Professional Documents
Culture Documents
Includes the following translations; Chinese-Simple, ChineseTraditional, Dutch, English, French, German, Russian & Spanish.
Table of Contents Contents What's new with this revision? Language Instructions Typical Audit Cycle ISO / TS Cross Reference Supplier Profile & Audit Record Standard Checklist Audit Scores & Findings Supplier Corrective Actions RoHS Requirements REACH Compliance Added Requirements Checklist Audit Scores & Findings Supplier Corrective Actions Audit Results Audit Team Recommendation Final Disposition Auditor Notes & Attachments Upload Audit Results to Database Quick Links Sign-in to ESAC Database ESAC Auditor Training Materials ESAC Help Request Request ESAC Database Access Sign up for ESAC Training Workbook Compatibility w/ Excel EU REACH Documents Auditor Qualifications
Contents Page: 1 of 64
General Instructions: a.) Set the Excel macro security to medium. Click "Enable Macros" when opening this file.) b.) Use the "Language" and "Show-Hide" buttons as necessary to facilitate use. c.) Read "Instructions" before using the ESAC Workbook. d) You must be registered to the ESAC Database to upload audit data.
Note: Use Excel 2003 or 2007 (or newer). Using Excel 2000 (or older) will cause malfunctions to occur.
2 3 4 5
Contents Page: 2 of 64
Auditor Qualifications Q: How well trained and experienced should someone be before leading an ESAC audit? A: See the recommendations below & the "ESAC Auditor Training Materials" link.
The recommendations below help ensure that Emerson auditors are appropriately trained and qualified before leading an ESAC audit. These guidelines are intended to promote consistency and professionalism. Each Division and Supply Chain Organization should establish their own requirements for auditor qualification and then monitor auditor performance. 1. Completion of an ISO 9001/TS16949 auditor training course (typ. 3 to 5 days), either lead auditor or internal auditor training, provided by a reputable registrar or consulting/training provider. Or, attend the ESAC Core Team's "Comprehensive Auditor Training" class (1-day plus ESAC audit participation). 2. Attend "Auditing with ESAC" class to learn about how to use ESAC and to properly apply scoring. Must pass written test to confirm training effectiveness. (This class is optional if the auditor has attended the "Comprehensive Auditor Training" class.) 3. Participate on one or two ISO based quality system audits of suppliers or Emerson production facilities (ie., internal audits). Recommended that at least one of the audits be an ESAC audit. (Note: Confirmation to lead an audit must come from the auditor's Division.) 4. It is always advisable to participate in re-training on ESAC or generic quality system auditing or take the ASQ "Certified Quality Auditor" exam. (This would be monitored by the Division.) In addition to training, Emerson auditors should have excellent interpersonal skills and general business knowledge. Source: ASQ.org, "Minimum Expectations for a Certified Quality Auditor" Must possess the knowledge and ability to effectively conduct different types of audits in a professional, ethical and objective manner using and interpreting applicable standards/requirements, with an awareness of potential legal and financial ramifications. Must be able to effectively plan, develop, communicate and execute an audit within a defined scope, including resource scheduling, conducting necessary meetings in performance of the audit and using appropriate auditing techniques. Must be able to verify, document and communicate audit results, develop an audit report and evaluate the effectiveness of corrective action/follow-up. Must possess interpersonal skills to resolve conflict, conduct interviews and make presentations effectively. Must be able to participate in, lead and facilitate teams. Must understand how quality principles relate to business processes and be able to explain the importance of aligning the audit function to the organization. Must be able to select and use a wide variety of quality and auditing tools and techniques in practical applications.
TOC
Have technical knowledge of the processes being audited and the ability to effectively use an process audit checklist when required.
Contents Page: 3 of 64
Available Languages
ChineseSimple ChineseTraditional
&
ChineseTraditional (
Dutch
Nederlands
LEVERANCIERSINSTRUCTIES: Klik op de knop rechts in de taal die u verkiest om de verschillende onderdelen van deze vragenlijst te tonen. Vervolledig de in lichtgroen gekleurde velden op de bladzijden "Leveranciersprofiel & Auditplan" and "Standaard vragenlijst". SUPPLIER INSTRUCTION: Click button to the right to display portions of this workbook in the language you choose. Complete the areas highlighted in light-green on the "Supplier Profile & Audit Plan" and "Standard Checklist" pages. INSTRUCTIONS FOURNISSEUR : Cliquer sur le bouton de droite pour afficher les diffrentes parties de ce questionnaire dans la langue de votre choix. Complter les zones repres en vert clair sur les onglets Renseignements fournisseur et plan d'audit et Questionnaire standard . LIEFERANTEN-ANWEISUNG: Knopf rechts anklicken um die Ansicht dieses Arbeitsbuches in der Sprache Ihrer Wahl anzuzeigen. Vervollstndige die hellgrn unterlegten Bereiche in den Seiten des Audit-Planes, Lieferanten-Profiles- und in den Standardchecklisten. : . , - " " " ". INSTRUCCION AL PROVEEDOR: Haga clic en el boton de la derecha para mostrar partes de este archivo en el idioma que escoja. Llene las areas en verde claro en las paginas "Supplier Profile & Audit Plan" y "Standard Checklist."
Dutch (Nederlands)
English
English
English
French
Franais
French (Franais)
German
Deutsch
Russian
Spanish
Espaol
Page: 4 of 64
1 Supplier to complete as indicated. Answer all questions in the Supplier Quality Capabilities section. Explain any answered with "No" or "Not Applicable". 2 Supplier to complete "Self-Audit" on Std Checklist (if requested by Division). Use column labeled "Supplier Self-Audit Score". Click column heading for guidelines.
1 Supplier to complete as indicated. Answer all questions in the Supplier Quality Capabilities section. Explain any answered with "No" or "Not Applicable". 2 Supplier to complete "Self-Audit" on Std Checklist (if requested by Division). Use column labeled "Supplier Self-Audit Score". Click column heading for guidelines.
1 Supplier to complete as indicated. Answer all questions in the Supplier Quality Capabilities section. Explain any answered with "No" or "Not Applicable". 2 Supplier to complete "Self-Audit" on Std Checklist (if requested by Division). Use column labeled "Supplier Self-Audit Score". Click column heading for guidelines.
3 Is there a documented corrective action system in use that focuses on elimination of problem root cause? 4 Are defined methodologies used to actively pursue cost containment and other continual improvement activities? (e.g., Lean, Six Sigma, Kaizen, 5S, etc.) 5 Are control plans (or equivalent) maintained that show the process steps, key inspection points, inspection/test method, sample size and frequency? 6 Are process capability studies, SPC or other statistical methods used to monitor and control production processes?
7 Are documented methods used to qualify and approve machinery, process equipment, inspection/test equipment and production tooling? 8 Is product conformance to specified requirements verified prior to further processing or shipment and are records maintained? 9 Are precautions taken to control and monitor the condition of product during storage, handling and shipping to prevent loss or damage? (e.g. shelf-life or ESD sensitive materials, etc.)
10 Are the materials and parts produced in accordance with applicable environmental and product safety regulations, laws and directives? (ie., RoHS, UL)
1 Supplier to complete as indicated. Answer all questions in the Supplier Quality Capabilities section. Explain any answered with "No" or "Not Applicable". 2 Supplier to complete "Self-Audit" on Std Checklist (if requested by Division). Use column labeled "Supplier Self-Audit Score". Click column heading for guidelines.
Contact #1
Contact #2
Contact #3
Contact #4
^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^
NOTES
REQUESTED x x x
RECEIVED ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^
1 Supplier to complete as indicated. Answer all questions in the Supplier Quality Capabilities section. Explain any answered with "No" or "Not Applicable". 2 Supplier to complete "Self-Audit" on Std Checklist (if requested by Division). Use column labeled "Supplier Self-Audit Score". Click column heading for guidelines.
First Name
Title
First Name
Title
Brown = Revised
Status
1.1
1.2
1.0 QUALITY MANAGEMENT
Quality reports, trend charts and data analysis identify areas of opportunity and are used by management on a routine basis. Records required.
Product quality yield data, top problems and corresponding improvement actions, status of preventive/corrective actions taken, internal audit results
1.3
1.0 QUALITY MANAGEMENT
Quality performance targets are clearly defined, included in the business plan and monitored for improvements.
1.4
1.0 QUALITY MANAGEMENT
Executive management participates in periodic quality system reviews that address quality related feedback from customers and internal quality metrics. Records required.
Analysis of field failures, inspection yields, resource needs, internal audit results, corrective action status, etc.
2.1
2.0 CONTINUOUS IMPROVEMENT
Preventive actions are taken based on the analysis of significant business trends, design reviews, customer satisfaction surveys or other meaningful inputs. Documented procedures required. Records required.
Management review meetings, goal setting, performance measurement, internal audits, action plans, customer surveys
Brown = Revised
Status
2.2
2.3
2.0 CONTINUOUS IMPROVEMENT
A corrective action system is in place that provides root cause analysis and takes timely and effective action to prevent recurrence. Documented procedures required. Records required.
Corrective action records, trend charts, meeting minutes, nonconformance frequency & cost analysis. Does CA system cover customer, internal & supplier issues?
3.1
The skill and education level required for each job is documented and appropriate training / re-training is provided. Records required.
Job descriptions, job skills assessment, training records, training manuals. Look for use of training aids & work instructions at work stations.
3.2
3.0 TRAINING & EDUCATION
Employee qualification / certification is maintained where the quality outcome of the process cannot be verified and is strongly dependent upon operator skill. Records required.
3.3
3.0 TRAINING & EDUCATION
Records of student testing, production quality records, audit records, interview workers to validate training records. Look for use of training aids & work instructions at work stations.
Brown = Revised
Status
4.1
4.0 OCCUPATIONAL HEALTH & SAFETY
4.2
The Occupation Health & Safety (OHS) policy states the organizations health and safety objectives and management's commitment to continual improvement of OHS metrics.
Policies and procedures, health & safety trend charts, accident rate improvement history, etc.
4.3
Procedures are used for the ongoing identification of hazards, the assessment of risks, and the implementation of necessary control measures.
Safety committee or group meeting minutes, accident investigation reports, safety audit reports
5.1
5.0 DESIGN DEVELOPMENT & SUPPORT
Customer needs and requirements are incorporated into product designs and/or manufacturing processes. Criticalto-Quality (CTQ) characteristics are identified and understood. Records required.
Market studies, customer/enduser surveys, technical design reviews, mfg process capability studies, formal process qualification plan, manufacturing verification tests, pilot runs, etc.
5.2
Product specifications and drawings are generated, controlled and maintained for new or changed product designs. Records required.
Complete product characteristics, application requirements, and other information essential for its safe and proper use and eventual disposal, etc.
Brown = Revised
Status
5.3
5.0 DESIGN DEVELOPMENT & SUPPORT
5.4
5.0 DESIGN DEVELOPMENT & SUPPORT
Human and technical resources are adequate to meet Emersons requirements for design collaboration, tooling design and electronic drawing and data exchange.
6.1
Production samples are inspected and provided to customers upon request. Records required.
6.2
Customer production requirements and quality specifications are reviewed to ensure they can be met on a consistent basis. Records required.
Procedures, design / process review minutes, FMEA's, mfg capacity plans, resource plans that address all product test, storage, packaging and shipment requirements
6.3
Reliability test plans are developed and routinely followed. Testing is used to verify design spec's, drive design improvements and provide an ongoing check of materials and workmanship. Documented procedures required. Records required.
Reliability test plans, test reports, improvement/corrective actions taken, design changes implemented
Brown = Revised
Status
6.4
6.0 QUALITY PLANNING
7.1
7.0 DRAWINGS & SPECIFICATIONS
New and revised customer specifications are reviewed and implemented in a timely manner. Documented procedures required.
Technical review of methods to be used, capability studies on similar parts, documented review procedure, ie., APQP, PPAP.
7.2
7.0 DRAWINGS & SPECIFICATIONS
Current process control documents are in place and used for production start-up and continuing production. Documented procedures required.
Customer specifications, engineering drawings, change notices, work instructions and specifications as applicable.
7.3
7.0 DRAWINGS & SPECIFICATIONS
Customer notification / approval occurs for changes to Control Plans, manufacturing site, product transfers, raw material or product obsolescence. Records required.
Customer notification procedure on major changes & compliance to Jedec standards JESD 46 and JESD 48 (or equivalent, if app.). Signed material / process change requests. Customers are notified of RoHS compliance status change.
7.4
Quality records are maintained. A record control system is in place for the identification, storage, protection, retrieval, retention time, and disposition of quality records.
Brown = Revised
Status
8.1
8.0 PROCUREMENT
8.0 PROCUREMENT
8.2
Purchases from unapproved suppliers are prevented by a properly controlled and available Approved Supplier List (ASL). Records required.
ASL, procedures for control and use of ASL, production material receipt records
8.3
8.0 PROCUREMENT
Preventive actions are taken to continuously improve performance of the supplier base. Records required.
Supplier quality performance analysis, performance trends, supplier audit reports, Inflation Model, documented goals regarding raw material cost containment
8.4
8.0 PROCUREMENT
A supplier quality assurance system ensures that all purchased product or material conforms to defined specifications and applicable regulatory or customer requirements. Records required.
Receiving inspection, supplier audits, source inspection, qualification testing, Certificate of Compliance (COC), component marking, labeling, etc.
8.5
8.0 PROCUREMENT
A system exists for the identification, verification and protection of customer supplied product that includes notifying the customer if product is damaged or lost. Records required.
Procedures, segregation during storage, limited and controlled access to stored inventories
9.1
9.0 INCOMING MATERIAL
Receiving inspection is performed per documented procedures and detailed work instructions. Records required.
Procedures, inspection instructions resources (manpower and equipment) allocated for incoming inspection
Brown = Revised
Status
9.2
9.3
9.0 INCOMING MATERIAL
Supplier corrective action requests require root cause investigation and records show responses are analyzed. Documented procedures required. Records required.
Availability of written procedure, standardized Corrective Action form, analysis of corrective action cycle time and closure measurements
Qualification plan that includes established goals for process yields/up-time, etc. and record of process capability, review and approval, etc.
Process flow diagram, statistical tools to be used, key inspection points, inspection frequency, records, control responsibility, inspection/test method, gaging used, acceptable yield rates
available where needed that accurately describe all work methods including inspections and tests to be done during production.
Sample size, frequency, method, document control dates/revision level, etc. Handling procedures for Electro-Static Discharge (ESD), RoHS compliant materials & other process conditions.
Brown = Revised
process adjustments are made per applicable work instructions to verify conformance at key points throughout the process and prior to shipment. Records required.
Typical Objective Evidence Records of inspections performed at incoming, first piece, in-process and/or final inspection or test. Capability study, material test, RoHS and other regulatory tests, etc.
Status
of product is identified and maintained throughout the production process. Records required.
Batch records, travelers, tags, labels, product markings or use of designated & identified areas.
production lots or issues that affect product reliability. Documented procedures required. Records required.
process parameters are reviewed and statistically based controls and/or problem solving tools are used to control variation.
Histograms, run charts, SPC charts, pareto analysis, cause & effect diagrams, DOE, mistake proofing, documented reaction plan & process corrections.
Documented reaction plan & process corrections. SPC trend charts showing current status vs. goals. Improvement plan.
Brown = Revised
Status
on charts and documented corrective action is taken to bring the process back into control. Documented procedures required. Records required.
and assemblies are segregated (where practical) and identified to prevent unapproved use. Documented procedures required. Records required.
Tags, marking, controlled staging areas, etc. Look for mixing of RoHS compliant & non-compliant materials.
(to the extent required by Emerson) to facilitate problem evaluation and corrective action. Documented procedures required. Records required.
Serial number records, lot number, date of manufacture, labeling and marking of containers or product, etc. Look for mixing of RoHS compliant & non-compliant materials.
to notify customers of nonconforming product that has already been shipped. Records required.
Brown = Revised
Status
Reproducibility studies are conducted to verify suitability of measuring devices for their use in checking product quality or control of processes. Records required.
test equipment are routinely calibrated and controlled per documented procedures. Records required.
Gage calibration stickers, calibration records, positive identification or segregation of out-of-calibration devices, and inventory, location & status records, etc.
calibrated against standards traceable to a recognized regulatory body or agency. Records required.
the validity of previous measurements done on products where out-of-calibration measuring devices were used. Records required.
Brown = Revised
to verify the suitability and accuracy of computer software prior to initial use in checking product quality or control of processes. Software is re-verified when revised. Records required.
Typical Objective Evidence Verification methods and records, revision levels, distribution/use control, etc.
Status
clearly defined area, with systematic tracking that provide traceability, particularly of customer-owned tools and equipment. Records required.
is followed. Product cannot be made with tools that are outside of maintenance period. Performance is audited
No equipment, tools, or fixtures are in use that are outside TPM schedule, or have unclear status
15.0 ENVIRONMENTAL
policy exists that includes a commitment to comply with relevant environmental legislation and regulations and to continual improvement and pollution prevention.
Brown = Revised
15.0 ENVIRONMENTAL
management system that ensures compliance to all applicable government regulations and there are no outstanding, unresolved violations of these regulations.
Typical Objective Evidence Records of agency/gov inspection or certification, doc'd procedures for measuring and monitoring environmentally sensitive activities w/ list of mtl's and areas where used, tracking of hazardous mtl's or waste.
Status
the use, disposal and emissions of hazardous chemicals and to ensure that Class I ozone depleting chemicals are not used in the manufacturing process.
15.0 ENVIRONMENTAL
on using materials that are; compliant with applicable regulations like RoHS & WEEE, biodegradable, recyclable, reusable, reduces pollutant emissions at the point of use.
Records/use of; non-hazardous (RoHS/WEEE compliant) materials in production, biodegradable materials, returnable containers or packaging, recycling program, packaging materials made of recycled materials.
and orderly. Tools and equipment are properly stored and readily available for use. Lighting and air quality are adequate.
Observe production, office & product storage areas for use of 5S/6S principles (Sort, Set-inorder, Shine, Standardize, Sustain + Safety)
are used to prevent product damage or loss in all phases of the material handling process.
Observe handling and transit of raw material, work-in-process, and finished goods.
Brown = Revised
followed to ensure proper control and preservation of handling, storage (FIFO), packaging, and delivery of product.
Typical Objective Evidence FIFO practices are defined, packaging specifications, test results, handling and storage procedures.
Status
reviewed and any concerns are communicated to the customer prior to initial production shipment. Packaging tests if required. Records required.
Technical review, packaging/shipping tests, packaging work instructions, carton strength tests
periodically inspected, and where applicable, actions are taken to prevent deterioration per documented procedures.
Doc'd list of shelf-life sensitive products/materials (e.g., sealants, adhesives, solder paste, paint/varnish, o'rings). Look for poor storage conditions & damage (e.g., rust or water damage). Handling procedures for Electro-Static Discharge (ESD) & other sensitive conditions.
developed that describe actions to be taken in the event of a major interruption of the manufacturing process.
Process covering utility interruptions, labor shortages, key equipment failures, major production issues.
Brown = Revised
documented and maintained that defines the requirements for material and process qualification, on-going compliance verification, manufacturing controls, declaration of compliance and records.
Typical Objective Evidence Documented procedures that set requirements for planning, verification, on-going control, record keeping & customer communications. Supplier's management support.
Status
requirements for RoHS compliance are reviewed and communicated prior to production start-up.
each RoHS controlled hazardous substance. Test sampling plan is based on analysis of risk for each commodity and/or manufacturing process used.
Assessment of risk by part-type or manufacturing process used. Procedures, test methods, sampling plan, control plan.
Training & education records. Interview engineering, technical, quality control personnel. Number of qualified personnel is adequate to prevent unacceptable delays.
inspection criteria are documented and available where needed, e.g. solder fillet, tin whiskers..
Test methods/procedures, tin whisker analysis instructions, XRF work instructions, QC audits, etc. Ref to Jedec/IPC Joint publication JP-002.
Acceptance limits do not exceed RoHS limits. References to recognized standard test protocols, such as, ISO, IEC, EPA.
Brown = Revised
goods are periodically tested with appropriate equipment to confirm RoHS compliance. Compliance declarations and test records are maintained for a minimum of 5 years.
Typical Objective Evidence RoHS testing procedure, sampling plan/frequency, test records. Use of XRF analyzer, atomic absorption analyzer, UVVIS equipment, etc.. Qualified independent chemical lab w/A2LA accreditation or equivalent
Status
handling methods are in place to prevent commingling or inappropriate use of both RoHS non-compliant and RoHS compliant items.
Documented procedures. Observation of handling / labeling techniques in use. Production operators are aware in distinguishing RoHS materials and processes versus non-RoHS. Look for mixing of RoHS compliant & non-compliant materials.
procedures in handling the screening, rework or refurbishing of finished goods returned from the field and customers.
Observation of handling / labeling techniques in use. Production operators are aware in distinguishing RoHS materials and processes versus non-RoHS. Documented procedures.
system is used to monitor the status of RoHS compliance and the declarations for each part number effected.
Database or other means is maintained to track RoHS compliance status by part number & declarations to customers.
documented and maintained that defines the requirements for REACH compliance and on-going verification.
Brown = Revised
Typical Objective Evidence Look for identification of an individual or individuals (i.e.., naming an entire department is not acceptable). Record the names and titles of the responsible individuals.
Status
place to communicate safe handling information (such as a Material Safety Data Sheet) for any dangerous substances contained in or on it's products.
Database/files. Records of communication to customers of the Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS) in the EU which may include Exposure Scenario (ES) and/or Risk Management Measures (RMM).
Emerson if they are providing (or will be providing) Emerson with products that contain Substances of Very High Concern (SVHC) that exceed 0.1% wt./wt.
If the official candidate list has been published by the ECHA (European Chemicals Agency), then look for records of communication to Emerson of the presence of SVHC, if applicable. Traceability of chemical identification.
Additional Findings
Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req #
Brown = Revised
Status
Not Applicable
Not Verified
Supplier On-Site Self-Audit Audit Std Std Chklst Chklst SCORE SCORE 0 8100 0% 0 8100 0%
Sum of Scores (excluding "n/a" & "Not Verified"): Maximum Total Score Available:
Top
On-Site Audit Findings Corrective Action plans will be submitted on (date): Emerson Audit Leader (name & title): Supplier QA Representative (name & title): CA-PA Verification & Finding Closure Date:
Brown = Revised
1.1
1.2
1.0 QUALITY MANAGEMENT
Quality reports, trend charts and data analysis identify areas of opportunity and are used by management on a routine basis. Records required.
Product quality yield data, top problems and corresponding improvement actions, status of preventive/corrective actions taken, internal audit results
1.3
1.0 QUALITY MANAGEMENT
Quality performance targets are clearly defined, included in the business plan and monitored for improvements.
1.4
1.0 QUALITY MANAGEMENT
Executive management participates in periodic quality system reviews that address quality related feedback from customers and internal quality metrics. Records required.
Analysis of field failures, inspection yields, resource needs, internal audit results, corrective action status, etc.
2.1
2.0 CONTINUOUS IMPROVEMENT
Preventive actions are taken based on the analysis of significant business trends, design reviews, customer satisfaction surveys or other meaningful inputs. Documented procedures required. Records required.
Management review meetings, goal setting, performance measurement, internal audits, action plans, customer surveys
Brown = Revised
2.2
2.3
2.0 CONTINUOUS IMPROVEMENT
A corrective action system is in place that provides root cause analysis and takes timely and effective action to prevent recurrence. Documented procedures required. Records required.
Corrective action records, trend charts, meeting minutes, nonconformance frequency & cost analysis. Does CA system cover customer, internal & supplier issues?
3.1
The skill and education level required for each job is documented and appropriate training / re-training is provided. Records required.
Job descriptions, job skills assessment, training records, training manuals. Look for use of training aids & work instructions at work stations.
3.2
3.0 TRAINING & EDUCATION
Employee qualification / certification is maintained where the quality outcome of the process cannot be verified and is strongly dependent upon operator skill. Records required.
3.3
3.0 TRAINING & EDUCATION
Records of student testing, production quality records, audit records, interview workers to validate training records. Look for use of training aids & work instructions at work stations.
Brown = Revised
4.1
4.0 OCCUPATIONAL HEALTH & SAFETY
4.2
The Occupation Health & Safety (OHS) policy states the organizations health and safety objectives and management's commitment to continual improvement of OHS metrics.
Policies and procedures, health & safety trend charts, accident rate improvement history, etc.
4.3
Procedures are used for the ongoing identification of hazards, the assessment of risks, and the implementation of necessary control measures.
Safety committee or group meeting minutes, accident investigation reports, safety audit reports
5.1
5.0 DESIGN DEVELOPMENT & SUPPORT
Customer needs and requirements are incorporated into product designs and/or manufacturing processes. Criticalto-Quality (CTQ) characteristics are identified and understood. Records required.
Market studies, customer/enduser surveys, technical design reviews, mfg process capability studies, formal process qualification plan, manufacturing verification tests, pilot runs, etc.
5.2
Product specifications and drawings are generated, controlled and maintained for new or changed product designs. Records required.
Complete product characteristics, application requirements, and other information essential for its safe and proper use and eventual disposal, etc.
Brown = Revised
5.3
5.0 DESIGN DEVELOPMENT & SUPPORT
5.4
5.0 DESIGN DEVELOPMENT & SUPPORT
Human and technical resources are adequate to meet Emersons requirements for design collaboration, tooling design and electronic drawing and data exchange.
6.1
Production samples are inspected and provided to customers upon request. Records required.
6.2
Customer production requirements and quality specifications are reviewed to ensure they can be met on a consistent basis. Records required.
Procedures, design / process review minutes, FMEA's, mfg capacity plans, resource plans that address all product test, storage, packaging and shipment requirements
6.3
Reliability test plans are developed and routinely followed. Testing is used to verify design spec's, drive design improvements and provide an ongoing check of materials and workmanship. Documented procedures required. Records required.
Reliability test plans, test reports, improvement/corrective actions taken, design changes implemented
Brown = Revised
6.4
6.0 QUALITY PLANNING
7.1
7.0 DRAWINGS & SPECIFICATIONS
New and revised customer specifications are reviewed and implemented in a timely manner. Documented procedures required.
Technical review of methods to be used, capability studies on similar parts, documented review procedure, ie., APQP, PPAP.
7.2
7.0 DRAWINGS & SPECIFICATIONS
Current process control documents are in place and used for production start-up and continuing production. Documented procedures required.
Customer specifications, engineering drawings, change notices, work instructions and specifications as applicable.
7.3
7.0 DRAWINGS & SPECIFICATIONS
Customer notification / approval occurs for changes to Control Plans, manufacturing site, product transfers, raw material or product obsolescence. Records required.
Customer notification procedure on major changes & compliance to Jedec standards JESD 46 and JESD 48 (or equivalent, if app.). Signed material / process change requests. Customers are notified of RoHS compliance status change.
7.4
Quality records are maintained. A record control system is in place for the identification, storage, protection, retrieval, retention time, and disposition of quality records.
Brown = Revised
8.1
8.0 PROCUREMENT
8.0 PROCUREMENT
8.2
Purchases from unapproved suppliers are prevented by a properly controlled and available Approved Supplier List (ASL). Records required.
ASL, procedures for control and use of ASL, production material receipt records
8.3
8.0 PROCUREMENT
Preventive actions are taken to continuously improve performance of the supplier base. Records required.
Supplier quality performance analysis, performance trends, supplier audit reports, Inflation Model, documented goals regarding raw material cost containment
8.4
8.0 PROCUREMENT
A supplier quality assurance system ensures that all purchased product or material conforms to defined specifications and applicable regulatory or customer requirements. Records required.
Receiving inspection, supplier audits, source inspection, qualification testing, Certificate of Compliance (COC), component marking, labeling, etc.
8.5
8.0 PROCUREMENT
A system exists for the identification, verification and protection of customer supplied product that includes notifying the customer if product is damaged or lost. Records required.
Procedures, segregation during storage, limited and controlled access to stored inventories
9.1
9.0 INCOMING MATERIAL
Receiving inspection is performed per documented procedures and detailed work instructions. Records required.
Procedures, inspection instructions resources (manpower and equipment) allocated for incoming inspection
Brown = Revised
9.2
9.3
9.0 INCOMING MATERIAL
Supplier corrective action requests require root cause investigation and records show responses are analyzed. Documented procedures required. Records required.
Availability of written procedure, standardized Corrective Action form, analysis of corrective action cycle time and closure measurements
Qualification plan that includes established goals for process yields/up-time, etc. and record of process capability, review and approval, etc.
Process flow diagram, statistical tools to be used, key inspection points, inspection frequency, records, control responsibility, inspection/test method, gaging used, acceptable yield rates
available where needed that accurately describe all work methods including inspections and tests to be done during production.
Sample size, frequency, method, document control dates/revision level, etc. Handling procedures for Electro-Static Discharge (ESD), RoHS compliant materials & other process conditions.
Brown = Revised
process adjustments are made per applicable work instructions to verify conformance at key points throughout the process and prior to shipment. Records required.
Typical Objective Evidence Records of inspections performed at incoming, first piece, in-process and/or final inspection or test. Capability study, material test, RoHS and other regulatory tests, etc.
of product is identified and maintained throughout the production process. Records required.
Batch records, travelers, tags, labels, product markings or use of designated & identified areas.
production lots or issues that affect product reliability. Documented procedures required. Records required.
process parameters are reviewed and statistically based controls and/or problem solving tools are used to control variation.
Histograms, run charts, SPC charts, pareto analysis, cause & effect diagrams, DOE, mistake proofing, documented reaction plan & process corrections.
Documented reaction plan & process corrections. SPC trend charts showing current status vs. goals. Improvement plan.
Brown = Revised
on charts and documented corrective action is taken to bring the process back into control. Documented procedures required. Records required.
and assemblies are segregated (where practical) and identified to prevent unapproved use. Documented procedures required. Records required.
Tags, marking, controlled staging areas, etc. Look for mixing of RoHS compliant & non-compliant materials.
(to the extent required by Emerson) to facilitate problem evaluation and corrective action. Documented procedures required. Records required.
Serial number records, lot number, date of manufacture, labeling and marking of containers or product, etc. Look for mixing of RoHS compliant & non-compliant materials.
to notify customers of nonconforming product that has already been shipped. Records required.
Brown = Revised
Reproducibility studies are conducted to verify suitability of measuring devices for their use in checking product quality or control of processes. Records required.
test equipment are routinely calibrated and controlled per documented procedures. Records required.
Gage calibration stickers, calibration records, positive identification or segregation of out-of-calibration devices, and inventory, location & status records, etc.
calibrated against standards traceable to a recognized regulatory body or agency. Records required.
the validity of previous measurements done on products where out-of-calibration measuring devices were used. Records required.
Brown = Revised
to verify the suitability and accuracy of computer software prior to initial use in checking product quality or control of processes. Software is re-verified when revised. Records required.
Typical Objective Evidence Verification methods and records, revision levels, distribution/use control, etc.
clearly defined area, with systematic tracking that provide traceability, particularly of customer-owned tools and equipment. Records required.
is followed. Product cannot be made with tools that are outside of maintenance period. Performance is audited
No equipment, tools, or fixtures are in use that are outside TPM schedule, or have unclear status
15.0 ENVIRONMENTAL
policy exists that includes a commitment to comply with relevant environmental legislation and regulations and to continual improvement and pollution prevention.
Brown = Revised
15.0 ENVIRONMENTAL
management system that ensures compliance to all applicable government regulations and there are no outstanding, unresolved violations of these regulations.
Typical Objective Evidence Records of agency/gov inspection or certification, doc'd procedures for measuring and monitoring environmentally sensitive activities w/ list of mtl's and areas where used, tracking of hazardous mtl's or waste.
the use, disposal and emissions of hazardous chemicals and to ensure that Class I ozone depleting chemicals are not used in the manufacturing process.
15.0 ENVIRONMENTAL
on using materials that are; compliant with applicable regulations like RoHS & WEEE, biodegradable, recyclable, reusable, reduces pollutant emissions at the point of use.
Records/use of; non-hazardous (RoHS/WEEE compliant) materials in production, biodegradable materials, returnable containers or packaging, recycling program, packaging materials made of recycled materials.
and orderly. Tools and equipment are properly stored and readily available for use. Lighting and air quality are adequate.
Observe production, office & product storage areas for use of 5S/6S principles (Sort, Set-inorder, Shine, Standardize, Sustain + Safety)
are used to prevent product damage or loss in all phases of the material handling process.
Observe handling and transit of raw material, work-in-process, and finished goods.
Brown = Revised
followed to ensure proper control and preservation of handling, storage (FIFO), packaging, and delivery of product.
Typical Objective Evidence FIFO practices are defined, packaging specifications, test results, handling and storage procedures.
reviewed and any concerns are communicated to the customer prior to initial production shipment. Packaging tests if required. Records required.
Technical review, packaging/shipping tests, packaging work instructions, carton strength tests
periodically inspected, and where applicable, actions are taken to prevent deterioration per documented procedures.
Doc'd list of shelf-life sensitive products/materials (e.g., sealants, adhesives, solder paste, paint/varnish, o'rings). Look for poor storage conditions & damage (e.g., rust or water damage). Handling procedures for Electro-Static Discharge (ESD) & other sensitive conditions.
developed that describe actions to be taken in the event of a major interruption of the manufacturing process.
Process covering utility interruptions, labor shortages, key equipment failures, major production issues.
Brown = Revised
documented and maintained that defines the requirements for material and process qualification, on-going compliance verification, manufacturing controls, declaration of compliance and records.
Typical Objective Evidence Documented procedures that set requirements for planning, verification, on-going control, record keeping & customer communications. Supplier's management support.
requirements for RoHS compliance are reviewed and communicated prior to production start-up.
each RoHS controlled hazardous substance. Test sampling plan is based on analysis of risk for each commodity and/or manufacturing process used.
Assessment of risk by part-type or manufacturing process used. Procedures, test methods, sampling plan, control plan.
Training & education records. Interview engineering, technical, quality control personnel. Number of qualified personnel is adequate to prevent unacceptable delays.
inspection criteria are documented and available where needed, e.g. solder fillet, tin whiskers..
Test methods/procedures, tin whisker analysis instructions, XRF work instructions, QC audits, etc. Ref to Jedec/IPC Joint publication JP-002.
Acceptance limits do not exceed RoHS limits. References to recognized standard test protocols, such as, ISO, IEC, EPA.
Brown = Revised
goods are periodically tested with appropriate equipment to confirm RoHS compliance. Compliance declarations and test records are maintained for a minimum of 5 years.
Typical Objective Evidence RoHS testing procedure, sampling plan/frequency, test records. Use of XRF analyzer, atomic absorption analyzer, UVVIS equipment, etc.. Qualified independent chemical lab w/A2LA accreditation or equivalent
handling methods are in place to prevent commingling or inappropriate use of both RoHS non-compliant and RoHS compliant items.
Documented procedures. Observation of handling / labeling techniques in use. Production operators are aware in distinguishing RoHS materials and processes versus non-RoHS. Look for mixing of RoHS compliant & non-compliant materials.
procedures in handling the screening, rework or refurbishing of finished goods returned from the field and customers.
Observation of handling / labeling techniques in use. Production operators are aware in distinguishing RoHS materials and processes versus non-RoHS. Documented procedures.
system is used to monitor the status of RoHS compliance and the declarations for each part number effected.
Database or other means is maintained to track RoHS compliance status by part number & declarations to customers.
documented and maintained that defines the requirements for REACH compliance and on-going verification.
Brown = Revised
Typical Objective Evidence Look for identification of an individual or individuals (i.e.., naming an entire department is not acceptable). Record the names and titles of the responsible individuals.
place to communicate safe handling information (such as a Material Safety Data Sheet) for any dangerous substances contained in or on it's products.
Database/files. Records of communication to customers of the Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS) in the EU which may include Exposure Scenario (ES) and/or Risk Management Measures (RMM).
Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req #
Emerson if they are providing (or will be providing) Emerson with products that contain Substances of Very High Concern (SVHC) that exceed 0.1% wt./wt.
If the official candidate list has been published by the ECHA (European Chemicals Agency), then look for records of communication to Emerson of the presence of SVHC, if applicable. Traceability of chemical identification.
Brown = Revised
TOTAL SCORES FOR THIS CHECKLIST ONLY Supplier Corrective & Preventive Action Plan Sum of Scores (excluding "n/a" & "Not Verified"): Maximum Total Score Available:
Top
Submitted by (name & title): Date Supplier CA-PA Plan Submitted: Reviewed by (EMR name & title): Date Supplier CA-PA Plan Reviewed:
Brown = Revised
1.1
1.2
1.0 QUALITY MANAGEMENT
Quality reports, trend charts and data analysis identify areas of opportunity and are used by management on a routine basis. Records required.
Product quality yield data, top problems and corresponding improvement actions, status of preventive/corrective actions taken, internal audit results
1.3
1.0 QUALITY MANAGEMENT
Quality performance targets are clearly defined, included in the business plan and monitored for improvements.
1.4
1.0 QUALITY MANAGEMENT
Executive management participates in periodic quality system reviews that address quality related feedback from customers and internal quality metrics. Records required.
Analysis of field failures, inspection yields, resource needs, internal audit results, corrective action status, etc.
2.1
2.0 CONTINUOUS IMPROVEMENT
Preventive actions are taken based on the analysis of significant business trends, design reviews, customer satisfaction surveys or other meaningful inputs. Documented procedures required. Records required.
Management review meetings, goal setting, performance measurement, internal audits, action plans, customer surveys
Brown = Revised
2.2
2.3
2.0 CONTINUOUS IMPROVEMENT
A corrective action system is in place that provides root cause analysis and takes timely and effective action to prevent recurrence. Documented procedures required. Records required.
Corrective action records, trend charts, meeting minutes, nonconformance frequency & cost analysis. Does CA system cover customer, internal & supplier issues?
3.1
The skill and education level required for each job is documented and appropriate training / re-training is provided. Records required.
Job descriptions, job skills assessment, training records, training manuals. Look for use of training aids & work instructions at work stations.
3.2
3.0 TRAINING & EDUCATION
Employee qualification / certification is maintained where the quality outcome of the process cannot be verified and is strongly dependent upon operator skill. Records required.
3.3
3.0 TRAINING & EDUCATION
Records of student testing, production quality records, audit records, interview workers to validate training records. Look for use of training aids & work instructions at work stations.
Brown = Revised
4.1
4.0 OCCUPATIONAL HEALTH & SAFETY
4.2
The Occupation Health & Safety (OHS) policy states the organizations health and safety objectives and management's commitment to continual improvement of OHS metrics.
Policies and procedures, health & safety trend charts, accident rate improvement history, etc.
4.3
Procedures are used for the ongoing identification of hazards, the assessment of risks, and the implementation of necessary control measures.
Safety committee or group meeting minutes, accident investigation reports, safety audit reports
5.1
5.0 DESIGN DEVELOPMENT & SUPPORT
Customer needs and requirements are incorporated into product designs and/or manufacturing processes. Criticalto-Quality (CTQ) characteristics are identified and understood. Records required.
Market studies, customer/enduser surveys, technical design reviews, mfg process capability studies, formal process qualification plan, manufacturing verification tests, pilot runs, etc.
5.2
Product specifications and drawings are generated, controlled and maintained for new or changed product designs. Records required.
Complete product characteristics, application requirements, and other information essential for its safe and proper use and eventual disposal, etc.
Brown = Revised
5.3
5.0 DESIGN DEVELOPMENT & SUPPORT
5.4
5.0 DESIGN DEVELOPMENT & SUPPORT
Human and technical resources are adequate to meet Emersons requirements for design collaboration, tooling design and electronic drawing and data exchange.
6.1
Production samples are inspected and provided to customers upon request. Records required.
6.2
Customer production requirements and quality specifications are reviewed to ensure they can be met on a consistent basis. Records required.
Procedures, design / process review minutes, FMEA's, mfg capacity plans, resource plans that address all product test, storage, packaging and shipment requirements
6.3
Reliability test plans are developed and routinely followed. Testing is used to verify design spec's, drive design improvements and provide an ongoing check of materials and workmanship. Documented procedures required. Records required.
Reliability test plans, test reports, improvement/corrective actions taken, design changes implemented
Brown = Revised
6.4
6.0 QUALITY PLANNING
7.1
7.0 DRAWINGS & SPECIFICATIONS
New and revised customer specifications are reviewed and implemented in a timely manner. Documented procedures required.
Technical review of methods to be used, capability studies on similar parts, documented review procedure, ie., APQP, PPAP.
7.2
7.0 DRAWINGS & SPECIFICATIONS
Current process control documents are in place and used for production start-up and continuing production. Documented procedures required.
Customer specifications, engineering drawings, change notices, work instructions and specifications as applicable.
7.3
7.0 DRAWINGS & SPECIFICATIONS
Customer notification / approval occurs for changes to Control Plans, manufacturing site, product transfers, raw material or product obsolescence. Records required.
Customer notification procedure on major changes & compliance to Jedec standards JESD 46 and JESD 48 (or equivalent, if app.). Signed material / process change requests. Customers are notified of RoHS compliance status change.
7.4
Quality records are maintained. A record control system is in place for the identification, storage, protection, retrieval, retention time, and disposition of quality records.
Brown = Revised
8.1
8.0 PROCUREMENT
8.0 PROCUREMENT
8.2
Purchases from unapproved suppliers are prevented by a properly controlled and available Approved Supplier List (ASL). Records required.
ASL, procedures for control and use of ASL, production material receipt records
8.3
8.0 PROCUREMENT
Preventive actions are taken to continuously improve performance of the supplier base. Records required.
Supplier quality performance analysis, performance trends, supplier audit reports, Inflation Model, documented goals regarding raw material cost containment
8.4
8.0 PROCUREMENT
A supplier quality assurance system ensures that all purchased product or material conforms to defined specifications and applicable regulatory or customer requirements. Records required.
Receiving inspection, supplier audits, source inspection, qualification testing, Certificate of Compliance (COC), component marking, labeling, etc.
8.5
8.0 PROCUREMENT
A system exists for the identification, verification and protection of customer supplied product that includes notifying the customer if product is damaged or lost. Records required.
Procedures, segregation during storage, limited and controlled access to stored inventories
9.1
9.0 INCOMING MATERIAL
Receiving inspection is performed per documented procedures and detailed work instructions. Records required.
Procedures, inspection instructions resources (manpower and equipment) allocated for incoming inspection
Brown = Revised
9.2
9.3
9.0 INCOMING MATERIAL
Supplier corrective action requests require root cause investigation and records show responses are analyzed. Documented procedures required. Records required.
Availability of written procedure, standardized Corrective Action form, analysis of corrective action cycle time and closure measurements
Qualification plan that includes established goals for process yields/up-time, etc. and record of process capability, review and approval, etc.
Process flow diagram, statistical tools to be used, key inspection points, inspection frequency, records, control responsibility, inspection/test method, gaging used, acceptable yield rates
available where needed that accurately describe all work methods including inspections and tests to be done during production.
Sample size, frequency, method, document control dates/revision level, etc. Handling procedures for Electro-Static Discharge (ESD), RoHS compliant materials & other process conditions.
Brown = Revised
process adjustments are made per applicable work instructions to verify conformance at key points throughout the process and prior to shipment. Records required.
Typical Objective Evidence Records of inspections performed at incoming, first piece, in-process and/or final inspection or test. Capability study, material test, RoHS and other regulatory tests, etc.
of product is identified and maintained throughout the production process. Records required.
Batch records, travelers, tags, labels, product markings or use of designated & identified areas.
production lots or issues that affect product reliability. Documented procedures required. Records required.
process parameters are reviewed and statistically based controls and/or problem solving tools are used to control variation.
Histograms, run charts, SPC charts, pareto analysis, cause & effect diagrams, DOE, mistake proofing, documented reaction plan & process corrections.
Documented reaction plan & process corrections. SPC trend charts showing current status vs. goals. Improvement plan.
Brown = Revised
on charts and documented corrective action is taken to bring the process back into control. Documented procedures required. Records required.
and assemblies are segregated (where practical) and identified to prevent unapproved use. Documented procedures required. Records required.
Tags, marking, controlled staging areas, etc. Look for mixing of RoHS compliant & non-compliant materials.
(to the extent required by Emerson) to facilitate problem evaluation and corrective action. Documented procedures required. Records required.
Serial number records, lot number, date of manufacture, labeling and marking of containers or product, etc. Look for mixing of RoHS compliant & non-compliant materials.
to notify customers of nonconforming product that has already been shipped. Records required.
Brown = Revised
Reproducibility studies are conducted to verify suitability of measuring devices for their use in checking product quality or control of processes. Records required.
test equipment are routinely calibrated and controlled per documented procedures. Records required.
Gage calibration stickers, calibration records, positive identification or segregation of out-of-calibration devices, and inventory, location & status records, etc.
calibrated against standards traceable to a recognized regulatory body or agency. Records required.
the validity of previous measurements done on products where out-of-calibration measuring devices were used. Records required.
Brown = Revised
to verify the suitability and accuracy of computer software prior to initial use in checking product quality or control of processes. Software is re-verified when revised. Records required.
Typical Objective Evidence Verification methods and records, revision levels, distribution/use control, etc.
clearly defined area, with systematic tracking that provide traceability, particularly of customer-owned tools and equipment. Records required.
is followed. Product cannot be made with tools that are outside of maintenance period. Performance is audited
No equipment, tools, or fixtures are in use that are outside TPM schedule, or have unclear status
15.0 ENVIRONMENTAL
policy exists that includes a commitment to comply with relevant environmental legislation and regulations and to continual improvement and pollution prevention.
Brown = Revised
15.0 ENVIRONMENTAL
management system that ensures compliance to all applicable government regulations and there are no outstanding, unresolved violations of these regulations.
Typical Objective Evidence Records of agency/gov inspection or certification, doc'd procedures for measuring and monitoring environmentally sensitive activities w/ list of mtl's and areas where used, tracking of hazardous mtl's or waste.
the use, disposal and emissions of hazardous chemicals and to ensure that Class I ozone depleting chemicals are not used in the manufacturing process.
15.0 ENVIRONMENTAL
on using materials that are; compliant with applicable regulations like RoHS & WEEE, biodegradable, recyclable, reusable, reduces pollutant emissions at the point of use.
Records/use of; non-hazardous (RoHS/WEEE compliant) materials in production, biodegradable materials, returnable containers or packaging, recycling program, packaging materials made of recycled materials.
and orderly. Tools and equipment are properly stored and readily available for use. Lighting and air quality are adequate.
Observe production, office & product storage areas for use of 5S/6S principles (Sort, Set-inorder, Shine, Standardize, Sustain + Safety)
are used to prevent product damage or loss in all phases of the material handling process.
Observe handling and transit of raw material, work-in-process, and finished goods.
Brown = Revised
followed to ensure proper control and preservation of handling, storage (FIFO), packaging, and delivery of product.
Typical Objective Evidence FIFO practices are defined, packaging specifications, test results, handling and storage procedures.
reviewed and any concerns are communicated to the customer prior to initial production shipment. Packaging tests if required. Records required.
Technical review, packaging/shipping tests, packaging work instructions, carton strength tests
periodically inspected, and where applicable, actions are taken to prevent deterioration per documented procedures.
Doc'd list of shelf-life sensitive products/materials (e.g., sealants, adhesives, solder paste, paint/varnish, o'rings). Look for poor storage conditions & damage (e.g., rust or water damage). Handling procedures for Electro-Static Discharge (ESD) & other sensitive conditions.
developed that describe actions to be taken in the event of a major interruption of the manufacturing process.
Process covering utility interruptions, labor shortages, key equipment failures, major production issues.
Brown = Revised
documented and maintained that defines the requirements for material and process qualification, on-going compliance verification, manufacturing controls, declaration of compliance and records.
Typical Objective Evidence Documented procedures that set requirements for planning, verification, on-going control, record keeping & customer communications. Supplier's management support.
requirements for RoHS compliance are reviewed and communicated prior to production start-up.
each RoHS controlled hazardous substance. Test sampling plan is based on analysis of risk for each commodity and/or manufacturing process used.
Assessment of risk by part-type or manufacturing process used. Procedures, test methods, sampling plan, control plan.
Training & education records. Interview engineering, technical, quality control personnel. Number of qualified personnel is adequate to prevent unacceptable delays.
inspection criteria are documented and available where needed, e.g. solder fillet, tin whiskers..
Test methods/procedures, tin whisker analysis instructions, XRF work instructions, QC audits, etc. Ref to Jedec/IPC Joint publication JP-002.
Acceptance limits do not exceed RoHS limits. References to recognized standard test protocols, such as, ISO, IEC, EPA.
Brown = Revised
goods are periodically tested with appropriate equipment to confirm RoHS compliance. Compliance declarations and test records are maintained for a minimum of 5 years.
Typical Objective Evidence RoHS testing procedure, sampling plan/frequency, test records. Use of XRF analyzer, atomic absorption analyzer, UVVIS equipment, etc.. Qualified independent chemical lab w/A2LA accreditation or equivalent
handling methods are in place to prevent commingling or inappropriate use of both RoHS non-compliant and RoHS compliant items.
Documented procedures. Observation of handling / labeling techniques in use. Production operators are aware in distinguishing RoHS materials and processes versus non-RoHS. Look for mixing of RoHS compliant & non-compliant materials.
procedures in handling the screening, rework or refurbishing of finished goods returned from the field and customers.
Observation of handling / labeling techniques in use. Production operators are aware in distinguishing RoHS materials and processes versus non-RoHS. Documented procedures.
system is used to monitor the status of RoHS compliance and the declarations for each part number effected.
Database or other means is maintained to track RoHS compliance status by part number & declarations to customers.
documented and maintained that defines the requirements for REACH compliance and on-going verification.
Brown = Revised
Typical Objective Evidence Look for identification of an individual or individuals (i.e.., naming an entire department is not acceptable). Record the names and titles of the responsible individuals.
place to communicate safe handling information (such as a Material Safety Data Sheet) for any dangerous substances contained in or on it's products.
Database/files. Records of communication to customers of the Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS) in the EU which may include Exposure Scenario (ES) and/or Risk Management Measures (RMM).
Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req # Req #
Emerson if they are providing (or will be providing) Emerson with products that contain Substances of Very High Concern (SVHC) that exceed 0.1% wt./wt.
If the official candidate list has been published by the ECHA (European Chemicals Agency), then look for records of communication to Emerson of the presence of SVHC, if applicable. Traceability of chemical identification.
Brown = Revised
TOTAL SCORES FOR THIS CHECKLIST ONLY Supplier Corrective & Preventive Action Plan Sum of Scores (excluding "n/a" & "Not Verified"): Date Supplier CA-PA Plan Submitted: Maximum Total Score Available: Standard Checklist Score: Reviewed by (EMR name & title): Date Supplier CA-PA Plan Reviewed: Dates:
Top
Section Scores Total Req'mnts 4 Mandatory Req'ments (M) M 1 Req. No. 1.1 1.2 1.3 1.4 2.1 2.2 2.3 3.1 3.2 3.3 4.1 4.2 4.3 5.1 5.2 5.3 5.4 6.1 6.2 6.3 6.4 7.1 7.2 7.3 7.4 8.1 8.2 8.3 8.4 8.5 9.1 9.2 9.3
Supplier SelfAudit SCORE On-Site Audit SCORE After CAPA Verif. SCORE
2.0
Continuous Improvement
M M M
3.0
4.0
0 M
5.0
1 M M
6.0
Quality Planning
9.0
Incoming Material
10.0
Manufacturing Quality
Section Scores Total Req'mnts 4 6 Mandatory Req'ments (M) M M 1 3 M Req. No. 10.1 10.2 10.3 10.4 10.5 10.6 11.1 11.2 11.3 11.4 12.1 12.2 12.3 12.4 12.5 13.1 13.2 13.3 13.4 13.5 14.1 14.2 14.3 15.1 15.2 15.3 15.4 16.1 16.2 16.3 16.4 16.5 16.6
Supplier SelfAudit SCORE On-Site Audit SCORE After CAPA Verif. SCORE
14.0
Preventive Maintenance
15.0
Environmental
0 M
16.0
M M
Section Scores Total Req'mnts 4 Mandatory Req'ments (M) 1 Req. No. 17.1 17.2 17.3 17.4 17.0 Restriction of Hazardous Substances (RoHS) 10 0 17.5 17.6 17.7 17.8 17.9 17.10 18.1 18.2 18.0 REACH Compliance 5 0 18.3 18.4 18.5
Number of Requirements Possible (including RoHS): Number of Requirements Audited: 81 0 27 0 Supplier SelfAudit SCORE On-Site Audit SCORE After CAPA Verif. SCORE
0% 0%
0% 0%
0% 0%
Revisions (shown in brown text): Added REACH Compliance section 18.0 and updated formulas.
Complete an On-Site Audit before making Audit Team Recommendation, then upload to ESAC database. Do NOT upload to ESAC database unless On-Site Audit was completed.
Date:
(mm/dd/yy)
Final Disposition
Final Disposition (FD):
Name & Title: FD Auditor Comments: (Required if FD does not meet guideline) Supplier Evaluation Record Only (No On-Site Audit was completed): Emerson Proprietary 96251836.xls.ms_office
Verify supplier's CAPA & re-score affected Requirements before making Final Disposition, then upload to ESAC database. Do NOT upload to ESAC database unless On-Site Audit was completed.
Date:
(mm/dd/yy)
Check (x) if Final Disposition was based on Supplier Profile, Self-Audit & review of objective evidence only. This SelfAudit file should be maintained by the Division or SCO. Do NOT upload to the ESAC database.