IECQ OPERATIONAL DOCUMENT - …documents.iecq.org/iecq/iecqdocuments.nsf/0...IECQ OD 706-4 Edition 1.0 2016-09 IECQ OPERATIONAL DOCUMENT IECQ Counterfeit Avoidance Programme Assessment,

IECQ OD 706-4 Edition 1.0 2016-09

IECQ OPERATIONAL DOCUMENT

IECQ Counterfeit Avoidance Programme Assessment, Evidence of Compliance Summary and Assessment Reporting Form (AS/EN/JISQ9100 revision C)

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IEC Quality Assessment System for Electronic Components (IECQ System)

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IECQ OD 706-4 Edition 1.0 2016-09

IECQ OPERATIONAL DOCUMENT

IECQ Counterfeit Avoidance Programme Assessment, Evidence of Compliance Summary and Assessment Reporting Form (AS/EN/JISQ9100 )

INTERNATIONAL ELECTROTECHNICAL COMMISSION ZZ PRICE CODE

IEC Quality Assessment System for Electronic Components (IECQ System)

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CONTENTS

CONTENTS ......................................................................................................................... 2INTRODUCTION .................................................................................................................. 31 Technical requirements (Objectives) – Principals ............................................................. 42 Instructions for Use ........................................................................................................ 43 Table 1 AS/EN/JISQ9100 revision C (2009-01) – Verification Criteria ............................... 5

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INTERNATIONAL ELECTROTECHNICAL COMMISSION ____________

IECQ Operational Document 706-4

IECQ Counterfeit Avoidance Programme Assessment, Evidence of

Compliance Summary and Assessment Reporting Form (AS/EN/JISQ9100)

INTRODUCTION

Development of the IECQ Counterfeit Avoidance Programme Worksheet and reporting form.

In order to assist the IECQ Counterfeit Avoidance Programme Assessment Team, the following worksheet was developed for the preparation reporting of assessments. It is recommended that links to process documentation and compliance data be established for presentation during the IECQ Counterfeit Avoidance Programme assessment. This worksheet shall be used to record and report the results of the assessment.

For the purposes of illustration, reference will be made to AS/EN/JISQ9100

The documentation and examples listed in the column “Examples of Records of Compliance” is not intended to be a comprehensive tabulation of all the items that must be included in the Counterfeit Avoidance Management Plan.

The right column, “Record of Compliance” is for the use of the assessment team to record their finding for each of the IECQ Counterfeit Avoidance Programme requirements during the assessment. The column will also be a permanent record of any “judgement” decisions made by the assessment team during the assessment, and should be achieved by the OEM and IECQ CB.

Document History

Date Summary

2016-09 Original issue

IECQ Secretariat c/o IEC Sydney Office The Executive Centre, Australia Square, Level 33 264 George Street, Sydney, NSW 2000 Australia

E-mail: [email protected] | Tel:+61 2 4628 4690 I Fx: +61 2 4627 5285 | http://www.iecq.org

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IECQ Counterfeit Avoidance Programme Assessment, Evidence of Compliance Summary and Assessment Reporting Form

(AS/EN/JISQ9100)

1 Technical requirements (Objectives) – Principals

This set of criteria is to be utilized by accredited Certification Bodies (CBs) to establish compliance, and grant certification to AS/EN/JISQ9100 revision C (2009-01) Quality Management Systems - Requirements for Aviation, Space and Defense Organizations to support IEC/TS 62668-1 anti-counterfeit audits when the CB is not already accredited by the IAQG and does not have a checklist.

This document is intended for use during certification audits of:

(a) AS/EN/JISQ9100 revision C, see Table 1

2 Instructions for Use

SAE AS9101 revision E ‘Quality management Systems Audit Requirements for Aviation, Space and Defense Organisations' describes the AS/EN/JISQ 9100 audit requirements including the requirement for the auditee to have previously constructed Process Effectiveness Assessment Report (PEARS) for review prior to the audit being scheduled.

AS/EN/JISQ9100 Clause: Reference to the specific clause in AS/EN/JISQ9100 being addressed (Table 1).

AS/EN/JISQ9100 Clauses required for the minimum requirements of IEC/TS 62668-1 compliance: Reference to the specific clause in AS/EN/JISQ9100 being addressed (Table 2).

Requirement: Description of the clause being addressed describing what activity is being evaluated.

Criteria for Compliance: Description of the clause being addressed describing what activity is being evaluated.

Record of Compliance: Acceptable evidence that the clause is being implemented and appropriate records being kept to demonstrate compliance. This column is for the IECQ Counterfeit Avoidance Assessment Team to record their findings and should include references to audit records e.g. procedure references and revision, quality plan references, program schedule references, management meeting minutes reference numbers, training procedures and records, etc.

Audit Trail/Information: Area used for notes, observations, information, items requiring additional follow-up.

Complies with the Clause: This column is for the IECQ Counterfeit Assessment Team to record their finding of satisfactory compliance or not.

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3 Table 1 AS/EN/JISQ9100 revision C (2009-01) – Verification Criteria

AS/EN/JISQ9100 revision C Clause

AS9100 rev C paragraph heading

Criteria for Compliance Record of Compliance

Audit Trail/Information

Complies with Clause

4.1 General Requirements

Describe your quality management system. Does it include a) the processes needed for the quality management system and their application throughout the organization (see 1.2) b) sequence and interaction of these processes, c) criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensuring the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitoring , measurement where applicable, and analyses of these processes, and f) implementation of actions necessary to achieve planned results and continual improvement of these processes. What are your customer and other regulatory requirements and how are these incorporated into your quality system? Are all required external regulatory requirements incorporated? Do you hold any external Third Party Certifications, e.g. ISO9001, TS16949 , EASA Part 21, EASA Part 145, FAA, TCCA, CAAC, AS9100, and AS9110? Is there quality planning/program for each product/order? Has the organisation any PEARS or Turtles for review?

Yes No o o

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4.2 Documentation requirements

Yes No o o

4.2.1 General What is your quality management system documentation? Does it include : a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures and records required by this International Standard, and d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes. How is this controlled? How often is it reviewed? Are documents and records saved in an easily acessible manner to enable future effective planning, operation and control ? Do all personnel within the business have easy access to the latest version? How do you ensure your personnel have access to the relevant parts? Which medium is used, e.g. company intranet, paper bases??

Yes No o o

4.2.2 Quality manual Does the Quality manual include: a) The scope of the quality management system and any exclusions? b) the documented QMS procedures c) a description of the interaction between QMS processes?

4.2.3 Control of Documents

How are the quality documents controlled? Does this include: a) approval processes for release? b) process to review and update? c) process to indicate changes and the current revision status ? d) that personnel have access wherever is required? e) a process to ensure all documents are legible and easily identifiable. f) access to external documents is available and controlled? g) process to prevent the use of obsolete documents and the process to identify them as being obsolete. Is this acceptable?

Yes No o o

4.2.4 Control of records

Are they under configuration control ? How are they identified, stored, protected, retrieved, re-approved and disposed of? How are suppliers records controlled and/or retained? Are the records legible, readily identifiable and retrievable?

5 Management Responsibility

Yes No o o

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5.1 Management Commitment

Interview the top management and determine if : a) they are committed to developing and maintaining the QMS b) how they communicate the importance of customer, statutory and regulatory requirements c) how they ensure quality objectives are met through the use of Process Effectiveness Audit reports (PEARS), etc. d) How they establish and maintain a Quality Policy e) how they conduct management reviews and f) how they ensure the necessary resources are available

Yes No o o

5.2 Customer Focus

How is performance to customer expectations managed? e.g. supplier ratings, scorecard, audit results . How is this enhanced for better customer satisfaction? How is product conformity measures and on-time delivery measured. What corrective actions are taken to improve these ?

Yes No o o

5.3 Quality Policy How does management ensure the quality policy is appropriate to the purpose of the organisation? Is there a commitment to comply and continually improve the QMS? Is there a framework for reviewing quality objectives? Is this communicated to members of the organisation? Is this periodically reviewed to ensure it is appropriate?

Yes No o o

5.4 Planning Yes No o o

5.4.1 Quality Objectives

How does top management ensure the quality objectives to meet the requirements for products are established at relevant functions and levels within the organisation? Is there a company organisational chart which defines roles and responsibilities? Is it adequate for purpose? Are the quality objectives measurable? Are there PEARS for these requirements?

Yes No o o

5.4.2 Quality Management System Planning

How is quality planning managed and quality objectives met and does it meet requirements in 4.1 ? How are changes managed and how do they impact the QMS?

Yes No o o

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5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority

Is there an organisation structure defining the roles and responsibilities within the organisation? Is this available to everyone in the organisation?

Yes No o o

5.5.2 Management Representative

Who is the member of the management team responsible for quality management ? Do they have the powers as stated in 5.5.2, i.e. a) ensuring that processes needed for the quality management system are established, implemented and maintained, b) reporting to top management on the performance of the quality management system and any need for improvement, c) ensuring the promotion of awareness of customer requirements throughout the organization, and d) the organizational freedom and unrestricted access to top management to resolve quality management issues? Do they have external liaisons?

Yes No o o

5.5.3 Internal Communication

Does top management ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system?

Yes No o o

5.6 Management Review

5.6.1 General How often does top management review the QMS? Does this review include: a) improvements and changes to the QMS and quality policy and objectives? Is this documented ? Select the last management review. Did this occur within the stated timeline?

Yes No o o

5.6.2 Review Input Review the last management review to determine if the Top management review include 5.6.2 a) to g) as follows; a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality management system, and g) recommendations for improvement.

Yes No o o

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5.6.3 Review output Review the last management review for the output decisions. Did this produce any actions per 5.6.3 a) to c) i.e. a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs.?

Yes No o o

6 RESOURCE MANAGEMENT

6.1 Provision of Resources

How are resources managed? Is this effective? Does it cover: a) implementing and maintaining the quality management system and continually improving its effectiveness, and b)enhancing customer satisfaction by meeting customer requirements?

Yes No o o

6.2 Human Resources

6.2.1 General How are employees recruited for their positions in the company and are their skills adequately matched to their roles including education, training, skills and experience? Can HR provide records to substantiate their recruitment process?

Yes No o o

6.2.2 Competence, Training and Awareness

Has the organisation planned and implemented training for 6.2.2 a) to e): a) determine the necessary competence for personnel performing work affecting conformity to product requirements, b) where applicable, provide training or take other actions to achieve the necessary competence, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills and experience (see 4.2.4). ? Are training records documented ?

Yes No o o

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6.3 Infrastructure Is the organisation adequately designed to maintain the infrastructure needed per 6.3 a) to c) to produce confirming product: a) buildings, workspace and associated utilities, b) process equipment (both hardware and software), and c) supporting services (such as transport, communication or information systems). If not, is this managed by subcontracting? How do they control subcontractors?

Yes No o o

6.4 Work Environment

Is the work environment controlled adequately to achieve conformity to product. Where electronic assemblies are manufactured do the environmental controls conform to ESD, MSL, temperature controls, humidity controls, lighting, weather requirements?

Yes No o o

7 Product realisation

7.1 Planning of Product Realization

Describe the product realisation planning process. Does it include design reviews and when they occur in the design phase? Are the requirements of 7.1 a) to f) adequately addressed: a) quality objectives and requirements for the product; NOTE Quality objectives and requirements for the product include consideration of aspects such as - product and personal safety, - reliability, availability and maintainability, - reducibility and inspectability, - suitability of parts and materials used in the product, - selection and development of embedded software, and - recycling or final disposal of the product at the end of its life. b) the need to establish processes and documents, and to provide resources specific to the product; c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance; d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4); e) configuration management appropriate to the product; f) resources to support the use and maintenance of the product. ?

Yes No o o

7.1.1 Project Management

Review some examples of product design project management plans. Are these implemented and managed taking product risks into account in a sufficient structured and controlled manner to meet schedule requirements?

Yes No o o

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7.1.2 Risk Management

Review an example of a design project management plans and check that 7.1.2 a) to e) requirements are addressed: a) assignment of responsibilities for risk management, b) definition of risk criteria (e.g., likelihood, consequences, risk acceptance), c) identification, assessment and communication of risks throughout product realization, d) identification, implementation and management of actions to mitigate risks that exceed the defined risk acceptance criteria, and e) acceptance of risks remaining after implementation of mitigating actions.

Yes No o o

7.1.3 Configuration Management

Describe the configuration control management process and check that 7.1.3 a) to e) requirements are addressed: a) configuration management planning, b) configuration identification, c) change control, d) configuration status accounting, and e) configuration audit.

Yes No o o

7.1.4 Control of Work Transfers

Describe how Work Transfers are arranged and check how the conformity of the work is carried out. Is it satisfactory?

Yes No o o

7.2 Customer-Related Processes

7.2.1 Determination of Requirements Related to the Product

How are customer product requirements determined ad do they meet 7.2.1 a) to d) requirements : a) requirements specified by the customer, including the requirements for delivery and post-delivery activities, b) requirements not stated by the customer but necessary for specified or intended use, where known, c) statutory and regulatory requirements applicable to the product, and d) any additional requirements considered necessary by the organization ?

Yes No o o

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7.2.2 Review of Requirements Related to the Product

How are bids processed and are 7.2.2 a) to e) requirements reviewed adequately before accepting the order to ensure: a) product requirements are defined, b) contract or order requirements differing from those previously expressed are resolved, c) the organization has the ability to meet the defined requirements, d) special requirements of the product are determined, and e) risks (e.g., new technology, short delivery time frame) have been identified (see 7.1.2)? Is the bid review process documented? How are changes to bids managed?

Yes No o o

7.2.3 Customer Communication

How are customer interactions managed and are 7.2.3 a) to c) adequately managed for : a) product information, b) enquiries, contracts or order handling, including amendments, and c) customer feedback, including customer complaints.?

Yes No o o

7.3 Design and Development

7.3.1 Design and Development Planning

How is the product design and development planned managed? Are 7.3.1 a) to c) adequately managed for : a) the design and development stages, b) the review, verification and validation that are appropriate to each design and development stage, and c) the responsibilities and authorities for design and development? Is there clear and effective management between different groups?

Yes No o o

7.3.2 Design and Development Inputs

How are design requirements documented? What reviews are carried out? Do they include 7.3.2 a) to d) for : a) functional and performance requirements, b) applicable statutory and regulatory requirements, c) where applicable, information derived from previous similar designs, and d) other requirements essential for design and development.? Are the inputs clear ? Are there any contradictions? Are they adequate?

Yes No o o

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7.3.3 Design and Development Outputs

What are the design and development outputs? Are they approved prior to release? Do they include 7.3.3 a) to e) and : a) meet the input requirements for design and development, b) provide appropriate information for purchasing, production and service provision, c) contain or reference product acceptance criteria, d) specify the characteristics of the product that are essential for its safe and proper use, and e) specify, as applicable, any critical items, including any key characteristics, and specific actions to be taken for these items.? What type of data is created?

Yes No o o

7.3.4 Design and Development Review

Describe the design review process . Does it follow 7.3.4 a) to c): a) to evaluate the ability of the results of design and development to meet requirements, b) to identify any problems and propose necessary actions, and c) to authorize progression to the next stage? Does it include representatives of the functions being reviewed? Are there review records and authorisations to proceed to the next stage? Are the results of the reviews recorded and are actions followed up and maintained?

Yes No o o

7.3.5 Design and Development Verification

How is verification performed and is it in accordance with the planned arrangements per 7.3.5? Are the results documented and are necessary actions maintained?

Yes No o o

7.3.6 Design and Development Validation

How is validation performed and is it in accordance with planned arrangements per 7.3.1 to meet requirements of the application ? Is this completed before delivery or implementation of the product? Are the results documented and corrective actions implemented?

Yes No o o

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7.3.6.1 Design and Development Verification and Validation Testing

Where there is a requirement for testing, are these documented , held under configuration control and reviewed to ensure they meet the requirements of 7.3.6.1 a) to e) as follows: a) test plans or specifications identify the product being tested and the resources being used, define test objectives and conditions, parameters to be recorded and relevant acceptance criteria, b) test procedures describe the method of operation, the performance of the test and the recording of the results, c) the correct configuration of the product is submitted for the test, d) the requirements of the test plan and the test procedures are observed, and e) the acceptance criteria are met.?

Yes No o o

7.3.6.2 Design and Development Verification and Validation Documentation

Does the final design or development documentation demonstrate that the product meets the requirements for all identified operational conditions?

Yes No o o

7.3.7 Control of Design and Development Changes

How are changes managed? Are they identified and are records maintained? Are the changes reviewed, verified and validated, as appropriate, and approved before implementation? Is the impact on the current build and already delivered product taken into account? Is the review process documented and are corrective actions finalised?

Yes No o o

7.4 Purchasing

7.4.1 Purchasing Process

Describe the Purchasing process and flow-down of requirements to the supplier. How are suppliers selected and approved? What is the approval process? Is this documented and is the approval criteria explained? Are external accreditations used? Is a register of suppliers maintained with the correct scope of approval per 7.4.1 a) ? Are suppliers regularly reviewed and necessary actions taken? Where customer approved special process are used, how is it ensured that they are followed? How are supplier managed when they do not meet requirements? How is the risk of using a new supplier managed? is this acceptable?

Yes No o o

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7.4.2 Purchasing Information

Does the Purchasing information include 7.4.2 a) to i) requirements as follows: a) requirements for approval of product, procedures, processes and equipment, b) requirements for qualification of personnel, c) quality management system requirements, d) the identification and revision status of specifications, drawings, process requirements, inspection/verification instructions and other relevant technical data, e) requirements for design, test, inspection, verification (including production process verification), use of statistical techniques for product acceptance, and related instructions for acceptance by the organization, and as applicable critical items including key characteristics, f) requirements for test specimens (e.g., production method, number, storage conditions) for design approval, inspection/verification, investigation or auditing, g) requirements regarding the need for the supplier to - notify the organization of nonconforming product, - obtain organization approval for nonconforming product disposition, - notify the organization of changes in product and/or process, changes of suppliers, changes of manufacturing facility location and, where required, obtain organization approval, and - flow down to the supply chain the applicable requirements including customer requirements, h) records retention requirements, and i) right of access by the organization, their customer and regulatory authorities to the applicable areas of all facilities, at any level of the supply chain, involved in the order and to all applicable records.?

Yes No o o

7.4.3 Verification of Purchased Product

Describe how the organisation ensures that the purchased product meets specified purchase requirements per 7.4.3 . Where product is taken pending completion of verification activities, describe how it is identified and recorded in order to allow recall and replacement if it is subsequently found not to meet requirements. Where verification is delegated to the supplier, describe how the requirements for delegation are defined and register of delegations maintained. Is this acceptable?

Yes No o o

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7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision

Describe how the organisation carries out production under controlled conditions per 7.5.1 to ensure : a) the availability of information that describes the characteristics of the product, NOTE This information can include drawings, parts lists, materials and process specifications. b) the availability of work instructions, as necessary, NOTE Work instructions can include process flow charts, production documents (e.g., manufacturing plans, travellers, routers, work orders, process cards) and inspection documents. c) the use of suitable equipment, NOTE Suitable equipment can include product specific tools (e.g., jigs, fixtures, molds) and software programs. d) the availability and use of monitoring and measuring equipment, e) the implementation of monitoring and measurement, f) the implementation of product release, delivery and post-delivery activities, g) accountability for all product during production (e.g., parts quantities, split orders, nonconforming product), h) evidence that all production and inspection/verification operations have been completed as planned, or as otherwise documented and authorized, i) provision for the prevention, detection and removal of foreign objects, j) monitoring and control of utilities and supplies (e.g., water, compressed air, electricity, chemical products) to the extent they affect conformity to product requirements, and k) criteria for workmanship, specified in the clearest practical way (e.g., written standards, representative samples, illustrations). Is this acceptable?

Yes No o o

7.5.1.1 Production Process Verification

What are the procedures for first article inspection? Is first article inspection being used appropriately and is it used to validate changes ?

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7.5.1.2 Control of Production Process Changes

Describe how authorised personnel to approve production changes per 7.5.1.2 are identified. Does this include processes, production equipment , tools and software programs. Is the impact of the change assessed? Is this acceptable?

Yes No o o

7.5.1.3 Control of Production Equipment, Tools and Software Programs

Describe how production equipment, tools, software programs etc., are validated prior to release for production and how they are maintained. Describe the storage conditions. Are these adequate?

Yes No o o

7.5.1.4 Post-Delivery Support

Describe post delivery support and explain how this meets the requirements of 7.5.1.4 a) to e): a) collection and analysis of in-service data, b) actions to be taken, including investigation and reporting, when problems are detected after delivery, c) control and updating of technical documentation, d) approval, control and use of repair schemes, and e) controls required for off-site work (e.g., organization’s work undertaken at the customer’s facilities). Is this acceptable?

Yes No o o

7.5.2 Validation of Processes for Production and Service Provision

Describe how special processes are validated per 7.5.2 a) to e) : a) defined criteria for review and approval of the processes, b) approval of equipment and qualification of personnel, c) use of specific methods and procedures, d) requirements for records (see 4.2.4), and e) revalidation. Are they acceptable?

Yes No o o

7.5.3 Identification and Traceability

Describe traceability of product within the production realization environment, including traceability records per 7.5.3 . Do the records state the actual build status at each assembly stage? How are they signed off? Do the products require unique identification and is this controlled? How far into the assembly is traceability maintained? Is this acceptable?

Yes No o o

7.5.4 Customer Property

How is customer property managed? Is it identified, verified, protected and safeguarded ? Are instances of loss, damage or otherwise reported to the customer? Are records maintained? Is this adequate? Does this include IP and personal data?

Yes No o o

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7.5.5 Preservation of Product

Explain how product preservation is carried out during internal processing and delivery per 7.5.5: a) cleaning, b) prevention, detection and removal of foreign objects, c) special handling for sensitive products, d) marking and labelling including safety warnings, e) shelf life control and stock rotation, and f) special handling for hazardous materials. Is this adequate?

Yes No o o

7.6 Control of Monitoring and Measuring Equipment

Explain how the organisation determines based on the monitoring and measurements put in place that there is evidence of conformity to product requirements per 7.6 and how the records are reviewed. Review the list of test and measuring equipment and the calibration/verification processes including test software, ATE, plotters etc. and how this is maintained . How are the environmental conditions maintained for calibration, inspection, measurement and testing ? Is there a traceable link to external calibration standards which can : b) be adjusted or re-adjusted as necessary; c) have identification in order to determine its calibration status; d) be safeguarded from adjustments that would invalidate the measurement result; e) be protected from damage and deterioration during handling, maintenance and storage. . Is there a recall process for product when equipment is found to have been used and is out of calibration? How is software verified as being the correct version of software before being used on a product? what happened to product which has been tested on equipment which is found to be out of calibration? Is this acceptable?

Yes No o o

8 MEASUREMENTANALYSIS AND IMPROVEMENT

8.1 General Describe the organisation implements the monitoring, measurement, analysis and improvement process for 8.1 a) to c): a) to demonstrate conformity to product requirements, b) to ensure conformity of the quality management system, and c) to continually improve the effectiveness of the quality management system.

Yes No o o

8.2 Monitoring and Measurement

Does this include use of acceptable models and relevant statistical techniques?

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8.2.1 Customer Satisfaction

Explain how customer perception and customer satisfaction is monitored? Does it capture the requirements of 8.2.1? What types of data is captured to determine this? Does it include product conformity, on-time delivery performance, customer complaints and corrective action requests? What are the organisations customer satisfaction improvement plans? Is this acceptable?

Yes No o o

8.2.2 Internal audit Explain how internal audits are carried out and if this addresses the requirements in 8.2.2 and conforms to the planned arrangements and the QMS? How are audits planned and how are auditors selected? is this documented? Are the records of audit documented and maintained? Is this effectively implemented? How does the organisation ensure auditors do not audit their own work? Are corrective actions completed in a timely manner? Is this acceptable?

Yes No o o

8.2.3 Monitoring and Measurement of Processes

Describe the methods for monitoring and measurement of the QMS. Do they achieve planned results? Are corrective actions raised when results are not achieved? When a nonconformity is raised does the organisation : a) take appropriate action to correct the nonconforming process, b) evaluate whether the process nonconformity has resulted in product nonconformity, c) determine if the process nonconformity is limited to a specific case or whether it could have affected other processes or products, and d) identify and control any nonconforming product (see 8.3).

Yes No o o

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8.2.4 Monitoring and Measurement of Product

Is the non-conformance process monitored for 8.2.3 a) to d) for : a) criteria for acceptance and/or rejection, b) where in the sequence measurement and testing operations are to be performed, c) required records of the measurement results (at a minimum, indication of acceptance or rejection), and d) any specific measurement instruments required and any specific instructions associated with their use? How are key characteristics controlled and monitored? Is product sampling based on recognised statistical sampling procedures? When product is released pending completion of testing, is it identified and recoded to allow for product recall? Do records indicate the person responsible for release of product for delivery? Do qualification records provide evidence that the product meets requirements? Does release of product only occur when all planned arrangements have been completed? Are all documents present?

Yes No o o

8.3 Control of Nonconforming Product

How is non-confirming product managed and does the process meet the requirements of 8.3: a) by taking action to eliminate the detected nonconformity; b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; c) by taking action to preclude its original intended use or application; d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started; - The organization’s nonconforming product control process shall provide for timely reporting of delivered nonconforming product; NOTE Parties requiring notification of nonconforming product can include suppliers, internal organizations, customers, distributors and regulatory authorities. e) by taking actions necessary to contain the effect of the nonconformity on other processes or products. Does this include customer returned product? Who are the approved signatories? Does this include delivered non-conforming product? How are the quarantine facilities maintained? When non-conforming product is reworked or corrected how is it re-inspected before being released? Are records documented? is this acceptable? Are items for scrap adequately identified physically?

Yes No o o

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8.4 Analysis of Data

How does the organisation collect appropriate data to demonstrate the suitability and effectiveness of the QMS? Does this follow 8.4? Is this acceptable?

Yes No o o

8.5 Improvement

8.5.1 Continual Improvement

How does the organisation continually improve the effectiveness of the QMS? Is this based on quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews? Are there regular management reviews? Are lessons learned captured and used for improvements? Is this acceptable?

Yes No o o

8.5.2 Corrective Action

How are Corrective Actions managed and is there a program of work or activity to eliminate their causes? Does the CA review process include the requirements of 8.5.2: a) reviewing nonconformities (including customer complaints), b) determining the causes of nonconformities, c) evaluating the need for action to ensure that nonconformities do not recur, d) determining and implementing action needed, e) records of the results of action taken (see 4.2.4), f) reviewing the effectiveness of the corrective action taken, g) flowing down corrective action requirements to a supplier when it is determined that the supplier is responsible for the nonconformity, h) specific actions where timely and/or effective corrective actions are not achieved, and i) determining if additional nonconforming product exists based on the causes of the nonconformities and taking further action when required.? Is this acceptable?

Yes No o o

8.5.3 Preventive Action

How are preventive actions managed? Do the processes include the requirements of 8.5.3 which includes a documented procedure which shall be established to define requirements for a) determining potential nonconformities and their causes, b) evaluating the need for action to prevent occurrence of nonconformities, c) determining and implementing action needed, d) records of results of action taken (see 4.2.4), and e) reviewing the effectiveness of the preventive action taken.? Is this acceptable?

Yes No o o

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Review of PEARS

Review the orgainisation’s PEARS.

Typical PEAR examples are:

- Customer Facing,

- Engineering Design and Development

- Planning,

- Provision of Inventory,

- Clear to Build for Production,

- Manufacture,

- Despatch,

- Product /process Improvement.

Do the PEARS adequately cover the organisation’s mode of operation? Are they clear and understandable? Do they measure the appropriate things?

Yes No o o

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