US Environmental Protection Agency Office of Pesticide Programs Office of Pesticide Programs Microbiology Laboratory Environmental Science Center, Ft. Meade, MD Standard Operating Procedure for Customer Feedback/Complaints SOP Number: ADM-06-01 Date Revised: 05-13-11 ------- SOP No. ADM-06-01 Date Revised: 06-01-11 Page 1 of 8 EPA/OPP MICROBIOLOGY LABORATORY ESC, Fort Meade,MD Standard Operating Procedure For Customer Feedback/Complaints SOP Number: ADM-06-01 Date Revised: 05/13/11 Initiated By: Date: / / Print Name: Quality Assurance Officer Technical Review: Date: / / Print Name: Technical Staff QA Review: Date: / / Print Name: QA Officer Approved By: Date: / / Print Name: Branch Chief Effective Date: / / Controlled Copy No.: Withdrawn By: Date: / / ------- SOP No. ADM-06-01 Date Revised: 06-01-11 Page 2 of 8 TABLE OF CONTENTS Contents Page Number I.0 SCOPE AND APPLICATION 3 2.0 DEFINITIONS 3 3.0 HEALTH AND SAFETY 3 4.0 CAUTIONS 3 5.0 INTERFERENCES 3 6.0 PERSONNEL QUALIFICATIONS 4 7.0 SPECIAL APPARATUS AND MATERIALS 4 8.0 INSTRUMENT AND METHOD CALIBRATION 4 9.0 SAMPLE HANDLING AND STORAGE 4 10.0 PROCEDURE AM) ANALYSIS 4 II.0 DATA ANALYSIS/CALCULATIONS 6 12.0 DATA MANAGEMENT/RECORDS MANAGEMENT 6 13.0 QUALITY CONTROL 6 14.0 NONCONFORMANCE AND CORRECTIVE ACTION 6 15.0 REFERENCES 7 16.0 FORMS AM) DATA SHEETS 7 ------- SOP No. ADM-06-01 Date Revised: 06-01-11 Page 3 of 8 1.0 SCOPE AND APPLICATION: 1.1 This SOP describes procedures for handling and documenting responses on customer service issues for the Microbiology Laboratory Branch (MLB). 1.2 Complaints and feedback can provide valuable insight into the quality and timeliness of MLB's deliverables and are used to improve the organization, management system, testing activities and overall customer service. 1.3 This SOP establishes the process to investigate, document, resolve and communicate in response to customer feedback. If corrective and preventive actions are necessary, SOP ADM-08: Corrective and preventive actions, is followed. 2.0 DEFINITIONS: 2.1 Customer feedback: Use of systematic methods for assessing the information from customers regarding the quality of the Microbiology Laboratory's deliverables. 2.2 Complaint: Negative comments (written or verbal) about MLB's activities, work product or service received from internal or external customers. 2.3 Corrective action: Action taken to eliminate the causes of a detected non- conformance, defect or other undesirable situation in order to prevent recurrence. 2.4 Preventive action: An action taken to prevent the occurrence of a non- conformance 3.0 HEALTH AND SAFETY: None 4.0 CAUTIONS: None 5.0 INTERFERENCES: 5.1 Negative feedback and complaints must be analyzed thoroughly. 5.2 Records shall be maintained of all complaints, investigations and follow up corrective actions taken by the laboratory. 5.3 Incomplete documentation can impede the work process. ------- SOP No. ADM-06-01 Date Revised: 06-01-11 Page 4 of 8 6.0 PERSONNEL QUALIFICATIONS: 6.1 The staff must be familiar with how to refer and investigate feedback/com pi ai nts from the customers. Familiarity with the current version of the SOP must be documented and maintained in the personnel training records. 7.0 SPECIAL APPARATUS AND MATERIALS: None 8.0 INSTRUMENT OR METHOD CALIBRATION: None 9.0 SAMPLE HANDLING AND STORAGE: None 10.0 PROCEDURE AND ANALYSIS: 10.1 Overview: MLB is responsible for generating product performance data for hospital disinfectants, tuberculocides, and other types of antimicrobial products making public health claims. In addition, MLB conducts basic and applied research to address questions raised by the Office of Pesticide Programs (OPP) and other customers. In the course of conducting these laboratory assessments, MLB generates standardized reports (deliverables) following a specific format including summary memos which provide an overview of the study and the resulting data and conclusions. These documents are provided to the study sponsor identified in the study protocol. The laboratory is interested in obtaining feedback on the study design, suitability of the data generated in the course of the study, the reporting format, whether the data meets the client's needs, and if the data are provided in a timely fashion. This feedback provides a foundation for modifying laboratory practices and procedures to improve services provided by the laboratory. For all antimicrobial efficacy reports, a standard form is submitted with the final report to solicit feedback from the customer. The feedback form is to be completed and returned by the customer. For research studies, a feedback form specific to the study may be developed. 10.2 Documenting feedback and complaints 10.2.1 The feedback or complaints may be provided in writing or by other means including email, telephone, or through the use of a standardized form. 10.2.2 Internal complaints and feedback may originate from staff and management from other branches, offices and divisions, including ------- SOP No. ADM-06-01 Date Revised: 06-01-11 Page 5 of 8 regional offices of EPA 10.2.3 External complaints and feedback may originate from study collaborators, other agencies, contractors, industry, private laboratories, stakeholders and consumers. 10.2.4 The complaint/feedback form must include the name of the person who lodged the complaint, the affiliated organization, date the complaint was received, and the nature of the complaint. 10.3 Processing Complaint, Feedback and Corrective Actions 10.3.1 The complaint or feedback is documented by the recipient and all feedback (positive and negative) is directed to the Branch Chief. The Branch Chief makes an assignment to the study director for review and resolution. 10.3.2 The Branch Chief, Quality Assurance Unit, and the assigned reviewer will meet to discuss the complaint/feedback and any resulting action that is recommended. 10.3.3 Data and records related to the study or the issue in question are pulled from file and reviewed. If specific information is provided in the feedback form or complaint, it is compared to the file. 10.3.4 The source of the feedback may be contacted if further explanation or details of the issue are required. 10.3.5 If the complaint and feedback is a non-conformance, it will be handled as a corrective action. The Branch Chief will be notified and a corrective action will be initiated using the Corrective Action Form (SOP ADM-07). 10.3.6 The extent of problem is investigated by examination of internal and external observations, situations, previous findings, if any, and causes with supporting evidence. 10.3.7 The Study Director and QAU are consulted and are kept informed. The QAU serves as the focal point for data quality, instrument problems, feedback and corrective actions. 10.3.8 If a corrective action(s) is/are identified: corrective action at the ------- SOP No. ADM-06-01 Date Revised: 06-01-11 Page 6 of 8 technical level is initiated by an MLB staff member, in consultation with the other members. Systematic problems are handled by the Branch Chief, Senior Science Advisor (SSA), and Team Leader in consultation with the QAU. 10.3.9 All records associated with the feedback are to be filed and maintained including the substance of the feedback and its resolution. A copy is filed with the product report or the study binder. 10.3.10 Customer complaints are shared with team members at branch meetings and the customer is notified in writing of the resolution of the complaint. 10.4 Processing positive feedback 10.4.1 The Branch Chief and Quality Assurance Unit should be notified about positive feedback received from the customers. 10.4.2 Documentation pertaining to the feedback is filed and maintained in official records. 11.0 DATA ANALYSIS/CALCULATIONS: None 12.0 DATA MANAGEMENT RECORDS MANAGEMENT: 12.1 Completed feedback forms are archived in secured file cabinets in room D217. Only authorized personnel have access to the secured files. Archived data are subject to OPP's official retention schedule contained in SOP ADM-03, Records and Archives. 13.0 QUALITY CONTROL: 13.1 The OPP Microbiology laboratory conforms to 40 CFR Part 160, Good Laboratory Practice Standards. Appropriate quality control measures are integrated into each SOP. 13.2 Studies are tracked in the Master Schedule, maintained electronically and archived as per SOP QA-04, Master Schedule. 14.0 NONCONFORMANCE AND CORRECTIVE ACTION: 14.1 Any non-conformance will be documented and the appropriate corrective action ------- SOP No. ADM-06-01 Date Revised: 06-01-11 Page 7 of 8 will be implemented. 15.0 REFERENCES: 15.1 International standard ISO/IEC 17025, Second Edition, 2005-05-15: General requirements for the competence of testing and calibration laboratories. 16.0 FORMS AND DATASHEETS: 16.1 Customer F eedb ack F orm ------- SOP No. ADM-06-01 Date Revised: 06-01-11 Page 8 of 8 16.1 Customer Feedback Form (Sample) Customer for: Customer: Date: Sent To (Name): Review of work: Recommendations: Signatures/Date U.S. Environmental Protection Agency Office of Pesticide Programs Biological and Economic Analysis Division Microbiology Laboratory Branch Fort Meade, Maryland Record of Customer Feedback Antimicrobial Testing Program ~ AD ~ OECA ~ Other Testing was conducted according to client specifications ~ Yes ~ No Report was well organized and included all elements ~ Yes ~ No Product was delivered on schedule in a timely ~ Yes ~ No manner Data supported the conclusions ~ Yes ~ No Courteous responsiveness of personnel ~ Yes ~ No Are additional studies necessary? Are changes to procedures or SOPs necessary? ~ Yes ~ No ~ Yes ~ No Additional comments: Thank you for your time. ------- |