Internal Audits ((Self Inspection)).pptx

A quality internal audit is a systematic, independent, and documented process for evaluating an organization's quality management system (QMS) to ensure it meets predefined standards, such as ISO 9001, and aligns with business objectives. It provides insights into performance, compliance, and areas for improvement.
Internal auditing is a crucial tool for maintaining consistency, compliance, and continual improvement within a quality management system. It involves examining processes, records, and systems to ensure they function efficiently while meeting quality standards.
Objectives of a Quality Internal Audit
A well-structured internal audit aims to:
- Ensure compliance with quality standards and regulations.
- Identify gaps and inefficiencies in the system.
- Support continuous improvement initiatives.
- Verify the effectiveness of corrective and preventive actions.
- Strengthen employee engagement in quality management.
A successful internal audit is built on the following principles:
- Independence: Auditors must be unbiased and objective.
- Competence: Auditors should have expertise in QMS.
- Systematic Approach: Audit activities must be planned and documented.
- Evidence-Based Decisions: Findings should be based on solid, factual evidence.
Audit Planning and Preparation
Before conducting an audit, proper planning ensures efficiency and effectiveness:
- Define the Scope: What areas will be audited?
- Set Audit Criteria: Are there regulations like ISO 9001 or internal policies to check?
- Prepare an Audit Checklist: A detailed list of items to review.
- Notify Auditees: Inform relevant departments of the audit.
Execution of an Internal Audit
An internal audit typically follows a structured process:
1. Opening Meeting
- Introduce auditors and explain the purpose of the audit.
- Review objectives and expectations with auditees.
2. Document Review
- Examine policies, records, and procedures.
- Assess compliance with quality standards.
3. On-Site Inspection
- Observe actual operations.
- Interview employees to gauge their understanding of quality processes.
4. Data Collection and Analysis
- Record non-conformities (deviations from standards).
- Identify best practices and improvement areas.
5. Closing Meeting
- Discuss findings with auditees.
- Provide initial feedback and recommendations.
Reporting Audit Results
A formal audit report summarizes findings and suggests corrective actions:
- Observations: Noteworthy findings.
- Non-Conformities: Areas that don’t meet standards.
- Recommendations: Steps to improve compliance.
- Follow-Up Actions: Define responsibilities and timelines for corrective actions.
Follow-Up and Continuous Improvement
The audit doesn't end with reporting; follow-up is essential for progress:
- Implement corrective actions to address gaps.
- Monitor improvements and re-audit as needed.
- Strengthen the organization’s culture of quality.
Conclusion:
A quality audit drives efficiency, accountability, and continual improvement

1. Internal 5/14/2025 1 [email protected]

2. Self Inspection & Self Development 5/14/2025 2

3. What's The meaning of Internal Audits, also known as Self Inspection in Quality , are a periodic process that examines documents and records to verify their alignment with actual operational practices. This evaluation assesses the extent to which a company's activities and processes comply with applicable laws, regulations, and established standard operating procedures. The primary goals are to ensure operational efficiency, continuously improve performance, minimize risks, enhance transparency, and prevent errors. Internal Audits / Self Inspections ? 5/14/2025 3

4. Objectives of Internal Audits Ensuring compliance with policies and regulatory laws. Ensuring the implementation of approved operational procedures, referred to in the quality system as Standard Operating Procedures (SOP). Analyzing performance and addressing any gaps between practical execution and documented procedures. Continuously improving performance. 5/14/2025 4

5. The Importance of Implementing Internal Audits Simply put: "Review your performance before someone else does." By implementing internal audits, an organization can: ✔ Avoid potential fines. ✔ Prevent performance weaknesses and maintain acceptable consistency. ✔ Preserve its reputation and enhance customer satisfaction. It’s a proactive approach to staying ahead and ensuring smooth operations 5/14/2025 5

6. Who Conducts Internal Audits? Performed by a specialized and trained team within the organization (provided that conflicts of interest and the influence of personal relationships are avoided), or by an independent and accredited entity (considered an external service provider subject to the guidelines for evaluating and selecting external service providers). 5/14/2025 6

7. Internal Audit Scope Internal audits may be financial in nature, where they examine financial records and performance, or they can focus on the company's quality management system , assessing compliance with quality standards and approved procedures. 5/14/2025 7

8. Internal Audit Timing Internal audits are a periodic exercise, with their frequency determined by risk assessments and the results of previous audits for the same auditee. There are two types in terms of timing: - Planned Internal Audits: These are routine audits carried out according to a predetermined schedule (often an annual plan), where the auditee is notified of the execution date in advance. - Unplanned Internal Audits (Internal Inspections): These occur as a measure to control performance and reinforce continuous monitoring. They may be initiated due to a customer complaint or following a regulatory visit. When Is the Internal Audit Conducted? 5/14/2025 8

9. Internal Audit Steps Examination of documents and records. Discussion with the operational teams. Monitoring the implementation in the field to assess the alignment of written procedures with actual execution. Stages of Internal Audit Implementation , simply ! 5/14/2025 9

10. Developing an Internal Audit Plan for the Quality Management System - Which activity/activities will be audited? - Which department or section will be audited? - What documents and records are required to be provided during the audit? - Which individuals are required to be present during the audit period? 1. Defining the Audit Scope 5/14/2025 10

11. Developing an Internal Audit Plan for the Quality Management System 1. The internal audit team should be qualified and trained. 2. It consists of a Lead Auditor and Internal Auditors. 3. The Lead Auditor holds a certificate from an accredited body as a Lead Auditor for the ISO 9001 system. 4. Depending on the nature and objective of the internal audit, there may be only one internal auditor. 5. The internal auditor has received the necessary training to perform his duties. 2. Selecting Internal Auditors 5/14/2025 11

12. 1- Elegance and Order (It is customary for a quality system auditor to be seen as exemplary in both appearance and performance.) 2- Punctuality and Time Management (Be a true role model right from the start.) 3- Neutrality and Independence (There should be no room for personal interests or conflicts of interest to influence your performance.) 4- Integrity and Transparency (Do not allow collegial relationships, kinship ties, or friendly dealings to play any role in your performance or decision-making.) 5- Precision and Avoidance of Exhaustion (Ensure you have ample rest before the visit and, while performing your duties, do not let any social engagements encroach on your work time.) 6- Focus and Avoidance of Distractions (Do not permit side discussions or casual chats to distract you or provide opportunities for establishing personal relationships that might lead to special interests.) Personal Traits of an Internal Auditor for the Quality Management System 5/14/2025 12

13. Developing an Internal Audit Plan for the Quality Management System An audit checklist covering all items of the quality system is prepared in advance. This checklist is considered essential, serving as a key reference and guide when preparing for any internal audit. It is the result of a brainstorming workshop among the qualified and specialized audit team. When preparing the checklist, international and local references and standards for the quality system—relevant to the company's field of work—should be taken into account. Depending on the activity or activities being audited, the basic checklist prepared earlier may be modified by adding, changing, or removing any item that is unnecessary, not implemented, or not mandatory. 3. Preparing the Audit Checklist 5/14/2025 13

14. - Commitment of senior management (the department or unit head) to implementing quality requirements. - The existence of a quality policy and objectives that are periodically reviewed. - An organizational structure supported by job description forms. - A training plan supplemented by continuous specialized training sessions. - Monitoring and evaluation of the performance of both operations and employees. - Tracking the achievement of quality in products or services. - Monitoring and evaluating the performance of external service providers. - Quality contracts. - Risk records along with their follow-up and identification of improvement opportunities. ISO 9001 Guiding Keys (and Their Adaptation for Each Audited Department or Section) 5/14/2025 14

15. Developing an Internal Audit Plan for the Quality Management System In the case of a scheduled internal audit, The responsible person(s) of the audited department should be contacted in advance of the audit date. The communication must be conducted using an appropriate, effective, and documented method. This notification includes: - Visit Date: Clearly stating the scheduled date of the visit - Audit Team Details: Providing the names of the audit team members If the auditors are external, a brief CV including their qualifications is recommended. - Visit Agenda : Outlining the schedule of the visit which typically starts with introductions and a clarification of the audit objectives / Detailing the steps of the audit process / Concluding with a closing session where the audit results are discussed / Indicating any break periods, such as for coffee or lunch, as agreed upon. - Required Documents and Records: Listing all the documents and records that must be provided during the internal audit. - Required Presence of Personnel: Specifying which individual(s) from the audited department's team are required to be present during the visit. This structured approach ensures that all parties are well informed and that the audit process is transparent and efficient 4. Contacting the Auditee 5/14/2025 15

16. Steps for Conducting Internal Audits for the Quality Management System Introduce yourself and your audit team. Explain the objectives and the rationale for the audit clearly. Reconfirm the agenda items with the auditee and then invite them to introduce themselves, their management, or their company. This approach builds mutual understanding and sets a collaborative tone for the audit process. First Step: Opening (Introduction) 5/14/2025 16

17. Steps for Conducting Internal Audits for the Quality Management System Request the documents pertaining to the audit and examine them thoroughly. Discuss and inquire about any ambiguities within them. Leverage your expertise to evaluate the authenticity, effectiveness, applicability, and seriousness of these documents. Step Two: Document Presentation 5/14/2025 17

18. Steps for Conducting Internal Audits for the Quality Management System Consider the previous step as representing a model virtual environment that might be ideal. Now, begin your real journey by visiting the actual sites where the documented processes are implemented. Walk around and engage with the employees—as much as possible without the supervisors' interference—to obtain firsthand insights. Compare what you personally observe and experience with what has been documented and recorded. Once again, your expertise will be essential in uncovering the underlying realities. Step Three: On-Site Tour 5/14/2025 18

19. Steps for Conducting Internal Audits for the Quality Management System A meeting called the "Wrap-up Meeting" is held, during which the Lead Auditor discusses their observations and the overall contents of the report. The auditee is given the opportunity to justify, discuss, and clarify any points. A professional internal auditor leaves the meeting with a clear understanding of the audit report, having fully grasped its content. Step Four: Closing (Discussing Visit Findings) 5/14/2025 19

20. Internal Audit Report The audit report is drafted by the auditors and approved by the Lead Auditor, and it includes three sections: - Positive Observations - Nonconformities (NCRs) - Opportunities for Improvement (OFI) Nonconformities may be categorized into three levels: - Critical Issues (Critical): Definition: Failure to include mandatory requirements in the quality management system that directly affect the quality of the product or service. Example: The absence of a means for customer communication. - Major Issues (Major): Definition: Basic written instructions exist but are not effectively implemented. Example: Failure to conduct a thermal distribution study for a pharmaceutical warehouse on time. - Minor Issues (Minor): Definition: Instructions or guidelines exist but are not consistently applied, and they do not have a direct impact on the quality of the product or service. Example: Failure to conduct employee training as scheduled. 1. Audit Report Preparation 5/14/2025 20

21. Internal Audit Report The report is sent after approval, within the timeframe specified in the organization's internal audit instructions, to the senior management of the audited entity. The responsible persons from the audited entity are required to respond to the report within the stipulated period using the approved Corrective/Preventive Action form. 2.Sending and Receiving the Response 5/14/2025 21

22. Internal Audit Report The internal audit team reviews the Corrective/Preventive Action (CAPA) plan, ensuring that it meets the requirements for an effective action plan as follows: - Identification of the Root Cause: Determining the underlying reason for the issue. - Corrective Actions and Prevention: Outlining procedures to address the issue and ensuring that it does not recur. - Responsibility for Implementation: Specifying the entity responsible for executing the plan. - Planned Implementation Deadline (DUE DATES) : Clearly stating the scheduled date for the completion of the corrective actions. Additionally, the team verifies the effectiveness of the proposed actions and the realism of the scheduled implementation due dates. If the actions were completed prior to submitting the plan, any supporting documentation can be attached to confirm this. Furthermore, the audit team may provide the auditees with the necessary guidance and advice to help prepare a robust action plan. 3. Reviewing the Report Response 5/14/2025 22

23. Internal Audit Report The Corrective/Preventive Action (CAPA) plan is approved by the audit team. The responsibility for following up on the plan’s implementation rests with the management of the audited entity, while the auditors are accountable for ensuring that the actions are completed by the planned due dates. If the scheduled due dates is exceeded, the auditor must request a justification for the delay and the establishment of a new date. The issue cannot be closed until objective evidence is provided. 4. Approving the Plan and Following Up on Corrective/Preventive Actions 5/14/2025 23

24. Remember! It is preferable to refer to internal audits as "internal audit visits" rather than "internal inspections" Even if you conduct an external review of a service provider for your company, you are still acting as an internal auditor, and that service provider is regarded as either an active success partner or a potential success partner. Your goal is to contribute to maintaining operational quality, avoiding gaps, and continuously improving performance. 5/14/2025 24

25. Remember! Do not withhold your knowledge and expertise; extend a helping hand to resolve problems and overcome obstacles encountered by your colleagues within the company or among the external service provider's team. Always offer your advice and suggestions. 5/14/2025 25

26. Remember! And remember very well: - You are a performance auditor, not a police officer. - Your goal is to improve, alert, and help correct mistakes—not to catch the person responsible for the error. Finally, let those being audited remember you in a positive light. Do your work as a firm expert, but always within an atmosphere of warmth and respect. 5/14/2025 26

27. 5/14/2025 27 [email protected]