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 Corrective Action System for proper treatment (QP04). This procedure describes the methodology by which ISOQAR collects and processes incident reports; and communicates the impact to staff members.
ISOQAR recognizes that incidents occur in daily operation that 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 dissatsifaction with ISOQAR service. Complaints may be:
internal in nature - raised by a ISOQAR staff member with regard to internal service, operations or employee performance
external in nature- raised by ISOQAR clients, suppliers or other affiliated organizations
complaints raised by client’s customers or stake holders
ISOQAR 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.
ISOQAR recognizes that the client may have some reservations or may not agree with the conduct of auditor, auditor impartiality / confidentiality, audit findings, certification committee decision and / or overall interaction with ISOQAR staff. Client is free to appeal against these 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.,/p>
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.
Any company or organisation who fails to satisfy an audit or surveillance may appeal against the decision. Client can also appeal when they have reservations regarding conduct of auditor, auditor impartiality / confidentiality, audit findings, certification committee decision and / or overall interaction with ISOQAR staff Where an appeal is received the following procedure will be followed.
The MD/ED/OD as applicable will appoint the members of the appeals committee and whose competency will be determined at time of appointment through F061B under the leadership of ED who will hear the appeal and determine the outcome. In case, MD / ED is part of the audit/ certification team, ED / MD shall decide the investigating officer for the appeals process. In such a scenario ED/MD shall approach Impartiality Committee and/or ISOQAR UK certification team to provide their inputs on the appeal. The decision on the appeal shall be taken based on the inputs by ISOQAR UK Certification committee and/or Impartiality committee by the appointed appeals committee. Results of the appeal will be reported to the board of directors.
- All appeals shall be received by the ED and details of appeals shall be recorded in the Appeals Register maintained by the ED. Receipt of appeal will be acknowledged
- ED shall investigate the appeal made and inform the client about its plan of action for investigation and action there upon.
- An investigation report (F070 Incident Report) for each individual appeal shall be maintained by the ED. In case, any further corrective action is required post actions identified and taken based on Incident report – Corrective action procedure QP04 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 shall be 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.
- Progress reports and out comes will be provided to the appellant
- ED shall ensure that details with respect to the appellant and actions there upon is not shared with the audit team members.
- ED shall ensure that no discriminatory action is taken against the appellant.
- Formal notice will be given to the appellant of the end of the appeals –handling process
- The client is made aware of the appeals process (F084) and the same is publically available..
Completion and submittal of incident report records for entry into the Corrective Action System
Incident investigation and analysis
Submission to Appeal subcommittee (for appeals)
Appeal review, analysis and decision
All ISOQAR staff members
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 (F070) recording all the information and details of the complaint. The filled report shall be submitted to Director Ops for further action. In case of internal source, the incident report shall be filled by the staff member and submit to Director Ops.
Director Ops 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.
In case of Complaints and Observations, it may be against ISOQAR (a system / procedure or a person) or a ISOQAR certified companies (client). In case of suggestion / opportunity for improvement, it is for ISOQAR to study the suggestion and decide.
In case of a complaint / observation against ISOQAR, Director Ops 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 possible complaints are –
- Administration - problems with appointments, certification files, certificates issued or issued late,
- Auditor/subcontractor problems with incomplete audit or surveillance documentation
- Agents - problems with general compliance with ISOQAR administration or audit procedures
The correction is effected immediately to satisfy the complainant. This may include training / counselling the person involved. The CAPA is discussed with other Directors 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 Director Ops studies the complaint and discusses with the auditor (last audit). 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,
Director Ops follows up with the client for the response. Depending on the response, Director Ops may decide to –
- Write to the complainant about the response and asks for his response.
- Ask further clarification from the client
- Depute an auditor to personally visit the client and investigate for system failure. Such visit shall be considered as special visit and charged to client.
- Request a joint meeting with client, complainant and ISOQAR
- Director Ops 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.
- Director (Operations) shall communicate with the client and the complainant whether to detail the compliant and its resolution on ISOQAR Website and if agreed by the client and complainant the extent to which it can be detailed will also be agreed. Depending on the input from the client and the complainant the compliant and its resolution shall be displayed on the ISOQAR Website. This display will be for a period of three months.
In case of suggestion / opportunity for improvement, the source is predominantly internal and the concerned staff member fills the incident report (F070) and submits to Director Ops. The other source may be internal / external audit.
Director Ops studies the suggestion to determine any conflict with ISO17021, ISOQAR Global policy and ISOQAR India 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. Director Ops determines the changes in existing documentation and implements through Document Change process (QP01).
In case of an appeal made by a client against a decision made by auditor, Lead auditor or certification committee, the appeal shall be recorded by Director Ops and forwarded to Appeal Subcommittee. Appeal subcommittee shall review the appeal, investigate (which may include discussion with concerned client, respective auditor / lead auditor and review of audit report). Appeal subcommittee may also direct any other lead auditor to visit the site and determine the validity of the appeal. The decision taken by Appeal subcommittee shall be communicated to the client and to Director Ops for necessary action. The case shall also be 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.
Director Operations will inform a certified client /any other interested party the appeals and complaint handling process of ISOQAR India if any complaints / appeals are received by certified clients / interested party. This is also publically available on ISOQAR website.