ISO 9001 Or AS9100 STAGE-1 Readiness Evaluation Data

ISO 9001 Or AS9100 STAGE-1 Readiness Evaluation Data

February 2, 2016

Rich Ashton

FARO Logistics Solutions

7070 Pontius Rd

Groveport, OH 43125

Project Number: 4035-Q-2505

The Stage-1 audit for FARO Logistics is scheduled for March 11, 2016. The duration of the Stage-1 audit will be 1-audit day/8hrs and will include a formal document and readiness review. The require additional 1-audit day/8hrs will be allocated between Groveport, OH (6hrs) & Jacksonville, FL (2hrs) on April 7th & April 8th 2016.

WE will update the Comprehensive Requirements Workbook form in during the March 11, 2016 audit.

This Stage-1 audit will be performed to:

  • Conduct a review of your management system documentation.
  • Evaluate the site-specific conditions and undertake discussions to determine the preparedness for the Stage-2 audit.
  • Review the status and overall understanding regarding requirements of the standard, in particular the identification of key performance or significant aspects, processes, objectives and operations of the management system.
  • Collect necessary information regarding the scope of the management system, processes and location(s) of your organization, and related statutory, regulatory aspects and compliance, e.g. quality, environmental, legal aspects of the operation, associated risks, etc.
  • Review the allocation of resources for Stage-2 and agree on the detail of the Stage-2 audit.
  • Provide a focus for planning the Stage-2 audit by gaining a sufficient understanding of the management system, site operations in the context of possible significant aspects of the management system.
  • Evaluate if the internal audits (i.e., QMS processes, manufacturing processes and applicable products) and management review have been completed, are being planned and performed effectively and that the level of implementation of the management system substantiates that your organization is ready for the Stage-2 audit.
  • Confirm the information provided by the organization used in application review (See #9 or #10 of Stage 1 report below)
  • For ISO/TS 16949 to verify that both you and design subcontractors have appropriate capability to meet ISO/TS clause 7.3 requirements in its totality, including interfaces between client and subcontractors.

To prepare for this assessment, please review the audit plan and associated information contained on the following page. This information will be the basis of this assessment and must be completed satisfactorily in order to proceed to Stage 2.

Please notify me if there are any specific safety/PPE requirements necessary to perform assessments in your facility or any other specific requirements. (EX. Specialized ID Requirements, Cell Phone requirements, etc.)

I plan to arrive at your facility at approximately _7:30______a.m./p.m. If you have any questions, please contact me at 330-388-2875. I look forward to working with you.

Sincerely,

John Cook

Lead Auditor

Smithers Quality Assessments, Inc. | 121 S Main Street – Suite 300 | Akron, Ohio 44308 | 330.762.4231 |

SQA-90 (Stage-1 Report) Revision: 1/11/2016 Page 1 of 15

Smithers Quality Assessments, Inc. – Confidential – ISO 9001:2008 w/o design

Client: FARO Logistics Solutions Project No: 4035-Q-2505Date: March 11, 2016

Site: Groveport, OH Stage 1SQA Auditor: John Cook


OPENING & CLOSING MEETING ATTENDEES

Name (please print clearly)OpeningClosingTitle

John Cook X X SQA Lead Auditor

OPENING MEETING AGENDA

 Introduce SQA Team including any other participants (e.g. AB, OP assessors, Authorities) - names, purpose and roles (e.g. Lead Auditor - including the lead auditor as the formal communication channel between the audit team and the auditee), Auditor and/or observer). Explain that an observer cannot influence or interfere in the audit process or outcome of the audit.

 Pass around Attendance Sheet.

 Ask for Introduction of Client Team.

 Describe standard/criteria; type of assessment (e.g. Stage 1, Stage 2, Surveillance, or Recertification); confirm scope of certification (i.e., the scope statement), review processes, number of shifts and pattern, organizational structure and current number of employees. Are there any off-site buildings? (If yes, record on the top of the matrix at the end of this report. Must be included in certain audits).

 Ask the client if there any outstanding issues related to their management system. If “no,” proceed with audit. If “yes,” note the issues.

 Explain objective (to assess continuing suitability and effectiveness of the supplier’s approved management system, compliance to the standard and continual improvement (ISO9001:2008) and maintaining effectiveness (ISO 13485:2003). These audits are an ongoing process – not a pass/fail exercise).

 Explain process for conducting audit including keeping the auditee informed of the audit progress, certification process (i.e. interviews, taking notes, reviewing records, objective evidence, clearance of non-conformances, verifying continuing system implementation and effectiveness). Please note, that an audit is based on a sample, and therefore is an element of uncertainty in the process. Consequently, processes could have other nonconformities. In addition, as an auditor you cannot consult, teach or offer solutions in any way! (CQAM-102)

 Explain nonconformities and findings (Major, Minor, OFI). No concerns. (Note: several minors in one requirement could equal a Major n/c). Major requires certificate suspension.

 Confirm the status of non-conformities from the previous review or audit.

 Review schedule (participants, required and selected elements). Ask if there are any required changes. If so, note in audit report or revise plan. Explain that the audit team leader and audit team shall be in control of executing the plan including audit activities and audit trails.

 Note: Surveillances are in 6 or 12 month cycles keyed to the last date of the Stage 2 or re-certification assessment.

 Daily wrap-up meetings: purpose is to discuss issues, no “surprises.”

 Review SQA confidentiality policy (auditors, exec. board, accreditation bodies).

 Review office accommodations, private work area with phone (will need to be in contact with the SQA office and other clients).

 SQA Policy requires that a guide accompany us at all times. Explain that the guide cannot influence or interfere in the audit process or outcome of the audit.

 Ask about safety policies, emergency and any special human resource considerations (i.e. unions, etc.)

 Reconfirm if there are any access restrictions for security reasons.

 Describe expectations of consultant if one is present (if applicable). NOTE: Per ISO/TS 16949 Rules a consultant may not be on-site during the assessment.

 Have there been any material changes at the company which have not been reported to SQA yet (ref Form SQA-51)?

 Conflict resolution steps: a) work with lead auditor/auditor; b) joint phone call between client, lead auditor/auditor and SQA Director of Operations; c) joint phone call between (b) plus SQA VP; d) formal complaint; e) appeal.

 Confirmation of language to be used during this audit activity.

 Conditions under which the audit may be terminated: Excessive number of nonconformities; a major nonconformity, unavailability of key personnel; previously unannounced material condition changes, e.g., sale of the organization or significant changes to labor relations or number of employees.

 Review ANAB Heads Up #61 & #178 (see SQA website for additional information)

 QMS Summary

Heads Up #61- Outputs Matter!- QMS

The consistent application of criteria in auditing an organization’s QMS with regard to achieving customer satisfaction, delivering conforming product, and continually improving the QMS is imperative. This is especially important to the continued reliance of the customer supply chain and other interested parties on the added value of the third-party certification system. To achieve the intended purposes of ISO 9001:2008, certified organizations must be held accountable. Outputs do matter!

Heads Up #178 (IAF/ISO Joint Communique - Expected Outcomes)

Expected Outcomes for Accredited Certification to ISO 9001 (from the perspective of the organization’s customers) “For the defined certification scope, an organization with a certified quality management system consistently provides products that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction.”

Heads Up #61- Outputs Matter!-EMS

Criteria and guidance for the certification process emphasize the need for the CB to consider an organization’s compliance with legal and other requirements and its environmental performance as factors essential to demonstrating that an EMS is effectively implemented.

Heads Up #178 (IAF/ISO Joint Communique - Expected Outcomes)

For the defined certification scope, an organization with a certified environmental management system is managing its interactions with the environment and is demonstrating its commitment to:

A.Preventing pollution.

B.Meet applicable legal and other requirements.

C.Continually enhancing its environmental management system in order to achieve improvements in its overall environmental performance.”

 Request a copy of the aspects/impacts to have on file at the SQA office (Recertification Only)

 Ask client if they have any additional questions

Auditor Signature Date

CLOSING MEETING AGENDA

 Pass around Attendance Sheet for closing sign-in.

 Have the management representative acknowledge receipt of the non-conformances (if any), recommendation and report with their signature on the bottom of the attendance sheet.

 Thank client for hospitality.

 Disclaimer (don’t read, just explain): This assessment was based on a sample only. Consequently, processes could have other nonconformities. The client must utilize the management system (especially their internal audit process) to maintain vigilance and assure the continued suitability, effectiveness and improvements of the system.

 Let the customer know, or remind the customer, that the level of integration, which affects the number of audit days, is subject to adjustment at future audits.

 Explain expectation to notify SQA if there are material changes at the organization.

 Positive comments regarding company.

 Summarize and re-emphasize highlights.

 Discuss any audit team activities taking place after the audit (e.g. submittal of audit report)

 Invite comments or questions from both sides; document unresolved issues.

 Ask client to comment on technical aspects of report, correct spelling errors, names, etc. Emphasize the client’s required adherence to SQA Agreement for Services (Client is responsible to control the SQA AFS).

 Remind client that they must maintain SQA-78, Comprehensive Requirements Workbook sections for the documented management system and processes and notify SQA if there are any material changes to the organization.

 Are there additional or remote sites affiliated with this one, which may need certification?

 Complaints and Appeals: To submit complaints, go to our website, click Problem resolution, fill out a Complaint form and submit. To process appeals, clients require submitting formal documentation to SQA Executive Certification Panel (ECP).

 Schedule next assessment.

 Review ANAB Heads Up #61 & #178 (see SQA website for additional information)

 QMS Summary

Heads Up #61- Outputs Matter!- QMS

The consistent application of criteria in auditing an organization’s QMS with regard to achieving customer satisfaction, delivering conforming product, and continually improving the QMS is imperative. This is especially important to the continued reliance of the customer supply chain and other interested parties on the added value of the third-party certification system. To achieve the intended purposes of ISO 9001:2008, certified organizations must be held accountable. Outputs do matter!

Heads Up #178 (IAF/ISO Joint Communique - Expected Outcomes)

Expected Outcomes for Accredited Certification to ISO 9001 (from the perspective of the organization’s customers) “For the defined certification scope, an organization with a certified quality management system consistently provides products that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction.”

Heads Up #61- Outputs Matter!- EMS

Criteria and guidance for the certification process emphasize the need for the CB to consider an organization’s compliance with legal and other requirements and its environmental performance as factors essential to demonstrating that an EMS is effectively implemented.

Heads Up #178 (IAF/ISO Joint Communique - Expected Outcomes)

For the defined certification scope, an organization with a certified environmental management system is managing its interactions with the environment and is demonstrating its commitment to:

A.Preventing pollution.

B.Meet applicable legal and other requirements.

C.Continually enhancing its environmental management system in order to achieve improvements in its overall environmental performance.”

 Request a copy of the aspects/impacts to have on file at the SQA office (Recertification Only)

 Ask client if they have any additional questions

Auditor Signature Date

CONFIDENTIAL

Stage 1

ASSESSMENT REPORT

Dates of Assessment:

March 11, 2016

for

FARO Logistics Solutions

7070 Pontius Rd

Groveport, OH 43125

Prepared by:

John Cook

Smithers Quality Assessments, Inc.

121 S. Main Street – Suite 300

Akron, Ohio 44308

Project No: 4035-Q-2505

ISO 9001:2008 w/o design

Note: This report is the property of Smithers Quality Assessments, Inc. (SQA). Parties are permitted to examine the contents only with the approval of the assessed client.

Smithers Quality Assessments, Inc. | 121 S Main Street – Suite 300 | Akron, Ohio 44308 | 330.762.4231 |

SQA-90 (Stage-1 Report) Revision: 1/11/2016 Page 1 of 15

ISO 9001 Stage 1 Readiness Evaluation Data

Company Name & Site: FARO Logistics SolutionsProject Number: 4035-Q-2505Date of Stage 1: March 11, 2106

Audit Time / Information To Be Assessed
During the Stage 1 Audit / Provide/List Details Below / Details of elements and clauses that need further development, findings that would be considered nonconformities if observed during the Stage-2 assessment / SQA Evaluation
Approved by
Lead Auditor
(Each Row)
725 am / Auditor arrive and Set up
730 am / Opening Meeting
800 am / (1) Conduct document review using Comprehensive Workbook as the tool. Ensure CRW processes match sequence and interaction of processes in manual.
Use SQA-146 Level of Integration form & SQA-07 Integrated Audit Additional Quote Worksheet for integrated audits to assess degree of integration. / SQA78 was completed and reviewed with updates.
The Quality Manual (ADM-000) (2) (2/25/16) was reviewed.
Reviewed BP procedures all current.
Process interaction diagram was reviewed (PG 25 & 26) / Further Development
Not Needed
APPROVED
800 am / (2) Clause 5.3 Quality Policy (Review the quality policy statement and verify it meets the standard)
( Check each as it applies) / ADM-000 (2) (2/25/16)
- quality policy – PAGE-10
FARO. CI program utilizes the requirements of 8.5.1 - quality policy, objectives, audits, management review, corrective and preventive action, and analysis of data – for all locations / Further Development
Not Needed
APPROVED
 / is appropriate to the purpose of the organization
 / includes a commitment to comply with the requirements and continually improve the effectiveness of the quality management system
 / is communicated and understood within the organization / Posted/banner/audits/meetings/training
900 am / (3) Key indicators/objectives (i.e., PPM, delivery, etc.): Metrics for all sites / To obtain ISO certification in 2015
Quality Objectives:
Primary – All Sites
- Customer Complaints
- Charge Backs
- On Time % - based on customer requirements
Secondary – Groveport, OH site
- Labor to Revenuer Ratio
- Total Head Count
- Total Man Hours
Business Process Matrix
Customer Satisfaction (feedback) – all sites
Audit Results (internal – all sites & external – just at Groveport, OH) / Further Development
Not Needed
APPROVED
10 am / (4) Internal audit process and results (one FULL system PROCESS-based audit).
( Check each as it applies) / (BP-13) (2/25/16)
At least once per calendar year. (S. Sabo & Internal Trained Auditors)
2016 audit schedule planned & scheduled for the new sites is scheduled for March 2016
Reviewed the process requirements.
All Audits WILL BE completed B4 the stage-2 assessment) / Further Development
Not Needed
APPROVED
 / Are audits planned based on status and importance of processes and areas to be audited?
 / Is audit frequency adjusted for previous CARs internal or SQA, management review discussion, process performance (metrics), customer issues?
 / Is the audit criteria, scope, frequency and methods defined in the procedure?
 / Does auditor selection ensure objectivity and impartiality (cannot audit own work)?
 / Procedure define who is responsible for planning and conducting audits, establishing the records and reporting the results?
 / Has management responsible for the area audited taken timely corrective action to respond to the issues identified during the internal audit (CARs)?
 / Verify internal auditor competency / All audits completed by Steve Sabo at IQS & Rich Ashton who was trained by QIS. (information was reviewed to verify auditor competency / Further Development
Not Needed
APPROVED
11 am / (5) Management review process and results. (Management review meeting must FOLLOW the FULL system process-based audit.)
( Check each as it applies) / (BP-16) (2/1/15)
MRM are completed at least annually at a minimum.
The 1st management review meeting at FARO was completed and on August 21, 2015. This meeting was reviewed by SQA for effectiveness & suitability on August 28, 2015. The 2nd management review will be completed on April 1, 2016. / Further Development
Not Needed
APPROVED
 / Was this information reviewed during the management review meetings?
 / results of audits?
 / customer feedback (and complaints),
 / process performance and product conformance (to requirements),
 / status of preventive actions, corrective actions
 / changes that could affect the quality management system
 / recommendations for improvements?
 / any needed changes to the quality management system
 / any needed changes to the quality policy and quality objectives
 / determination of (levels of) suitability, adequacy and effectiveness of the system?
 / Do the outputs from management review meetings include those decisions and actions related to:
-improving the effectiveness of the quality management system and its processes,
-improvement of product related to customer requirements, and
-resource needs.
1230 pm / (6) Corrective Actions / (BP-12 & 14 & 15) (2/1/15)
Customer satisfaction process based on complaints, returns, customer feedback.
Corrective Actions are issued per the basis of complaints, quality, audits, and suppliers.
No Actions identified
Own report or customer supplied report (OS&D)
Product segregated & identified.
Each site has input to corrective action process with Groveport, OH over seeing each actions item. ISO records are part of the inter active network with each site owning their own folder..
Action Log (ADM-008) / Further Development
Not Needed
APPROVED
 / Reviewing nonconformities (including customer complaints)?
 / Determining causes of nonconformities?
 / Evaluating the need for action to make sure nonconformities do not recur?
 / Determine and implement action needed?
 / Record the results of actions taken?
 / Review the effectiveness of the corrective action taken?
130 pm / (7) Customer complaint/satisfaction process and results: / See evidence in section (6) Action Log (ADM-008)
130 pm / (8) Process for addressing continual improvement:
130 pm / (9) Additional observations, e.g., from shop floor tour, etc. / Further Development
Not Needed
APPROVED
130 pm / (10) Review scope of the audit – number of employees, number of operating shifts, remote sites, support locations, outsourced processes, and justified exclusions
* If product design responsible there must be evidence of a fully implemented design that uses the defined process, otherwise scope cannot include Design. / Scope= Provides customized logistics for industrial, commercial and consumer customers
number of employees= Total number of employees for all sites = 275
number of operating shifts= 2-SFT 8hrs each
remote sites= N/A
support locations=
Groveport, OH 80 & 5 that support each site
Columbus, OH = 40
Dallas, TX = 45
Jacksonville, FL = 10
Santa Fa Springs & Norwalk, CA = 80
outsourced processes= N/A
justified exclusions= 7.3 Design
design responsible= N/A / Further Development
Not Needed
APPROVED
130 pm / (11) Review RFQ (SQA-07), PIC Sheet (SQA-27), Opportunity Assessment, and potential threats to impartiality. Identify any significant differences review with client and document in details column. / Complexity= LOW
Justification if different from Quote: Complexity the same
Quoted Stage 2 days= 6-days total
Groveport, OH = 1-day
Jacksonville, FL = 1.5-days
Santa Fe Springs & Norwalk, CA = 3.5-days
Recommended Stage 2 days= 6.5-days total adding 1-day from stage-1 days & decreasing ½-day from Jacksonville, FL
Justification for change (MD-5): Increased Groveport, OH from 1-day to 1.75-days & Jacksonville, FL to 1.25-days due to adding stage 1 day to stage-2 days Jacksonville, FL decreased from 1.5-days to 1-day due to decrease in employees. / Further Development
Not Needed
APPROVED
130 pm / (12) Number of audit-days required for Stage-2:_6.5-days______
Document any changes (increases or decreases) to the number of audit-days quoted, including justification for same (See Note 1 & 2 below) / 6.5-days total adding 1-day from stage-1 days & decreasing ½-day from Jacksonville, FL
Justification for change (MD-5): Increased Groveport, OH from 1-day to 1.75-days & Jacksonville, FL to 1.25-days due to adding stage 1 day to stage-2 days Jacksonville, FL decreased from 1.5-days to 1-day due to decrease in employees. / Further Development
Not Needed
APPROVED
(13) All items identified in the Stage-1 audit agenda were reviewed and found acceptable. / Further Development
Not Needed
APPROVED
330 pm / Closing Meeting
4 pm / Depart
(13) FINAL AUDITOR APPROVAL TO PROCEED TO STAGE-2 AUDIT: / STAGE 2 AUDIT DATES:
April 7, 2016 = Jacksonville, FL
April 8, 2016 = Groveport, OH (2-auditors)
April 10, 2016 – April 12, 2016 = Santa Fe Springs & Norwalk, CA / Lead Auditor: John Cook
Date: March 11, 2016

Note 1: Based on what is learned throughout the Stage-1 assessment, determine the number of audit-days required for Stage-2. This may be an increase or decrease from the audit-days quoted. It is up to the judgment of the auditor, and may only be determined after Stage-1 is complete. If there is an increase, be sure the client agrees; document the reasons for the increase in the Stage-1 report. Must justify per MD-5. If there is a decrease, the auditor must first gain approval of SQA management and then document in the Stage-1 report the justification for the reduction in audit-days.