The purpose of this procedure is to describe handling of incident, complaint and appeals received from the client, in house and from other parties.
This procedure covers all complaint and appeal received at Organization by any means, like written, verbal, e–mail etc. It also includes adverse findings during audits, inspection, survey or other third-party assessment services performed by LiberoGroup.
Quality Manager is responsible for receiving the complaint and appeal from the clients / other parties. They, in consultation with the office staff and involved individuals are responsible for handling, validating and analysis of the complaint and appeal to the satisfaction of the clients / other parties
The overall responsibility to execute this procedure is given below.
Completion and submittal of incident report records for entry into the Corrective Action System
All LiberoGroup staff members
Incident investigation and analysis
Quality Manager with technical assistance as required.
Handling of Appeals and Submission to Appeal subcommittee (for appeals)
Appeal review, analysis and decision
4.0 Description of activity
4.1 Quality System Incidents
For the purposes of this document “Quality System Incidents” are defined as complaints, suggestions, observations and opportunities for improvement. Quality System Incident data is entered into the QP_04_Procedure for Corrective and Preventive Actions. This procedure describes the methodology by which LiberoGroup collects and processes incident reports and communicates the impact to staff members.
LiberoGroup recognizes that incidents occur in daily operation and collectively have an impact on the Quality Management System. In order to properly analyze and address system issues a consistent and thorough process for collection of information is vital.
Complaints are incidents of grievance or dissatisfaction with LiberoGroup service.
Complaints may be:
- internal in nature – raised by a LiberoGroup staff member with regard to internal service, operations or employee performance
- external in nature- raised by LiberoGroup clients, suppliers or other affiliated organizations
- complaints raised by client’s customers or stake holders
4.3 Terminology used in this procedure for incidents
The incidents and complaints are considered as any of the below 4 types and procedure describes the system for handling the same.
LiberoGroup recognizes that positive feedback is as important as negative. Suggestions are vital in identifying preventive action and system improvement. As with complaints, suggestions may be internal or external in nature, written or verbal.
LiberoGroup recognizes that the client may have some reservations or may not agree with the conduct of auditor/surveyor, audit/survey findings, certification committee decision and / or overall interaction with LiberoGroup staff. Client is free to communicate the same to LiberoGroup Appeal subcommittee and this is treated as an appeal from the client.
Observations are witnessed incidents of service/operational deficiency, malfunction and or failure. Observations are often made by individuals independent of the activity witnessed and therefore objective in nature. Observations also play important role in identification of preventive action and system improvement.
4.3.4 Opportunities for Improvement
Opportunites for Improvement are incidents where the system has not failed, yet greater operational efficiency may be obtained in analyzing current practice. Opportunites for Improvement are often collected internally, but input from external sources is also beneficial.
4.4 Receipt of Incidents
The quality incident may be reported by any means – verbal or written. In case of an external source, the incident report may be received by any staff member. The staff member shall fill the Incident report recording all the information and details of the complaint. The filled report shall be submitted to Quality Manager for further action. In case of internal source, the incident report shall be filled by the staff member and submit to Quality Manager.
Quality Manager shall contact (telephone, email, letter) the external source to acknowledge the receipt of information within 5 working days of receipt. He shall understand the issue in details from the source (to avoid any error in writing the report). He may decide to personally meet the initiator, depending on the gravity and seriousness of issue.
All such incidents received by any means or by any one is first of all recorded in the Incident report with the details of;
- Complaint and appeal sr. No.,
- Way of receipt,
- Received by,
- Name of client / third parties,
- Description of complaint and appeal,
- Reference of services against, which complaint and appeal is raised alongwith the reference ,date and other details.
Client / other parties’ complaint and appeal incident report are issued to the Quality Manager for analysing the root cause.
Quality manager validates the complaint after checking necessary back–up records or personal interview of auditors / surveyors / staff members (who were involved into the job).
4.5 Handling of Client Complaint and Observations
In case of a complaint / observation against LiberoGroup, Quality manager analyses the issue to determine if there is system error or person error. He shall determine the root cause and determine correction, corrective and preventive action.
The correction is effected immediately to satisfy the complainant. This may include training / counseling the person involved. The CAPA is discussed with management during next Management Review. Appropriate action is taken based on discussions (change in procedure / formats, training to all personnel etc). An email is sent out to all staff detailing the issue and remedial action (for information). A copy of the complaint and investigation details is maintained in the respective individual’s personnel file for reference at the performance appraisals.
In case of a complaint / observation against a certified client, the Quality Manager studies the complaint and discusses with the auditor / surveyor (last audit / survey). If the complaint is found genuine and valid i.e. indicates a system failure, the complaint is sent to the client for a response. No confidential reports or information will be sent to complainants without written permission from the client. Adequate time is given to the client for response. If required, Quality Manager follows up with the client for the response. Depending on the response, Quality manager may decide to:
- Write to the complainant about the response and asks for his response.
- Ask further clarification from the client
- Depute an auditor / surveyor to personally visit the client and investigate for failure. Such visit shall be considered as special visit and charged to client.
- Request a joint meeting with client, complainant and LiberoGroup
Quality manager shall communicate with the complainant at the end of the process detailing the findings and to formally close the complaint. A copy of the correspondence is kept in the client file for records and the same is passed to auditor during next audit. The details of all complaints and action taken (Correction, CAPA) are discussed in Management Review and IC meeting.
4.6 Handling of Appeals
Any company or organisation who fails to satisfy an audit or surveillance may appeal against the decision. Where an appeal is received the following procedure will be followed.
The MD will appoint the members of the appeals committee under the leadership of MD who will hear the appeal and determine the outcome. In case, MD are part of the audit/ certification team, MD shall decide the investigating officer for the appeals process. In such a scenario MD shall approach Impartiality Committee and/or LiberoGroup team to provide decision on the appeal. The decision on the appeal shall be taken based on the decision by LiberoGroup committee and the Impartiality committee. Results of the appeal will be reported to the board of directors.
- All appeals shall be received by the Technical Manager and details of appeals shall be recorded in the Appeals Register maintained by the Technical Manager.
- Technical Manager shall investigate the appeal made and inform the client about its plan of action for investigation and action there upon.
- An investigation report (Incident Report) for each individual appeal shall be maintained by the Technical Manager. In case, any further corrective action is required post actions identified and taken based on Incident report QP_04_Procedure for Corrective and Preventive Actions is implemented.
- A copy of the investigation report shall be sent to the client.
- In case of any further ambiguity, the same shall be reviewed by the board of directors and appropriate decision arrived at.
- In case the issue still remains open; the same shall be intimated to the accreditation board for its valuable comments.
- All appeals made are collated and analyzed on a yearly basis.
- Necessary corrective and preventive actions shall be taken based on the appeal trend.
- Appeal trends and corrective and preventive action taken shall also be reviewed as part of the Management committee meeting and Impartiality committee meeting.
- Technical Manager shall ensure that details with respect to the appellant and actions there upon is not shared with the audit / survey team members.
- Technical Manager shall ensure that no discriminatory action is taken against the appellant.
- The client is made aware of the appeals process and is available to him on request.
In case of an appeal made by a client against a decision made by auditor, Lead auditor, surveyor or certification committee, the appeal shall be recorded by Quality Manager and forwarded to Appeal Subcommittee. Appeal subcommittee shall review the appeal, investigate (which may include discussion with concerned client, respective auditor / lead auditor / surveyor and review of audit / survey report(s)). Appeal subcommittee may also direct any other lead auditor / surveyor to visit onsite and determine the validity of the appeal. The decision taken by Appeal subcommittee shall be communicated to the client and to Quality Manager for necessary action. The case is also discussed during the next MRM and Impartiality Committee meeting. In special cases, the case may be discussed with Impartiality Committee members on one-to-one basis.
4.7 Handling of Suggestions /Opportunity for improvement
- In case of suggestion / opportunity for improvement, the source is predominantly internal and the concerned staff member fills the incident report and submits to Quality Manager. The other source may be internal / external audit.
- Quality Manager studies the suggestion to determine any conflict with ISO17021, LiberoGroup Policy. In case the suggestion is in conflict, the same is communicated to the initiator. However, the suggestion is also discussed in Management review. In case the suggestion is found not in conflict, the suggestion is studied for benefits and the impact on other processes.
- The suggestion is accepted if found beneficial and does not adversely impact any other process. Quality Manager determines the changes in existing documentation and implements through Document Change process (QP01).
- If any certified client or interested party asks for the appeal/complaint handling process then it is forwarded to Quality manager. He will inform a certified client /any other interested party the appeals and complaint handling process of LiberoGroup if any complaints / appeals are received by certified clients / interested party
4.8 Closing of complaint and appeal
Depending on the nature of the non–conformity, the Quality Manager / Technical Manager may follow up with requests for corrective and preventive actions. When the investigation of client complaint and appeal determines that remote operation or other external organizations contributed to the complaint and appeal, the Technical Manager or his delegate contacts these organizations and provides them with all relevant information.
Every client complaint and appeal is recorded. The records are maintained by the Quality Manager / Technical Manager. When there are copies of written communication, reports and other documents related to a complaint and appeal, these records are organized into a file and are identified with the complaint and appeal number and also having records of the corresponding corrective or preventive actions. The records of investigations that concern product quality or other test characteristics are maintained by Technical Manager. Based on analysis of Client / Other Parties complaint and appeal, necessary actions are taken and client is replied for closing the complaint and appeal. Quality Manager identifies need for taking corrective and preventive action to prevent such complaint and appeal in future and accordingly concerned person is informed.
In case of negative certification decision the client can file a complaint or appeal within 7 working days after notification of the negative certification decision from LiberoGroup.
All the complaint and appeal received by Organization will be closed within 7 working days after receipt of the complaint and appeal. Operation Manager / Technical Manager is authorised for closing of complaint and appeal.
- QP_01_Document Control
- QP_04_Procedure for Corrective and Preventive Actions
7.0 Working Forms
- WF_2300_Incident report
- WF_2400 Incident Log
8.0 Revision History
Update to LiberoGroup in order to cover all brands
Inclusion of appeal deadline upon negative certification decision notification