1.0 PURPOSE: 1.1 The purpose of this procedure is to implement a system for planned internal quality audits to verify compliance of the quality activities and related results with the planned arrangement and to determine the effectiveness of the quality system.
2.1 This procedure is applicable to all activities of the quality system and requirements of the national and international standards in the company.
3.1 Management Representative
5.1 Planned internal Quality Audits are designed for one or more of the following purposes:
5.1.1 To determine conformity or nonconformity of the activities to the specified requirement and elements of the International Standard/ Quality system.
5.1.2 To determine the effectiveness of the implemented quality system in achieving the specified quality policy and quality objectives.
5.1.3 To verify compliance of quality activities and related results with the planned arrangements, documented quality system.
Planned internal Quality Audits are of Three Types in Pharmaceutical or others Organization:
- Internal Audit, External Audits by Regulatory Bodies, Certification Bodies, Notified Bodies and Customers
- Un-announced audits by the Regulatory Bodies
- Internal quality audits are conducted at least twice a year.
5.2 Planned internal Quality Audits planning and scheduling
5.2.1 M.R. makes an annual plan for the internal audit.
5.2.2 Based on the annual plan, M.R. prepares an audit schedule based on the status and importance of the activity. He appoints the auditors for each area to be audited. Each audit team is required to audit all applicable elements of the quality system in the assigned department/function for audit.
5.2.3 M.R. informs the audit schedule to all auditors and the auditees.
5.2.4 Audit is conducted by the trained personal, independent of those having direct responsibility for the area/activity to be audited, wherever applicable & practical. External competent persons may also be hired specifically for carrying out internal audits.
5.3 Executing the audit
5.3.1 During the audit, the auditor, covers the entire scope of the auditor as advised by the M.R.
5.3.2 Before starting an audit, the auditor properly prepares a checklist wherever required for convenience in audit, to save wastage of time during the audit, and to follow a professional approach.
5.3.3 M.R. conducts an opening meeting among the auditors and audit heads to ensure the availability of the resources and facilities required to conduct the audit.
5.3.4 pieces of evidence are collected through interviews, the examination of documents,s, and observations of activities & conditions in the concerned area/function.
5.3.5 Clues indicating nonconformity are noted if they seem significant even though not covered by the checklist and are investigated.
5.3.6 Information collected through interviews is verified by obtaining the same information from other independent sources like physical observation, measurements, and records.
5.3.7 All audit findings are documented at the end of the audit, the audit team and audit head review the entire finding to identify the actual nonconformity. Audit findings are documented on the non-conforming report.
5.3.8 All the audit finding and nonconformity are acknowledged by the auditee or auditee head.
5.4 Audit Report
5.4.1 Audit report is prepared for identified nonconformity on Nonconformity reports for its accuracy and completeness and submitted to the auditee.
5.5 Audit Completion
5.5.1 Audit is completed on the submission of the audit report to the auditee.
5.6 Corrective action and follow-up:
5.6.1 Auditor is responsible only for the identification of the nonconformity.
5.6.2 Auditee dept. Is responsible for determining and initiating corrective action required to correct the nonconformity or its cause and for the closure of the raised nonconformity report.
5.6.3 Corrective action and its follow-up are completed within a time period, agreed by the auditor and auditee dept. If required, M.R. is also consulted in this regard.
5.6.4 On the agreed completion date or earliest possible, the auditor goes to the auditee department And verifies the satisfaction & effective implementation of the corrective action taken.
5.6.5 Auditor records his comments regarding verification of the corrective action taken. On satisfaction, he signs and closes the nonconformity.
5.6.6 M.R. includes the audit report with details of the corrective actions taken on the agenda of the next management review meeting.
5.6.7 All the documents in use must be duly approved and controlled prior to the issue to the user department.
5.6.8 Obsolete documents shall be removed immediately from the point of use.
NOTE: The audits that will be conducted include various applicable statutory and regulatory standards to avoid any oversight and lapses, e.g., all the statutory approvals, ISO 13485:2016, MDD 93/42/EEC as amended 2007/47, list of standards applied audits.
External Audits: External Audits are conducted by Regulatory Bodies, Certification Bodies, Notified Bodies, and Customers.
Regulatory Bodies: The Regulatory Bodies including CDSCO, State Licensing Authority. These Regulatory Bodies conduct audits and inspections at our site with prior information and sharing of the audit schedule. The communication regarding travel and stay (if required) is done with the respective designated Medical Device Officer / Drug Inspectors. The observations or deficiencies given by the Medical Device Officers / Drug Inspectors are eliminated by way of taking appropriate corrective actions and submitting the same to the Regulatory Authorities.
Notified Bodies: The audits are conducted annually. When the audit plan is received and the audit is conducted by the Notified Body Auditors. The Notified Body auditors provide the audit results, and if there is any nonconformity, we submit the root cause, corrective action plan, and based on the acceptance of the corrective action plan, the corrective actions are taken and completed as per the target dates.
Certification Bodies: The Certification Body audits us as per ISO / EN ISO 13485. The audits are conducted annually. The audit plan is received, and the audit is conducted by the Auditors. The auditors provide the audit results, and if there is any nonconformity, we submit the root cause, corrective action plan, and based on the acceptance of the corrective action plan, the corrective actions are taken and completed as per the target dates.
Follow-Up Audits: The follow-up audits are required to be conducted by these Regulatory / Notified and Certification Body only when there is a serious nature nonconformity that can affect the quality management system and product performance noticed during routine audits. The root cause analysis and corrective action plan are submitted to the auditors, and after acceptance of the same, the corrective action is initiated to be completed within the stipulated period of time. The auditors decide to verify the same on-site or off-site depending upon the type of nonconformity, and only after the verification of the evidence, the continuation is maintained.
Unannounced Audits: These are audits that are generally carried out by the Regulatory Bodies and Notified Bodies to verify the compliance to the requirements as a result of either a complaint or their own requirements, like the European Directive demands an un-announced audit within three years from the date of the certification audit. Handling of the unannounced audits is important from the point of view that it keeps everyone on the toes to ensure that there is no shortfall in compliance at any given point in time.
To our understanding, based on the directive, there will be a minimum of two auditors for an unannounced audit. They can come any time from the beginning of the shift till the end of the shift. Unannounced audits are not conducted on the weekly off and public holidays. The major focus during the unannounced audit will be on the production and inspection activities. The auditors will explain the reason for the audit and how the audit will be conducted. The auditors are allowed to pick the samples from the production line and do the verification that may include all the documents and persons from design till batch release, including validations as well. The auditors are allowed to take samples from the production line (as per their decision). The auditors are to cooperate throughout the audit as we do for the routine audits.
6.1 Always ensure the current revision of the documents is in use.
6.2 Audit records shall be legible and easy to retrieve.
7.1 Requirements of ISO 13485:2016, MDD 93/42/EEC, IMDR 2017.
9.2 Master Copy file.