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1 1. PURPOSE 1.1. The purpose of this procedure is to provide for a system and instructions, and to assign responsibilities for receiving, processing, and investigating customer complaints. 2. APPLICATION 2.1. This procedure applies to all customer complaints. 3. POLICY All complaints, written or verbal, concerning a distributed product or customer service will be documented by the staff, reported to management in a timely manner, and expeditiously investigated when necessary CORRECTIVE AND PREVENTATIVE ACTION REQUEST (CAPA) The complaint is elevated to a CAPA Investigation when it is determined by Quality or the CEO that further action should be taken with the design, the manufacturing process, the testing procedure or any other circumstance to prevent the reoccurrence of the issue. When a complaint does not appear to be significant, repetitive, or systemic and can be easily resolved, QA can consult the parties involved to bring quick resolution to the problem without the generation of a formal Corrective And Preventative Action Request An event is elevated to a CAPA when it has been determined that: The event is likely to put a patient at risk, and The event appears to be significant, repetitive, or systemic Significant, recurring or systemic events may be elevated to a CAPA at the discretion of quality assurance, department supervisors or the CEO Reported adverse outcomes/reactions that are potentially related, directly or indirectly, to an allograft shall be investigated thoroughly and expeditiously. Adverse Reaction final reports are reviewed and approved by the Medical Director. The Medical Director will be involved in determination of the impact and resolution of an adverse outcome. 4. PROCEDURE 4.1. DEFINITIONS Accident - any occurrence, not associated with a deviation from SOP, standards or regulations during donor screening, testing, retrieval, processing, quarantining, labeling, storage, distribution of a tissue that may affect the performance, biocompatibility, or freedom from transmissible pathogens of the tissue or the ability to trace a tissue to the donor Adverse Reaction A noxious and unintended response to an implanted tissue. Any event reasonably related to implanted tissue that is fatal, life threatening, permanently disabling, or requires or prolongs hospitalization and/or requires additional surgical procedures. Adverse Reactions must be investigated Complaint Any written or oral communication concerning dissatisfaction with the identity, quality, packaging, durability, reliability, safety, effectiveness, or performance of tissue. 1

2 Complaint Types Product Complaint: Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a product after it is released for distribution General complaint: Any customer complaint that is not a product complaint (definition above). General complaints would typically include complaints about advertising and product information; availability; late, lost and wrong deliveries; billing mistakes; pricing; etc Corrective Actions Actions taken to correct a non-conforming condition Deviation An event that is a departure from a procedure or normal practice Error An adverse reaction, a process error or a repeat audit finding. A departure, whether or not intentional, from standards and regulations during donor screening, testing, retrieval, processing, quarantine, labeling, storage, or distribution of tissue that may cause infectious disease transmission, adversely affect the clinical performance of the tissue, or interfere with the ability to trace a tissue to the donor Incident Nonconformity associated with, but not limited to, one of the following: raw material, donor hold/quarantine, product failure, process failure or a quality control/assurance failure Investigation An investigation into the root cause of the error or incident, an evaluation of the corrective action implemented, if applicable, and an evaluation of preventative action for future errors of the same nature Malfunction: the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device Reportable Complaint: Any complaint that represents an event which must be reported to FDA under 21 CFR 1271 (HCT/P s) Serious Injury: an injury or illness that a) is life threatening, b) results in permanent impairment of a body function or permanent damage to a body structure, or c) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure RECEIVING AND LOGGING CUSTOMER COMPLAINTS All after-sale customer communication, whether written or verbal, is forwarded to Customer Service. Verbal communication by phone is documented on QF CUSTOMER COMPLAINT FORM during or immediately following, the conversation with the customer All customer feedback and complaints are recorded QF CUSTOMER COMPLAINT FORM by Customer Service. If a customer provides an internal complaint number when reporting a complaint, it should be documented in the description section. 2

3 4.3. CLASSIFYING COMPLAINTS Customer Service reviews all new complaints and classifies them into one of the following categories: Product Complaints - Deficiency related to the labeling, packaging, quality, identity, durability, reliability, safety, effectiveness, or performance of an allograft after it is released for distribution General Complaints - Not a product complaint. Typically includes complaints about advertising and product information; availability; late, lost and wrong deliveries; billing mistakes, pricing, etc 4.4. PROCESSING GENERAL COMPLAINTS After a general complaint is documented, Quality evaluates the complaint and determines: Who in the company shall be informed about the complaint; What reply shall be forwarded to the complainant; and Whether a corrective or preventive action shall be recommended to deal with the underlying causes Results of these determinations are recorded in section 3 5 of QF CUSTOMER COMMENT/COMPLAINT FORM If an investigation is not required the reason and the name of the individual responsible for the decision not to investigate are recorded in Section 4 of QF CUSTOMER COMMENT/COMPLAINT FORM. If an investigation is not required Pages 2 and 3 of QF CUSTOMER COMMENT/COMPLAINT FORM are not completed and are not attached to page General complaints should be reported to management in a timely manner. The name of the individual notified, the date of the notification and the method of notification shall be documented in the space provided in Section 3 of QF CUSTOMER COMMENT/COMPLAINT FORM EVALUATING AND INVESTIGATING PRODUCT COMPLAINTS Complaints that are classified as product complaints are forwarded to Quality for evaluation and, when appropriate, are formally investigated. A representative from the involved department may also be called upon to assist in the investigation Product complaints should be reported to management in a timely manner. Product complainants regarding potential adverse events shall be reported to management as soon as possible and not later than 24 hours after receipt of the information. The name of the individual notified, the date of the notification and the method of notification shall be documented in the space provided in Section 3 of QF CUSTOMER COMMENT/COMPLAINT FORM Product complaints are formally investigated when: Complaint involves a possible failure of a product, labeling, or packaging to meet any of its specifications; and/or Complaint represents an event which must be reported to FDA under 21 CFR 1271; unless such investigation has already been performed for a similar complaint and another investigation is not necessary. 3

4 For other types of complaints (in the product complaint category) Quality decides on a case-by-case basis whether a formal investigation shall be conducted, and, if so, what shall be the scope and objectives of the investigation Whenever a product complaint is not followed with a formal investigation, the reason no investigation was made and the name of the individual responsible for the decision not to investigate are recorded in Section 4 of QF CUSTOMER COMMENT/COMPLAINT FORM. Pages 2 and 3 of QF CUSTOMER COMMENT/COMPLAINT FORM are not completed or attached to page 1 when an investigation is not required The investigation should examine the possible causes of the failure of the product, labeling, or packaging to meet any of its specification. A copy of or list of the documents and information reviewed should be included in the report When there is a possibility that tissue has been contaminated, processing procedures should be reviewed and other tissue processed simultaneously or from the same donor evaluated. Contract processors will be notified and this request made of them The investigation shall determine whether associated tissue may be affected. If associated tissues may be affected, they shall be located and quarantined until the incident is resolved Complaint investigations are documented in Section 7 of QF CUSTOMER COMMENT/COMPLAINT FORM Complaints that are medical in nature shall be reviewed by the Medical Director In addition to documenting complaint investigations in Section 7 of QF , investigations may also be documented on the appropriate NCR form: QF Supplier Nonconformance Report, QF Internal Nonconformance Report, QF Internal Deviation Report. Additionally, NCR relating to the complaint may have already been performed. If an NCR form is utilized, the NCR # assigned to the form should be documented in the space provided in section 3 of QF Customer Comment/Complaint Form REPORTABLE ADVERSE EVENTS When product complaint evaluation determines that the complaint represents an event which must be reported to FDA under 21 CFR Part 1271, QF COMPLAINT LOG is marked REPORTABLE to clearly identify this special status of the complaint Reportable complaints are always investigated, and results of the investigation are documented in Section 7 of QF CUSTOMER COMMENT/COMPLAINT FORM. Reportable events will also be documented in the donor record The reporting process is specified in QOP-8502 RECALL, ADVERSE REACTIONS, DEVIATION REPORTS, AND ADVISORY NOTICES In addition to records required for non-reportable investigations, the records for reportable complaints also include a determination of: Whether the product failed to meet specifications Whether the product was being used for treatment or diagnosis; and The relationship, if any, of the product to the reported incident or adverse event. 4

5 HCT/P REPORTABLE EVENT Use FDA Form 3500A to report HCT/P adverse events no later than 15 calendar days of the initial receipt of information You must report to FDA an adverse reaction involving a communicable disease (if there is a reasonable possibility that the HCT/P caused the response) if it: Results in a patient death, Is life-threatening, Results in permanent impairment of a body function Results in permanent damage to a body structure, or Necessitates medical or surgical intervention, including hospitalization, 4.7. CORRECTIVE AND PREVENTIVE ACTION Quality reviews customer complaints and results of investigations, if any, to determine whether a formal corrective and preventative action request (CAPA) shall be initiated to deal with the underlying causes When a corrective action is initiated, the CAPA number is entered in the customer complaint record. The actions are initiated and implemented in accordance with Operational Procedure QOP-8504, CORRECTIVE AND PREVENTIVE ACTIONS When the investigation of a customer complaint determines that remote operations, subcontractors, or other external organizations contributed to the complaint, Quality contacts these organizations and provides them with all relevant information. When appropriate, Quality may issue formal corrective action requests to responsible subcontractors NONCONFORMING PRODUCT OR PROCESS DEVIATION If it is determined that the product is nonconforming or there was a process deviation, QF INTERNAL NONCONFORMANCE REPORT should be completed following QOP-8301 NONCONFORMING PRODUCT PROCESS DEVIATION CONTROL RECORDS Every customer complaint is documented. The records are maintained by Quality. Written communication, investigation reports, and other documents related to a complaint, are attached to QF CUSTOMER COMMENT/COMPLAINT FORM Customer complaints records and files are maintained by Quality. 5. REFERENCED DOCUMENT 5.1. Operational Procedure QOP-8301: Control of Nonconforming Product 5.2. Operational Procedure QOP-8501: Continual Improvement 5.3. Operational Procedure QOP-8502: Corrective and Preventive Action 6. ASSOCIATED RECORDS 6.1. Customer complaints records: Customer Complaint records. 5

6 6.2. Complaint investigation records: Files with communication, memoranda, minutes of meetings, reports with results of investigations, and other such documents and records pertaining to complaint investigation Corrective and preventive actions: Records of corrective and preventive actions per Operational Procedure QOP-85-04, Corrective and Preventive Actions. 6

7 7. FLOW CHARTS/DECISION TREES Verbal or Written Complaint Received General Information recorded by Customer Service or Quality in Section 1 of QF CUSTOMER COMMENT/COMPLAINT FORM Complete Section 2 of QF CUSTOMER COMMENT/COMPLAINT FORM. Complaint Type Determined. Product information recorded, if applicable. Will customer return product? Assign Return Authorization Number; provide customer with QF TISSUE RETURN AUTHORIZATION FORM AND return instructions Quality documents reason why no investigation was required on QF Forward COMPLAINT/COMMENT FORM to Quality for Evaluation. Investigation Required? Perform receiving inspection according to QOP-8505 Disposition Tissue according to QOP-8505 Quality investigates complaint Complete FDA Form 3500A according to QOP-8502 PRODUCT RECALL, ADVERSE REACTIONS, DEVIATION REPORTING, AND ADVISORY NOTICES Complete QF CORRECTIVE AND PREVENTATIVE ACTION FORM according to QOP-8504 CORRECTIVE AND PREVENTATIVE ACTION Reportable Event? Nonconforming Product? Corrective Action Request required? Complete Nonconformance Report and disposition tissue according to QOP-8301 NONCONFORMING PRODUCT PROCESS DEVIATION Develop and execute Action Plan Perform Follow-Up Final Review and Acceptance All documents and records are processed to completion. Records stored by Quality 7