Attachment 2 W911N220R0025.pdf
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- W911N2-20-R-0025
About this file
This document is an audit report for an ISO 9001:2015 certification assessment conducted at Letterkenny Army Depot. The assessment identified 7 minor nonconformities related to quality control processes, shipping of nonconforming products, equipment calibration documentation, and management review inputs. Based on the nonconformities noted, registration was recommended subject to closing out the identified issues. The report also included observations regarding equipment calibration and control of nonconforming product procedures. The organization was required to address all nonconformities and provide corrective actions to the auditor within 30 days.
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Government and Military Certification Systems, Inc.
GMCS-AR-01 QMS 1200 G Street NW, Suite 800 Rev 12;10/2018 Washington, DC 20005
(202) 351-6837 Phone
AUDIT REPORT
CLIENT INFORMATION
Organization Name: Letterkenny Army Depot (LEAD) Audit Standard: ISO 9001:2015
Address: 1 Overcash Avenue City, State, Zip: Chambersburg, PA 17201 Phone: ( IAF Code(s):
17, 19, 22, 31, 35, 36 Email:
Contact Name: No. of FTE, PTE, and
Contractors: 2,192 Number of Shifts: 3
Stage 1 Audit * Complete the following for the initial Audit ONLY unless otherwise directed by GMCS.
“X” here for Surveillance and Recertification audits and skip to Stage 2
Stage 1 Auditor: # Days on site: # Days off site: Date:
Completed Documentation Review Attached? Yes No Follow-up Stage 1 Audit required? Yes No
Review ofSite Specific Conditions For Readiness For Stage 2
Overall is the organization Ready for the Stage 2 Audit Yes No Management Review and Internal Audit process deemed ready for the Stage 2 audit? Yes No Are there adequate resources available for the Stage 2 Audit? Yes No Has Audit Plan/Schedule Been Provided For Stage 2 during Stage 1? Yes No
Stage 1 Audit Conclusion:
Acceptable: Ready for Stage 2 Unacceptable: Not Ready – Follow-up Stage 1 Required
Auditors Signature:
You may Type your name in lieu of signing
Date:
Describe When Unacceptable Describe unacceptable concerns on Page #5
Follow-up document review required? Yes No
Stage 2, Recertification, or Surveillance Audit Final Audit Results Lead Auditor: Esmat Doss Auditor Grade:
Lead Auditor # Days on site: 4 Total # Audit Days: 4 On-Site Dates: April 8-11, Auditor(s):
NA
Auditor Grade:
Technical Expert (if used):
Language of Audit:
English
Other:
Type of Visit: Initial Registration Follow-up
Special Audit Surveillance Re-assessments
Type and Number of Non-conformities
0 Major Nonconformities (Does not conform) 7 Minor Nonconformities (Conforms with Conditions) 4 OBS, OFI, AOC (Conforms)
Rev 12;10/2018 Washington, DC 20005
(202) 351-6837 Phone
Audit Team Conclusion
The Audited Organization confirms: (check boxes)
Recommends Does not recommend
That Quality System Registration be:
Granted (Initial Certification Only) Continued (Surveillance Audits Only) Extended (Recertification Audits Only)
Signed by Lead Auditor: Esmat Doss Date: April 11, 2019
Client information is correct:
Audit details indicated above are correct All non-conformances have been fully explained Management commits to correcting non-conformances
Client:
Position: Quality Assurance Specialist Date: April 11, 2019
NOTE: ALLMINOR CORRECTIVE ACTION PLANS AND CLAUSE ANALYSIS MUST BE APPROVED PRIOR TO AWARD OF THE CERTIFICATE!
ALLMAJOR CORRECTIVE ACTIONS MUST BE CLOSED & VERIFIED PRIOR TO AWARD OF THE CERTIFICATE!
Rev 12;10/2018 Washington, DC 20005
(202) 351-6837 Phone
OPENING AND CLOSING MEETING CHECKLIST
Auditors are instructed to use the Opening Meeting and Closing Meeting Agendas to ensure that all required topics have been covered and completed.
SUMMARY OF ASSESSMENT
A 4-day site assessment was carried out at the Letterkenny Army Depot (LEAD) premises. The Audit
Schedule presented to the organization's management was followed and/or modified during the course of the assessment in order to accommodate the physical layout of the facility and the various locations and schedules of key activities.
Throughout the remainder of the assessment, the examination of objective audit evidence along with the interviewing of personnel provided the GMCS auditor(s) with the objective evidence required to come to a conclusion on the overall recommendation stated herein.
NONCONFORMANCE’S NOTED DURING THE ASSESSMENT (place number of NC’s in space below; in none place N/A)
0 MAJOR nonconformity(s) noted during the assessment. ISO 9001Clause Number(s): NA
7 MINOR nonconformity(s) noted during the assessment. ISO 9001Clause Number(s): 10.2, 9.1.3, 7.1.5, 9.3.2
ASSESSMENT CONCLUSION
During the Closing Meeting, all assessment findings, observations and opportunities for improvement were discussed to ensure that they were fully understood and agreed to by the organization's management and representatives. Based on the nonconformances noted above the organization was then informed that registration/continued registration as an organization of assessed quality would be recommended.
1. OPENING MEETING
The Letterkenny Army Depot (LEAD) representatives attended the Opening Meeting held in the conference room, as listed on the Attendance Sheet appended to this Report. The purpose, scope and procedure for the assessment was discussed and explained by the Lead Auditor. The Opening Meeting Checklist was used as the basis for this meeting. All present were invited to attend the daily debriefing and/or Closing Meeting with all other relevant personnel. During the Opening Meeting, the scope of the assessment was confirmed as
Rev 12;10/2018 Washington, DC 20005 well as the organization name that appears or will appear on the Certificate of Conformance. After the formal
Opening Meeting, the organization’s Management System was assessed for conformance with documented procedures as well as the requirements of ISO 9001:2015.
2. ASSESSMENT
Familiarization with the Letterkenny Army Depot (LEAD) premises was undertaken via a brief physical tour.
The working practices of the Organization were assessed for conformance with documented procedures and the requirements of the management system using the previously prepared Assessment Checklist.
Objective evidence, in the form of interviews, records, materials, and working documents were examined for conformance, and personnel were questioned to ascertain their knowledge and understanding of the quality principles and procedures pertinent to their positions. Other functions assessed were found to conform with documented procedures and the requirements of the applicable management system standard. During the auditor’s private preparation time at the end of the assessment, it was concluded that all pertinent elements of the applicable Management System Standard had been addressed by the Audit Team.
NONCONFORMANCE’S, OBSERVATIONS & OPPORTUNITIES FOR IMPROVEMENT IDENTIFIED
Stage 1 Notes, Comments Here If Applicable (NOTE: Items to follow-up on during Stage 2 must also be placed here)
Stage 1 Notes and Follow-up for Stage 2: NA
List Nonconformities If Applicable CAR's Issued: Yes No (If No skip this block)
Nonconformities (Note: Use GMCS provided NC numbers):
NC # 1 (Minor) – Re. Machining QC, there are four (4) repeatable nonconformities that are holding the same defective code number were found. It is an indication that taken corrective action was not effective.
NC # 2 (Minor) - Re. mechanical repairs workshop, it was found that the component of part # 11481763-1 and serial number 014003 was passing all inspection and testing points as per WI-1148763-3M and the presented checklist dated 11.20.2018. The component was shipped to the client on Feb. 11th 2019. The component was returned back from the client due to bare metal on platform rotation gear. Shipping of default product can affect the degree of customer satisfaction.
NCR # 3 (Minor) – Re. welding workshop, there is no evidence presented to proof that welding machines are calibrated by accredited company.
NCR # 4 (Minor) – Re. welding workshop, the dates that are written on some of the calibration stickers are not written correctly by day/month/year. Calibration date: 10.18, due date: 10.19. Accordingly, these stickers can be used forever (date of calibration is not adequately traceable).
Rev 12;10/2018 Washington, DC 20005
NCR # 05 (Minor) - Re. Painting Area (370/5P700), report number 317065 for air/gas source is issued on
10.30.2017 by TRI Testing, Inc. which is accredited by AIHA. The report is not holding a validity date or the frequency of testing (date of next reporting is not adequately identifiable).
NCR # 06 (Minor) - Re. Painting Area (370/5P700), the instruction states that the filter of the gage MAGNEHELIC should be changed when the gage reading reaches 0.45. The presented log sheet shows that the instruction is adequately followed. There is no evidence presented to proof the calibration of the gage to ensure the effectiveness of gage readings.
NCR # 7 (Minor) – Re. Management Review Meeting that conducted on November 05th 2018, the management review inputs is missing the following points:
- Changes in external and internal issues that are relevant to the QMS.
- Performance of external providers.
- The adequacy of resources.
List Observations, Improvement Opportunities and Strengths
Observations, Opportunities for Improvement, Areas of Concern (Conforms):
Observations:
OBS # 01 – As per the audit plan that sent to Letterkenny Army Depot (LEAD), TMDE has to be audited to verify and review records of calibration. It was found that TMDE is not part or under the control of the Letterkenny Army Depot (LEAD). However, by tracking most measuring equipment and devices of LEAD, it was found that the majority of these equipment and devices are calibrated by TMDE. In the event that TMDE is not capable of calibrating any of the measuring equipment and devices, the TMDE and or the Letterkenny Army Depot (LEAD) can contract accredited labs to perform the calibration services. Based on the above information, the following points can be recorded:
• There are many accredited labs are contracted to perform the specific calibrations as the US Army Primary Standards Laboratory, located at Redstone Arsenal, AL (accredited by A2LA, accreditation certificate is valid till April 30th 2019), Hexagon Metrology, Inc. (accredited by ANAB/ANSI, accreditation certificate is valid till October 11th 2019) and ACUCAL, Inc. accredited by A2LA, accreditation certificate is valid till April 30th 2019).
• The majority of the LEAD equipment and devices are calibrated by TMDE based on the issuance of stickers (not certificates of calibration. Accordingly, no accredited calibration certificates were provided during the audit regarding these equipment and devices (meeting with Michael Christian, the TDME Equipment Calibration Leader).
• This issue has to be discussed between LEAD Management and GCMS Management.
OBS # 02 – Re. Control of Nonconforming Product, QSP5 R 04, consider revising the procedure to cover the dealing with consequences as required by clause 10.2.1.a.2 of the ISO 9001:2015.
Opportunities for Improvement:
Rev 12;10/2018 Washington, DC 20005
OFI # 01 – Re. Painting Area (370/5P700), consider identifying quality risks as delay time to achieve the target and human errors and assess them as the developed one for safety risks and environmental risks.
OFI # 02 – Re. QSP 24 (Risk and Opportunity Manual), It is highly recommended to provide employees with a specialized training regarding risk management planning, risk identification, risk assessment, risk response planning and risk monitoring and mitigation.
3. CLOSING MEETING
The findings of the assessment were presented to Letterkenny Army Depot (LEAD) representatives during the Closing Meeting held in the conference room of the facility. The Closing Meeting Checklist was used as the basis for this meeting. All conformances and nonconformances, as well as, classification of nonconformances were fully discussed and agreed to by all parties prior to the auditor(s) leaving the facility.
If Corrective Action Requests (CARs) were identified, they were discussed to ensure that they were fully understood and original copies were left with the Management Representative. The method of report distribution, use of registration marks and notification of registration and/or maintenance of registration by
GMCS were explained during the Closing Meeting. All GMCS Corrective Action Requests must be sent to the
Lead Auditor within 30 days of the last day of the onsite audit.
4. FOLLOW UP
The organization should be prepared to provide a written response with a corrective action plan to address any non-nonconformances identified during the course of the audit. The organization is to fully address any and all CAR's, prior to the next scheduled audit activity at which time the assigned assessor will follow-up and verify the effectiveness of corrective actions undertaken. Original copies of CAR's should be completed and retained by the organization for this purpose. Major nonconformities may require a return visit to close out the identified nonconformities. Assuming that Letterkenny Army Depot (LEAD) intends to maintain ISO 9001 certification, all corrective action requests must be provided to GMCS on or before May 11, 2019.
Rev 12;10/2018 Washington, DC 20005
Finalizing The Assessment
ISO 9001 &The 8 Management Principles Notes to Auditor: Complete this portion during Auditor Caucus time prior to closing meeting. Any “Not Effective” response should be followed by placing a note in the “Notes” section below. This portion will be used as one measures of quality management system improvement between surveillance/recertification audits.
Complete for ISO 9001:2015Assessments.
CUSTOMER FOCUS -The organization has demonstrated a high level of customer focus and awareness. Customer needs are clearly understood and customer requirements are being met.
Highly Effective Effective Effective But Needs Improvement Not Effective
LEADERSHIP - The organization has demonstrated effective leadership necessary to ensure effective quality management that has enhanced customer satisfaction. Personnel are involved in meeting organizational goals and objectives.
Highly Effective Effective Effective But Needs Improvement Not Effective
INVOLVEMENT OF PEOPLE - The organization has demonstrated effective use of personnel and has involved people throughout the organization to bring about effective quality management.
Highly Effective Effective Effective But Needs Improvement Not Effective
PROCESS APPROACH - The organization has demonstrated effective process-based quality management and has identified and managed its linked processes effectively. Linkages between processes are adequately defined and implemented.
Highly Effective Effective Effective But Needs Improvement Not Effective
SYSTEM APPROACH – The organization has demonstrated effective management of its system of related processes in meeting its objectives.
Highly Effective Effective Effective But Needs Improvement Not Effective
CONTINUAL IMPROVEMENT - The organization has demonstrated that it has implemented effective improvement processes that measure and report upon the organizations performance.
Highly Effective Effective Effective But Needs Improvement Not Effective
RISKS AND OPPORTUNITIES–The organizations has an effective system to address risks and opportunities.
Highly Effective Effective Effective But Needs Improvement Not Effective
MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS - The organization has demonstrated supplier relationships beneficial to each party and that enhance value to the organization and its suppliers.
Highly Effective Effective Effective But Needs Improvement Not Effective
INTERNAL AUDIT SYSTEM – The Internal audit system has proven to be effective.
Highly Effective Effective Effective But Needs Improvement Not Effective
MANAGEMENT REVIEW – Management Review has been conducted and proven to be effective.
Highly Effective Effective Effective But Needs Improvement Not Effective
Notes:
Management System Overall Effectiveness Over Three Years:
Stage 2 Audit Highly Effective Effective Effective But Needs Improvement Not Effective Surveillance Audit #1* Highly Effective Effective Effective But Needs Improvement Not Effective Surveillance Audit #2* Highly Effective Effective Effective But Needs Improvement Not Effective Surveillance Audit #3** Highly Effective Effective Effective But Needs Improvement Not Effective Surveillance Audit #4** Highly Effective Effective Effective But Needs Improvement Not Effective Surveillance Audit #5** Highly Effective Effective Effective But Needs Improvement Not Effective Recertification Audit Highly Effective Effective Effective But Needs Improvement Not Effective
Note To Auditor: Review Management System Reports from previous audit activities (within the current certification cycle), add effectiveness in the blocks above. For Recertification Audits recommend a Re-certification of MS Effectiveness Rating as Highly Effective or Effective only if the AVERAGE effectiveness rating over the last Audit Cycles averages out to be "Effective" or better. This is required for re-certification decision.
Rev 12;10/2018 Washington, DC 20005
* For Annual surveillance audits. ** For Semi Annual surveillance audits.
Rev 12;10/2018 Washington, DC 20005
Finalizing the Audit:
AUDIT PREPARATION REVIEW
Notes to Auditor:
• Complete as part of audit preparation process
• Initial / Sign where indicated – if Team Leader is in training, Lead Auditor to sign.
Preliminary Team assignment acceptable Yes Change required (detail below)
Preliminary time allowance acceptable Yes Change required (detail below)
Checklist complete and adequate Yes No (Explain in Notes Section)
Team has at least one SIC/NACE Qualified Member Yes Auditor name: Esmat Doss
All Auditors able to comply with impartial and confidentiality requirements Yes No (Explain in Notes/Change Below)
Stage 1 documentation review corrections verified and/or Stage 1 concerns addressed.
Yes No N/A (If NO, explain on Page 5
Stage 1 Notes) Notes and / or Changes required:
SIGNIFICANT CHANGES TO THE CLIENT ORGANIZATION OR THE REGISTRATION
Notes to Auditor:
Complete this form as part of Auditor Review prior to closing meeting.
The number of shifts: 1. 2. 3. 4. Other
Number of Shifts audited: 1. 2. 3. 4. Other
Shift Change information (describe times when shifts change)
Justification for NOT auditing ALL off shifts. NOTE: A reasonable justification shall be provided. If there are no off shifts state NA.
Third shift will be audited combine with shift 1 in second surveillance.
The scope of the registration has not changed.
The scope of the registration has changed as follows:
QMS Changes and Concerns for Next Audit: Review TMDE lab.
Certificate Scope of Registration: (For Recertification and Surveillance Check “No Changes” if applicable)
Rev 12;10/2018 Washington, DC 20005
Finalizing The Assessment
AUDIT SUMMARY REPORT REVIEW INITIAL, SURVEILLANCE, REASSESSMENT & FOLLOW-UP
• Complete this form prior to leaving client site, either as part of closing meeting preparation, or after the closing meeting.
Have all checklist pages been completed, project number, auditors name, etc. Yes No
For Stage 1 Audits, the Document Review Report Is Attached? Yes N/A
Have you made a copy of the Audit Summary Report and left it with the Client?
Have you made a copy of the Documentation Review Report and left it with the client?
Review of Customer Complaints Conducted?
Yes No
Yes N/A
Yes No
Has the Organization signed and dated the “Agreement for Use of the Marks.”
COMPLETE FOR ALL AUDIT ACTIVITIES
Yes
Audit Report written on: April 11, 2019.
Audit Report Submitted on:
(Stage 1 Audit)
(Stage 2 Audit)
4/13/2019 Surveillance/Special/Follow-up Audit
Recertification Audit
Yes No
Yes No
Yes No
NOTE TO AUDITOR:
I have reviewed and verified the effectiveness of the Nonconformance’s identified from the previous audit and deem them to be:
not applicable (none issued).
to be closed and effective (list the CAR Number(s) below.
not Closed and not effective. (list the CAR Number(s) and explain why below.
CAR # T1970544-1 The process to perform the complete internal audit to ISO 9001:2015 is not effective
I have signed and attached the “Verification of Effectiveness of closed” CAR’S from the previous audit.
Yes N/A
• If the audit team’s recommendation is to “grant registration,” the lead auditor will explain the Use of the Marks to the organizations management and have them complete, sign, and date the “Agreement for Use of the Marks.”
Rev 12;10/2018 Washington, DC 20005
Ethics Certification Note: If two or more auditors are on the team, the LeadAuditor will sign on behalf of the team. Each auditors nameshould appear under "I/We".
I/We, Esmat Doss certify that we have not participated in the development of this Quality
Management System, provided consulting and/or conducted internal audits at Letterkenny Army
Depot (LEAD) for the last two (2) years. I/We do not have any other known conflict of interest or lack of impartiality issues.
I/We are fully aware of the ethical, impartiality and conflict of interest requirements of IAS
Accreditation Rules and ISO/IEC 17021:2015.
I certify I am in full compliance with the signing and dating of this document.
Auditor Signature: Esmat Doss
Date: 04.11.2019
Exemplar Global/ IRCA QMS, EMS & OHS Lead Auditor (A009981)
Customer Verification:
To the best of our knowledge, we believe the signed affidavit by the above named auditor to be true and correct.
Quality Assurance Specialist April 11, 2019 Name Title Date
Rev 12;10/2018 Washington, DC 20005
Agreement for Use of the Marks GMCS Marks
Certificate of Conformity
GENERAL
The above mark is a certification mark owned by Government and Military Certification Systems, Inc.
(“GMCS”)and the International Accreditation Service (IAS), respectively. GMCS and IAS shall retain exclusive rights and control over the use of theirrespective marks. Permission to use a certification mark and Certificate of Conformity is granted or withdrawn at the sole discretion of GMCS. GMCS allows a registered organization to use the mark in any professional, technical, trade, or other business publications. Although the marks can be used on product packaging, any such reference shall not imply product conformity or product endorsement based on the GMCS registration process nor shall the Marks be placed or used on any products, calibration/metrology, or laboratory testing reports. The Certificate of Conformity may be photocopied, scanned, or duplicated provided that the print and marks are legible. GMCS maintains the right to require the organization to cease using a mark or Certificate of Conformity at any time if it fails to utilize the Mark as required or has its certification with GMCS suspended or revoked.The client may not use the IAS mark by itself. The client may use the GMCS mark by itself or with the IAS mark.
USE APPLICATION AND REPRODUCTION OF MARKS
GMCS Mark Requirements: Check here if applying for use of the GMCS mark.
- the GMCS marks are each to be printed in pure black and white or as provided to the client by GMCS.
The client is not permitted to change the mark or its colors (except for pure black and white) in any manner.
IAS Mark Requirements: Check here if applying for use of the IAS mark.
Rev 12;10/2018 Washington, DC 20005
- the IAS mark are to be printed in pure black and white or as provided to the client by GMCS. The client is not permitted to change the mark or its colors (except for pure black and white) in any manner.
The IAS mark may not be used by itself. The IAS mark may only be used with the GMCS mark.
Agreement on Use of the Marks and Certificate of Conformity
This Agreement is binding upon the registered organization. Failure to strictly abide by this Agreement and the Use of Mark restrictions may result in the suspension, withdrawal, or discontinuance of the right to use both the Certificate of Conformity and the Mark. I, the undersigned, have read and agree to abide by the terms of this Agreement and GMCS restrictions on using the GMCS Mark and IAS Mark.I further understand that if registration is suspended or withdrawn, GMCS will require that my organization discontinue all advertising that contains any reference to our management system being registered by GMCS and shall return the Certificate of Conformity and the Marks provided to our organization to GMCS. The organization also agrees not to use any registration document, registration mark, report, or any part thereof in a misleading manner. By signing this agreement, the organization agrees to maintain a documented procedure for the control and use of the Certificate of Conformity and all GMCS marks.
Please sign the following:
April 11, 2019 Authorized representative signature Date
Letterkenny Army Depot (LEAD) Organization Name
1 Overcash Avenue Address
Chambersburg PA 17201 City State Postal Code
| AUDIT REPORT |
| Stage 2, Recertification, or Surveillance Audit Final Audit Results |
| OPENING AND CLOSING MEETING CHECKLIST |
| Throughout the remainder of the assessment, the examination of objective audit evidence along with the interviewing of personnel provided the GMCS auditor(s) with the objective evidence required to come to a conclusion on the overall recommendation st... |
| NONCONFORMANCE’S NOTED DURING THE ASSESSMENT (place number of NC’s in space below; in none place N/A) |
| 0 MAJOR nonconformity(s) noted during the assessment. ISO 9001Clause Number(s): NA |
| 7 MINOR nonconformity(s) noted during the assessment. ISO 9001Clause Number(s): 10.2, 9.1.3, 7.1.5, 9.3.2 |
| ASSESSMENT CONCLUSION |
| During the Closing Meeting, all assessment findings, observations and opportunities for improvement were discussed to ensure that they were fully understood and agreed to by the organization's management and representatives. Based on the nonconforman... |
| 4. FOLLOW UP |
| The organization should be prepared to provide a written response with a corrective action plan to address any non-nonconformances identified during the course of the audit. The organization is to fully address any and all CAR's, prior to the next sc... |
| Finalizing the Audit: |
| AUDIT PREPARATION REVIEW |
| Notes to Auditor: |
| SIGNIFICANT CHANGES TO THE CLIENT ORGANIZATION OR THE REGISTRATION |
| Finalizing The Assessment |
| Ethics Certification |
| Auditor Signature: Esmat Doss |
| Date: 04.11.2019 |
| Exemplar Global/ IRCA QMS, EMS & OHS Lead Auditor (A009981) |
| Agreement for Use of the Marks |
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