QTI Internal Audit

QTI Sensing Solutions INTERNAL AUDIT REPORT

• GENERAL INFORMATION

• DATE:

  Date

• SITE:

• 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 #:

• 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 (CPAR):

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 the current AS9100 certification status?

  Certified

  Past Due

  Not Certified

• Certification expiry date:

• 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?

• Identify standards certified to:

• ISO 9001:2008

• AS9100

• 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 (4.2.3).

• Document control system includes:

• - Procedure for approval.

• - Change or Revision control.

• - Identification & legibility.

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

• - Obsoleting documents.

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

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

• 4. How are the quality management system procedures defined, implemented and maintained? (4.2.1).

• 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).

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• 5. How is the integration/interaction of the Quality Management System business process demonstrated? (4.2.2).

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

  Compliant

  Non-Compliant

  N/A

• May also be shown on process maps such as Turtle Diagrams, flowcharts

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• Records should demostrate operational effectiveness and conformity to requirements.

  Compliant

  Non-Compliant

  N/A

• 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

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

  Compliant

  Non-Compliant

  N/A

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? (5.2, 8.2.1, 8.4)

• Organization clearly defines who their internal and external customers are

  Compliant

  Non-Compliant

  N/A

• 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)

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

  Compliant

  Non-Compliant

  N/A

• Improvement actions are defined and implemented when goals or improvement is not met.

  Compliant

  Non-Compliant

  N/A

• 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?

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• Improvement plan deployment is monitored.

  Compliant

  Non-Compliant

  N/A

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? (5.3)

• Quality Policy defined and approved by top management.

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• 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

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• 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

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. (5.4.1)

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• ( Identify Quality objective metrics)

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

  Compliant

  Non-Compliant

  N/A

• 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?

• 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

• Metrics are trended for performance monitoring towards goals.

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• 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

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 (5.5.1)

• 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

• Personnel in the organization are aware of roles and responsibilities

  Compliant

  Non-Compliant

  N/A

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

• 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

• Representative is part of the management team.

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• Representative promotes awareness of customer requirements throughout the organization.

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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.

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

• 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

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

  Compliant

  Non-Compliant

  N/A

• 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; (5.6)

• Planned changes to the Quality Management System.

  Compliant

  Non-Compliant

  N/A

• Quality Policy review.

  Compliant

  Non-Compliant

  N/A

• Quality objectives review.

  Compliant

  Non-Compliant

  N/A

• Results of audits ( internal, external and customer audits).

  Compliant

  Non-Compliant

  N/A

• Customer feedback ( performance metrics and satisfaction surveys).

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• Status of preventive and corrective actions.

  Compliant

  Non-Compliant

  N/A

• Follow-up action status from previous reviews.

  Compliant

  Non-Compliant

  N/A

• Recommended improvements to the Quality Management System.

  Compliant

  Non-Compliant

  N/A

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? (6.2)

• 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

• Progress towards meeting training requirements is planned and monitored.

  Compliant

  Non-Compliant

  N/A

• 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

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

  Compliant

  Non-Compliant

  N/A

• Training records are maintained.

  Compliant

  Non-Compliant

  N/A

• 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?

• 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

• 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

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

  Compliant

  Non-Compliant

  N/A

• 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

• 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?

• 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

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• Training materials are available in support of training courses.

  Compliant

  Non-Compliant

  N/A

• Training completion metrics or reports are monitored by management.

  Compliant

  Non-Compliant

  N/A

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

• 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

• Effectiveness of training is evaluated per the defined method.

  Compliant

  Non-Compliant

  N/A

• Improvement actions defined and implemented forbtraining effectiveness gaps.

  Compliant

  Non-Compliant

  N/A

• 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

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

• Management defines Goals and Objectives on a yearly basis.

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

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

  Compliant

  Non-Compliant

  N/A

• Metrics are trended for performance monitoring towards goals.

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• 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

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

• 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

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? (6.3) Includes;

• Buildings, workspace and associated utilities.

  Compliant

  Non-Compliant

  N/A

• Layout of equipment to improve workflow efficiency.

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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? (6.4)

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• 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.

  Compliant

  Non-Compliant

  N/A

• Rewards and recognition are tied to 5S improvement.

  Compliant

  Non-Compliant

  N/A

• 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

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? (7.2)

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

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

• Defines statutory and regulatory requirements.

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

• Records of the contract review including changes are maintained.

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

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• 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.

  Compliant

  Non-Compliant

  N/A

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

• Users are identified and made aware of the changes.

  Compliant

  Non-Compliant

  N/A

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

• Product Information

• Describe process.

• Enquiries, contracts including changes

• Describe

• Customer feedback, including customer complaints.

• Describe

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? (7.3)

• Defines key tasks, responsabilities, and deliverables.

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• Records retention requirements are defined.

  Compliant

  Non-Compliant

  N/A

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

• Product function or performance requirements.

• Statutory and regulatory requirements.

• Previous/ similar designs ( where applicable).

• 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.

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

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

• Verification to design and development inputs.

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

• Product acceptance criteria ( which includes functional testing).

• 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.

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

• 4. 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)

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  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.)

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

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  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.)

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

• Qualification plans are defined and implemented for tools and equipment identified ( i.e. Machine capabilities studies, test fixture qualifications, gage R & R, etc.)

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

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

• 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.

  Compliant

  Non-Compliant

  N/A

• 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?

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

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• 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.)

  Compliant

  Non-Compliant

  N/A

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

• 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.)

  Compliant

  Non-Compliant

  N/A

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

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

• Troubleshooting guide is revision controlled.

  Compliant

  Non-Compliant

  N/A

• Troubleshooting guide is effectively communicated to users.

  Compliant

  Non-Compliant

  N/A

• Mechanisms are in place for user support and feedback.

  Compliant

  Non-Compliant

  N/A

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

• Actual performance is evaluated against established reliability targets.

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

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

  Compliant

  Non-Compliant

  N/A

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

• Product Improvement / Engineering Change

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

• Design and development changes are identified and recorded.

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• 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).

  Compliant

  Non-Compliant

  N/A

• 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.)

  Compliant

  Non-Compliant

  N/A

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

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• 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.

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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? (7.4.1)

• Purchased product must conform to specified purchased requirement.

  Compliant

  Non-Compliant

  N/A

• 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? (7.4.2)

• Requirements for approval.

  Compliant

  Non-Compliant

  N/A

• Requirement for qualification of personnel.

  Compliant

  Non-Compliant

  N/A

• QMS requirements.

  Compliant

  Non-Compliant

  N/A

• 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? (7.4.3)

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

  Compliant

  Non-Compliant

  N/A

• Defines how incoming material identified to indicate its status.

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• Defines how nonconforming incoming product is dispositioned.

  Compliant

  Non-Compliant

  N/A

• 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)

• Supplier evaluation and selection process is defined. Includes:

  Compliant

  Non-Compliant

  N/A

• Criteria for selection, evaluation and re-evaluation.

  Compliant

  Non-Compliant

  N/A

• Quantified criteria for approval to ASL.

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• Scope includes special process suppliers.

  Compliant

  Non-Compliant

  N/A

• 5. How does the organization ensure the following?

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  N/A

• Assigns corrective actions when suppliers fail to meet requirements.

  Compliant

  Non-Compliant

  N/A

• Closes any known performance of capability gaps with suppliers.

  Compliant

  Non-Compliant

  N/A

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

  Compliant

  Non-Compliant

  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?

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

  Compliant

  Non-Compliant

  N/A

• 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.).

  Compliant

  Non-Compliant

  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)

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

  Compliant

  Non-Compliant

  N/A

• 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

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? (7.5).

• 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

• 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

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

  Compliant

  Non-Compliant

  N/A

• 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

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

  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.)? (7.5).

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

  Compliant

  Non-Compliant

  N/A

• 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

• 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

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RESULTS

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• Observations:

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7.6 - Control of Monitoring and Measuring Devices

• This section assesses the organization's ability to control monitoring and measuring devices.

• 1. How does the documented Calibration process address the following? ( ISO 7.6)

• 1.1 Identify the monitoring and measurement that must be taken to provide evidence of product conformity including the IMT equipment needed.

  Compliant

  Non-Compliant

  N/A

• 1.2 Establish processesnto ensure that monitoring and measurement can be carried out and is carried out according to defined requirements.

  Compliant

  Non-Compliant

  N/A

• 1.3 Requirements clearly defined for qualification and approvals of 3rd party calibration providers.

  Compliant

  Non-Compliant

  N/A

• 1.4 Process included for handling tools found damaged and / or accidently damaged during use.

  Compliant

  Non-Compliant

  N/A

• 1.5 Formal process is defined for risk and recall analysis on tools/ equipment found out of calibration.

  Compliant

  Non-Compliant

  N/A

• 2. How does the calibration program ensure valid results through the following? ( ISO 7.6)

• 2.1 Calibrate and/ or verify IMT equipment prior use and at specified intervals against traceable standards to NIST or other national standards.

  Compliant

  Non-Compliant

  N/A

• 2.2 Document the calibration method used when no traceable standards exist.

  Compliant

  Non-Compliant

  N/A

• 2.3 Adjust the IMT equipment to bring it within calibration requirements. Record and maintain before and after calibration measurements.

  YES

  NO

  N/A

• 2.4 Put a calibration sticker on the IMT equipment in a visible location that includes equipment ID, last calibration date, calibration due date and the person that performed the calibration.

  YES

  NO

  N/A

• 2.5 IMT equipment not used to measure product conformity must have a 'reference only' sticker.

  YES

  NO

  N/A

• 2.6 Safeguard the IMT equipment from adjustments that could invalidate the calibration.

  Compliant

  Non-Compliant

  N/A

• 2.7 Protect the IMT equipment from damage and deterioration while in use and in storage.

  Compliant

  Non-Compliant

  N/A

• 2.8 IMT equipment not in use is tagged and stored to prevent its unintended use.

  Compliant

  Non-Compliant

  N/A

• 3. How do you deploy and monitor the calibration program to addressbthe following:

• 3.1 Maintain a master list of IMT equipment that includes equipment ID, description, calibration interval, last calibration date, calibration due date, location, calibration source and tools status. List includes employee and customer owned tools.

  Compliant

  Non-Compliant

  N/A

• 3.2 Status tracking tool is in place and is proactively maintained ( i.e. spreadsheet, database, 3rd party web tool, etc.(.

  Compliant

  Non-Compliant

  N/A

• 3.3 On demand reports are available and actively used to manage progress ( i.e. overdue tools/ equipment report, upcoming due tools/ equipment report).

  Compliant

  Non-Compliant

  N/A

• 3.4 Calibration process metrics areidentified, trended, analyzed, and improved toward goals as appropriate ( i.e. On-time completion of calibration, % out of tolerance, etc.).

  Compliant

  Non-Compliant

  N/A

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

• 4. How is software in IMT equipment verified at defined intervals?

• 5. How do you maintain records of calibration and verification according to Control of Records requirements? ( ISO 7.6)

• 5.1 Records are maintained for in-use house and 3rd party calibration.

  Compliant

  Non-Compliant

  N/A

• 5.2 Records include equipment ID, NIST standards (or international equivalent), temperature, humidity, technician performing calibration and certification to ISo 17025.

  Compliant

  Non-Compliant

  N/A

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RESULTS

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• Observations:

• Opportunities for Improvement:

8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

• SUB-SECTION:

  Select 8.2 - Monitoring and Measurement; 8.3 - Control of Non-conforming Product; 8.5 - Improvement;

  • 8.2 - Monitoring and Measurement;
  • 8.3 - Control of Non-conforming Product;
  • 8.5 - Improvement;

8.2 - Monitoring and Measurement

• This section assesses the organization's ability to control monitoring and measurement.

• Internal Audit Program.

• 1. How do you ensure the Internal Audit process addresses the following? (ISO 8.2.2)

• 1.1 A documented procedure is required. Defines the responsabilities and requirements for planning and conducting audits, establishing records and reporting results.

  Compliant

  Non-Compliant

  N/A

• 1.2 Defines qualification requirements of the internal auditors.

  Compliant

  Non-Compliant

  N/A

• 1.3 Selection of auditors and conduct of audits ensures objectivity and impartiality of the audit process.

  Compliant

  Non-Compliant

  N/A

• 1.4 Auditors do not check their own work.

  Compliant

  Non-Compliant

  N/A

• 1.5 Auditors are trained and results including in their training records.

  Compliant

  Non-Compliant

  N/A

• 2. How do you assure the audit schedule addresses the following? ( ISO 8.2.2)

• 2.1 Establish an internal audit schedule to determine if the organization's QMS conforms to requirements and ISO 9001.

  Compliant

  Non-Compliant

  N/A

• 2.2 Schedule includes QMS and process audits.

  Compliant

  Non-Compliant

  N/A

• 2.3 Takes into consideration the status and the importance of the processes and areas to be audited, as well as the results of previous audits.

  Compliant

  Non-Compliant

  N/A

• 2.4 Schedule addresses auditor assignment impartiality to the area assigned.

  Compliant

  Non-Compliant

  N/A

• 2.5 Includes audit criteria, scooe, frequency and methods.

  Compliant

  Non-Compliant

  N/A

• 3. How are audit results monitored and used for continual improvement? ( ISO 8.2.2)

• 3.1 Report audit results to management and include in management review.

  Compliant

  Non-Compliant

  N/A

• 3.2 Take corrective actions without undue delay to eliminate detected nonconformities and their causes.

  Compliant

  Non-Compliant

  N/A

• 3.3 Perform verification follow-up to verify the effectiveness of the corrective actions.

  Compliant

  Non-Compliant

  N/A

• 3.4 Maintain internal audit records according to Control of Records.

  Compliant

  Non-Compliant

  N/A

• 3.5 Internal audit process metrics are identified, trended, analyzed, and improved towards goals as appropriate ( i.e. performance to schedule, # findings open and closed, aging of open actions, etc.).

  Compliant

  Non-Compliant

  N/A

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

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• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

8.3 - Control of Non-Conforming Product

• This section assesses the organization's ability to control nonconforming product.

• 1. How do you ensure the nonconforming materials / product process addresses the following? ( ISO 8.3, 8.4)

• 1.1 A documented procedure is required. Defines the controls and related responsabilities and authorities for dealing with nonconforming product.

  YES

  NO

  N/A

• 1.2 Product that does not conform to product requirements is identified and controlled for prevent it from being delivered to the customer.

  YES

  NO

  N/A

• 1.3 Required actions if nonconforming product escapes to the customer is defined.

  YES

  NO

  N/A

• 1.4 Control of nonconforming product process metrics are identified, trended, analyzed, and improved towards goals as appropriate ( i.e. cycle time/aging to disposition decision, time to implement disposition actions, $'s tied up in MRB, MRB participation, scrap levels, rework levels, corrective actions status, etc.)

  YES

  NO

  N/A

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

• 2. How are materials identified, segregated, and dispositioned? ( ISO 8.3)

• 2.1 Nonconforming product is tagged and segregated from good product.

  YES

  NO

  N/A

• 2.2 A cross-functional team (MRB) is used to disposition nonconforming product.

  YES

  NO

  N/A

• 2.3 The team dispositions nonconforming product to either eliminate it, rework, get concession from the customer to use as-is, or scrap.

  YES

  NO

  N/A

• 2.4 Records of the nonconformity and any subsequent actions taken are maintained according to Control of Records.

  YES

  NO

  N/A

• 3. How are Corrective Actions identified and implemented to drive effective improvements? ( ISO 8.3)

• 3.1 Criteria is defined to determine what Non-conforming materials require formal corrective actions ( i.e. major issues, repeat issues, top issues from analysis, customer impact, high scrap cost, etc.)

  YES

  NO

  N/A

• 3.2 Evidence that Corrective Actions are launched when above criteria is met.

  YES

  NO

  N/A

• 3.3 Corrective action report include determining and documenting any needed containment actions.

  YES

  NO

  N/A

• 3.4 Root Causes sampled demonstrate comprehensive root cause analysis to determine systemic issues ( i.e. 5 why, cause and effect diagram, etc.) / Personnel involved have been through problem solving training ( i.e. 8D)

  YES

  NO

  N/A

• 3.5 Corrective actions are validated as effective ( i.e. physical validation and approval of actions taken, pre-determined monitoring periods, periodic audits of corrective actions, measuring repeat occurences, etc.)

  YES

  NO

  N/A

• 4. How do you ensure that reworked product is verified to ensure that it meets the same requirements as non-reworked product? (ISO 8.3)

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

8.5 - Improvement

• This section assesses the organization's ability to continually improve the effectiveness of the quality management system.

• Corrective and Preventive Action.

• 1. How do you ensure that your corrective action process addresses the following? (ISO 8.5.2)

• 1.1 Take Corrective Actions to eliminate the causes of nonconformities to prevent recurrence and are appropriate to the effects on the nonconformity.

  Compliant

  Non-Compliant

  N/A

• 1.2 Review of corrective actions by management and included in the management review meeting.

  Compliant

  Non-Compliant

  N/A

• 1.3 Determine training requirements and train users as required ( process and problem solving tools)

  Compliant

  Non-Compliant

  N/A

• 1.4 Evidence that 8D methodology is effectively utilized for any AMAT reported quality defects ( there should be knowledge of the top issue along with corresponding 8D reports).

  Compliant

  Non-Compliant

  N/A

• 1.5 Defined process to notify customers when issues are found after the delivery of the product customers. The process should include the risk assessment of customer impact, traceability of suspected materials, and customer notification ( i.e. global recall notice, etc.).

  Compliant

  Non-Compliant

  N/A

• 1.6 Corrective action process metrics are identified, trended, analyzed, and improved towards goals as appropriate ( i.e.. # open, # closed, cycle time open / aging, adequacy of closure rates, etc.)

  YES

  NO

  N/A

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

• 2. How does the documented corrective action procedure address the following? ( ISO 8.5.2)

• 2.1 What corrective actions need to be issued against ( e.g. product, QMS process, suppliers, customers complaints, etc.)

  Compliant

  Non-Compliant

  N/A

• 2.2 When corrective actions need to be taken.

  YES

  NO

  N/A

• 2.3 Determine the cause of the nonconformance. Includes problem solving tools that can be used to find root cause ( e.g. 5-Why, fishbone diagram, pareto analysis, etc.)

  Compliant

  Non-Compliant

  N/A

• 2.4 Containment actions are defined, documented and implemented when necessary.

  Compliant

  Non-Compliant

  N/A

• 2.5 Taking corrective actions with specified time periodnof completion.

  Ensure

  Does Not Ensure

• 2.6 Reviewing the effectiveness of corrective actions taken.

  Compliant

  Non-Compliant

  N/A

• 2.7 Maintaining records according to Control of Records.

  Addressed

  Not Addressed

• 3. How do you ensure that your preventive action process address the following? ( ISO 8.5.3)

• 3.1 Determines actions to eliminate the causes of nonconformities to prevent their occurence and are appropriate to the effects of the potential problem.

  YES

  NO

  N/A

• 3.2 Review od preventive actions by management and included in the management review meeting.

  YES

  NO

  N/A

• 4. How does the documented preventive action procedure address the following? (ISO 8.5.3)

• 4.1 Identifying potential nonconformities and their causes.

  YES

  NO

  N/A

• 4.2 What preventive actions need to be issues against (e.g. product, QMS process, customer complaints, etc.)

  YES

  NO

  N/A

• 4.3 Determining how and when actions need to be taken.

  YES

  NO

  N/A

• 4.4 Reviewing the effectiveness of preventive actions taken.

  YES

  NO

  N/A

• 4.5 Maintaing records according to Controls of Records.

  YES

  NO

  N/A

• Continual Improvement Program.

• 5. How does the Continual Improvement Program address the following? (ISO 8.5.1)

• 5.1 Sources for continual improvements should be defined and inputs collected ( i.e. employees suggestions, top issues form analysis of internal and external data, actions from management reviews, strategic planning sessions, etc.)

  Compliant

  Non-Compliant

  N/A

• 5.2 Management leads opportunity review, prioritization, and resource allocation process ( i.e. focus on high ROI and customer satistacion opportunities).

  Compliant

  Non-Compliant

  N/A

• 5.3 Appropriate improvement methods utilized based on the naturemof the opportunity ( i.e. action item, 8D project, six sigma project, lean project, kaizen event, etc.)

  YES

  NO

  N/A

• 5.4 Personnel have been trained in the use of the selected improvement methodology and improvement tools.

  YES

  NO

  N/A

• 5.5 Management oversight of program implementation and achievement of results towards established goals.

  Compliant

  Non-Compliant

  N/A

• 5.6 Rewards and / or recognition program is defined and implemented in support of the continual improvement program.

  YES

  NO

  N/A

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

2.1.6 - Cycle Time Improvement (CTI)

• A system is in place to reduce the time it takes to complete a continuous, repetitive work process from start to finish.

• 1. How does Senior Management focus on cycle time improvement?

• 1.1 Management establishes clear goals and objectives for cycle time reduction ( i.e. value streams have defined cycle time/ lead time baselines and future state goals for improvement)

  Compliant

  Non-Compliant

  N/A

• 1.2 Management has identified owners for cycle time improvement projects ( i.e. Value stream managers, project leaders).

  YES

  NO

  N/A

• 1.3 Targeted cycle time improvements are clearly linked to overall bussiness objectives.

  YES

  NO

  N/A

• 1.4 Cycle time improvement goals, status, and project status are effectively communicated throughout the organization.

  YES

  NO

  N/A

• 1.5 Cycle time improvement success are parts of an overall rewards and recognition system.

  YES

  NO

  N/A

• 1.6 Cycle time improvement progress monitoring & results.

  YES

  NO

  N/A

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

• 2. How are cycle time improvement methodology and training defined and implemented?

• 2.1 Formal improvement methodologies are identified and utilized to drive cycle time improvement projects ( i.e. Value stream mapping as part of the lean/six sigma methodology, specific methodologies for cycle time as analysis and improvement, bussiness process re-engineering methods, etc)

  Compliant

  Non-Compliant

  N/A

• 2.2 Quantifiable method and process is used to evaluate, prioritize, and implement cycle time improvements initiatives ( i.e. Cost/benefit analysis, ROI analysis, etc.)

  Compliant

  Non-Compliant

  N/A

• 2.3 Training programs are defined and implemented for cycle time improvement projects participants at a minimum.

  YES

  NO

  N/A

• 2.4 Cycle time improvement methods training has been incorporated into appropriate training curriculums ( training requirements).

  YES

  NO

  N/A

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

2.2 BUSINESS SYSTEMS AND ORGANIZATIONAL CAPABILITIES

• SUB-SECTION:

  Select 2.2.4 - Material Control System; 2.2.8 - Maintenance of Equipment Used in Production;

  • 2.2.4 - Material Control System;
  • 2.2.8 - Maintenance of Equipment Used in Production;

2.2.4 Material Control System

• A material control system provides timely flow of materials meeting production requirements. A production control system that provides fabrication, assembly, test and shop load schedules is in use.

• 1. Do you have a computer based materials management system that addresses the following?

• 1.1 Sales order entry.

  YES

  NO

  N/A

• 1.2 Purchasing planning (e.g. buyer purchase schedules, order status & alert reports, etc.)

  YES

  NO

  N/A

• 1.3 Manufacturing planning (e.g. Production plans ans priorities, job leveling, sequencing / routing, target ship dates, etc.)

  YES

  NO

  N/A

• 1.4 Order configuration management.

  YES

  NO

  N/A

• 1.5 Capacity planning.

  YES

  NO

  N/A

• 1.6 Capable of providing current and location of materials ( e.g. Ordered, received, inventory, production, allocated, scrapped, shipped, etc.)

  YES

  NO

  N/A

• 2. How are material control parameters established, monitored, analyzed, and acted upon to improve productivity? ( e.g. Inventory turns, inventory levels physical inventory accuracy, cycle count inventory accuracy, scrap levels, etc.)

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

• 3. How do you address capacity planning to include the following?

• 3.1 Integrated into ERP system ( preferred ).

  Addressed

  Not Addressed

• 3.2 Dynamically shows process/ line loading and available capacity.

  Addressed

  Not Addressed

• 3.3 Factors in both direct and indirect headcount data into utilization calculations.

  Addressed

  Not Addressed

• 3.4 Factors in purchased material lead times and customer's required lead times.

  Addressed

  Not Addressed

• 3.5 Ramp up contingency plan exists and is regularly updated to include lead times for resource increases ( manpower, equipment, facilities, etc.)

  Addressed

  Not Addressed

• 4. How do you measure and monitor bottlenecks/constraints and implement necessary actions? ( e.g. Demand levels, utilization loading, throughputs, efficiencies, yields, downtime, scrap, cycle time, value stream maps, etc.).

• 5. How are visual management techniques used to aid with materials controls and management?

• 5.1 5S status.

  YES

  NO

  N/A

• 5.2 Scheduling and prioritization status.

  YES

  NO

  N/A

• 5.3 Visual signs.

  YES

  NO

  N/A

• 5.4 Pictorial work instructions.

  YES

  NO

  N/A

• 5.5 Production boards with metrics.

  YES

  NO

  N/A

• 5.6 Andon system.

  YES

  NO

  N/A

• Lean Manufacturing.

• 6. What Lean Concepts and tools training have been implemented?

• 6.1 Training courses have been established.

  YES

  NO

  N/A

• 6.2 Personnel directly involved with lean concepts and tools application have been trained.

  YES

  NO

  N/A

• 6.3 All personnel have been trained in basic lean concepts.

  YES

  NO

  N/A

• 7. How do you utilize Value Stream Mapping analysis to guide the usage of lean improvement tools for optimum results?

• 7.1 Product lines / families have been designated owners for Value Stream Mapping Analysis.

  YES

  NO

  N/A

• 7.2 Current state value stream maps are developed and used to determine the biggest opportunities for improvement through the application of lean improvement tools. ( i.e. kaizen events, pull system, li ne design, standarized work, Poka Yoke, SMED, TPM, Pull systems / kanban, FIFO, 5S, Visual Management, etc.)

  YES

  NO

  N/A

• 8. How do you utilize lean methods and tool for continual monitoring and improvement?

• 8.1 Future state value stream maps and corresponding improvement plans and measurable improvement targets are developed (i.e. lead time reduction, cycle time reduction, inventory turns improvement, product and process quality improvement, cost reduction, productivity/efficiency improvements, set-up time improvements, etc.)

  YES

  NO

  N/A

• 8.2 Management monitors improvement plan implementation status.

  YES

  NO

  N/A

• 8.3 Evidence of a continual improvements over time ( i.e. when future state is achieved a new future state is developed).

  YES

  NO

  N/A

• 8.4 Well defined work cells ( e.g. similar production processes are grouped and arranged to improve work flow productivity and meet takt.)

  YES

  NO

  N/A

• 8.5 Continuous flow principles are incorporated on the factory floor and enable product to move through the value stream one piece (ideally) at a time with little or no inventory or waste.

  YES

  NO

  N/A

• 8.6 Pull systems (customer/supplier Kanban with system signals/pull approach, job kitting) are in place to pull WIP through the factory to meet customer demand.

  YES

  NO

  N/A

• 8.7 Leveling - scheduling systems are used to smooth production requirements, visual job boards highlight problem areas and required production, and flexible worksurface can be re-allocated to address bottlenecks.

  YES

  NO

  N/A

• 8.8 Goals and indicators exist for all appropriate machine areas with a program to continuously reduce setup times.

  YES

  NO

  N/A

• 8.9 Employees suggestion system focused on waste reduction.

  YES

  NO

  N/A

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

2.2.8 Maintenance of Equipment Used in Production

• Equipment used in production in maintained in a manner that produces consistent results within specified tolerances.

• 1. How does the Equipment Maintenance process address the following?

• 1.1 Preventive maintenance activities are defined for all production equipment and test equipment.

  Addressed

  Not Addressed

• 1.2 Methodology is established on how PM frequencies are determined and adjusted.

  Addressed

  Not Addressed

• 1.3 Master list that includes all PM activities for all production equipment and teste equipment is established. Includes equipment type, equipment ID, equipment location, PM frequency, scheduled dates for PM's.

  Addressed

  Not Addressed

• 1.4 PM tasks are defined via procedure and/or checklist. Checklist is used during PM activity. Values are recorded when checked.

  Addressed

  Not Addressed

• 1.5 Records exist to support implementation of all maintenance tasks ( dailies, weeklies, monthlies, etc.)

  Addressed

  Not Addressed

• 1.6 PM tasks are at minimum based on equipment manufacturer's suggestion ( i.e. from equipment manuals).

  Addressed

  Not Addressed

• 1.7 On demands reports are available and actively used to manage progress (i.e. overdue maintenance tasks report, upcoming maintenance task report).

  Addressed

  Not Addressed

• 1.8 Equipment Maintenance process metrics are identified, trended, analyzed, and improved towards goals as appropriate ( i.e. on-time completion of maintenance tasks, equipment downtimes, etc.)

  Addressed

  Not Addressed

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

• 2. How are statistical methods used for each piece of equipment to measure and improve the effectiveness of the PM program?

• 2.1 MTBF ( mean time between failure) to analyze maintenance frequency & MTTR ( mean time to repair) to reduce repair cycle time.

  YES

  NO

  N/A

• 3. How does Preventive maintenance training address the following?

• 3.1 Organization has been trained in TPM principles ( evidence of training records).

  Addressed

  Not Addressed

• 3.2 Training program for operators to perform routine maintenance on the equipment they operate has been developed and implemented.

  Addressed

  Not Addressed

• 3.3 Training program for maintenance technicians has been developed and implemented.

  Addressed

  Not Addressed

• 3.4 Required and completed training is maintained in employees training records.

  Addressed

  Not Addressed

• 3.5 Appropriate controls are in place to measure and monitor performance and results if maintenance is outsourced.

  Addressed

  Not Addressed

• 4. How is spare parts usage analyzed ans used to set inventory levels?

• 4.1 MTTR is used to identify top hitters if equipment downtime is due waiting for spare parts.

  YES

  NO

  N/A

• 5. How is production equipment and test fixtures with measurement capability part of the calibration program ( e.g. Temperature, time, pressure, etc.)?

• 6. Are Equipment manuals and test work instructions (TOMS = test operational method sheets) readily available for all production equipment and test fixtures?

• 7. What are your contingency plans to handle test fixture breakdowns?

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VALIDATION SCORES

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

2.3 - Statistical Methods

• Statistical Methods (SM) shall be supported with a formal implementation plan, effectively implementated throughout the organization and reinforced with an appropriate training program.

• 1. How are statistical methods plans or procedures defined to address the following?

• 1.1 Monitoring and analyzing product and process quality metrics ( trend charts, variability trending, pareto, etc.)

  Addressed

  Not Addressed

• 1.2 As part of manufacturing process design, qualification, and on-going monitoring (i.e. DOE, gage R&R, FMEA, Process Capability Analysis, SPC, etc.)

  Addressed

  Not Addressed

• 1.3 Continual Improvement program ( i.e. six sigma projects, CpK improvement projects.)

  Addressed

  Not Addressed

• 1.4 Procedure or plan is approved by senior management and identifies roles and responsabilities for deployment and monitoring.

  Addressed

  Not Addressed

• 2. How is the statistical methods procedure or plan implemented for monitoring and analyzing product and process quality metrics ( trend charts, control charts, variability trending, pareto, etc.) (ISO 8.2.3, 8.2.4, 8.4) Examples of metrics to be monitored and analyzed;

• 2.1 Product quality ( i.e. supplier quality, internal product quality including defect levels, scrap, and rework, and customer experienced product quality)

  Compliant

  Non-Compliant

  N/A

• 2.2 Process quality ( i.e. manufacturing process yields, testing yields, critical process capabilities, statistical process control or critical to quality parameters).

  Compliant

  Non-Compliant

  N/A

• NOTE: Identify product and process quality metrics on the " Metrics" worksheet.

• 3. If SPC is utilized as a process control, how have run rules been established with operators trained to identify out of control conditions?

• 3.1 Evidence that appropriate actions are promptly taken.

  YES

  NO

  N/A

• 4. How is the statistical methods procedure or plan implemented in support of manufacturing process controls design and qualification ( i.e. DOE, gage R&R, FMEA, Process Capability Analysis, etc.)?

• 5. How is the statistical methods procedure or plan implemented in support of the Continual Improvement program ( i.e. six sigma projects, CpK improvement projects)?

• 6. How is statistical methods training planned and deployed to address the following?

• 6.1 Statistical methods and tools training requirements are defined to include identification of who needs what training ( i.e. training matrix, training curriculums) / requirements also define refresher training requirements.

  Addressed

  Not Addressed

• 6.2 Training materials ( internal and / or external) are available in support of statistical metods/tools training requirements.

  Addressed

  Not Addressed

• 6.3 Courses are taught by subject matter experts ( i.e. training are practical experience based, certified in six sigma, qualified external consultants, etc.)

  Addressed

  Not Addressed

• 6.4 SM training plans are developed and training completion is monitored ( records, reports, etc.)

  Addressed

  Not Addressed

• 6.5 Methods are implemented to validate that SM training is effectively used on the job ( i.e. evaluation of demonstrated use of skills, defined requirements for certifications that include demonstrated use of skills and achievement of results ( i.e. green/black belt certifications), defined requirements to maintain certification levels ( i.e. continued demonstrated use of skills and achievement results), etc.)

  Addressed

  Not Addressed

• 7. If applicable, how is the AMAT SSPCM ( Supplier Statistical Process Control Monitoring) tool used for process capability and control monitoring and improvement?

• 7.1 There is an agreement with AMAT on the product/process characteristics to be monitored via SSPCM.

  YES

  NO

  N/A

• 7.2 Evidence that SSPCM data is all being entered and reviewed in a timely manner.

  YES

  NO

  N/A

• 7.3 Evidence that actions are defined and taken when out of control conditions are present.

  YES

  NO

  N/A

• 7.4 Evidence that process capability improvement projects are defined and implemented when CpK < 1.33.

  YES

  NO

  N/A

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VALIDATION SCORES

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RESULTS

• Summary:

• Strenghts:

• Observations:

• Opportunities for Improvement:

3.1 SOFTWARE QUALITY

• SUB-SECTION:

  Select 3.1.1 - Documented Process; 3.1.5 - Configuration Management and Change Control;

  • 3.1.1 - Documented Process;
  • 3.1.5 - Configuration Management and Change Control;

3.1.1 - Documented Process

• An approved documented process shall be used to guide the development and maintenance of all sofware that impacts total customer satisfaction.

• 1. How does your software lifecycle management process address the following?

• 1.1 Documented process for software lifecycles exists, is approved by management, and is maintained ( i.e. software development cycle has been established showing process from conception to release)

  Addressed

  Not Addressed

• 1.2 Evidence supports that appropriate personnel have been trained in the process.

  Addressed

  Not Addressed

• 1.3 Organization follows one or more industry standard models/guidelines for software development such as CMMI, Agile, Extreme Programming, etc. Methodology provides context for organization's selected software lifecycli management process.

  Addressed

  Not Addressed

• 1.4 A strategy exists to improve the documented process along the SW development model guidelines.

  Addressed

  Not Addressed

• 2. How do you address software project management?

• 2.1 Project Managers are assignated to manage projects throughout the software development lifecycle phases.

  Addressed

  Not Addressed

• 2.2 Project plans are developed with specific tasks, dates and milestones that align with lifecycle process ( plans address integration with hardware project plans)

  Addressed

  Not Addressed

• 2.3 Status on project plans is updated throughout the project.

  Addressed

  Not Addressed

• 2.4 Management level progress monitoring is in place ( execution to plans, achievement of deliverables, etc.)

  Addressed

  Not Addressed

• 3. How do you ensure conformance to the software lifecycle process? ( Sample one or more projects/ enhancements and follow it through the development lifecycle with attention to compliance to documented process ( a few areas to sample are making sure all functionality is documented, demonstrated testing to requirements, formal version control and release).

• 4. How do you use customer feedback for driving continual Improvement?

• 4.1 Mechanisms are implemented to receive customer feedback on software quality (i.e. bugs, satisfaction feedback, etc.)

  YES

  NO

  N/A

• 4.2 Evidence that feedback is collected, reviewed, acted on, and communication loop closed with customer ( look for standarized means of tracking bugs).

  YES

  NO

  N/A

• 4.3 Evidence that customer satisfaction feedback data is used to measure, trend, analyze, and improve the effectiveness of the software lifecycle process.

  YES

  NO

  N/A

• 5. What software development lifecycle process metrics are identified, trended, analyzed, snd improved towards goals as appropriate? Examples of metrics:

• 5.1 Performance to milestones, completion of tasks at milestones, testing results, post release changes, field performance, bugs reported, etc.).

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

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VALIDATION SCORES

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