Audits & Inspections – QBit QA Consulting

Audits & Inspections

In an ever-evolving business landscape, organizations face increasing pressures to maintain compliance, optimize operations, and manage risks effectively. QBit QA Consulting understands the challenges businesses encounter and the importance of maintaining transparency, efficiency, and regulatory compliance. QBit QA offers comprehensive Audit and Inspection services designed to help you navigate complexities and achieve sustainable growth.

QBIt QA Audit and Inspection services provide an objective and thorough evaluation of your processes and compliance framework. QBit QA Consulting will work closely with your team to identify areas of improvement, ensure regulatory compliance, and implement best practices.

TYPES OF AUDIT & INSPECTIONS

Internal Audit: An internal audit is an independent, objective assurance and consulting activity designed to add value and improve an organization’s operations by evaluating and improving the effectiveness of risk management, control, and governance processes.
External Audit: An external audit is a systematic, independent examination of a company’s operations and processes to ensure compliance with regulations, industry standards, and quality requirements, conducted by external auditors or regulatory agencies.
- Supplier Audit: Supplier audits are essential for ensuring the quality, safety, and compliance of raw materials, equipment, and supplies, ultimately protecting patient safety and maintaining regulatory compliance. These audits assess a supplier’s facilities, quality management system, and processes to verify adherence to industry standards and regulatory requirements.
Product Audit: A product audit is a systematic examination and evaluation of a product or service to ensure it meets specified quality standards, customer requirements, and regulatory compliance, often conducted after manufacturing but before reaching the customer.
System or Process Audit: A system audit evaluates the overall effectiveness of an organization’s management system, while a process audit focuses on the effectiveness of specific processes within that system.
“For Cause” Audit: A “for-cause” audit, also known as a directed audit, is a type of audit triggered by a specific issue or concern, such as a potential non-compliance, a serious quality concern, or an adverse event, rather than being part of a routine or scheduled audit.
Site Qualification Audit: A Site Qualification Audit (also known as a Site Qualification Visit or SQV) is an assessment conducted by sponsors or Contract Research Organizations (CROs) to evaluate a potential clinical trial site’s capabilities and readiness. It ensures the site can conduct the trial successfully and maintain data integrity, focusing on facilities, equipment, staff qualifications, and compliance with Good Clinical Practice (GCP) and regulatory requirements.
Regulatory Audit: A regulatory audit is an inspection of an organization to ensure that it complies with laws, regulations, and internal policies. Regulatory audits can be conducted by government agencies or third parties.
Regulatory Inspections: Regulatory inspections are evaluations conducted by government agencies to ensure compliance with legal, safety, and quality standards, verifying adherence to regulations and industry best practices.
Surveillance inspections: Surveillance inspections are conducted to monitor the manufacturing process and the quality of FDA regulated products on the market. The agency uses the inspection to evaluate whether a manufacturer is complying with quality manufacturing practices.
For-cause inspections: For-cause inspections are triggered when the agency has reason to believe that a facility has quality problems, to follow up on complaints or to evaluate corrections that have been made to address previous violations.
Follow-up inspections: Follow-up inspections are conducted to verify compliance and/or corrective actions in the wake of previous violative inspections, violative samples, or following official agency action (e.g., a warning letter or enforcement action).
Pre-Approval Inspection: A pre-approval inspection (PAI) is performed to contribute to FDA’s assurance that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete.

Regulatory Audits and Inspections are planned and conducted differently and their conduits have different levels of authority.

Inspections:
The term ‘inspection’ is typically associated with the FDA’s process for on-site reviews. FDA inspectors are badge-carrying members of a law enforcement agency. Their job is to ensure that the law is upheld and pharmaceutical and medical device companies are compliant. They can take enforcement action that could lead to jail time, fines and other legal ramifications. They can inspect anyone who manufactures pharmaceutical or medical devices, while the definition of “manufacturer” is fairly broad. It covers companies who may play just one role in the whole manufacturing process, such as sterilization or repackaging.

Audits:
Registrars who conduct audits are a third-party representative of the European body. They don’t have the same kind of enforcement abilities as the FDA.

HOSTING AN AUDIT OR INSPECTION

1. Understand the Inspection Scope and Purpose:

Know the Regulations: Thoroughly understand the relevant regulations and standards applicable to your industry and the specific area being inspected.
Define the Scope: Determine the specific processes, systems, or areas that will be examined during the inspection.
Clarify Objectives: Understand the purpose and objectives of the inspection to ensure you’re adequately prepared.

2. Prepare Your Organization:

Internal Audit: Conduct internal audits to identify potential areas of non-compliance and implement corrective actions before the regulatory inspection.
Risk Assessment: Identify and assess potential risks related to regulatory compliance.
Documentation: Ensure all relevant documents, records, and procedures are organized, accessible, and up-to-date.
Train Your Team: Train employees on relevant regulations, procedures, and inspection protocols.
Develop an Audit Plan: Create a comprehensive plan outlining the inspection process, timelines, and responsibilities.

3. During the Audit:

Be Prepared: Have all necessary documentation readily available and be prepared to answer questions thoroughly and accurately.
Maintain Open Communication: Establish clear communication channels with the inspectors and respond promptly to any requests or questions.
Be Professional: Maintain a professional and cooperative attitude throughout the inspection process.
Document Everything: Keep detailed records of all inspection activities, findings, and corrective actions.

4. Post-Audit:

Address Findings: Develop and implement a plan to address any non-compliance findings identified during the inspection.
Continuous Improvement: Use the inspection results to identify areas for improvement and implement ongoing monitoring and control measures.
Follow-Up: Ensure that corrective actions are implemented effectively and that the organization is compliant with all relevant regulations.

CONDUCTING AN AUDIT

1. Planning and Preparation:

Identify the purpose and scope: Clearly define what the audit aims to achieve and what areas will be covered.
Determine the audit scope: Decide which processes, systems, or areas will be included in the audit.
Define the audit objectives: What specific questions or issues will the audit address?
Develop an audit plan: Outline the steps, timeline, and resources required for the audit.
Assign roles and responsibilities: Determine who will be responsible for different tasks during the audit.
Prepare an audit checklist: Create a checklist to ensure all necessary areas are covered during the audit.
Notify stakeholders: Inform the relevant parties about the audit, its scope, and schedule.
Start a digital data room: Organize and store documents in a secure and accessible manner.
Set up a shared calendar: Use a shared calendar to schedule meetings and track progress.

2. Conducting the Audit:

Open meeting: Hold an opening meeting to discuss the audit scope, objectives, and timelines.
Fieldwork: Conduct the audit by collecting evidence, reviewing documents, and interviewing relevant personnel.
Document findings: Record all observations, issues, and findings during the audit.
Maintain open communication: Keep stakeholders informed about the audit progress and any issues identified.
Provide daily updates: Keep stakeholders informed of the audit progress.
Debrief immediately with a post-mortem: Discuss the audit findings and next steps immediately after the audit.

3. Post-Audit Activities:

Analyze findings: Review the collected data and identify any issues or areas for improvement.
Develop action plans: Create a plan to address any identified issues and implement corrective actions.
Assign responsibility: Assign responsibility for implementing the action plans.
Track progress: Monitor the implementation of action plans and track progress towards achieving the audit objectives.
Follow-up: Conduct follow-up audits to ensure that corrective actions have been implemented effectively.
Prepare an audit report: Summarize the audit findings, conclusions, and recommendations.
Conduct a closing meeting: Discuss the audit findings and any outstanding issues.
Close out the audit: Finalize the audit process and ensure that all outstanding issues have been addressed.
Review Audit Recommendations: Review the audit recommendations to ensure they are effective and feasible.
Allocate Resources: Allocate the necessary resources to implement the audit recommendations.
Document changes: Document all changes made as a result of the audit.
Continuous improvement: Use the audit findings to identify areas for continuous improvement.