Internal quality audit – The tool for improvement and regulatory compliance (ISO 19011)

Internal Quality Audit must above all be a communication tool in the company.
Internal Quality Audit is an integral part of Quality System; it is in a way the Quality Assurance of the Quality System. When it is correctly used, it is a true means for Continuous Improvement of Quality and for keeping or putting systems into regulatory compliance. Through Audit Report and Corrective Action follow-up, Quality System evolution will be assured. Internal Quality Audit will also verify Quality Indicators pertinence and efficiency for Process Control and follow-up of executives reporting.

 Know the vocabulary of Quality Assurance and especially of Quality Audit.

 Understand Standards and Regulatory requirements regarding Quality System.

 Know Internal Audit stakes and techniques. Know Audit On-Site activities from A to Z.

 Understand the role of Quality Indicators and Executives Reporting.

 Know attitudes to adopt by Auditors.

1. Normative References and Regulatory Requirements

What are the Normative references regarding Audits? Presentation of main references for Regulatory Quality Assurance (GMP, cGMP, GLP, GCP, ICH …). Presentation of global Standards and of Standards specific to Audit (ISO 9000:2005, ISO 9001:2008, ISO 19011:2002, ISO 100XX …).

2. Quality System and Quality Tools

Quality, what is it? Description of Quality Policy, Quality Management Role, necessary tools (Quality Manual, Quality Plan, Procedures, Working Instructions …), and of Documentation Management.

3. Audits - Definitions

Which terms do we use in Audit and what do they mean? Definition of terms regarding Quality documentation (Quality Manual, Procedures, Process …) and those regarding Audit (review, audit, inspection, report, requirements, auditors, auditees …). Master all the Audit key words regarding methodology, principles, chronology and independence notion.

4. Audits – Cultural and Human Aspects

What are Cultural and Human aspects to take into consideration? The word Audit comes from Latin « Audire » which means « Listen »! The Auditor must take into consideration Cultural and Human elements (stress, objectivity, confidentiality regarding the auditee …) while keeping its independence and neutrality.

5. Audits - Objectives, Missions, Techniques, and Attitudes

What are Audit objectives? This is not only to list issues! What are Audit missions? The Audit is a common tool to be in the service of all! What are the techniques regarding Audit? Checklists are not an end but a starting point! What are the attitudes regarding Audit? An Auditor is Human with its strengths and its weaknesses! Know the different Audit techniques: Observation, Open and close questions, Documents review, Interviews …, and their advantages and inconvenient.

6. Audits – On-Site Activities from A to Z

Know the different Audit phases from preparing with its perimeter and its objective to notification, planning, conducting and following the audit. Prepare Opening Meeting with the reminder of objective. Audit restitution and conclusion (strengths, weaknesses, and findings / observations …). Generate Audit Report; a gap is not necess-arily a findings! Findings are supported by evidences! Follow-up corrective actions.

7. Indicators and Executives Reporting

Define the content of Executive Reporting with pertinent, verifiable and quantifiable indicators which allow following-up compliance and ability to meet requirements and correcting non-conformities.

8. Review of ISO 19011:2002

Review of recommendations contained in the Standard.

9. Practical Case Study

Simulation of an Audit with auditors and auditees: Audit of the Internal Quality Audit Process. Selection of applicable references, Comparison of the content of audited procedure with the predefined requirements, Preparing an Audit checklist, Simulation of On-Site Audit activities (auditors / auditees): writing findings, bringing evidences, Evidences and gaps analysis and synthesis formalized as findings. Proposal of remediation and improvement solutions.

EXERCICES
Several exercises are proposed all along the training course.

A Multiple Choices Questionnaire is proposed at the end of the training session in order to evaluate the acquired knowledge.