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STANDARD OPERATING PROCEDURE AUDITS AND SURVEYS This document defines Verify’s Standard Operating Procedure (SOP)

STANDARD OPERATING PROCEDURE

AUDITS AND SURVEYS

This document defines Verify’s Standard Operating Procedure (SOP) reflecting best practice for all Verify Project Specialists (PS) performing Audits and Surveys. Customer documented requirements or a Field Quality Plan (FQP) always take precedence over this SOP.

INTRODUCTION

Audits and Surveys are an evaluation of an organization’s systems, processes or products, performed by competent, independent, objective, and unbiased persons. The purpose of an Audit and Survey is to:

Ensure the Supplier’s internal organization, systems, and processes are in accordance with required standards, specifications, regulations, and/or contractual requirements.

Evaluate the Supplier’s internal controls to determine if conformance will continue, and identify areas of non-compliance or areas of risk that may require changes in procedures or controls.

Highlight the effectiveness and opportunities for improvement related to the audited systems, processes or products.

Throughout this Standard Operating Procedure, Audits and Surveys will be referred to collectively as Audit(s).

Audits are a snap-shot in time. Audits are performed when required:

1. By contract.

2. As a part of the Customer’s objective evidence of their control of the sub-tier Suppliers.

3. When Supplier performance fails to meet Customer expectations.

Audits are performed by interfacing with appropriate Supplier personnel and collecting evidence of compliance and non-compliance through interviews, examination of appropriate documents and observation of the activities and conditions in the area of concern. Results of Audits will be conveyed by the completion of an Audit checklist and Audit report.

The four (4) main types of Audits required by Verify customers are described below.

Systems Audit Conducted at pre-defined intervals, dependant on Supplier performance, a Systems Audit is an examination of a complete system or sub-system to determine whether activities and results comply with planned arrangements and whether these arrangements are implemented effectively to achieve all

arrangements are implemented effectively to achieve all Page 1 of 12 INSTR 75-03P-02 Revision 00; Release
arrangements are implemented effectively to achieve all Page 1 of 12 INSTR 75-03P-02 Revision 00; Release

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STANDARD OPERATING PROCEDURE AUDITS AND SURVEYS objectives. The Audit should also determine whether the system

STANDARD OPERATING PROCEDURE

AUDITS AND SURVEYS

objectives. The Audit should also determine whether the system documentation is adequate to achieve all desired objectives.

A Systems Audit is characterized by its emphasis on the macro nature of

the organization’s systems. A Systems Audit should be broad and general

in nature rather than narrow and limited in scope.

Process Audit

Where the Systems Audit is general in nature, the Process Audit is much more narrowly defined. A Process Audit revolves around verifying the manner in which people, material and machines work together to produce

product or result. A Process Audit compares and contrasts the manner in which the end-product is produced to the written procedures and workmanship standards used to control the manufacturing process responsible for building the product. Process Audits are appraisal and analytical in nature.

a

The Process Audit is also concerned with the validity and overall reliability of the process itself. For example, is the process consistently producing acceptable results? Do non-value added steps exist in the process? Are the processes current in terms of meeting the Customer’s existing and future

requirements?

Product Audit

The word “audit” in Product Audit is somewhat of a misnomer given that a Product Audit is predominantly a detailed inspection of a particular product, group of products or specific part numbers as defined by the Customer. It is a verification of both attribute and variable data and may also focus on related processes, systems, or sub-tier suppliers performance.

In order for the Project Specialist to confirm that the particular product is being produced correctly and adequately, Product Audits are best conducted while the product is actually in production at the Supplier’s facility. The Audit will consist of an in-depth examination of a particular product (hardware, processed material, or software) to evaluate whether it conforms to product specifications, performance standards and Customer requirements. Product Audits are typically performed as a validation of delegated Supplier operations to ensure the objective and thorough performance of the delegated Source Inspection function. Audit elements examined include the adequacy and effectiveness of user instructions, the methodologies applied, traceability, sub-tier Supplier and material control, product compliance and performance to specified requirements, packaging, shipment preparation, and protection.

packaging, shipment preparation, and protection. Page 2 of 12 INSTR 75-03P-02 Revision 00; Release Date:
packaging, shipment preparation, and protection. Page 2 of 12 INSTR 75-03P-02 Revision 00; Release Date:

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STANDARD OPERATING PROCEDURE AUDITS AND SURVEYS Regulatory Audit A Regulatory Audit is preformed when a

STANDARD OPERATING PROCEDURE

AUDITS AND SURVEYS

Regulatory Audit A Regulatory Audit is preformed when a Customer wishes to obtain independent assurance as to the Supplier’s compliance with a required regulation, directive or law; for example; the Buy American Act, Berry Amendment, Restriction of Hazardous Substances (RoHS), or Occupational Safety and Health Administration (OSHA) regulations.

1. DISPATCHING AND SCHEDULING

1.1 The Verify Project Specialist’s initial assignment may be scheduled by the Verify Program Team, eLaunch or the Customer, based on information contained within the Project Specialist’s contract package or as detailed from the Verify Program Team.

1.2 An Audit Package will be made available to the Project Specialist that will contain all the necessary documentation and data required for the Project Specialist to successfully complete the Audit. Each Audit Package will include a clearly defined Audit due date. Where possible, an Audit Package will contain details of supplier performance history including copies of previous Audit reports and corrective actions.

1.3 Following satisfactory completion of the initial assignment, the ongoing method for Project Specialist dispatch will be identified by the Verify Project Leader. Work requests to the Project Specialist may come from the Customer, the Supplier, or the Verify Program Team.

1.4 The Verify dispatch and field coordination system (eLaunch and eConnect) may be available to the Supplier, Customer, and Verify personnel to provide web-based, real-time access to all project status and results.

1.5 Primary responsibility for confirming the validity and schedule of the Audit request rests with the Verify Project Specialist. If the Verify Project Specialist has any questions or concerns, he/she should contact either Verify or the Customer as detailed in the Program Communication Summary (PCS) document.

in the Program Communication Summary (PCS) document. Page 3 of 12 INSTR 75-03P-02 Revision 00; Release
in the Program Communication Summary (PCS) document. Page 3 of 12 INSTR 75-03P-02 Revision 00; Release

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STANDARD OPERATING PROCEDURE AUDITS AND SURVEYS 2. AUDIT PREPARATION / SUPPLIER INTERFACE 2.1 The Project

STANDARD OPERATING PROCEDURE

AUDITS AND SURVEYS

2. AUDIT PREPARATION / SUPPLIER INTERFACE

2.1 The Project Specialist will interface directly with the Supplier to confirm the Supplier’s readiness and all arrangements prior to any Audit visit. Confirmation of the following items is essential:

2.1.1 The facility indicated is the proper site for Audit to be performed.

2.1.2 The scope

Package is

understood by the Supplier and the necessary supplier documentation will be available for review by the Project Specialist.

of

the Audit

as indicated

in

the Audit

2.1.3 Supplier security restrictions and requirements are addressed.

2.1.4 Facility safety requirements area addressed including the need for any Personal Safety Equipment (PSE).

2.1.5 A clean, clear area in which to work and hold any necessary meetings will be available for the duration of the Audit.

2.2 The Project Specialist will agree to a mutually convenient date and time to perform the Audit. Estimated duration of the Audit will depend upon the Audit scope and complexity of the Supplier’s organization, number of issues encountered during the Audit, and any limitations mandated by the Verify customer. If the Supplier cannot accommodate the Audit before the required due date, the Project Specialist will notify the Verify Program Team immediately for guidance.

3. AUDIT PREPARATION – COMPREHENSION OF REQUIREMENTS

Prior to arriving on-site to perform the Audit, the Project Specialist shall ensure their complete understanding of all Customer requirements and will:

3.1 Review the complete Audit Package.

3.2 Ensure that a complete and current Audit Checklist is available for the Audit to be performed. In certain cases, particularly with Process Audits, the auditor may need to prepare their own checklist based on the Customer specified requirements. A generic Verify form is available as a template for this purpose.

3.3 If available, review any Audit reports and corrective actions from previous Audits performed at the Supplier.

actions from previous Audits performed at the Supplier. Page 4 of 12 INSTR 75-03P-02 Revision 00;
actions from previous Audits performed at the Supplier. Page 4 of 12 INSTR 75-03P-02 Revision 00;

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STANDARD OPERATING PROCEDURE AUDITS AND SURVEYS 3.4 Obtain the Supplier’s website address and review it

STANDARD OPERATING PROCEDURE

AUDITS AND SURVEYS

3.4 Obtain the Supplier’s website address and review it for company and commodity familiarization.

3.5 Prepare an outline Audit agenda to include the structure and sequence of the primary Audit elements, expected areas to be covered, anticipated duration, and Supplier personnel / departments required to support the Audit process. A generic Verify form is available as a template for this purpose.

4. AUDIT PREPARATION – CONFIRMATION

Once the Audit schedule is agreed to by the Supplier and the Audit requirements have been reviewed and understood, the Project Specialist will confirm with the Supplier and the Verify Program Team via eConnect, e-mail or fax:

4.1 Audit date, time, and estimated duration.

4.2 Scope of Audit and outline agenda.

4.3 Requirement to hold an opening meeting with relevant Supplier personnel (see paragraph 5.2).

The Verify Project Specialist will ensure that the Verify eLaunch and eConnect are updated with the confirmed schedule if eConnect and eLaunch are used by the Customer program.

5. ARRIVAL AT THE SUPPLIER FACILITY

5.1 The Project Specialist shall ensure that they arrive on-site as per the previously agreed and confirmed schedule. Sufficient time should be given to complete any site access requirements.

5.2 The Project Specialist shall chair an opening meeting with appropriate Supplier personnel, including those responsible for Supplier performance in the areas to be audited, in order to address:

5.2.1 Scope of Audit.

5.2.2 Prepared Audit agenda.

5.2.3 Audit logistics including availability of work area, meeting rooms, escort requirements, availability of relevant personnel and departments.

5.2.4 Availability of necessary Supplier documentation.

5.2.4 Availability of necessary Supplier documentation. Page 5 of 12 INSTR 75-03P-02 Revision 00; Release Date:
5.2.4 Availability of necessary Supplier documentation. Page 5 of 12 INSTR 75-03P-02 Revision 00; Release Date:

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STANDARD OPERATING PROCEDURE AUDITS AND SURVEYS 5.2.5 Procedure the Project Specialist will follow for reporting

STANDARD OPERATING PROCEDURE

AUDITS AND SURVEYS

5.2.5 Procedure the Project Specialist will follow for reporting Audit findings and corrective action requests.

5.2.6 Schedule for closing meeting (see paragraph 12.1).

6. AUDIT PERFORMANCE OVERVIEW

6.1 It is important to remember that the Project Specialist is acting on behalf of the Verify Customer and is expected to operate in an organized and professional manner at all times. The Project Specialist will strive to maintain and enhance the Supplier relationship and obtain new information for the Customer.

6.2 The Audit will be performed by interfacing with appropriate Supplier personnel and collecting objective evidence of compliance and non-compliance (findings) through interviews, examination of appropriate documents and observation of the activities and conditions in the area of concern.

Objective evidence is defined as tangible or physical evidence that someone, when reviewing an Audit report or checklist, can evaluate for themselves and provides compelling proof that the Audit was actually performed as indicated, and that the criteria for compliance or non-compliance was upheld.

6.3 The Project Specialist should be escorted by the Supplier at all times during the Audit process unless a document or product review is taking place in a single controlled area (i.e. during a Product Audit).

6.4 During interview with Supplier personnel, the Project Specialist will ensure that they ask only leading questions rather than questions that can be answered simply by a “yes” or “no” answer.

6.5 If any non-compliance is noted by the Project Specialist, the Supplier escort should be notified immediately in order to give the Supplier the maximum amount of time to investigate and correct the potential non-compliance.

6.6 The value of the Audit will not be measured by the quantity of non- compliances, observations or recommendations established during the Audit - but by the quality. For example did the Audit findings adversely affect (or have the potential to affect) product quality, reliability, safety, etc. or did the Audit observations / recommendations prompt improvement in supplier performance?

6.7 Based

on

extensive

Verify

Audit

experience,

the

majority

of

Audits

performed

will

result

in

at

least

one

significant

finding

or

several

observations and recommendations.

finding or several observations and recommendations. Page 6 of 12 INSTR 75-03P-02 Revision 00; Release Date:
finding or several observations and recommendations. Page 6 of 12 INSTR 75-03P-02 Revision 00; Release Date:

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STANDARD OPERATING PROCEDURE AUDITS AND SURVEYS 7. SYSTEMS AUDIT - PRINCIPALS 7.1 Following completion of

STANDARD OPERATING PROCEDURE

AUDITS AND SURVEYS

7. SYSTEMS AUDIT - PRINCIPALS

7.1 Following completion of the opening meeting, the Systems Audit will begin with a tour of the Supplier’s facility to allow the Project Specialist to become familiar with the Supplier’s organizational and operational structure.

7.2 Based on the prepared Audit agenda and checklist, the Project Specialist will review each system element to confirm either compliance or non-compliance to specified requirements. This will be predominantly accomplished by following a product or process flow from start to finish – identifying the critical control points throughout.

7.3 The Project Specialist will take notes throughout the Audit and reference procedures and records as necessary.

7.4 Using their Audit skill and experience, the Project Specialist will ensure that each Audit element is addressed to the necessary depth to ascertain compliance or non- compliance. Priority and Audit depth will be given to those Audit elements that directly impact product quality, reliability, and safety.

7.5 The Project Specialist will directly engage and interview a comprehensive cross- section of Supplier personnel that are responsible for the area, process, or product being audited.

7.6 Objective evidence of both compliance and non-compliance will be recorded on the provided Audit checklist. Clear narrative of improvement opportunities and recommendations will also be included.

8. PROCESS AUDIT - PRINCIPALS

8.1 The initial stage of the Audit requires that the Supplier’s existing procedures are fully documented, as they are the basis of the Audit review. The Project Specialist will review all documented procedures for adequacy and completeness at the earliest possible stage. Review will be based on specified Customer requirements (i.e. standards, specifications, drawings or contractual obligations).

8.2 If the Project Specialist establishes that existing procedures are not fully documented, are inadequate, or do not completely address Customer requirements, the Supplier will be notified immediately.

8.3 The Project Specialist will then establish that the written procedures are being followed, letter-by-letter, move by move. If this is not the case, then either the procedure requires revision to match the practice or the practice needs to be brought in line with the procedure.

the practice needs to be brought in line with the procedure. Page 7 of 12 INSTR
the practice needs to be brought in line with the procedure. Page 7 of 12 INSTR

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STANDARD OPERATING PROCEDURE AUDITS AND SURVEYS 8.4 Depending on contractual requirements, the documentation for a

STANDARD OPERATING PROCEDURE

AUDITS AND SURVEYS

8.4 Depending on contractual requirements, the documentation for a process may be “frozen.” In other words, the process documentation has been reviewed and agreed upon by the Customer and no deviations from that process are allowed. In those instances, the Project Specialist will spend a greater amount of time auditing compliance rather than identifying potential enhancements.

8.5 The final stage of the Process Audit is to further reflect on current procedures and process controls and whether there are improvement opportunities.

8.6 Objective evidence of both compliance and non-compliance will be recorded on the provided form or checklist. Clear narrative of improvement opportunities and recommendations will also be included.

8.7 Verify will always ensure that the Project Specialist performing a Process Audit is an expert with the particular process, technology, or commodity under review.

9. PRODUCT AUDIT – PRINCIPALS

9.1 The Product Audit will be performed separately from any other Audit or Supplier visitation (i.e. not performed in conjunction with a Quality System Audit or Source Inspection).

9.2 The Project Specialist will start the Audit with a comprehensive review of all appropriate drawings, EO (Engineering Orders), CO (Change Orders), BOM (Bill of Materials), travelers, routers, shop documentation and all other product related materials.

9.3 The Project Specialist will perform a walk through of the entire product’s production cycle, including the materials, out-sourced activities and may also include packaging and shipping.

9.4 The Project Specialist will perform a detailed inspection of the appropriate product based on any Customer-specified key characteristics and sampling requirements. The inspection will include verification of tools and measuring equipment.

9.5 The Project Specialist will confirm correctness and adequacy of all sub-tier Supplier and material requirements including Supplier approvals, traceability, and availability of all necessary materials and process certifications.

9.6 Packaging and shipment controls will also be reviewed by the Project Specialist as part of the Product Audit.

by the Project Specialist as part of the Product Audit. Page 8 of 12 INSTR 75-03P-02
by the Project Specialist as part of the Product Audit. Page 8 of 12 INSTR 75-03P-02

Page 8 of 12 INSTR 75-03P-02 Revision 00; Release Date: 06/29/2009

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STANDARD OPERATING PROCEDURE AUDITS AND SURVEYS 9.7 Objective evidence of both compliance and non-compliance will

STANDARD OPERATING PROCEDURE

AUDITS AND SURVEYS

9.7 Objective evidence of both compliance and non-compliance will be recorded on the provided checklist. The Project Specialist will ensure that all items observed such as work order numbers, lot numbers, purchase order numbers, tooling, and gages are recorded.

9.8 Verify will always ensure that the Project Specialist performing a Product Audit is an expert with the particularly product technology under review.

10. REGULATORY AUDIT – PRINCIPALS

10.1 The initial stage of the Regulatory Audit requires that that the Supplier’s existing procedures or methods used for regulation compliance are properly documented, as they are one of the bases of the Regulatory audit review. The other bases for the Regulatory audit will be sample commodities or activities that the regulation is governing.

10.2 The Project Specialist will start the Audit with a comprehensive review of all appropriate procedures, instructions and other related materials affecting regulation compliance.

10.3 The Project Specialist will perform a walk through of the entire commodity or activity cycle relevant to the regulation.

10.4 The Project Specialist will perform a detailed inspection / review of the regulated commodity / activity.

10.5 The Project Specialist will confirm correctness and adequacy of all sub-tier supplier and commodity requirements including requirements flow down, supplier approvals and availability of and necessary materials and activity certifications.

10.6 Objective evidence of both compliance and non-compliance will be recorded on the provided checklist. The Project Specialist will ensure that all items observed are recorded.

10.7 As part of the Regulatory Audit report, the Project Specialist will summarize the supplier’s process for regulatory compliance and where the audited commodity or activity complies with the regulation. The Project Specialist will also note the effectiveness of the supplier’s process and highlight any improvement

of the supplier’s process and highlight any improvement Page 9 of 12 INSTR 75-03P-02 Revision 00;
of the supplier’s process and highlight any improvement Page 9 of 12 INSTR 75-03P-02 Revision 00;

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STANDARD OPERATING PROCEDURE AUDITS AND SURVEYS 11. RECORDING AUDIT RESULTS 11.1 The Project Specialist will

STANDARD OPERATING PROCEDURE

AUDITS AND SURVEYS

11. RECORDING AUDIT RESULTS

11.1 The Project Specialist will take comprehensive notes of all Audit activity throughout the Audit process.

11.2 Results of the Audit shall be subsequently recorded using the forms / checklist (either hard copy or web based) provided as part of the Audit Package.

11.3 For hard copy forms, black, ball-point pens are the only authorized method the Project Specialist shall use to record information.

11.4 Answering a question yes or no on the provided form / checklist is not sufficient and the Project Specialist must provide objective evidence or commentary to support their answer.

11.5 Blanks are not allowed on any Audit documentation, unless directed by the document itself. In many instances, a small line in the space is sufficient to indicate that the item was looked at and not disregarded.

11.6 Every question has an answer, even if that answer must be an N/A (not applicable). Note that any Not Applicable or N/A must be fully explained unless specifically directed by the document itself not to do so.

11.7 Legibility of the checklists and Audit reports is of paramount importance and the Project Specialist will ensure legibility of every document.

11.8 Completed forms and checklists are the Project Specialist’s work product. This is the Customer deliverable and the Project Specialist will be measured against the quality, accuracy, and value of the completed forms / checklists.

11.9 Corrections, to any document can only be made by a single line strike-through of the incorrect information, inserting the corrected information, followed by the Project Specialist’s initials.

followed by the Project Specialist’s initials. Page 10 of 12 INSTR 75-03P-02 Revision 00; Release Date:
followed by the Project Specialist’s initials. Page 10 of 12 INSTR 75-03P-02 Revision 00; Release Date:

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STANDARD OPERATING PROCEDURE AUDITS AND SURVEYS 12. VISIT COMPLETION 12.1 A closing meeting will be

STANDARD OPERATING PROCEDURE

AUDITS AND SURVEYS

12. VISIT COMPLETION

12.1 A closing meeting will be arranged with appropriate Supplier personnel (at a minimum those responsible for Supplier performance in the areas audited). The Project Specialist will take the necessary amount of time to prepare for this closing meeting, ensuring that all Audit elements as per the Audit checklist have been covered and the required objective evidence of compliance or non-compliance is available and correct.

12.2 The closing meeting will:

12.2.1 Review the Audit results and outcome.

12.2.2 Address any outstanding issues.

12.2.3 Ensure that the Supplier is formally notified of any non-compliances and is provided with the necessary objective evidence.

12.2.4 Where responsibility for raising Supplier Corrective Actions has been delegated to the Project Specialist, ensure that the Supplier is provided with copies of Supplier Corrective Action Request (SCAR) and the process of responding to the SCAR is clearly explained to the supplier.

12.2.5 Thank the Supplier for their cooperation throughout the Audit.

12.3 The Project Specialist will complete the necessary Audit documentation and send the appropriate copies to Verify as detailed on the Program Communication Summary -- within 48 hours of Audit completion.

12.4 The Project Specialist will retain his/her own copy of all Audit documentation for a minimum of two (2) years following completion of Audit.

13. CORRECTIVE ACTION FOLLOW-UP

On certain Verify programs, the Project Specialist will be delegated responsibility for solicitation of Supplier response to Supplier Corrective Action Requests (SCAR) in addition to the validation and close out of the necessary corrective and preventive actions. A separate Verify Standard Operating Procedure for Corrective Action Management provides instruction for managing the Corrective Action Process.

instruction for managing the Corrective Action Process. Page 11 of 12 INSTR 75-03P-02 Revision 00; Release
instruction for managing the Corrective Action Process. Page 11 of 12 INSTR 75-03P-02 Revision 00; Release

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STANDARD OPERATING PROCEDURE AUDITS AND SURVEYS 14. PROCESS FLOWCHART PS ensures all requirements are understood

STANDARD OPERATING PROCEDURE

AUDITS AND SURVEYS

14. PROCESS FLOWCHART

PS ensures all requirements are understood and all necessary personnel will be available for Audits and Survey activities

Supplier briefed on Audit outcome

Audits documentation completed and distributed

Corrective action follow- up as authorized

PS arrives on-site at scheduled date and time
PS arrives
on-site at
scheduled
date and
time

Using correct documentation PS conducts and documents the Audits or Survey

PS confirms readiness of Supplier
PS confirms
readiness of
Supplier
the Audits or Survey PS confirms readiness of Supplier 15. AUDIT FORMS 15.1 Generic Audit Checklist

15. AUDIT FORMS

15.1 Generic Audit Checklist Form

15.2 Generic Audit Agenda Form

15.3 Corrective Action Form (FRM 75-03P-05)

Agenda Form 15.3 Corrective Action Form (FRM 75-03P-05) Page 12 of 12 INSTR 75-03P-02 Revision 00;
Agenda Form 15.3 Corrective Action Form (FRM 75-03P-05) Page 12 of 12 INSTR 75-03P-02 Revision 00;

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