Report No: SARA-CA Assessment Type: Re-Certification & Upgrade. Assessment Dates: 09/19/ /21/2016. Page 1

Transcription

1 Lead Auditor: Thomas Morris Company Name: Kokusai Soko America, Inc. Address: 1521 Francisco Street, Unit A Torrance, CA Phone: Fax: jerry@kskla.com Management Rep: Jerry Aguirre Standard: ISO 9001:2015 Checklist used: Form , Rev. B Certificate No: SARA-2007-CA-0064-A Expiration Date: November 27, 2016 Additional Location Addresses (If applicable): None Page 1

2 Table of Contents Assessment Report A. Assessment Summary B. Conclusions C. Observations and Opportunity for Continuous Improvement D. Nonconformities E. Effectiveness of Internal Auditing & System F. Certification Details G. The Company s Documentation H. Scope of the Assessment Visit I. Information for Company Audit Report Opening Meeting Attendance Closing Meeting Attendance People Interviewed List J. Evidences (For Lead Auditor to complete) APPENDIX 1 - Assessment Conclusions of Nonconformities APPENDIX 2 - Assessment Schedule APPENDIX 3 - Three (3) Year Surveillance Schedule The audit criteria; The audit objectives; Page 2

3 A. ASSESSMENT SUMMARY (Conformance Notes) (conformance and assessment notes are in the checklist) Re-Certification(3 years) (As per assessment schedule. Stage 1 may be required) The effectiveness of the management system in its entirety in the light of internal and external changes, and its continued relevance and applicability to the scope of certification, Demonstrated commitment to maintain the effectiveness and improvement of the management system in order to enhance overall performance, & whether the operation of the certified management system contributes to the achievement of the organization's policy and objectives. Activities covered during this assessment: The audit scope, particularly identification of the organizational or functional units or processes audited and the time of the audit; (refer Audit Plan) Any deviation from the audit plan and their reasons (refer Audit Plan); N/A Any significant issues impacting on the audit program; (refer Audit Plan) N/A Significant changes, if any, that affect the management system of the client since the last audit took place; (refer activity form) - N/A Any unresolved issues, if identified; (refer this report, activity form, NCR) N/A Where applicable, whether the audit is combined, joint or integrated; (report) N/A A disclaimer statement indicating that auditing is based on a sampling process of the available information; (report) The audited client is effectively controlling the use of the certification documents and marks, if applicable; (refer report/process notes) Verification of effectiveness of taken corrective actions regarding previously identified nonconformities, if applicable. (Refer NCR Form) Risk Based Approach Assessment (refer report/process notes) Use of Process Approach (refer report/process notes) Vigilance, Recall, Advisory and Medical Device Regulations (ISO only) - (N/A) EMS Regulation, Non-Compliance issue by related authority, (ISO 14001) - (N/A) Evaluated the implementation, including effectiveness, of the client's management system, Information and evidence about conformity to all requirements of the applicable management system standard or other normative document, Performance monitoring, measuring, reporting and reviewing against key performance objectives and targets (consistent with the expectations in the applicable management system standard or other normative document), The client's management system and performance as regards legal compliance, Operational control of the client's processes, Internal auditing and management review, Management responsibility for the client's policies, Links between the normative requirements, policy, performance objectives and targets, Consistent with the expectations in the applicable management system standard or other normative document), any applicable legal requirements, responsibilities, competence of personnel, operations, procedures, performance data and internal audit findings and conclusions. Page 3

4 B. CONCLUSIONS (select correct option): Audit team has reviewed: Examined and verified the structure, policies, processes, procedures, records and related documents of the client organization relevant to the management system, Determined that these meet all the requirements relevant to the intended scope of certification, Determined that the processes and procedures are established, implemented and maintained effectively, to provide a basis for confidence in the client's management system, Communicated to the client, for its action, any inconsistencies between the client's policy, objectives and targets (consistent with the expectations in the relevant management system standard or other normative document) and the results. A statement on the conformity and the effectiveness of the management system together with a summary of the evidence relating to: 1. Management system meet applicable requirements and expected outcomes; 2. internal audit and management review process; 3. conclusion on the appropriateness of the certification scope; 4. confirmation that the audit objectives have been fulfilled. Notes: 1. For major non-conformities, re-assessment and verification of effective implementation evidence is required for before recommendations. 2. Failure to effectively implement any correction actions identified by SARA could result in a Major nonconformity being raised at the next assessment. C. OBSERVATIONS and OPPORTUNITIY FOR FUTURE IMPROVEMENT (List all): Feedback from Surveillance II audit: The master calibration schedule list MTE#, description, MFG/Model number, MFG. serial# and calibration frequency. Few observations comments for system improvements are described below: 1. Consider adding CAL Date and DUE Date to the master calibration schedule or other type of document. (The CAL Date and DUE Date are documented on the service provided documents and on the measurement equipment) Page 4

5 2. Consider documenting verification requirements. (Has not been address.) Found the analysis of data to be appropriate to demonstrate the suitability and effectiveness to the company s quality system. The company performed analytical statistical methods from damage reports, customer surveys, customer complaint, supplier quality & not on-time delivery, internal corrective action system, customer corrective action system, customer negative feedback, complaint to vendor system, and discrepancy reports using bar graphs of statistical quality control method. The design and development of the infrastructure and work environment was well plan. The infrastructure and environment for the operation of process (location and position of the racks) is well established and maintained for easy access and safety for the warehouse personnel operating the forklift. In an isolate area of the warehouse, a protected/lock cage was design and developed per an interested party request was verified and validated by the interested party. The warehouse personnel abilities; knowledge and skills are at a high level of competence. D. NONCONFORMITIES: 1. This Audit Yes (See attached Nonconformance Reports and list nonconformance report numbers here) No 2. Previous Audit Non-Conformities Closure Status, if any: None E. Statement on the Conformity and Effectiveness: (Conformance records on the checklist.) 1. Management system meet applicable requirements and expected outcomes; 2. internal audit and management review process; 3. conclusion on the appropriateness of the certification scope; 4. Confirmation that the audit objectives have been fulfilled. Statement: This is a three years assessment re-certification from the re-certification audit in 2013 and certification upgrade to ISO 9001:2015. The audit evidence found from the company s quality management system has been established and documented to the ISO 9001:2015 requirements. This audit was also considered the performance of the management system over the period of certification, and includes the review of last 3-years surveillance audit reports (from 2013 Page 5

6 through 2015) and 3-year NCRs trend analysis. The result of this review has found it was acceptable and in compliance with ISO 9001:2008. The company s customer complaints were verified during each audit. No negative trends were identified last cycle as far as complaints, quality, and regulatory issues are concerned. Areas covered during the audit were context of the organization, leadership, planning, support, operation, performance evaluation, and improvement. Areas covered during the audit found to be conformed to the company s policy, objectives, procedures and customer requirements. The management review process for the certification upgrade (ISO 9001:2015) has been performed. The management review was conducted on 09/12/2016. The company management reviews and assesses the quality management system regarding its suitability, adequacy, effectiveness and opportunities for improvement. Evaluation of the need for change of the quality management system, including the quality policy and objectives, are part of the review process. The management review process is well established, documented, implemented and maintained. The outside lead auditor performed the audit process on 08/16/2016 per the company quality management system requirements and ISO 9001:2015 standard. Personal interviews and records show the internal audit process is effectively implemented. F. Certification Details Registration Scope Areas not applicable to scope International freight forwarding, Physical movement of customer owned merchandise and documentation service for export to overseas. None G. THE COMPANY S DOCUMENTATION (Not a requirement for ISO 9001:2015 only) Page 6

7 H. SCOPE OF THIS ASSESSMENT VISIT 1. Company Scope (See Certification Detail): Same as Registration 2. Activities Assessed (schedule): Assessment Plan and Schedule, Form Assessment Method: The assessment was based on random samples and therefore nonconformities may exist which have not been identified. 4. Distribution: If you wish to distribute copies of this report external to the organization, all pages must be included. SARA Registrar Lead Auditor Name: Thomas Morris Lead Auditor Title: Lead Auditor Kokusai Soko America, Inc. Representative Name: Jerry Aguirre Representative Title: Assistant General Manager Date: 09/21/2016 Date: 09/21/2016 I. Information to Company 1. Audit Report 2. Opening Meeting Attendance 3. Closing Meeting Attendance 4. People Interviewed List J. EVIDENCES (to be completed by Lead Auditor) 1. Opening Meeting Agenda (on-site) 2. Opening Meeting Attendance (on-site) 3. Employee Interviewed (on-site) 4. Closing Meeting Agenda (on-site) 5. Closing Meeting Attendance (on-site) 6. Activity Form (on-site) 7. Audit Package Checklist (after audit) 8. Assessment Checklist/notes (on-site) 9. Non-conformity Report, if any (on-site) 10. Assignment Sheet for Auditor (before audit) Page 7

8 APPENDIX 1- Assessment Conclusions of Nonconformities Assessment Conclusions of Nonconformities Major Minor Total: 0 0 Non-conformities information are written in Non-Conformity Report APPENDIX 2 Assessment Schedule Audit Schedule (please attach to report before sending to SARA office) Assessment Report Rev. B Form Approval: DCR # , Standards American Registrations Authority Registrar Inc. Page 8

9 APPENDIX 3- Three (3) Year Surveillance PROCESS/FUNCTION/ACTIVITIES/AREA AND RELATED CLAUSES SURVEILLANCE ASSESSMENT 1 st year 2 nd year 3 rd year Re-certification Context of the Organization 4.1, 4.2, 4.3, 4.4 X X X Leadership 5.1, 5.2, 5.3 X X X Planning 6.1, 6.2, 6.3 X X X Support Resources 7.1.1, 7.1.2, 7.1.3, 7.1.4, 7.1.5, X X Competence, Awareness, and Communication 7.2, 7.3, 7.4 X X Documented Information 7.5.1, 7.5.2, X X Operation Operation planning and control 8.1 X X Requirements for Services 8.2.1, 8.2.2, 8.2.3, X X Design and Development of Services 8.3.1, 8.3.2, 8.3.3, 8.3.4, 8.3.5, X X Control of Externally Provided Processes, Products and Services 8.4.1, 8.4.2, X X Services Provision 8.5.1, 8.5.2, 8.5.3, 8.5.4, 8.5.5, 8.5.6, 8.6, 8.7 X X Performance evaluation Monitoring, Measurement, Analysis and Evaluation 9.1.1, 9.1.2, X X X Internal Audit & Management Review 9.2, 9.3 X X X Improvement 10.1, 10.2, 10.3 X X X Use of the Registration Mark and Certificate reference X X X Note: The 3-year Surveillance schedules are defined for auditor and customer convenience. The 3-year plan or specific schedule for specific audit can be changed at any time during the assessment day for auditor and customer convenience. Assessment Report Rev. B Form Approval: DCR # , Standards American Registrations Authority Registrar Inc. Page 9