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Product Complaint Procedure N SN 01 0 - 01 Rev No : 0 0 Effective date : 16 / 6 /20 20 Supersedes : 00 Page : 1 of 4 Prepared by: Reviewed by: Approved by: RIN Assistant KAL HOD CAD HOD 1.0 Purpose 1.1 To provide clear and precise procedure on how to manage the product complaint. 2.0 Scope 2.1 This SOP is applicable for the complaints received on the product s manufacture d by IKOP Sdn Bhd. 3.0 Reference 3.1 Guideline on G DP , 2018 4.0 Responsibility 4.1 All personnel 4.1.1 The complaint should be recor ded in Complaint Record Form by all personnel who receive s the complaint 4.2 Quality Assurance (QA) / Quality Control (QC) department 4.2.1 A case number is iss ued to each complaint and the Complaint Register is updated by th ese department s. T hen, the complaints will be kept in appointed files . 4. 3 HOD of Quality Assurance (QA) / Quality Control (QC) department 4. 3 .1 The head of departments should review the whole process to ensure that the product complaints are properly mana ged and investigated. T he head of department should also ensure that an appropriate measure was carried o ut on the product complaint so that the same issue recurred. 4. 4 Designated Personnel 4. 4 .1 Des i gnated responsible person must be appointed to manage the product complaints. These per sonnel are authorized to initia te investigation and decide on the appropriate actions to be conducted . Product Complaint Procedure N SN 01 0 - 01 Rev No : 0 0 Effective date : 16 / 6 /20 20 Supersedes : 00 Page : 2 of 4 Prepared by: Reviewed by: Approved by: RIN Assistant KAL HOD CAD HOD Terms Condition 5.1 HOD Head of D epartment 5.2 SOP Standard Operating Procedure 5.3 GDP Good Distribution Practic e 5.4 QA/QC Quality A ssurance/ Quality Control 6.0 F low chart Receive complaints from complainants START Record all complaints in Complaint Record Form properly Report complaints to QA/QC department QA/QC department shall documen t the complaints on Complaint Record Form Designated per s onnel shall initiate i nvestigation and decide on the measures to be taken P roduct recall? Corrective action? After investigation, a response shall be given to complainant within defined timeframe Product Complaint Procedure N SN 01 0 - 01 Rev No : 0 0 Effective date : 16 / 6 /20 20 Supersedes : 00 Page : 3 of 4 Prepared by: Reviewed by: Approved by: RIN Assistant KAL HOD CAD HOD 7 .0 Procedure 7 .1 A procedure on the handling of all complaints for a possible product defect should be developed. 7 . 2 Complaints may be received form complainant via verbal feedback or written feedback. Verbal feedback may be received directly from the person while w ritten complaints may be received either in compl aint form, emails, or letters. 7 . 3 A ll complaints acknowledged by complainant shall be recorded properly with all the specific details usin g the Complaint Record Form (FORM - XXX) . 7 . 4 A ll complaints regarding the products must be reported to the QA / QC immediately. 7 .5 Upon receiving reports on product complaints, QA/QC department will document the complaints on a Complaint Record Form (FORM - XXX). The details of the complaint shall include case number of the complaint, customer details (name, business address and phone number), product, batch number, quantity involved, and reasons for complaint. Additional information shall be requested from the originating source if the data is inadequate 7 .6 Complaints shall be managed by appointed personnel who is responsible to initiate Any outcomes, decision and action shall be recorded in Complaints Record Form Maintain a Complain t Register Form Review all complaints as part of annual Product Quality Review END Product Complaint Procedure N SN 01 0 - 01 Rev No : 0 0 Effective date : 16 / 6 /20 20 Supersedes : 00 Page : 4 of 4 Prepared by: Reviewed by: Approved by: RIN Assistant KAL HOD CAD HOD investigation and decide on the action to be taken 7 .7 Consideration should be given if a product defect is found or suspected in a batch in o rder to determine whether other batche s are affected as well . 7 .8 A recall shall be initiated when a severe quality problem is fou nd on the product after the investigation and/or the product can potentially cause side effects. If the product is to be recalled, all National Regulatory Authorities shall be informed. Meanwhile, corrective action shall be done to prevent recurrence for m inor problem which is not associated with product quality. 7 .9 The investigation is recommended to be completed within XX days starting from receiving the product complaints. After the investigation is completed, a response shall be pro vided to the complainant within a reasonable defined timeframe 7 .10 Any outcomes from investigation, decision made or action taken and the corrective action to prevent recurrence shall be recorded in the Complaint Record Form (FORM - XXX) and referenced to the corresponding batch records. 7 .11 Maintain a C o mplaint R egister form (FORM - XXX) and the details that shall be included are the complaint case number, date, product, batch number, brief description of the complaint, the proposed completion date and actual completion date, and remarks (e.g. product recal l number). 7 .12 In order to determine the presence of recurring issues that need attention and can provide possible justification to recall the product, all complaints shall be reviewed as part of annual Product Quality Review 8 .0 Reference to another document 8 .1 Complaint Record Form (FORM - XXX) 8 .2 Complaint Register Form (FORM - XXX) 9 .0 Appendixes 9 .1 N / A