Internal Auditor Questionnaire: Ensuring Compliance and Best Practices

In the pharmaceutical industry, maintaining compliance and adhering to best practices is critical to ensuring the safety and efficacy of drugs and medical devices. With the ever-changing regulatory landscape, it can be challenging for companies to keep up with the latest requirements and standards. In order to meet these requirements, companies must establish internal audit processes that cover all aspects of their operations. One valuable tool in this process is an internal auditor questionnaire. An internal auditor is responsible for evaluating the company’s processes and procedures to ensure compliance and identify areas for improvement. This questionnaire can help identify areas where the company may be falling short and take corrective action, when needed, to implement best practices and meet the regulatory requirements.

In this blog post, we will provide a comprehensive guide on how to build an internal auditor questionnaire or a checklist specific to the company’s products and processes. The guide will cover the various activities involved in the audit, the key areas to focus on, and examples of audit questions for each area. The blog post is an essential resource for internal auditors, compliance officers, and quality assurance professionals. The questionnaire can also be used as a guide to expand the scope of a specific audit activity, such as planning for supplier audits. By following a well-crafted questionnaire, internal auditors can be confident that they are asking the right questions and covering all the necessary areas to ensure compliance and best practices.

A Closer Look at the Top Features of an Effective Internal Audit Questionnaire

Internal auditors play an important role in ensuring that their company is compliant with the Quality Management System guidance (e.g., ISO QMS, Pharmaceutical Quality Systems (PQS) guidance), Good Manufacturing Practices (cGMP) and other applicable regional and international regulations. To ensure the best practices, an internal auditor questionnaire must be drafted that covers all the activities necessary for compliance and best practices. The internal auditor questionnaire should include mainly a list of audit areas such as quality policy, personnel, product development, production, documents, facilities and equipment, self-inspection, management responsibilities, evaluation of suppliers and purchasing process, supplier qualification status, risk analysis, monitoring and control, complaints and recalls, corrective and preventive actions (CAPA), and measurement, analysis, and improvement over time.

The following guide can be used to build an internal audit questionnaire and to train new auditors:

• Each audit question should provide examples of best practices and compliance. For example, the quality policy audit question should include examples of the company’s commitment to quality and how it is implemented throughout the organization. The personnel audit question should include examples of the company’s policies and procedures related to training, selection, and performance evaluation of personnel.
• The development and implementation audit question should include examples of the company’s processes for developing and implementing new products, processes, and services. The production audit question should include examples of the company’s processes for the manufacture of products and services.
• The documents audit question should include examples of the company’s policies and procedures for document control and record keeping. The facilities and equipment audit question should include examples of the company’s policies and procedures for maintaining, inspecting, and calibrating facilities and equipment.
• The self-inspection audit question should include examples of the company’s processes for conducting internal quality audits. The management responsibilities audit question should include examples of the roles and responsibilities of management for the quality management system.
• The evaluation of suppliers and purchasing audit question should include examples of the company’s processes for evaluating potential suppliers and purchasing materials and services. The supplier production and analysis audit question should include examples of the company’s processes for monitoring, verifying, and analyzing supplier performance.
• The risk analysis audit question should include examples of the company’s processes for identifying, assessing, and controlling risks. The monitoring and control audit question should include examples of the company’s processes for monitoring and controlling processes, products, and services.
• The complaints and recalls audit question should include examples of the company’s processes for handling complaints and conducting recalls. The corrective and preventive actions (CAPA) audit question should include examples of the company’s processes for identifying, investigating, and implementing corrective and preventive actions.
• The measurement, analysis, and improvement audit question should include examples of the company’s processes for measuring, analyzing, and improving the quality management system. In addition to a QMS that is integrated with processes for manufacturing, clinical research, and development, an effective internal auditor questionnaire should cover all of these activities and audit areas.

List of Activities

1. Establish an overall quality management system

This activity is meant to ensure that the company has a quality management system that meets ISO guidance and cGMP requirements. This system should include:

• Quality policy
• Personnel
• Development and implementation
• Production
• Documents
• Facilities and equipment
• Self-inspection
• Management responsibilities
• Evaluation of suppliers and purchasing
• Supplier production and analysis
• Risk analysis
• Monitoring and control
• Complaints and recalls
• Corrective and preventive actions (CAPA)
• Measurement, analysis, and improvement

2. Monitor and audit the quality management system

This activity is meant to ensure that the company’s quality management system is functioning properly. This should include:

• Regular internal audits to check for compliance with the quality management system
• Review of quality records to ensure accuracy and completeness
• Review of customer feedback to identify areas for improvement
• Regular reviews of performance metrics
• Review of risk management processes
• Review of corrective and preventive actions (CAPA) processes
• Review of supplier quality control processes
• More…

It is important to have a proper validation process which includes the review and monitoring of processes, testing of activities, assessment of performance, and feedback from stakeholders. It is also important to have procedures to identify and investigate nonconforming products and to follow up with corrective and preventive actions. Read more here!

Auditor Questionnaire Sample

Instructions:
Please answer the following questions honestly and to the best of your knowledge. Your responses will help the auditor determine the accuracy and compliance of the pharmacy’s practices.

List of Key Audit Areas:

1. Quality Policy:

• Is the company’s quality policy appropriately documented and updated when necessary?
• Are the company’s quality objectives regularly monitored and reported?
• Is the policy documented and communicated to personnel?

2. Personnel:

• Does the company have personnel with the appropriate qualifications and training to carry out their duties?
• Is there a system in place to ensure that personnel are adequately trained and qualified?
• Are personnel adequately trained and qualified?
• Are records of personnel training and qualifications kept?

3. Development and Implementation:

• Are manufacturing and other processes adequately documented and controlled?
• Are changes to processes adequately documented and controlled?

4. Production:

• Are production processes and procedures followed?
• Are good manufacturing practices (GMP) followed?

5. Documents:

• Are documents related to the quality management system appropriately stored and archived?
• Are documents regularly reviewed for accuracy and completeness?
• Are department SOPs current and revised regularly with applicable changes?
• Are SOPs available at the point of use valid and current?

6. Facilities and Equipment:

• Are the company’s facilities and equipment adequately maintained and calibrated?
• Are safety and hygiene standards met?
• Are environmental controls in place and meet regulatory requirements for use of raw materials and waste disposal?

7. Self-Inspection:

• Are self-inspections regularly carried out?
• Are any identified non-conformances or areas for improvement adequately addressed?
• Are procedures followed for communication of results to the individuals responsible and management?

Most companies are aware of the importance of communication for better management of projects, teams, processes, quality and people. What most companies also miss is the role of communication for success in the top management and answer to a few basic questions: what is effective communication for senior executives, what are the key elements of effective communication styles and the skills and competencies required to be a good communicator? Read more…

8. Management Responsibilities:

• Are management responsibilities clearly defined and communicated?
• Are managers held accountable for their responsibilities?
• Are management meetings conducted regularly and minutes documented?

9. Evaluation of Suppliers and Purchasing:

• Are suppliers qualified according to a well-defined and approved procedure?
• Are suppliers evaluated on a regular basis?
• Are purchased materials and equipment adequately inspected and tested?

10. Supplier Follow-ups:

• Are suppliers’ production and analysis processes monitored?
• Are suppliers’ performance regularly reviewed?
• Are records maintained for supplier audits and results communicated to the management?

11. Risk Analysis:

• Are potential risks identified and documented?
• Are risks monitored and managed?
• Are risk assessment results communicated to the concerned personnel and the management?

12. Monitoring and Control:

• Are processes and products monitored and controlled?
• Are trends and patterns in product and process performance identified and acted upon?
• Are operators trained and clear about the procedure for communicating out-of-trend results to the manager?

13. Complaints and Recalls:

• Are customer complaints and product recalls promptly identified and addressed?
• Are customer complaints and product recalls adequately tracked and monitored?
• Are customer complaints investigated according to a well-defined procedure and communicated to the management? (annual product quality reviews)

14. Corrective and Preventive Actions (CAPA):

• Are corrective and preventive actions (CAPA) promptly identified, implemented, and monitored?
• Are corrective and preventive actions (CAPA) adequately documented?
• Are corrective actions implemented in a timely fashion and their effectiveness monitored and documented?

The PDCA is a framework for thinking clearly about continuous process improvement. Basically, the PDCA offers a feedback loop for truly clear thinking about improvement. Read more here!

15. Measurement, Analysis, and Improvement:

• Are performance metrics regularly tracked and reported?
• Are process and product improvements regularly identified and implemented?
• Are equipment calibrated regularly? (show me the proof)

Key Takeaways

• Internal auditor questionnaires should include a comprehensive list of activities and audit areas relevant to the pharma industry.
• The list of audit areas should cover areas such as quality control, data management, and inventory management.
• Each audit question should be relevant to the specific activities and audit areas that need to be monitored for compliance.
• Auditors should also provide clear examples for each audit question in order to ensure that all team members understand their responsibilities and best practices.
• The Audit Questionnaire should include activities and areas that are relevant to the pharmaceutical company’s operations and industry.
• It should also provide examples for each audit question, to ensure that auditors can properly assess the company’s compliance with regulations and best practices.
• Examples should be provided for each audit question to ensure that auditee and new auditors understand the scope of the audit.
• Auditors should be adequately trained and knowledgeable to effectively identify any issues or non-compliance and provide recommendations for corrective actions or improvements.
• Finally, the questionnaire should be designed to enable internal auditors to identify any potential risks or violations of regulations and best practices.

Summary

Internal auditors play a crucial role in ensuring that companies are adhering to these standards and best practices. To achieve this, it is essential to have a detailed questionnaire that covers all areas of the business and its operations. This questionnaire should include a comprehensive list of activities and audit areas that the auditor should focus on during the audit process.

The blog post is an essential resource for internal auditors, compliance officers, and quality assurance professionals. The questionnaire can also be used as a guide to expand the scope of a specific audit activity, such as planning for supplier audits.

---

Disclaimer: The views and opinions expressed on PharmaRead are those of the authors and do not necessarily reflect the official policy or position of any agency or organization. PharmaRead articles are provided for information only with a focus on global health, pharmacy practice, and healthcare systems in Low- and Middle-income Countries (LMICs). Readers should seek expert opinion for use, implementation or application of this knowledge based on their individual circumstances.