wy Revision No. 3 Doc. Code 2017 PRCDQ0O4 f®. PROCEDURE Page No. 1 of8 Control of Non-Conformity and Corrective Action [lat Prepared 24 duly 2018 Date of Effectivity 30 OCT 208 1.0 OBJECTIVE To outline the responsibiliies and methods for identifying causes of nonconformites in the QMS, initating corrective action/s and performing follow-up to ensure that those corrective action/s have been effective in eliminating the nonconformities. Our Quality Management System is created toward the proactive elimination of actual and potential Gefciencies. Non-conformties in products, services, processes and our management system are investigated and action implemented to prevent their occurrence. 2.0 SCOPE This procedure applies to all QMS nonconformities, whether identified during intemal Quality Audits or Management Reviews, by way of customer feedback or by Management in general. This procedure also covers the following activities: Determining the causes of the detected and potential nonconformities; Evaluating the need for action to prevent the occurrence and recurrence of nonconformities: Determining and implementing action needed Records of the results of action/s taken; Reviewing the effectiveness of the corrective actions taken; Defining the controls and related responsibilities and authorities for dé services, fealing with nonconforming 3.0 DEFINITION OF TERMS: 31 Internal Quality Audit (IQA) - Systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent fo which the audit criteria are fulfilled 3.2 Management Review - A structured meeting that must take place at regular intervals to discuss the functioning of the Light Rail Transit Authority's Quality Management System (QMS) and to take action to correct it when necessary. 3.3 Stakeholder’s Complaint - A complaint coming from passengers, suppliers, concessionaires, lessees, etc, as an expression of dissatisfaction related to LRTA's products, services or the complaints handling process itse'f, where a response or resolution is explicitly or implicitly expected. | by Documents that do not bear fresh LRTA'S oficial document stamp are considered “Uncontrolled” AD werent rena satay | CONTROLLED COPY ||Doc. Code 2017.PR.CDQ.004 I. PROCEDURE Page No. 20f8 wy Revision No. 3 Control of Non-Conformity and Corrective Action | Date Prepared 24 duly 2078 Date of Effetivi 39-0 | 34 Criteria - set of policies, against audit evidence 35. Audit Findings - results of evaluation ofthe collected evidence against Audit Criteria 38 Consequences/Effects - result or effect of a non-confomily condiion Procedures or requirements, Audit ctiteria are used as a reference 37 Correction - actionis taken to rectiy or climinatermitigate a detected non conformity 3.8 Cause - an identified reason for the presence of a defect or problem, 39 Corrective Action - Action to eliminate the causels of Nonconformity and to prevent recurrence, 3.10 Conformity (C) - fulfllment of a requirenient 311 Nonconformity (NC) isa nonaflment or failure to meet a requirement 3.12 Request for Action (RFA) - document used to: * Record a non-conformity and/or complaint, feedback : * Identiy the consequences and root-cause of the nonconformity: * Determine correction and corrective action, * Review the effectiveness of corrective action/s taken 3.13 Root Cause - is a factor that caused a nonconformance and should be eliminated through Process improvement, 3:14 Root Cause Analysis ~ method of problem solving used for identifying the root cause of problems, 3.18 Audit Follow up - monitoring of progress of corrective action 4.0 RESPONSIBILITIES 4.1 Head, IQA Team Reviews if the | correction was __sufficienth addressediresolved. the non-conformity or shall” by recommended for corrective action of the auditee. 4.2 Overall IQA Team Leader Evaluates if correction and corrective actions are Appropriate and monitors if implemented effectively, 4.4 DepartmentDivision/Units/Office Heads Ensures that all RFAS received are properly Tesponded and submitted to the IQA Team 4.3 Internal Quality Audit Team Validates if the corrections and corrective actions have been effectively carried out beh Pocuments that do not bear iresh LRTA's ofcial document stamp are considered "UncontoleDoc. Code 2017.PR.CDQ.004 f*. PROCEDURE Page No, 30f8 w Revision No. 3 Control of Non-Conformity and Corrective Action [Date Prepared 24 duly 2018 Date of Efeciviy 99 ocr mm 4.5 Initiator 4.8 Employees and Process Owners 5.0 PROCEDURE DETAILS Responsible for the correctness. an id reliability of reported findingssissues and concems. Determines, analyzes and documents the Cause/s of {he Non-conforming conditions -ansing. from” the Implementationstructure of the process.” and responsible for implementing the corrections. and Corrective actions. 5.1 Identification of nonconforming and potential Nonconforming products/services Nonconformin the following Internal Quality Audit (IQA) Management Review Products and Service Realization Supplier Non-conformance Suppliers Performance Benchmarking 1g productsiservices may be detected through or as a result of (but not limited to) Client Feedback! Customer Satisfaction ‘Surveys 5.2 _ Issuance/Receiving and Verification of RFA 5.2.1 The IQA Team Leader shall evaluat CorOFl 5.2.2 When non-conformity (NC) following procedure: as a result of Internal Quality Ai other source; and effects of Non Conformity The Initiator document the nonconformity by preparing Request For Action te and recommend if the issued RFA is whether NC, Or @ potential nonconformity is detected, implement the (RFA) Form \udit, Management Review, Stakeholder's Complaint and The Initiator shall identify the detailed criteria, discussion of findings and consequences The initiator may combine multiple non-conformities with similar conditionsfrequirements into a single non-conformity LE an Xap Usht Rall Tranett Aatberty MASTER COPY Documents that do not bear fresh LRTA's official document slamp are considered "Uncontoled™~~ [ Doc. Code 2017-PR.CDQ.004 fe. PROCEDURE Page No. 4of8 Ww Revision 3 Control of Non-Conformity and Corrective Action pate Prepared 24 duly 2018 ate of Effectviy $0 OCT 2018 * The Initiator submits accomplished and signed RFA to the Head, IQA Team for review and control number assignment, as follows: a. Receiving Office.Initiator.Year.Series Number “Series Number is assigned by the Head, IQA Team and shall be reset as the year starts Examples O0A.IQA.2018.001 - For Office of the Administrator PLD.IQA.2018.001 ~ For the Planning Department © The Head, IQA Team shall be responsible for the issuance of the RFA to the Concerned Department/Division/Unit/Office Head: * The Overall IQA Team Leader shall monitor the status of actions and inilates folow. Ups until the non-conformity is resolvediciosed * DepartmentDivsion/Otfice/Unit Head acknowiedge receipt of RFA. 5.3 Correction/Mitigation, Root Cause Analysis and Corrective Action When an RFA is received by the concerned departmentidivision/unitlotfice head, implement the following procedure 53.1 Department Division’ UnitsOfice Heads shal immediately make a correction! Iitgaton action or a stop gap solution of the non-conformty while analyzing its cause, 5.32 Perform a Root-Cause Analysis (RCA) for the non-conformty. As necessary, use quality tools such as a "Fishbone Diagram’ to further identify and analyze the root cause of the problem; 53:3 Formulate corrective action using the results of the RCA, The action to be taken shall address the identified cause/s of the NC: a Documents that do not bear fresh LRTA's offal document slap are considered" UnconTONe? D LUght Rall Transit Authority MASTER COPYDoc, Code 2017 PRODON mM PROCEDURE Page No ee Re No. Control of Non-Conformity and Corrective Action Oa se 2 uly 2018 __| Date of Effectivit 80 OCT 2018 534° The personnel responsible in providing and implementing the corectve action shall include the following information: + Acdetailed description of action/s taken to correct the problem * Timeline for implementation of corrective action + Proposed corrective action taken to prevent recurrence + Method for the determination of effectiveness with acceptance criteria * Identify the stating point of monitoring and end point of correction andlor corectve action duly signed by the concemed departmentdivision/unilofice head: 5.3.5 Duly accomplished and signed RFA by the concemed departmentidivision/unitfoffice heads Shall be returned to the Head, IQA Team on or before seven (7) working days upon receipt of RFA. 5.4 Disposition and Monitoring of Corrective Action Taken 5.4.1 The concemed DepartmentDivision/Unit/Office Heads shall be responsible to carry out the Decessary corrective actions. To lower the risk of recurrence of detected NCs, and the risk of occurrence of potential NCs, concemed DepartmentDivision, UnitiOfice Heads shal monitor if actions are carried out according to the targeted implementation date. 54.2 The Overall IQA Team Leader shal review and evaluate if comective actions sufficiently address the root cause of non-conformities. 54:3 _ Relumed RFA without a stated root cause, or without corrections or corrective actions that will solve the root cause WILL BE REJECTED. 5.5 Determining Effectiveness of Corrective Action 55.1 The Overall IQA Team Leader shall evaluate and validate ifthe corrections and corrective action’s has been effective in mitigating the cause of the non-conformity before the Correction action can be successfully completed. The effectiveness verification must be documented on the RFA Form. A793 Documents that do not bear fresh LRTA's offical document stamp are considered "Unoonirole?” o Light Rall Transit Authority MASTER COPYDoc. Code 2017,PR.CDQ.004 a. PROCEDURE Page No. 6018 Revision No. 3 4 a . Date Prepared 24 July 2018 Nis nti qu pare ly Control of Non: ‘Conformity and Corrective Action Date of Effectity 30 OCT 0 'n evaluating the effectiveness of the Corrective Action, the following shall be considered: Was the problem captured accurately and completely? Has the extent of the problem been captured? Was the cause effectively identified and mitigated? ‘Was the corrective Action completely defined, planned, documented, verified, validated and implemented as intended? 5.6 Follow-ups 5.6.1 To check the effectiveness of corrective action taken, a follow-up activity shall be done by the assigned IQA Team Leader 5.6.2 The assigned IQA Team Leader should ‘complete the following information under Follow Up of the RFA as follows: © The date of the follow-up * The result of the follow-up. In case that the corrective action taken is not effective in resolving the problem, this will be discussed to the attention of the concemed Department / Division / Unit / Office Head and another corrective action plan may be initiated. ‘The Status / Remarks Printed Name and Signature of the IQA Team Leader and its members and concurrence of the Auditee / Process Owner / Department / Division Head/Unit/Office Heads 5.6.3 The assigned IQA Team Leader will follow up all Corrective Action/s to ensure effective and timely responses are achieved. IQA Team Leader wil culminate/conclude the RFA when objective evidence of satisfactory resolution has been achieved. Preventive action such as, implementing, modifying or enforcing procedures, policies or controls will be taken to avoid ‘epetition of the non-conformance where necessary 5.6.4 The Head, IQA Team directs the Deputy Document Controller to record follow-ups made and indicate in the remarks column the status ofthe issued RFA on the RFA Receiving and Issuance Registry. a ‘Documents that do not bear fresh LRTA’s official document stamp are considered “‘Uncontroled”™ es ght Rail Transit Aathortty MASTER CopyDoc. Code 2017 PRCDOOGE fh, PROCEDURE Page No. Tof8 Ww _ a Revision No. 3 Control of Non-Conformity and Corrective Action | 22% repored_—_| 24 7 ann 5.7 Timeframes The Overall IQA Team Leader shall evaluate the effectiveness of the action taken and monitor if implemented on the target completion date, However, in the event that corrective action/s not implemented on the said completion date, the Auditee shall request for an extended time schedule indicating the reason and the resources needed to complete the corrective actionls to the Head, IQA Team and Head, QMS Core Team. 5.8 Closeout When the Auditee successfully implemented all corrective action/s and verified their effectiveness by-the Overall IQA Team Leader, the Head IQA Team will submit a report to the Head QMS Core ‘Team for Management Review. The IQA Team Leader wil provide the Auditee with a copy of the RFA with the stamp "CLOSED" under the remarks column. 5.8 Record the Results Any changes to the quality management system procedures, as a result of corrective actions, will be recorded. All documentation and records generated by the corrective action process will be managed in accordance with ISO 9001:2015 Clauses 4.3; 87.2 and 10.2.2 5.7 Management Review The Management Committee shall hold reviews of corrective actions that are brought by the Head, QMS Core Team to verify the effectiveness of corrective actions taken and potential improvement to other areas of the organization as required under Section 8.4 Management Review of the Quality Manual. cial document stamp are considered “Uncontrolled” Ge Documents that do not bear fresh- : Doc. Code 2017, PR.CDQ.004 f*. PROCEDURE Page No 8018 | ww L Revision No 3 : ; ive Action (Date Prepared 26 July 2076 Control of Non-Conformity and Corrective Action Date of Efectvity 30 Oct 20 The topics for the reviews will include: Tesources required to complete corrective actions. Report of all corrective actions closed during the preceding semester Reports of corrective actions taken and its effectiveness: improvements and changes. 6.0 REFERENCES 6.1. Quality Manual - 2017.0M.CDQ,001 6.2. Clause 10.2 ISO 9001:2015 ~ Non Conformity and Corrective Action 7.0 QUALITY RECORDS 7.1 RFA Receiving and Issuance Registry - 2017.FO,QA.007 se0ti2er8 7.3 Request For Action (RFA) - 2018. Fo. cdo. 009 Review of all unresolved corrective actions including proposed timeline for completion and any Review of Request for Action Receiving and Issuance Registry including recommended Prepared by: Reviewed by: Overall | b a . MS, MARIA ESTELA S, BOQUIREN a paki TAPIA |QA Team Leader Head, IQA Team a IM aro “Approved by: ENGR. ALFREDO yar. ENGR. NELON P.VLLANUEVA | GEN. RRANALDO |. BERROVA | Overaittak Tam Leader Hebtr@ts Core Team | Adminifrator OC ‘Documents that do not bear fresh LRTA's oficial document stamp are considered Uncontrolled” ra Light Rail Transit Authority MASTER COPY