Internal quality audit and supplier audit

Audit: Improvement and Regulatory Remediation Tool (ISO 19011).

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. Supplier Audit is an integral part of the decision process for supplier selection, but allows also adapting company strategy regarding a supplier imposed on the company. It allows bringing guarantees regarding design, manufacturing, system, product, raw material, and services. It allows also answering to regulatory requirements which impose these audits.

OBJECTIVES

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

Understand Standards and Regulatory requirements regarding Quality System.

Know Standards and Regulatory require-ments in order to conduct pertinent and efficient internal as well as supplier Audits

Know Internal Audit stakes and techniques.

Know the different Audit steps.

Know Audit On-Site activities from A to Z.

Understand the role of Quality Indicators and Executives Reporting.

Know attitudes to adopt by Auditors.

Know key audit points.

Know how to define supplier Audit objective and to justify it.

Know how to prepare an Audit and appropriate Checklists.

Know how to make the Audit synthesis and formalize it in a clear and concise report.

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. Why perform Audit and who to audit?

Activities and actors concerned. Client-Supplier Relationship internally and externally and the responsibilities of each partie. Different types of Suppliers: API, Systems, Services … Which Supplier to audit?

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. Review of ISO 19011:2002

Review of recommendations contained in the Standard.

10. Normative References and Regulations regarding Supplier Audit

Presentation of Normative References and Regulations specific to Supplier Audit (ISO, GAMP, ICH, CMM, SPICE …). The different approaches according to the type of Supplier. Help to elaborate checklists: Risk analysis; Regulations Analysis, References Analysis, Previous Audit Review, advices and tricks, …

11. Specificities of Computerized System Suppliers

Principles of Computerized System Engineering and IS Quality:
Software life cycle: basis process, support process, and organizational process
Responsibilities and Actors
Configuration Management
Change Management Domains and items to include in the Audit checklist for Computerized System Supplier: design, exploitation, maintenance, safety, training, project management, documentation, configuration management, change management… Non-conformities frequently found. Techniques to use during On-Site Audit.

12. Practical Case Study: Simulation of Audits with auditors and auditees

Practical Case Study 1: Audit of 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.
Practical Case Study 2: Audit of Raw Material Supplier Selection of applicable references, 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.
Practical Case Study 3: Audit of Computerized System Supplier Selection of applicable references, 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.

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.