B08_J.6_SoW_Exhibit 2 Production Readiness Review Audit.docx

CONTROLLED//CTI//DL ONLY

FOUO – CONTROLLED UNCLASSIFIED INFORMATION

PRODUCT MANAGER SOLDIER PROTECTIVE EQUIPMENT

AUDIT REPORT

Contract:

Audit Date:

MM/DD/YYYY

8/21-23/2017 Audit Location:

Auditee(s): (insert a name)

Audit Criteria:

ISO 9001:2015

Widget Design Widget-X PPP, and referenced documentation for Contract Y

Audit Type, Objectives and Scope:

Conduct an audit of Widget production processes. Audit ISO 9001:2015 compliance, adherence to Widget design Widget-x Production Process Package (PPP), and Contract Number.

Summary of Audit Findings:

[Summarize the number of audit findings in this area and identify the paragraph in the audit criteria. Note that this is a brief summary of the audit. Details of the audit finding will be inserted on the last page Summary of Findings]

Product Manager Soldier Protective Equipment

Product Engineer

Table 1: Audit Findings

Summary of Findings

Definitions:

A nonconformance (NC) is a noncompliance to a requirement in ISO 9001:2015, a contractual requirement, or an internal requirement.

An opportunity for improvement (OFI) is not a nonconformance but something identified by an Auditor that is worthy of bringing to the attention of management primarily for the purpose of improvement or safety.

An observation (OBS) is neither a nonconformance nor an opportunity for improvement, but merely serves as documentation of something covered during the audit.

Reference Internal Reference Description

Note: Include this table if it is a QMS Audit, Product Audit etc.; ensure that audit evidence or artifacts are included in an Appendix to this report.

Table 1: Audit Findings (continued)

Summary of Findings

Definitions:

A nonconformance (NC) is a noncompliance to a requirement in ISO 9001:2015, a contractual requirement, or an internal requirement.

An opportunity for improvement (OFI) is not a nonconformance but something identified by an Auditor that is worthy of bringing to the attention of management primarily for the purpose of improvement or safety.

An observation (OBS) is neither a nonconformance nor an opportunity for improvement, but merely serves as documentation of something covered during the audit.

Reference Internal Reference Description

Note: Include this table if it is a QMS Audit, Product Audit etc.; ensure that audit evidence or artifacts are included in an Appendix to this report.

Table 2: PRR Audit Report Summary Matrix

Safety Assessment/User Health Hazard Assessment/ Hazardous Dispositional Assessment and Disclosure NOTE: Contractor Format can be used; The contractor shall provide an assessment with supporting data that the system design has been analyzed for it life cycle, is safety to use and does not pose a hazard to the Solider during use through the product disposal life cycle. Further that the Government will not incur additional cost for disposal because of hazardous disposal classification for individual nor volume disposal because of EPA or Federal Law for associated processing methods, raw materials or integration techniques used in the design of the end item.

The system requirements are fully met in the final production configuration. All design variants have been tested against the Personal Protective Equipment specification requirements and the design meets all requirements. All design variants have been identified in the Production Process Package.

Adequate measures are in place to support production: Personnel, equipment, infrastructure, raw materials, subcontractor relationships/actual Procure Orders.

Design-for-manufacturing considerations ensure ease and efficiency of production and assembly.

Risks have been identified, credibly assessed, and characterized; and mitigation efforts have been defined.

The bill of materials has been reviewed and critical parts identified.

Delivery schedules have been verified;

Alternative sources for resources have been identified, as appropriate.

Adequate raw materials, spares have been planned and budgeted.

Required facilities and tools are sufficient for end item production.

Specified special tools and test equipment are available in proper quantities.

Note: Include this table only for a PRR Audit; ensure that audit evidence or artifacts are included in an Appendix to this report.

Table 2: PRR Audit Report Summary Matrix (continued)

Production and support staff are trained and qualified.

Drawings or Patterns created, reviewed and are certified.

Production engineering and planning are sufficiently mature for production.

Production processes and methods are consistent with quality requirements, First Article Test Samples, contract requirements.

Qualified suppliers are identified, audited, and available with materials that are to be procured.

Purchase Orders are reviewed and validated (i.e. Berry Compliance is verified); as appropriate, evidence that the subcontractors have all necessary drawings or patterns, product samples were received and deemed acceptable.

Qualified suppliers are available for materials that are to be procured: Subcontractor facility and resources are verification and validated by the Prime Contractor; subcontractor production readiness verification letter and evidence that all purchase orders have been awarded.

Note: Include this table only for a PRR Audit; ensure that audit evidence or artifacts are included in an Appendix to this report.

Summary of Findings

Audit Areas of Coverage:

Process Flow (Include if appropriate to the type of audit you conducted; ensure that all process and their place of performance are properly identified based on the contract language) Assembly (Include if appropriate to the type of audit you conducted) Work Instructions (Include if appropriate to the type of audit you conducted the templates reviewed and fines of compliance) Templates (Include if appropriate to the type of audit you conducted the templates reviewed and fines of compliance) Non-Conforming Product Process (Include if appropriate to the type of audit you conducted the templates reviewed and fines of compliance, number each finding and state period for correction, follow-up and closure) DCMA participation (Include if appropriate to the type of audit you conducted DCMA’s participation)

Summary: (Provide a concise summary of event of your audit findings; include follow-up and closure instructions to the contractor. If follow-up is required the audit should add the event on their Outlook calendar to ensure the event is tracked.)

Disclosure: The Lead Auditor will add to the dissemination list and provide the audit information and reports to whomever the Contractor deems appropriate as long as that dissemination follow the procedure below:

· Audit Reports shall retain the dissemination list and labeled with Distribution Statement F.

· The markings on Audit Reports shall comply with 32 CFR 2002.20(b);

· The top and bottom of each page shall contain the following marking centered on the page: FOUO – CONTROLLED UNCLASSIFIED INFORMATION.

· The contractor shall not exact any portion of the Audit Report to solicit new business nor to allege endorsement by Government.

Reference: (Include objective evidence materials reviewed and inspected during the audit)

CC:

Contracting Officer (insert a name) APM: (insert a name) COR (insert a name) Systems Engineer (insert a name) Contractor: (insert a name) DCMA (if appropriate insert name)

PM SPE Form 4, 30 August 2017 1 - 6 | Page Revision 3.2

FOUO – CONTROLLED UNCLASSIFIED INFORMATION

Distribution Statement F: Further dissemination only as directed by Product Manager - Soldier Protective Equipment, ATTN: SFAE-SDR-SPE (Chief, Quality Assurance), 10170 Beach Road, Building 328T, Fort Belvoir, VA 22060-5800 or higher Program Executive Office Soldier authority.

PM SPE Form 4, 30 August 2017 6 - 6| Page Revision 3.2

CONTROLLED//CTI//DL ONLY

image1.gif image2.emf