1 002 1 supplier quality audit questionnaire

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

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.:

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:

8. QUALITY SYSTEM DESCRIPTION:

Field	Value
8.1	Is your facility ISO certified?
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?
8.6	Date of most recent inspection:
8.7	Issued 483 or warning letter?
8.8	Is there a Quality Manual in place? Note: If yes, please forward a copy of quality manual with this response.
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.
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.
8.11	Does your company have any other registrations, licenses or certifications?
8.11	If yes, please list.

9. DOCUMENT AND CHANGE CONTROL:

Field	Value
9.1	Does your company have document control program?
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?
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?
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?
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?
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?

11. MATERIAL HANDLING AND CONTROL:

Field	Value
Please indicate if there are written procedures or policies for the following material processes:
11.1	Handling?
11.2	Storage?
11.3	Lot Control?
11.4	Marking/Identification?
11.5	Packaging?
11.6	Shipping?
11.7	Non-conformance?
11.8	Restocking?

12. NON-CONFORMING MATERIAL:

Field	Value
12.1	Does your company have any non-conforming material?
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?
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?
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?
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?
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?
14.7	Does your company have a recall program?
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?
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?
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?
15.3	Are tools and test equipment marked with:
	15.3.a. Identification Number?
	15.3.b. Calibration Date?
	15.3.c. Calibration Due Date?
15.4	Are calibration devices traceable to National Institute of Standards and Technology (NIST) or a recognized government standards certification body?
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?
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
Qualification**:	Qualified
* 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: | |