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 Standard Operating Procedures (SOPs) SOP Number: ADM-06-00 Date Revised: 09-13-10 ------- SOP No. ADM-06-00 Date Revised 09-13-10 Page 1 of 8 EPA/OPP MICROBIOLOGY LABORATORY ESC, Fort Meade,MD Standard Operating Procedure For Customer Feedback/Complaints SOP Number: ADM-06-00 Date Revised: 09/13/10 1.0 TITLE AND APPROVAL PAGE: Initiated By: Date: / / Print Name: Quality Assurance Officer Technical Review: Date: / / Print Name: Technical Staff Approved By: Date: / / Print Name: Branch Chief Effective Date: / / Controlled Copy No.: Withdrawn By: Date: / / ------- SOP No. ADM-06-00 Date Revised 09-13-10 Page 2 of 8 2.0 TABLE OF CONTENTS I.0 TITLE AND APPROVAL PAGE 2.0 TABLE OF CONTENTS 3.0 SCOPE 4.0 DEFINITIONS 5.0 CAUTIONS/INTERFERENCES 6.0 HEALTH AND SAFETY 7.0 PERSONNEL QUALIFICATIONS 8.0 RESPONSIBILITIES 9.0 PROCEDURES 10.0 ENVIRONMENTAL MANAGEMENT II.0 REFERENCES 12.0 ATTACHMENTS 1 2 2 2 2 3 3 3 3 6 6 6 3.0 SCOPE: This SOP describes procedures for handling and documenting responses on customer service issues for the Microbiology Laboratory Branch (MLB). Complaints and feedback can provide valuable insight into the quality and timeliness of MLB's deliverables and can be used to improve the organization, management system, testing activities and overall customer service. This SOP establishes the process to investigate, document, resolve and communicate the causes of non-conformance in products, processes and deliverables. Corrective and preventive actions are documented and maintained. 4.0 DEFINITIONS: 4.1 Customer feedback: Use of systematic methods for assessing the information from customers regarding the quality of the Microbiology Laboratory's deliverables. 4.2 Complaint: Negative comments (written or verbal) about MLB's activities, work product or service received from internal or external customers. 4.3 Corrective action: Action taken to eliminate the causes of a detected non- conformance, defect or other undesirable situation in order to prevent recurrence. 5.0 CAUTIONS/ INTERFERENCES: 5.1 Negative feedback and complaints must be analyzed thoroughly. Records shall be ------- SOP No. ADM-06-00 Date Revised 09-13-10 Page 3 of 8 maintained of all complaints and the investigations and follow up corrective actions taken by the laboratory 6.0 HEALTH AND SAFETY: None 7.0 PERSONNEL QUALIFICATIONS: The staff must be familiar on how to refer and investigate feedback/complaints from the customers. Familiarity with the current version of the SOP must be documented and maintained in the personnel training records. 8.0 RESPONSIBILITIES: 8.1 The MLB Branch Chief or designee is responsible for ensuring the implementation of the customer feedback procedures described in this SOP. 8.2 MLB staff are required to be familiar with the content of this SOP including recording/documenting feedback and complaints from customers, and initiating and coming to a resolution of a problem or concern. 8.3 The quality assurance unit monitors the comments and complaints received to identify trends, the type of resolutions employed and the corrective actions. 9.0 PROCEDURES: 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, the feedback form specific to the study will be developed. ------- SOP No. ADM-06-00 Date Revised 09-13-10 Page 4 of 8 The following steps provide information as to how to handle feedback from the customers 9.1 Documenting feedback and complaints: The feedback or complaints may be provided in writing or by other means including email, telephone, or through the use of a standardized form. • Internal complaints and feedback may originate from staff and management from other branches, offices and divisions including regional offices of EPA. • External complaints and feedback may originate from study collaborators, other agencies, contractors, industry, private laboratories, stakeholders and consumers. • 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. 9.2 Processing Complaint, Feedback and Corrective Actions • The complaint or feedback is documented by the recipient. • 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. • The Branch Chief, Quality Assurance Unit, and the assigned reviewer will meet to discuss the complaint/feedback and any resulting action that is recommended. • Data and records related to the study or 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. • The source of the feedback may be contacted if further explanation or details of the issue are required which can be accomplished by using the Complaint and Feedback Form (see sectionl2.0 Attachments) • 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 No. ADM-06-00 Date Revised 09-13-10 Page 5 of 8 • The extent of problem is investigated by examination of internal and external observations, situations, previous findings, if any, and causes with supporting evidence. • Senior Science Advisor, Team leader and QA unit can be consulted and informed. The QAO serves as the focal point for data quality, instrument problems, feedback and corrective actions. • Corrective action(s) is(are) identified. Corrective action at the technical level is initiated by an MLB staff member, possibly in consultation with the other members. Systematic problems are handled by the Branch Chief, Senior Science Advisor (SSA), Team leader or QAO. • Through the auditing process, the Quality Assurance Unit monitors and documents the quality of the lab work and reports. Targeted audits and reviews may serve as part of corrective actions. • Immediate corrective actions (on the spot) are handled by informing the analysts and long term corrective actions, as identified by audits, are corrected in consultation with the QAO, Team Leader, Senior Science Advisor or Branch Chief. • All actions must be reported to the QAU and approved by the Branch Chief. The effectiveness of the corrective actions are monitored and verified during subsequent audits and management review. • All records associated with the feedback and the corrective action report are to be filed and maintained including the substance of the feedback and its resolution. • The Branch Chief and quality assurance unit must be notified when the corrective action is complete and records are filed. Processing positive feedback • The Branch Chief and Quality Assurance Unit should be notified about positive feedback received from the customers. • Documentation pertaining to the feedback is filed and maintained in official records. ------- SOP No. ADM-06-00 Date Revised 09-13-10 Page 6 of 8 10.0 ENVIRONMENTAL MANAGEMENT: Records may be maintained electronically to reduce the use of paper. 11.0 REFERENCES: General requirements for the competence of testing and calibration laboratories. International standard ISO/IEC 17025, Second Edition, 2005-05-15. 12.0 ATTACHMENTS: 12.1 Customer Feedback Form 12.2 Corrective Action Report Form ------- SOP No. ADM-06-00 Date Revised 09-13-10 Page 7 of 8 12.1 Customer Feedback Form (Sample) U.S. Environmental Protection Agency Office of Pesticide Programs Biological and Economic Analysis Division Microbiology Laboratory Branch Fort Meade, Maryland Record of Customer Feedback Customer for: Antimicrobial Testing Program Customer: Select one (AD/OECA Other) Date- Name: Reviev.' of Testing was conducted according to dent specifications Select one (yes no) Tvork: Report was. well organized and included aB elements Select one (yes'no) Product was delivered on schedule in a timely manner Select one (yes no) Data supported the conclusions. Select one (yes'no) Courteous responsiveness of personnel Select one (yes 'no) Recommend additional studies Select one (yes'no) Recommend changes to procedures or SOPs Select one (yes no) Additional comments: Thank you for > our time. ------- SOP No. ADM-06-00 Date Revised 09-13-10 Page 8 of 8 12.2 Corrective Action Report Form (sample) U.S. Environmental Protection Agency Office of Pesticide Programs Biological and Economic Analysis Division Microbiology Laboratory Branch Record of Corrective Action Report Initiated I Date: SSATL Conm nr Affected Projects) and/or Analysis: Major Area #r Situation InTesitgated: Findings: Conclusion/Corrective Actions: Initiator: Date: Brach Chief: Date: Submitted to QAU: Date: Follow Up Due Date: Date Closed: QAU Signature: Date; ------- |