iapmo r&t registration servicesisoicmd.iapmo.org/docs/audit/audit_25155_genera hq report... ·...
TRANSCRIPT
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORT
Table of Contents
Section 1 Facility Information
Section 2 Client Information Update
Section 3 Audit Schedule
Section 4 Conflict of Interest
Section 5 Audit Planning Matrix
Section 6 Entry Meeting Checklist
Section 7 Opening/Closing Meeting Attendance
Section 8 Objective Evidence
Section 9 Exit Meeting Checklist
Section 10 Audit Summary
Section 11 NCR and OFI Summary
Section 12 NCR and OFI Summary by Process
Section 13 3-year audit plan
Section 14 Interview log
Disclaimer
This is a confidential report and is subject to the confidentiality agreement between the client and IAPMO R&T as documented in IAPMO R&T Policy. The contents of this report may be disclosed only in its entirety by authorized persons or personnel.
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 1 of 18
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORT
1. Facility Information
Audit Number ISO-09-20545Organization Name Genera Corporation
Number of Employees 13
Company Contact (title, phone and email)
Jackson [email protected]
Type of audit Stage 2 Surveillance 1 Surveillance 2 Re-Cert
Other (please explain)Audit Standard ISO 9001:2015 ISO 14001:2015 OHSAS 18001:2007
Other (list here)Address (included all locations if there are multiple
2800 Saturn Street, Brea, CA 92821 (Headquarters)
Any permanent or temporary locations? (i.e. construction site, customer site, etc.
N/A
IAF Code 29
Scope of certification Overall Scope (HQ): Wholesale Distribution of Automotive Parts/ Mostly Lighting in Conformance with Customer Specific Requirements.Scope of Branch Warehouses: Warehousing of Automotive Parts in Conformance with Customer Specific Requirements
List any previous NCR’s from previous audits, verify that they have been implemented and closed. Attach the signed NCR from previous audit.
N/A
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 2 of 18
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORT
2. Client Information Update
Client SummaryThe headcount of the organization is and changed significantly since last audit. (has or has not)If the number of employees has changes signifigantly, contact the office to determine if the auit time needs to be adjusted.The number of shifts worked by the organization is and changed since the last audit. (has or has not)
If shifts have been added, contact the office to determine if the audit time needs to be adjusted.The registration scope of the management system ( continues to be appropriate) ( requires change due to the following factors)
If scope has changed, contact the office to determine if the audit time needs to be adjusted. Not applicable no adjustments necessary.
Based on the information above, the audit time has been adjust ed by days.ISO elements, determined to be not applicable, continue to be justified or have been changed from the last audit?
Not applicable ISO elements Justified?
8.3 Design and Development Yes No
Yes No
Yes No
Yes No
Have the organizations processes or documented information changed significantly? Yes No
If yes please explain.
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 3 of 18
13 Has not
0
1 Has not
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORT
3. Audit Schedule
The Audit Team will require interviewing key personnel in managing activities and others performing the activities associated with your quality management system. Please review the Audit Schedule to determine if the affected personnel will be available during the times indicated.
The Audit Team will also require a private "meeting" room that can serve as our "base" of operating during the assessment. It would also be very helpful if arrangements could be made to have box lunches available as we will need the time during the lunch break for Audit Team discussion.
For any concern relevant to the this Audit Schedule, or if you have any questions concerning the assessment, please contact the Lead Auditor at [email protected] or 1-877-4-MY-ISO-1.
Day # 1 Audit Date: June 21st, 2017Time Lead Auditor Auditor 1 Auditor 2
8:30 AM Auditor Arrival
8:35 AM Opening Meeting/Facility Tour
8:50 AM – 10:50 AM
Quality Management System/Management
-
10:50 AM – 12:30 PM
Sales
12:30 PM – 1:00 PM
Lunch
1:00 PM –3:30 PM
Leadership/Management
3:30 PM5:30 PM
Audit Trail Follow-upAuditor Time/Daily wrap up Meeting/ Auditor Departure
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 4 of 18
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORTDay # 2 Audit Date: June 22nd, 2017
Time Lead Auditor Auditor 1 Auditor 2
7:00 AM Auditor Arrival
7:05 AM9:00 AM
Inventory/Purchasing
9:00 AM –10:00 AM
Product Integration -
10:00 AM-11:00AM
Auditor Time/Closing Meeting/ Auditor Departure
Note: Auditor Arrival time is estimated. Times can be adjusted while auditor is on-site.
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 5 of 18
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORT
4. Conflict of Interest
In the past 24 months, have you received any gifts, benefits, loans, or compensation from the company being audited? Yes No
If yes please provide details.
Do you have any business or personal relationships with the company being audited? Yes No
If yes please provide details.
In the past 24 months, have you been employed by a company or have you provided any consulting services to the company being audited? Yes No
If yes please provide details.
Do you or does any member of your immediate family have any financial interest or employed by the company be audited? Yes No
If yes, please provide details.
All the above information has been gone over with the client and both the lead auditor and the client representative agree with the above information.
Lead auditor Name Client Name Date
Jeff Rangel Genera Corp 6/21/2017
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 6 of 18
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORT
5. Audit Planning Matrix
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 7 of 18
Stage 2 Audit Planning Matrix (reference 4.4.1 above)ISO Sect. QMS Processes
ManagementOrder
Review and Planning
Purchasing Production
4.1 X4.2 X4.3 X4.4 X5.1 X5.2 X5.3 X6.1 X6.2 X6.3 X7.1 X7.2 X7.3 X7.4 X7.5 X8.1 X X X X8.2 X X8.3 Excluded Excluded Excluded Excluded8.4 X X8.5 X8.6 X X8.7 X X9.1 X X X X9.2 X9.3 X10.1 X10.2 X10.3 X
Mgmt. process is to be audited during all audits
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORT
6. Entry Meeting Checklist
1) Introduce members of the audit team
2) Introduce observers
3) Review scope and objectives of the audit
4) Short summary of methods & procedures to be used, including;
5) Non-conformances: Defined major, minor and OFI’s. A series of related minors can be combined to form a Major. NCR’s found in the previous assessment that have not been acted upon or still open due to inaction will be considered a Major Nonconformance. State the organization’s responsibility to respond to NCR’s in the time frame agreed upon between the organization and the lead auditor.
6) Establish official communication links between auditor and auditee
7) Confirm resources and facilities are available to audit team
8) Discuss confidentiality issue
9) Identify need for safety or personal protection requirements
10)Confirm time and date for closing meeting
11)Verify understanding of the audit plan
12)Verify all document review deficiencies corrected, internal auditcycle and management review completed
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 8 of 18
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORT
7. Opening/Closing Meeting Attendance
Name Title Open Close
Jeff Rangel Auditor
Annie Wong Product Integration VP
Jackson Kwok President/COO
Zak Tay Director of Product
Sun Hong Product Manager
Cora Shiu Manager
Peter Lai Sr. Manager
Vince Wu IT
Daniel Brucic CC Supervisor
Vi Ngo Accounting
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 9 of 18
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORT
8. Objective Evidence
Assessment of Leadership1) Have you determined external and internal
issues relevant to the organization?Interested parties are documented in quality manual. Rev 6/20/17
2) Do any of these issues potentially affect the organization’s ability to achieve intended results?
Use of SWOT documents and Hoshin Plan
3) Who are the interested parties? Customers, employees, owners4) Where have the requirements for these
parties been identified?Quality Manual
5) Where has the scope of the QMS been documented?
Quality manual page 4
6) Where are the QMS processes identified? Process Turtle Maps in quality manual7) How is the effectiveness of the QMS
determined?Results of audits, process performance in relation to objectives.
8) How does the organization utilize the risk based thinking approach?
When speaking with top management risk based thinking is involved with every process. Quality manual and Hoshin Report. Company SWOT document.
9) How does the organization get employees involved in both risk based thinking and continual improvement?
Bi-Weekly meetings, monthly top management meetings, quarterly national meetings.
10) How was the quality policy created? Top management11) How is the quality policy communicated? Posted throughout facility and on company
intranet12) How are the organizational roles,
responsibilities and authorities defined and communicated?
Job descriptions and organizational chart
13) Has an internal audit been completed? Yes, between dates of 5/3/17 and 5/11/1714) Has a management review been
completed?Yes, 6/13/2017
15) Have there been any recent continual improvement activities?
Training for employees by outside agencies, conferences.
16) Have there been any recent corrective actions?
Yes results from internal audits
17) Is the organization using the IAPMO and/or ANAB/KAN marks? If so, verify that it is used in accordance with documented procedure.
No marks are being used at this time
18) Any recent customer complaints? Yes, tracked in data base. Currently meeting customer satisfaction objectives.
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 10 of 18
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORT
Assessment of: Management
Referencing the Audit Plan Matrix, make sure to verify all applicable ISO 9001:2015 requirements.
Process inputs: ISO Requirements, customer requirements, regulatory requirements, interested parties requirements. These are all used to document, implement our QMS. Other inputs: company goals, customer goals, customer complaints, etc.
Process outputs: measurable quality objectives and data, CAR’s, customer feedback, minutes from mgmt. review meetings, documented information (procedure, records) , interested parties
Objective evidence to verify control: Quality Manual Rev 062017
When interviewing management and leadership it is evident they are very committed to the company, workplace and employees.Leadership takes accountability for the QMS.
Top Management stated that improvements projects are devolved from risk-based thinking, process risk analysis (their process chart). Found from internal audits, corrective actions internally and from customers and from management review.
Corrective and preventative actions are kept on secured company network and all employees at all sites have access to the Oracle system that is where records are kept. Reviewed Corrective actions 053117-01 dated 5/31/17 closed on 6/19/17, and verified during audit.
Meetings are held bi-weekly with top management and leadership of the departments. Minutes are documented for these meetings. Reviewed meeting held 5/15/17 and 6/12/17. As well as every quarter for national meetings.
The support and infrastructure at the company is very good. Facility is clean, new, and moral and environment is healthy and held very high by top management.
Management review was conducted on 6/13/17 and all ISO requirements were addressed and fulfill standard requirements. Input is from all sites not just headquarters. It is held at least annually.
Internal audit was reviewed and conducted between the dates of 5/3/17 and 5/11/17. Auditor training on file, there were two minor non-conformances 05917 and 051217. Reviewed both and verified closure.
Quality policy is in the manual as well as employees have access to it on the company intranet and cards with the policy are given out. All employees interviewed were familiar with the policy.
Doc control is covered by IT Dept. Interviewed and secured network backed up per S2.2 backups done daily.QF 133 doc control log, QSI 113, QF 132, QF 109 dated and signed 6/20/19. All doc change request are signed dated and released.
HR and job training records are held at headquarters. Reviewed job descriptions for warehouse worker, warehouse manager.Reviewed training records for sales department, IT and Inventory/Purchasing.QFC-119, QFC-114 QSI-132Process measurement: Results of audits, customer retention, management review minutes
Process determined to be effective? Yes No
Based on samples reviewed process found to be effective
Non-conformances, Observations, and Opportunity of Improvements:NC #1 10.2.1 When a non-conformity occurs, including any arising from complaints, the organization shall; evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere by; reviewing and analysis the nonconformity, determining the causes of the nonconformity.
CA#051217-01 does not display understanding of determining the causes of the nonconformity
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 11 of 18
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORTAssessment of: Inventory/Purchasing
Referencing the Audit Plan Matrix, make sure to verify all applicable ISO 9001:2015 requirements.
Process inputs: customer requirements, computer, PO, phone, email, supplier survey, inventory reports
Process outputs: Tracking numbers, order acknowledgements, Completed PO, Approved vendors, C of C.
Objective evidence to verify control: Suppliers are evaluated at least annually; the evaluation criteria is defined and strictly adhered to/ monitored; the criteria included on-time-delivery, cost, quality, new products support and service maintained on form QF-102. Reviewed Suppliers: I-Yuan and TYC. Both are below the evaluation level of 85%, reviewed corrective action submitted by genera and action plans submitted by the supplier for both suppliers below the level.
Suppliers in Orcale system are approved suppliers. PID approves the suppliers and was able to show process for qualification.Suppliers are evaluated at least annually; the evaluation criteria is defined and strictly adhered to/ monitored; the criteria included on-time-delivery, cost, quality, new products support and service maintained on form QF-102
Genera placed two types of purchase orders – manual and automated through Oracle ERP; the purchases are made based on current inventory level, monthly forecast, current back orders, current POs in place and lead time etc; reviewed inventory level for preceding 6 months that aids in developing forecast for various product lines; purchase orders are typically placed on Tuesdays of each week; reviewed by more than one pair of eyes; reviewed and sampled the following purchase orders31702410 to Anton dated 6/21/17 signed and dated by supplier, hard copy kept in binder with original issued to supplier.
Weekly meetings are held to provide updates and all applicable information necessary. End of delivery reports are used to track. Verified team’s awareness of quality policy, objectives/ targets, quality management system processes/ procedures, personnel training/ competence and process/ operational controls - found to be satisfactory; reviewed the implementation effectiveness of key processes/ procedures required by the standard including document and record control, internal audit, control of non-conforming product, corrective and preventive action etc and found to be effectively managed;
Reviewed purchase orders:31702108 to Anton 5/23/1731701804 Anton 5/2/173170213 TYC 6/12/17
Process measurement: Fill Rate above 90% currently YTD tracking is 91%.
Process determined to be effective? Yes No
Based on samples reviewed process is found to be effective
Non-conformances, Observations, and Opportunity of Improvements:None
Assessment of: Sales
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 12 of 18
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORTReferencing the Audit Plan Matrix, make sure to verify all applicable ISO 9001:2015 requirements.
Process inputs: ERP system, computer, customer requirements, RFQ, phone, email
Process outputs: Order acknowledgement, sales order, travelers
Objective evidence to verify control:Reviewed the process of sales order processing that entails forwarding of sales orders (PO from customer) to call center via email; dispatch of order confirmation from call center to customer; order is released to warehouse for packing and shipping; the customer satisfaction/ surveys are handled by call center or corporate; Genera has an iStore (online order system) wherein their customers have access to place online orders that is integrated with their Oracle ERP.Reviewed the process of sales order processing that entails forwarding of sales orders (PO from customer) to call center via email; dispatch of order confirmation from call center to customer; order is released to warehouse for packing and shipping; the customer satisfaction/ surveys are handled by call center or corporate; Genera has an iStore (online order system) wherein their customers have access to place online orders that is integrated with their Oracle ERP system;
Customer complaints are handled by supervisor and if necessary escalated to PID/Management. They are tracked on a customer complaint log on Excel.Specific customer requirements are all uploaded to their file on oracle, (shipping type, etc).
Once an order is received and it is reviewed for accuracy (currently orders are enter at a rate of 100% accuracy) an order acknowledgement goes out as a PDF reviewed these for all of the orders I reviewed via the main style of order. iStore, phone and email.#111700552 for EDI 1/18/17 (email)#517002753 1/11/17 (iStore)#111700546 3/1/17 (phone)#11700746 5/1/17 (fax)All orders were signed, dated, released to the closest warehouse for order fulfillment. Reviewed the automatic order acknowledgements.Verified the quality policy and QMS procedures awareness; personnel training, quality objectives and process controls - found to be satisfactory; checked implementation effectiveness of documented procedures required by this standard such as document and record control, control of non-conforming product, internal audit, corrective and preventive action and found to be effective.
The use of the company intranet is highly used to communicate within all departments. All employees interviewed were able to pull up work instructions and or procedures.
QF-130QF-131QF-127QF-110Process measurement: Number of Visit to customers per year 360 currently YTD is 151 currently on pace to achieve. New customers 10 so far this year currently 8, achieve goal.
Process determined to be effective? Yes No
Based on samples reviewed process found to be effective.
Non-conformances, Observations, and Opportunity of Improvements:None
Assessment of: Product Integration
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 13 of 18
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORTReferencing the Audit Plan Matrix, make sure to verify all applicable ISO 9001:2015 requirements.
Process inputs: New market research, OEM Samples
Process outputs: Completed traveler, validation reports and results.
Objective evidence to verify control: Interviewed different staff members in this department. New product development starts with automobile companies releasing new models of vehicles. Once that one comes out the PID team researches the products and purchases the items. Sent to a supplier to recreate the product. Once recreation is done it is sent back to the PID team to validate the products. Reviewed various process controls such as graphic design needs for ads, brochures, company catalogs bi-annual, uses Photoshop, In Design, and Illustrator program to obtain special effects, such as, lighting effects, close-ups, flyers; pricing is also performed where information is obtained from Product Managers using the PP Form; PP Form Check List, Product Specialist issues the PP form to calculate how many items to bring in, check pricing with competitive pricing, correct descriptions, e-catalog, and coordinate and AAPEX (Automotive Expo) Trade shows.. The “Quality Planning Checklist, PP Form.
Reviewed various process controls such as graphic design needs for ads, brochures, company catalogs bi-annual, uses photoshop, In Design, and Illustrator program to obtain special effects, such as, lighting effects, close-ups, flyers; pricing is also performed where information is obtained from Product Managers using the PP Form; PP Form Check List, Product Specialist issues the PP form to calculate how many items to bring in, check pricing with competitive pricing, correct descriptions, e-catalog, and coordinate and AAPEX (Automotive Expo) Trade shows.. The “Quality Planning Checklist, PP Form., and the ISIR
Weekly updates and meetings are performed. Reviewed complaints that were escalated to PID team Case #241776 and 241782.
Reviewed all checklists, market research, forms and process for the following part/product numbers:3170229631702365ISIR 11-653573800-9ISIR 20-9787-00-9
All forms were signed, completed, dated and released to the next process.
QFC-101 Quality Control ProcessQFC-126 New Item Pre-ProductionQFC-127 New Product Development ProcessQF-144 PP Form Checklist
Process measurement: Achievement Rate 95% currently 98.5%
Process determined to be effective? Yes No
Based on samples reviewed process is found to be effective
Non-conformances, Observations, and Opportunity of Improvements:None
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 14 of 18
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORT
9. Exit meeting checklist
1) Restate purpose and scope of audit (initiate with positives)
2) State non-conformances/observations in order of significance 3) Present conclusions concerning quality system effectiveness
4) Discuss need for submittal of corrective actions
5) Establish response time for corrective actions
6) Verify understanding and agreement if recommended
7) Restate confidentiality of all information gathered
8) Ask if there are any questions or any feedback from the organization
9) Discuss appeals process
10)Note copy of audit report will be submitted as soon as possible, preferably with two weeks of this audit.
11) Schedule the next audit
Next audit date
Next audit type Surveillance 1 Surveillance 2 Re-cert
12)Thank you and good bye
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 15 of 18
June 2018
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORT10.Audit Summary
NCRs found None Major: Minor: 1 Observation:
NOTE: For any NCR’s issued during the audit a separate NCR form (form 008) shall be issued, separate from this audit report. Page 1 of the NCR form shall be completed and signed by both the Lead auditor and the client.
List all observations on the NCR/OFI summary below
Follow up required? None
Yes, please identify the follow up plan.
NOTE: for major nonconformities, a re-visit may be required to verify and close the NCR. Major NCR’s need to be verified and closed within 60-days.
Registration Assessment (for stage two audits and re-assessment audits)
I recommend the issuance of a certificate of registration
I recommend the issuance of a certificate of registration upon receipt of satisfactory corrective action plans
I do not recommend the issuance of a certificate of registration and a re-audit is required
Surveillance audit
I recommend continuance of registration
I recommend that the certificate of registration be suspended, reduced, extended or withdrawn.
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 16 of 18
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORT11. NCR/OFI Summary
(For NCR’s identify the NCR # and brief description. For OFI identify the OFI # and a brief description)NCR/OFI # DescriptionNCR#1 Weak review and analysis of the non-conformity. (root cause analysis)
12.NCR and OFI Summary by Process
13.3-year audit plan
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 17 of 18
QMS Processes{Management
} Inventory/Purchasing Sales Product Integration
Initial 2015 audit
NC#1
Surveillance 1
Surveillance 2
RecertificationNOTE: list OFI-(#) for opportunities and NCR-(#) for NCR’s
Example; if there is an opportunity for the management process then identify OFI (1)Example; if there is 3 nonconformities for the management process then identify NCR (3)
QMS Processes{Management
} Inventory/Purchasing Sales Product Integration
Surveillance 1 P P P
Surveillance 2 P P
Recertification P P P P
IAPMO R&T REGISTRATION SERVICES5001 E. Philadelphia St, Ontario, CA 91761
AUDIT REPORT
14. Interview Log
ISO FORM 009 Issued: 3/30/00 Revised: 03/07/2016 Page 18 of 18
{Management} Inventory/Purchasing Sales Product Integration
Auditee Jackson Kwok Peter Lai Brandon Le Zak Tay
Auditee Annie Wong Cora Shiu Steve Annie
Wong
Auditee
Auditee
Auditee
Auditee
Auditee
Auditee
Auditee
Auditee
Auditee
Auditee