Complaint Handling Survey

Answer the questions below as they relate to your firm. If your firm manufactures more than one class of device, please answer the questions with respect to the class of device to which the greatest amount of complaint activity applies. If your firm has multiple locations, fill out the survey for a location that actually processes complaints.

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* 1. Which class of device generates the greatest amount of complaint activity for your firm?

Class I

Class II

Class III

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* 2. What is the approximate number of US-based employees in your firm?

0 - 100

101 - 500

501 - 1000

1001 - 10,000

10,001 - 50,000

Over 50,000

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* 3. How many FTEs (full time equivalents) are directly involved in your firm's complaint handling process? (Note one FTE would work a 40-hour work week. Two part time employees each of whom devotes 20 hours per week to an area together would equal one FTE.)

2-5

6-10

Other (please specify)

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* 4. Of the following, which is the most common method that customers or others, e.g., sales and service personnel, use to communicate complaints about your medical devices?

Call a designated number for complaints

Call the main number for the firm

Use the "Contact Us" link on the firm's web site

Use a specific link for complaints on the firm's web site

Communicate directly with company field personnel

Other (please specify)

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* 5. If your firm uses a web-based solution to capture complaints via the internet, what is the name of the firm who developed the solution?

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* 6. If your firm uses a web-based solution to capture complaints via the internet, please explain its best and worst features.

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* 7. If your firm uses a commerical software application for complaint handling and processing, what is the name of the firm that developed the application?

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* 8. If your firm uses a commerical software application for complaint handling and processing, please describe its best and worst features.

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* 9. Regardless of the method of communication used, which of the following groups provide the most complaints to your firm about your devces?

Health care professionals

User facilities

Patients

Your service representatives

Your distributors

Other (please specify)

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* 10. Is an acknowledgement routinely sent to the individual who reported the complaint?

Yes

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* 11. When does your firm send correspondence to the complainant following closure of the complaintt?

Never

Always

When requested by the complainant

When requested by sales or service personnel

When a failure investigation is conducted

When a corrective action has been implemented

Other (please specify)

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* 12. In those cases where a corrective action is implemented, how often does your firm send a summary of the corrective action to the complainant?

Always

Most of the time

Sometimes

Rarely

Never

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* 13. Are all service calls screened for issues that meet the definition of a complaint?

Yes

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* 14. If service calls are screened to determine if they meet the definition of a complaint, are potential complaints reported through the established complaint handling process?

Yes

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* 15. Are all service reports that represent an MDR-reportable events considered to be a complaint and processed in accordance with 21 CFR 820.198

Yes

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* 16. When do you consider a complaint closed?

When a failure investigation is initiated

When a failure investigation is completed

When corrective action has been initiated, or it is determined that no action is required

When corrective action is completed

Other (please specify)

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* 17. In your evaluation of incoming complaints, what criteria does your firm use as a basis for not investigating the complaint? (Please check all that apply.)

A failure investigation is already open for the device

An adequate investigation of the alleged complaint failure mode has already been performed

A corrective action is already open for the same failure mode

The device was not properly used

Complaint does not involve a possible failure of the device, labeling or packaging to meet specifications

Complaint does not involve an event that is potentially reportable under the MDR regulation

Firm is unable to obtain the device for analysis

Complaint is for a product not manufactured by the firm

Other (please specify)

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* 18. What is your firm's goal for the time to close a complaint?

Less than 30 calendar days

31 - 45 calendar days

46 - 60 calendar days

More than 60 calendar days

Other (please specify)

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* 19. What is the maximum number of calendar days that you believe it is acceptable for a complaint to remain open?

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* 20. What information do you trend? Please check all that apply.

Number of complaints by individual device type

Number of complaints by product family

Number of complaints by failure mode

Number of complaints by failure mechanism confirmed by failure analysis

New complaints per period (e.g., month, quarter, etc.)

Average days to complaint closure

Complaints closed per period

Total complaints remaining open per period

Other (please specify)

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* 21. If your firm has a cross-functional team that meets regularly to discuss newly reported failure modes, trends, and the effectiveness of corrective actions, how often does the team meet?

Weekly

Biweekly

Monthly

Quarterly

Firm does not utilize team meetings for this analysis

Other (please specify)

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* 22. For complaints that COULD AFFECT PATIENT OR USER SAFETY, how many complaints for the same reported failure mode will trigger a failure investigation?

2 - 4

5 or more

Triggers have not been implemented

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* 23. For complaints NOT HAVING a significant impact on safety and effectiveness, how many complaints for the same reported failure mode will trigger a failure investigation?

2 -4

5 or more

Triggers have not been implemented

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* 24. How does your firm address complaints that require corrective action?

Corrective action is handled as part of the complaint managment system

Corrective action is initiated through a CAPA process that is separate from the complaint managment system

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* 25. Below is a list of challenges that firms have in meeting the requirements of 21 CFR 820.198. Please rank the level of difficulty for each of the following with 1 being the most challenging and 5 being the least challenging.

	1	2	3	4	5
Obtaining sufficient details about the event or malfunction from the firm's sales, service and clinical personnel	Obtaining sufficient details about the event or malfunction from the firm's sales, service and clinical personnel 1	Obtaining sufficient details about the event or malfunction from the firm's sales, service and clinical personnel 2	Obtaining sufficient details about the event or malfunction from the firm's sales, service and clinical personnel 3	Obtaining sufficient details about the event or malfunction from the firm's sales, service and clinical personnel 4	Obtaining sufficient details about the event or malfunction from the firm's sales, service and clinical personnel 5
Obtaining sufficient details about the event or malfunction from the device user	Obtaining sufficient details about the event or malfunction from the device user 1	Obtaining sufficient details about the event or malfunction from the device user 2	Obtaining sufficient details about the event or malfunction from the device user 3	Obtaining sufficient details about the event or malfunction from the device user 4	Obtaining sufficient details about the event or malfunction from the device user 5
Obtaining the device back from the customer	Obtaining the device back from the customer 1	Obtaining the device back from the customer 2	Obtaining the device back from the customer 3	Obtaining the device back from the customer 4	Obtaining the device back from the customer 5
Obtaining commitments from other departments to conduct a failure investigation or initiate corrective action in a timely manner	Obtaining commitments from other departments to conduct a failure investigation or initiate corrective action in a timely manner 1	Obtaining commitments from other departments to conduct a failure investigation or initiate corrective action in a timely manner 2	Obtaining commitments from other departments to conduct a failure investigation or initiate corrective action in a timely manner 3	Obtaining commitments from other departments to conduct a failure investigation or initiate corrective action in a timely manner 4	Obtaining commitments from other departments to conduct a failure investigation or initiate corrective action in a timely manner 5
Having sufficient resources in the complaint handling function	Having sufficient resources in the complaint handling function 1	Having sufficient resources in the complaint handling function 2	Having sufficient resources in the complaint handling function 3	Having sufficient resources in the complaint handling function 4	Having sufficient resources in the complaint handling function 5

Question Title

* 1. Which class of device generates the greatest amount of complaint activity for your firm?

Question Title

* 2. What is the approximate number of US-based employees in your firm?

Question Title

* 3. How many FTEs (full time equivalents) are directly involved in your firm's complaint handling process? (Note one FTE would work a 40-hour work week. Two part time employees each of whom devotes 20 hours per week to an area together would equal one FTE.)

Question Title

* 4. Of the following, which is the most common method that customers or others, e.g., sales and service personnel, use to communicate complaints about your medical devices?

Question Title

* 5. If your firm uses a web-based solution to capture complaints via the internet, what is the name of the firm who developed the solution?

Question Title

* 6. If your firm uses a web-based solution to capture complaints via the internet, please explain its best and worst features.

Question Title

* 7. If your firm uses a commerical software application for complaint handling and processing, what is the name of the firm that developed the application?

Question Title

* 8. If your firm uses a commerical software application for complaint handling and processing, please describe its best and worst features.

Question Title

* 9. Regardless of the method of communication used, which of the following groups provide the most complaints to your firm about your devces?

Question Title

* 10. Is an acknowledgement routinely sent to the individual who reported the complaint?

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* 11. When does your firm send correspondence to the complainant following closure of the complaintt?

Question Title

* 12. In those cases where a corrective action is implemented, how often does your firm send a summary of the corrective action to the complainant?

Question Title

* 13. Are all service calls screened for issues that meet the definition of a complaint?

Question Title

* 14. If service calls are screened to determine if they meet the definition of a complaint, are potential complaints reported through the established complaint handling process?

Question Title

* 15. Are all service reports that represent an MDR-reportable events considered to be a complaint and processed in accordance with 21 CFR 820.198

Question Title

* 16. When do you consider a complaint closed?

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* 17. In your evaluation of incoming complaints, what criteria does your firm use as a basis for not investigating the complaint? (Please check all that apply.)

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* 18. What is your firm's goal for the time to close a complaint?

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* 19. What is the maximum number of calendar days that you believe it is acceptable for a complaint to remain open?

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* 20. What information do you trend? Please check all that apply.

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* 21. If your firm has a cross-functional team that meets regularly to discuss newly reported failure modes, trends, and the effectiveness of corrective actions, how often does the team meet?

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* 22. For complaints that COULD AFFECT PATIENT OR USER SAFETY, how many complaints for the same reported failure mode will trigger a failure investigation?

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* 23. For complaints NOT HAVING a significant impact on safety and effectiveness, how many complaints for the same reported failure mode will trigger a failure investigation?

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* 24. How does your firm address complaints that require corrective action?

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* 25. Below is a list of challenges that firms have in meeting the requirements of 21 CFR 820.198. Please rank the level of difficulty for each of the following with 1 being the most challenging and 5 being the least challenging.

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* 26. Which of the challenges listed above is the most difficult at your location?

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* 27. In your experience what is the most effective technique you have observed to encourage your IN-HOUSE and FIELD PERSONNEL to report complaints?

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* 28. In your experience what is the most effective technique you have observed to encourage your CUSTOMERS to report complaints?

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* 29. In your experience what is the most effective technique that your firm uses to get the device back from the customer who made the complaint?

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* 30. In the following space, please provide any additional comments on the areas covered by this survey or complaint handling in general.