CooperSurgical Supplier Audit Report

• Supplier

• Location
  Address

• Conducted on

  Date

• Number of Days Audit conducted

• Prepared by

• The audit provided an overview of all processes and quality system requirements. The main objective of the audit was to focus on the elements applicable to the company's Quality Management System. The audit methodology consisted of interviews with management and employees as well as review of procedures and records relevant to the area for compliance with the documents indicated above. Systems and records were selected for review from current and recent quality system data.
  
  The audit was performed to evaluate the overall effectiveness of the quality management system and to identify opportunities for improvement. The audit assessed adherence to the elements of the Audit Standards listed below.
  

• References The following standards provided the basis for the questions and procedures that were used in support of the assessment:

  Select ISO 13485:2016 ISO 9001:2015 FDA QSR Other

  • ISO 13485:2016
  • ISO 9001:2015
  • FDA QSR
  • Other

• Other

• Purpose/Background

• Add location
  Address

• Number of Employees

• Square Footage

• Number of Buildings

• Number of Years in Business

• Ownership

  Private

  LLC

  Corporation

  Other

• Other

• Obtain copy of current organization chart

• ISO Registered

  Yes

  No

  N/A

• Registrar

• Standard Registered

  Select ISO 13485:2016 ISO 9001:2015 FDA QSR Other

  • ISO 13485:2016
  • ISO 9001:2015
  • FDA QSR
  • Other

• Scope of Registration

• Expiration date of certificate

  Date

• Other Sites listed on Certificate

Additional Site

• Address

• City, St, Country

• FDA registered

  Yes

  No

  N/A

• Registration number

• Review list of parts/services within scope of audit (attach list)

• Supplier provides products/services to the following CooperSurgical sites

  Select Trumbull Stafford Falmouth (Research Instruments) Origio - Malov Origio-Olstykke Costa Rica Venlo Origio-BV Leisegang GMBH Paragard

  • Trumbull
  • Stafford
  • Falmouth (Research Instruments)
  • Origio - Malov
  • Origio-Olstykke
  • Costa Rica
  • Venlo
  • Origio-BV
  • Leisegang GMBH
  • Paragard

• Auditor Guidance: If applicable, review previous audits conducted by CooperSurgical (or entity) to verify effectivity and implementation of the correction and corrective actions. Any Findings will be captured in the Post-Audit Summary Section

Audit Preparation

• Review corrective actions for previous audit findings, and found to be appropriately addressed

  Yes

  No

  N/A

• Finding captured in Post Audit Summary Section

• Capture Details of previous Finding

• Auditor Guidance: This section will be completed at the conclusion of the audit. If the audit results in findings, a Follow-up shall be initiated to capture the task for tracking audit finding closure.

Audit Impressions

• BEST PRACTICES / POSITIVE IMPRESSIONS

Positive Impression

• Opportunities for Improvement

OFI

Audit Findings

• The number of findings in each category from this audit are listed below and will be tracked to closure. . Responses are due within the time frame stipulated based on the finding category. The responses should include a comprehensive investigation and Action Plan with Due Dates and assigned resources.

• Number of Critical Findings (a written response is required within 7 calendar days):

• Number of Major Findings (a written response is required within 21 calendar days):

• Number of Minor Findings (a written response is required within 30 calendar days):

• Audit Findings

Audit Finding

• Finding category

  critical

  major

  minor

• ISO Element

• Supplier Corrective Action Number Assigned

• Finding Description

Results

• Audit Results

  Approved

  Conditional

  Failed

• Active: Supplier is eligible to be added to, or remain on, the CooperSurgical Approved Supplier List

• Conditional: Supplier status to be set to Conditional on the CooperSurgical Approved Supplier List until such time that the findings are complete. Any existing products shall have the Incoming Inspection criteria reviewed.

• Failed: Existing Supplier shall have their status updated to Probation. New suppliers are not eligible to be added to the Approved Suppliers list until such time that the Findings are complete.

• Auditor Guidance: Capture the audit team, along with Independent reviewer (prior to sending report to the supplier

• Audit Team

Add Auditor(s)

• Auditor

• Role

  Lead Auditor

  Auditor

• Signature

  Sign

• Independent Reviewer

Reviewer

• Independent Reviewer

• Signature

  Sign

Auditor Guidance

• Auditor Guidance: this section is used to capture notes during the facilitation of the audit - this section should NOT be included in the final report to the supplier. This section should be deleted upon printing.

Follow-up Notes

• Notes to follow-up

Notes

• Note

• Auditor Guidance: Section is used to capture the employees reviewed during the audit. Ensure training appropriate training records are reviewed. This section will be included in the final report.

Employee

• Employee Name

• Job Title

• Location

  Select Receiving Incoming Quality Control Warehouse/Stores Production Area Shipping/Distribution Office Area Lab Area Other

  • Receiving
  • Incoming Quality Control
  • Warehouse/Stores
  • Production Area
  • Shipping/Distribution
  • Office Area
  • Lab Area
  • Other

• If Other selected - indicate Location

• Training Records Verified

• Auditor Guidance: Record the Documents reviewed throughout the audit. This section is included on the final report

SOP/Procedure/Form

• SOP/Form Number

• Title

• Revision

• Auditor Guidance: section is used to capture any documents (e.g. validations protocols and reports, drawings, memos, etc) reviewed during the audit. This section will be included in the final report.

• Document Reviewed

Document

• Title

• Reference Number

• Date

  Date

• Notes

• Auditor Guidance: record the suppliers reviewed throughout the audit - verify suppliers are properly evaluated and monitored (including inclusion on Approved Supplier List). Review supplier file. This section will be included in the final report.

• Supplier

Supplier

• Supplier Name

• Reviewed Supplier evaluation

• Supplier included in Monitoring process

• Supplier File Reviewed

• Auditor Guidance: record gauges reviewed during the audit. Capture the due date, and location. Verify calibration record

IMTE

• ID

• Type/Description

• Due Date

  Date

• Location

  Select Receiving Incoming Quality Control Warehouse/Stores Production Area Shipping/Distribution Office Area Lab Area Other

  • Receiving
  • Incoming Quality Control
  • Warehouse/Stores
  • Production Area
  • Shipping/Distribution
  • Office Area
  • Lab Area
  • Other

• Location

• Calibration Record Verified

• Auditor Guidance: Record the reference number of the Batch, Work Order or DHR. Verify the part number being produced is the current revision. Confirm the procedures/work instructions/method sheets being used to manufacture the part are the current revision. This section will be included in the final report.

• Batch Records/Work Orders/DHR

Batch Record/Lot Information

• Batch Record

• Part Number

• Date

• Location

  Select Receiving Incoming Quality Control Warehouse/Stores Production Area Shipping/Distribution Office Area Lab Area Other

  • Receiving
  • Incoming Quality Control
  • Warehouse/Stores
  • Production Area
  • Shipping/Distribution
  • Office Area
  • Lab Area
  • Other

• Location

• Auditor Guidance: Record the machinery used in the manufacturing of the product. Record the machine type and Preventive Maintenance Due Date, along with PM records. If validation was executed, review the validation report. This section will be included in the final report.

• Asset/Machinery

Asset Identification

• Machine ID

• Machine Type

• PM Due Date

  Date

• Preventive Maintenance Records Reviewed

• Validation Required

  yes

  no

• Validation Number

• Validation Reviewed

• Auditor Guidance: record the raw material used in the manufacturing process. Be sure to record supplier (see Supplier Section), as well the raw material specification, purchase order to the supplier for material, and any relevant Certificates. This section will be included in the final report.

• Materials

Material

• Material information

• Lot Number (If available)

• Location

  Select Receiving Incoming Quality Control Warehouse/Stores Production Area Shipping/Distribution Office Area Lab Area Other

  • Receiving
  • Incoming Quality Control
  • Warehouse/Stores
  • Production Area
  • Shipping/Distribution
  • Office Area
  • Lab Area
  • Other

• Location

• Review Material Specifications

• Review Purchase Order for Material

• Purchase Order Number

• Review applicable Material certifications (from Incoming records)