compliant

  Non-Compliant

  N/A

• 1.3 Process characteristics (including customer specific) have been identified with approval criteria.

  Compliant

  Non-Compliant

  N/A

• 1.4 Reaction plans are available for each process characteristic that identifies what to do when it does not pass approval criteria.

  Compliant

  Non-Compliant

  N/A

• 1.5 Product release requirements have been identified for each step of production, including delivery and post-delivery.

  Compliant

  Non-Compliant

  N/A

• Auditing Repair Suppliers?

  YES

  NO

• FOR REPAIR SUPPLIERS:

• 1.6 Controls are in place to ensure that the supplier is servicing to the latest revision level of the OEM.

  Compliant

  Non-Compliant

  N/A

• 1.7 Replacement parts meet or exceed OEM specifications.

  Compliant

  Non-Compliant

  N/A

• 2. How do you ensure production support equipment is readily available to support all manufacturing processes (e.g. tooling fixtures, jigs, IMT equipment, etc.)? (ISO 7.5).

• 2.1 Equipment is verified prior to use (e.g. PM required, calibration, gage R&R, etc.).

  Compliant

  Non-Compliant

  N/A

• 2.2 Tooling management program is in place that includes maintenance & repair, tool set-up, equipment manuals, tooling identification that defines status, and required spare parts.

  Compliant

  Non-Compliant

  N/A

• 3. What CNC controls re in place?

• 3.1 CNC Programs are effectively protected from unauthorized changes (through error proofing and not just policy).

  Compliant

  Non-Compliant

  N/A

• 3.2 Effective closed loop communication exist on programming problems encountered.

  Compliant

  Non-Compliant

  N/A

• 3.3 CNC programming quality is monitored, evaluated and improved as necessary.

  Compliant

  Non-Compliant

  N/A

• 4. How do you validate requirements are being met for processes where the output cannot be verified until the product is in use? ( ISO 7.5.2)

• 4.1 Validate and approve the process to demonstrate the capability of the process to meet product performance criteria ( e.g. Cupon testing, destructive pull testing, functional testing, etc.).

  Compliant

  Non-Compliant

  N/A

• 4.2 If any changes are made to any part of a validated process, it is re-validated.

  Compliant

  Non-Compliant

  N/A

• 4.3 Records are maintained of process validation.

  Compliant

  Non-Compliant

  N/A

• 5. How do you ensure product identification and traceability methods provide traceablity of product back to the following? (ISO 7.5.3)

• 5.1 Origin of raw materials / parts.

  Compliant

  Non-Compliant

  N/A

• 5.2 Equipment / operator performing process steps and key measurements.

  Compliant

  Non-Compliant

  N/A

• 5.3 Data collected related to qualitynrequirements ( e.g. Inspection data, test data, etc.)

  Compliant

  Non-Compliant

  N/A

• 5.4 Dates processing steps completed.

  Compliant

  Non-Compliant

  N/A

• 5.5 Clear and consistent identification of products during product realization ( e.g. Travelers, cards, stickers, etc.)

  Compliant

  Non-Compliant

  N/A

• 6. How do you ensure Customer property is controlled for the following? (ISO 7.5.4)

• 6.1 Process exists to identify, verify, protect and safeguard the property.

  YES

  NO

  N/A

• 6.2 Materials with shelf lives are marked and appropriate controls are implemented.

  YES

  NO

  N/A

• 7. How do you ensure that adequate packaging, handling, and storage of raw and work in process materials is in place to avoid inadvertent damage? (ISO 7.5.5)

• 7.1 Product or material is preserved during processing and through delivery to prevent it from being damage, lost, unsuitable ( perishable) , or obsolete ( paste shelf life).

  YES

  NO

  N/A

• 7.2 Materials with shelf lives are marked and appropriate controls are implemented.

  YES

  NO

  N/A

• 8. How do you ensure you meet the requirements for the AMAT Decommissioning, Decontamination, and Declaration process ( CORPEHS008)?

• 8.1 Appropriate personnel are trained on Decommissioning, Decontamination, and Declaration process.

  YES

  NO

  N/A

• 8.2 Controls have been established and implemented to ensure adherence to requirements.

  YES

  NO

  N/A

• 9. How do you ensure you meet the requirements for the AMAT Workmanship Standards (0250-09954)?

• 9.1 Appropriate personnel are trained on workmanship standards.

  YES

  NO

  N/A

• 9.2 Controls have been defined and implemented for the applicable sections of the standard ( i.e. Employee training, internal workmanship standard documents/ training materials, procedures updated, work instructions updated, etc.)

  YES

  NO

  N/A

• 10. How do you ensure you meet the requirements of the AMAT Corporate Packaging Requirements ( 0250-00098)?

• 10.1 Appropriate personnel are trained on Corporate Packaging Requirements.

  YES

  NO

  N/A

• 10.2 Controls have been defined and implemented to ensure adherence ( i.e. Employee training, internal packaging instructions, procedures updated, etc.)

  YES

  NO

  N/A

• Is section 6.4 part of the assessment?

  YES

  NO

  N/A

• 11. If applicable, what ESD process controls been identified and implemented?

• 11.1 ESD controls, equipment, and training.

  YES

  NO

  N/A

• 11.2 Audits are performed to ensure ESD compliance. Records are maintained.

  YES

  NO

  N/A

• 12. If applicable, what cleanroom controls been identified and implemented?

• 12.1 Protocol requirements for people, equipment and material entering the cleanroom.

  YES

  NO

  N/A

• 12.2 Effective particle monitoring program for all areas of the cleanroom.

  YES

  NO

  N/A

• 12.3 Cleaning requirements for the cleanroom.

  YES

  NO

  N/A

• 12.4 Periodic compliance audits.

  YES

  NO

  N/A

• Critical Part PQP Management

• 13. If applicable, how do you manage your PQPmprogram to meet the following requirements?

• 13.1 Critical Parts List is available and shows which parts require PQP's.

  YES

  NO

  N/A

• 13.2 PQP completion status report is maintained and reviewed by management ( i.e. Inactive part, not started, in process, complete waiting for AMAT approval, AMAT approved, etc.).

  YES

  NO

  N/A

• 13.3 Clearly defined action plans ( who, what, whens) are in place for PQP's not yet completed or approved by AMAT.

  YES

  NO

  N/A

• 13.4 PQP's for parts in volume production have been completed and approved by AMAT.

  YES

  NO

  N/A

• 13.5 PQP documentation matches production processes ( compare PQP samples to production routers / travelers)

  YES

  NO

  N/A

• 14. If applicable, how do you ensure effective PQP change management?

• 14.1 PQP's are periodically evaluated to ensure updates are made and re-qualified when needed ( i.e. FMEA updated periodically with historical quality data, process control plans revised, Gage R&R revisited, site location changes, engineering changes, specification/standards revision changes, etc.)

  YES

  NO

  N/A

• 14.2 PQP's are revision controlled with history of changes maintained.

  YES

  NO

  N/A

• 15. If applicable, how do you monitor, analyze, and improve PQP parts to meet product quality, process quality, or reliability targets?

• 15.1 Quality/ Reliability performance levels and process capabilities for PQP parts are regularly monitored.

  YES

  NO

  N/A

• 15.2 SPC data is maintained in the AMAT SSPCM tool when required.

  YES

  NO

  N/A

• 15.3 PQP part's in volume production are meeting product quality / reliability and process capability goals.

  YES

  NO

  N/A

• 15.4 Evidence that improvement actions/ projects are identified and progress is monitored when goals are not being met ( i.e. Cpk's < 1.33, QPPM or DPU not at goal).

  Compliant

  Non-Compliant

  N/A