Attachment_8.docx

Attachment 8

COMPLAINT RESOLUTION PROCESS

(November 2013)

I. RECEIPT OF COMPLAINTS

Comments concerning the inspector’s proficiency or manner of performance may originate from:

A. Letters or telephone calls from facilities or other sources directly to the Office of Partnerships (OP), formerly DFSR.

B. Reports from FDA’s toll-free facility information telephone line.

C. Audit Reports.

D. Regional Radiological Health Representatives (RRHRs), MQSA Auditors, District offices, or State programs.

II. PROCESS FOR HANDLING COMPLAINTS

OP / ORA / Contract Project Officer should:

A. Record the complaint and refer the complaint to the Contract Project Officer B. Assure confidentiality if the complainants release their identities C. Contact the RRHR.

D. For state inspectors, contact the State Program Managers who are responsible for investigating and resolving inspector quality assurance issues as stated in the Statement of Work (SOW) contract for each state. For FDA inspectors, contact the FDA Supervisor.

E. Discuss the alleged problem and provide the documentation and information that is received in FDA to the appropriate individuals.

F. Follow-up with written documentation to the State Program Manager or FDA Supervisor regarding the issue and FDA’s complaint resolution processes.

G. If appropriate to the situation, notify the auditor of the concern about the inspector.

H. Send an acknowledgement letter to the complainant regarding the process that the State Program Manager/FDA Supervisor will follow to address the complaint.

State Program Director/FDA Supervisor should:

A. Investigate and provide FDA with written documentation of their finding regarding allegation. The written documentation shall be provided to FDA no later than 30 calendar days after notification by FDA.

B. Consult with the RRHR and OP regarding the most appropriate resolution, particularly where FDA is involved in the solution.

C. Communicate directly with the inspector.

D. Notify the complainant, the Contract Project Officer, and the RRHR in writing about their investigation and the proposed resolution, no later than 45 calendar days after notification of the complaint from FDA.

TYPES OF RESOLUTION

A. Special training (e.g., mentoring).

B. Suspension. During the investigation of serious or multiple complaints attributed to the inspector, the inspector may be suspended from conducting MQSA inspections. During suspension, FDA should deactivate the inspector’s MPRIS account and request that the laptop computer and other equipment are turned over to the inspector’s immediate supervisor. Return to active status should depend upon the satisfactory resolution of any problems.

C. Decertification. After a thorough review and audit of the inspector’s work, and/or an investigation of any and all complaints, an inspector may be decertified if FDA determines that the inspector is not proficient in performing the duties of an MQSA inspector. Likewise, serious ethics violations, a breach of integrity or violations of the FDA Statement of Conduct can result in decertification.

D. No action indicated. If complaint was unfounded or inspector followed FDA procedures and policies, no further action should be required. FDA closes the issue with a note for the record.

RECORD KEEPING

FDA should:

A. Maintain a record of all complaints/action taken as part of the inspector’s file.

B. Maintain confidentiality of all records (as required by the MQSA Privacy Act of 1995).

C. Provide yearly summary of complaints and resolutions to the OP senior management, ORA, and the RRHRs.

NOTES:

FDA also receives many positive comments concerning MQSA inspector’s manner of performance and proficiency. FDA forwards letters of acknowledgment to the sender and the inspector and their supervisor.

FDA does not regard facility inquiries into inspector’s findings during an inspection as a complaint against the inspector. Rather, OP researches the inquiry with the assistance from the inspector. FDA then notifies the facility of the outcome.