# QUALITY AUDIT QUESTIONNAIRE

## Supplier Quality Audit Questionnaire
Therma Corp.

## Table of Contents
| Section | Description | Page |
| --- | --- | --- |
| 1 | General Information | 4 |
| 2 | Type of Manufacture or Service Provided for Therma Corp. | 4 |
| 3 | Type of Product(s) Provided for Therma Corp. | 4 |
| 4 | Business Information | 5 |
| 5 | Facility Description | 5 |
| 6 | Number of Employees | 5 |
| 7 | Major Equipment/Capacity | 5 |
| 8 | Quality System Description | 6 |
| 9 | Document and Change Control | 7 |
| 10 | Process Control / Inspection and Testing | 7 |
| 11 | Material Handling and Control | 8 |
| 12 | Non-Conforming Material | 8 |
| 13 | Traceability | 8 |
| 14 | Corrective and Preventive Action | 9 |
| 15 | Calibration | 10 |
| 16 | Quality System Audit | 10 |
| 17 | Other Comments | 11 |
| 18 | References | 11 |
| 19 | Overall Qualification Rating | 11 |

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## 1. GENERAL INFORMATION:
| Field | Value |
| --- | --- |
| Company Name: |  |
| Street Address: |  |
| City, State, Zip Code: |  |
| Phone Number: |  |
| Fax Number: |  |
| Form Completed By & Title: |  |
| Date Form Completed: |  |
| Email Address: |  |
| Date of Last Survey: |  |
| Contact Person: Karen Lee, P.E.  Email Address: klee@therma.com  Fax Number: 408-347-3405  Mail: 1601 Las Plumas Avenue, San Jose, Ca 95133-1613 |  |

## 2. TYPE OF MANUFACTURE OR SERVICE PROVIDED FOR THERMA CORP.:

## 3. TYPE OF PRODUCT(S) PROVIDED FOR THERMA CORP.:

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## 4. BUSINESS INFORMATION:
| Field | Value |
| --- | --- |
| 4.1 | How long in business? |
| 4.2 | Annual sales? |
| 4.3 | Manufacturing Locations(if other than above address) |
| 4.4 | President's Name: |
| 4.5 | Operations Manager's Name: |
| 4.6 | Quality Assurance Manager's Name: |

## 5. FACILITY DESCRIPTION:
| Field | Value |
| --- | --- |
| 5.1 | Size of building(s) in square feet: |

## 6. NUMBER OF EMPLOYEES:
| Field | Value |
| --- | --- |
| 6.1 | Manufacturing: |
| 6.2 | Quality Assurance/Quality Control: |
| 6.3 | Research and Development: |
| 6.4 | Technical Support/Customer Service: |
| 6.5 | Administrative/Other: |

## 7. MAJOR EQUIPMENT/CAPACITY:

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## 8. QUALITY SYSTEM DESCRIPTION:
| Field | Value |
| --- | --- |
| 8.1 | Is your facility ISO certified? | □ Yes | □ No (If no, skip to Question 8.5.) |
| 8.2 | What ISO certification(s) do you have?  Note: Please forward a copy of ISO certificate(s) with this response. |  |
| 8.3 | What are the certification expiration dates? |  |
| 8.4 | Who is the Notified Body? |  |
| 8.5 | Is your facility registered with the FDA? | □ Yes | □ No (If no, skip to Question 8.8.) |
| 8.6 | Date of most recent inspection: |  |
| 8.7 | Issued 483 or warning letter? | □ Yes | □ No |
| 8.8 | Is there a Quality Manual in place?  Note: If yes, please forward a copy of quality manual with this response. | □ Yes | □ No |
| 8.9 | Is there a written policy for roles and responsibilities of quality control and quality assurance units?  Note: If yes, please forward a copy of the policy with this response. | □ Yes | □ No |
| 8.10 | Is there an organization chart that defines responsibility, authority, and interrelation of personnel who manage, perform, and verify work?  Note: If yes, please forward a copy of the organization chart with this response. | □ Yes | □ No |
| 8.11 | Does your company have any other registrations, licenses or certifications? | □ Yes | □ No |
| 8.11 | If yes, please list. |  |

## 9. DOCUMENT AND CHANGE CONTROL:
| Field | Value |
| --- | --- |
| 9.1 | Does your company have document control program? | Yes | No |
| 9.1 | If yes, please forward a copy of the document control procedure with this response. |  |
| 9.2 | Does your company have a change control program or procedure? | Yes | No |
| 9.2 | If yes, please forward a copy of the program or procedure with this response. |  |

## 10. PROCESS CONTROL / INSPECTION AND TESTING:
| Field | Value |
| --- | --- |
| 10.1 | Does your company have process control/inspection and testing procedures? | □ Yes | □ No |
| 10.1 | If yes, please forward a copy of the procedures with this response. |  |
| 10.2 | If inspected, does your company have a procedure to address inspection parameters? | □ Yes | □ No |
| 10.3 | If certification is used to accept incoming material or components, describe how your company performs the process. |  |
| 10.4 | Does your company have process and final inspection testing procedures? | □ Yes | □ No |
| 10.4 | If yes, please forward a copy of the procedure with this response. |  |
| 10.5 | Are the results of all inspections and testing documented with dates and signatures of individuals involved? | □ Yes | □ No |

## 11. MATERIAL HANDLING AND CONTROL:
| Field | Value |
| --- | --- |
| Please indicate if there are written procedures or policies for the following material processes: |  |
| 11.1 | Handling? | □ Yes | □ No |
| 11.2 | Storage? | □ Yes | □ No |
| 11.3 | Lot Control? | □ Yes | □ No |
| 11.4 | Marking/Identification? | □ Yes | □ No |
| 11.5 | Packaging? | □ Yes | □ No |
| 11.6 | Shipping? | □ Yes | □ No |
| 11.7 | Non-conformance? | □ Yes | □ No |
| 11.8 | Restocking? | □ Yes | □ No |

## 12. NON-CONFORMING MATERIAL:
| Field | Value |
| --- | --- |
| 12.1 | Does your company have any non-conforming material? | Yes | No |
| 12.1 | If yes, please describe the disposition of non-conforming material (or reference and attach procedure): |  |

## 13. TRACEABILITY:
| Field | Value |
| --- | --- |
| 13.1 | Does your company have a procedure to trace raw material/component? | Yes | No |
| 13.1 | If yes, please forward a copy of procedure with this response. |  |

## 14. CORRECTIVE AND PREVENTIVE ACTION:
| Field | Value |
| --- | --- |
| 14.1 | Does your company have an internal system for corrective and preventive action? | □ Yes | □ No |
| 14.1 | If yes, please forward a copy of procedure with this response. |  |
| 14.2 | Does your company have a formal complaint system with written records for each complaint and investigation? | □ Yes | □ No |
| 14.2 | If yes, please forward a copy of procedure with this response. |  |
| 14.3 | Briefly describe how to handle customer's complaints. Describe who is responsible for the system, what records are maintained, if and how evaluations are performed. |  |
| 14.4 | Does your company perform failure investigation and trend analysis of customer's complaints? | □ Yes | □ No |
| 14.5 | Can you describe your system to ensure linkage of customer's complaints to positive corrective and maintenance action? |  |
| 14.6 | Do you provide feedback to your customers on all complaints with respect to corrective and preventive action taken? | □ Yes | □ No |
| 14.7 | Does your company have a recall program? | □ Yes | □ No |
| 14.7 | If yes, please forward a copy of the program with this response. |  |
| 14.8 | Does your company have a procedure for handling returned goods? | □ Yes | □ No |
| 14.8 | If yes, please forward a copy of return procedure with this response. |  |

## 15. TEST OR MEASUREMENT VERIFICATION:
| Field | Value |
| --- | --- |
| 15.1 | Does your company have calibration program policy for measurement devices? | □ Yes | □ No |
| 15.1 | If yes, please forward a copy of program with this response. |  |
| 15.2 | Does your company maintain a system to ensure that measuring devices and test equipment are calibrated within specified frequencies? | □ Yes | □ No |
| 15.3 | Are tools and test equipment marked with: |  |
|  | 15.3.a. Identification Number? | □ Yes | □ No |
|  | 15.3.b. Calibration Date? | □ Yes | □ No |
|  | 15.3.c. Calibration Due Date? | □ Yes | □ No |
| 15.4 | Are calibration devices traceable to National Institute of Standards and Technology (NIST) or a recognized government standards certification body? | □ Yes | □ No |
| 15.4 | If yes, and not NIST, please list name of certification body. |  |
| 15.5 | Please describe your procedure how to handle out of calibration results. |  |

## 16. QUALITY SYSTEM AUDIT:
| Field | Value |
| --- | --- |
| 16.1 | Does your company have annual quality audit policy/procedure? | Yes | No |
| 16.1 | If yes, please forward a copy of the procedure with this response. |  |
| 16.2 | What department is responsible for audits? |  |

## 17. OTHER COMMENTS:
|  |  |
| --- | --- |
|  |  |

## 18. REFERENCES: Provide three references if available
|  |  |
| --- | --- |
|  |  |

## 19. OVERALL QUALIFICATION RATING:
| Field | Value |
| --- | --- |
| Deficiencies*: | None | Minor | Major |
| Qualification**: | Qualified | Unqualified |  |
| * See Therma's SOP 1.002 for major and minor deficiency definitions.  ** See Therma's SOP 1.002 for qualified and unqualified rating description. |

| This signature below certifies that the information contained in this document accurately reflects the current status of our company. |
| --- | --- |
| Name(Printed): |  |
| Title: |  |
| Signature: |  |
| Date: |  |