Follow
1.0 OBJECTIVE
To provide a procedure to establish a systematic detection and evaluation of non-conformance from different sources and effective implementation and follow up action of their corrective and preventive measures.
2.0 SCOPE
This SOP shall be applicable for all employees responsible for detection, evaluation, correction and prevention of non-conformance of different sources.
3.0 ASSOCIATED DOCUMENTS
3.1 SOP No. IONGE025 Internal Quality Audits
3.2 SOP No. IONQA018 Handling and Disposition of Non-conforming Raw and Packaging Materials
3.3 SOP No. IONQA019 Handling and Disposition of Non-conforming Products
3.4 SOP No. IONQA020 Handling of Process Non-conformance
3.5 SOP No. IONQA022 Handling of Customer Complaints
3.6 SOP No. IONGE026 Control of Non-Conformities
3.7 SOP No. IONGE028 Quality Risk Management
4.0 RESPONSIBILITY/ACCOUNTABILITY
4.1 Head of Quality/Sr. Manager, Quality
4.1.1 He or she shall review the corrective and preventive actions of non-conformity.
4.1.2 He or she shall evaluate the effectiveness of QM system on corrective and preventive actions.
4.2 Head of Production
4.2.1 He shall ensure implementation of suggested and approved actions by Head of departments.
4.2.2 He shall Inform Head of Quality/Sr. Manager, Quality of all corrective and preventive actions.
4.3 Manager, Production/DGM, Engineering
4.3.1 He shall assign an employee to investigate when inter departmental involvement is required.
4.4 Head of Department
4.4.1 He shall receive non-conformance reports and thereby investigate, determine and implement corrective and preventive measures.
4.4 Officer of Concerned Department
4.4.1 He shall report to the Head of Department of any non-conformance.
4.4.2 He shall Implement the corrective and preventive actions.
4.4.3 He shall investigate if assigned for and submit post implementation report.
5.0 ABBREVIATIONS AND DEFINITIONS
5.1 QAO – Quality Assurance Officer
5.2 SBM – Strategic Brand Management
6.0 PRECAUTIONS /SPECIAL INSTRUCTIONS
Not applicable.
7.0 PROCEDURE
7.1 To eliminate the cause of nonconformity corrective action shall be taken to prevent recurrence. Corrective action shall be appropriate to the effect of nonconformity encountered.
7.2 To eliminate the cause of potential nonconformity preventive action shall be taken to prevent occurrence. Preventive action shall be appropriate to the effect of potential problem.
7.3 Important variables causing the non-conformities shall be identified through investigation.
7.3 Corrective Action
7.3.1 Corrective action shall deal with immediate elimination of actual cause(s) of non-conformity from the quality system, which presupposes the reprocessing, recall or destruction of unsatisfactory product, process etc.
7.3.2 The corrective action procedure includes the following steps :
Reviewing non-conformity
Investigating
Determining the action needed
Evaluating the need for action
Implementing the decided action
Reviewing effectiveness of action taken
7.3.2.1 Reviewing non-conformity
7.3.2.1.1 Corrective action shall begin with the reviewing of non-conformance from different sources.
7.3.2.1.2 QA personnel raising non-conformance shall review and categorize the source in form no. GE027-01 by putting tick mark in one of the 05 columns. He or she shall assign a non-conformance reference number as per SOP no. IONGE026.
7.3.2.1.3 The Units have identified its five originating source of non-conformance, namely –
Process
Material
Product
Audit Report
Customer Complaint
Process Non-conformance
The process non-conformance shall be handled as per SOP No. IONQA020.
Non-conformance of Raw and Packaging Material
Non-conformance of material can originate during receipt or disposition of material or during manufacturing. The non-conformance of material shall be handled as per SOP No. IONQA018.
Non-conformance of Product
Non-conformance of intermediate and bulk product and finished product shall be handled according to SOP No. IONQA019.
Audit Report Non-conformance
Non-conformance identified during audit shall be handled according to SOP No. IONGE025.
Non-conformance Originating from Customer Complaint
SBM Department shall send the customer complaint to Sr. Manager, Quality. The non-conformance originating from customer complaint shall be handled as per SOP No. IONQA022.
7.3.2.2 Investigating
7.3.2.2.1 Important variables shall be considered to find the root cause of critical non-conformities through investigation.
7.3.2.2.2 Head of Quality and/or Sr. Manager, Quality shall be responsible for planning, coordinating, managing and overseeing the CAPA program to investigate the cause of non-conformance originating from materials/product, process, audit reports and customer complaints.
7.3.2.2.3 In case, assistance is required from other department or external sources, Sr. Manager, Quality shall forward the form no. GE027-01 to Manager, Production or DGM, Engineering.
7.3.2.2.4 Head of Department shall also decide any investigation of the non-conformance observed during internal audit and non conformance originating from customer complaint.
7.3.2.2.5 In all the cases an investigation report shall be prepared and submitted to Manager, Production or DGM, Engineering or Sr. Manager, Quality.
7.3.2.3 Determining the action needed
Analyzing the investigation report and other quality related considerations necessary corrective actions shall be determined and proposed by Auditor or concerned department in charge with assigned responsibility and completion time. The proposed action shall be jointly discussed by Production, Engineering and QA.
7.3.2.4 Evaluating the need for action
Sr. Manager, Quality and/or Head of Quality shall evaluate the need for action to ensure that the non-conformity does not occur. It shall be assessed jointly with Production and Engineering whether the action proposed is sufficient or not. If not, further required actions shall be included and approved by Quality.
7.3.2.5 Implementing the decided action
7.3.2.5.1 The agreed actions shall be implemented by the person assigned by Sr. Manager, Quality or Manager, Production or DGM, Engineering.
7.3.2.5.2 The responsible employee of the concerned department shall then submit a post implementation report to Sr. Manager, Quality.
7.3.2.6 Reviewing effectiveness of action taken
Sr. Manager, Quality and/or Head of Quality shall review the effectiveness of the action taken by assessing the frequency of recurrence annually. Considering the nature of non-conformance and its effect on product quality, necessary preventive measures shall be taken and recorded.
7.4 Preventive Action
7.4.1 Preventive action shall deal with elimination of potential non-conformity from the quality system.
7.4.2 The preventive action procedure includes the following steps :
Determining potential non-conformance
Investigating the cause
Determining the action needed
Evaluating the need for action
Implementing the decided action
Reviewing effectiveness of action taken
7.4.2.1 Determining potential non-conformance
7.4.2.1.1 Preventive action shall begin with the determination of potential non-conformance from different sources. Sources may be material, equipment, personnel, environment, measurement system and method. Potential non-conformities originating from any of the above sources shall be reported through Form No. GE027-02.
7.4.2.1.2 QA personnel shall raise the potential non-conformance and categorize the source in form no. GE027-02 by putting tick mark in one of the 06 columns. He or she shall assign a non-conformance reference number and forward to Sr. Manager, Quality.
7.4.2.2 Investigating the cause
7.4.2.2.1 Sr. Manager, Quality shall initiate an investigation team consisting of Production, Engineering and QA personnel.
7.4.2.2.2 The investigation shall determine the root cause of potential non-conformities through risk management (SOP No. IONGE028).
7.4.2.2.3 The investigation team shall be responsible for planning, coordinating, managing and overseeing the preventive action program to investigate the cause of potential non-conformance.
7.4.2.2.4 An investigation report shall be prepared and submitted to Sr. Manager, Quality.
7.4.2.3 Determining the action needed
The investigation team shall determine the appropriate steps for preventive action and assign responsibility with completion time.
7.4.2.4 Evaluating the need for action
Sr. Manager, Quality and/or Head of Quality shall evaluate the need for action to prevent occurrence of non-conformity. It shall be assessed jointly with Production and Engineering whether the action proposed is sufficient or not. If not, further required actions shall be included and approved by Quality.
7.4.2.5 Implementing the decided action
7.4.2.5.1 The agreed actions shall be implemented by the person assigned by Sr. Manager, Quality or Manager, Production or DGM, Engineering.
7.4.2.5.2 The responsible employee of the concerned department shall then submit a post implementation report to Sr. Manager, Quality.
7.4.2.6 Reviewing effectiveness of action taken
Sr. Manager, Quality and/or Head of Quality shall review the effectiveness of the action taken by assessing the frequency of occurrence annually. Considering the nature of potential non-conformance and its effect on product quality, necessary measures shall be taken and recorded.
7.4.3 Head of Quality/Sr. Manager, Quality shall place the report in management review meeting.
7.5 Management Review
7.5.1 The non-conformities reported in Form No. GE027-01 and GE027-02 shall be discussed in the Management Review Meeting.
7.5.2 The Management Review Committee shall decide further action if needed in addition to action already taken to handle a stated non-conformity.
7.5.3 All such decisions shall be implemented in a similar manner as corrective and preventive actions are taken.
