Ultimate Guide to Effective Audits for Better Quality & Safety

Audit Management and Continuous Improvement in Safety Management

Regulatory bodies, including OSHA, insist on Continuous Improvement to ensure safety performance. For businesses to truly focus on safety, they must have the right safety practices in place that help identify gaps and make changes to the overall safety management program to fill the gaps. The same can be applied to quality management also.

Safety audits are conducted in the storage areas, manufacturing units, warehouses, and suppliers. It includes a review of the associated documents and interviews with operations personnel to understand whether the processes are implemented diligently. Root cause analysis is also part of safety audits.

Safety leaders can use the safety audit reports to understand the strengths and weaknesses of the safety initiatives. It helps to evaluate the safety-related policies, procedures, and controls and take necessary measures to reduce risks. Based on the findings, the management and the safety team can also introduce changes to improve the safety management processes.

Audit Trail as per 21 CFR Part 11

The FDA's 21 CFR Part 11 regulation focuses on electronic records and electronic signatures. As part of the regulation, it requires organizations to maintain an audit trail. An audit trail is a chronological record of everything in the system, including details of who performed the activity, what modification happened, when it was done, and the reason behind it. An audit trail allows the organization to remain compliant and helps identify and address security breaches and fraudulent activity. Simply put, an audit trail provides an end-to-end view of the system activity.

Audit Automation

ISO 19011 defines auditing as a systematic, independent, and documented approach to obtaining objective evidence and determining the extent to which the audit criteria are fulfilled. Audit criteria could be a legal requirement, showing the compliance or non-compliance of the processes and products to the regulatory standards. The requirements encompass work instructions, policies, procedures, contractual obligations, etc.

Broadly, there are two types of audits - internal and external. Internal audits are conducted by, or on behalf of, the organization itself. External audits are either second-party or third-party audits that stakeholders or independent auditing organizations can conduct. Manual audit management processes can make it difficult to have visibility and transparency, making them ineffective and prone to errors.

With automated audit management, businesses can simplify documentation, assign responsibilities, and monitor progress with access to real-time data. This can help improve process efficiency and compliance, initiate CAPA, and provide access to audit trails.

Agile Audits and AI in Audit management

An agile audit allows the internal audit team to meet expectations by accelerating audit cycles, providing timely insights, and cutting process times – all with a more efficient documentation process. In auditing for product and process quality, agile audits can be used to improve the suit process outcome as it is more efficient, offers valuable insights, gives a better understanding of risks, and provides deeper and actionable insights

An agile audit allows audits to be broken down into smaller pieces and reviews to be provided at the end of each short cycle. It can also be leveraged whenever several audits have been scheduled within a time period when there is a need to improve collaboration between stakeholders and when there is a need for more relevant and highly impactful reports with less documentation.

The agile audit requires planning, multiple sprints, a correspondingly high number of reviews and reporting, communication, visibility into the process, tracking, and monitoring. ComplianceQuest uses AI in the Audit Management solution to manage the entire audit workflow on one platform. It facilitates building a flexible, scalable, and configurable audit management workflow based on the organization’s specific needs. AI can also automatically assign days to respond to an audit finding.

What is a Layered Process Audit?

Layered Process Audits (LPAs) bring together employees from different departments of the organization instead of only the quality team. LPAs can be used to assess quality at every step, from the design stage to when the finished product is ready to be shipped out. More like a checklist, the LPA enables a risk-based strategy that helps ensure that the process aligns with relevant standards, facilitates continuous Improvement, and identifies high-risk inputs at the beginning of each shift. With LPAs, manufacturers can exercise better and greater control over various processes, take quick corrective/preventive action at all layers, reduce mistakes or nonconformances, improve the overall quality of work, increase revenues, and reduce the total cost of quality.

Layered audits have been commonly used in the automotive and aerospace industries as it focuses on Total Quality Management (TQM) and Total Employee Involvement (TEI).

To conduct LPA, one must answer up to 10 short 'yes or no' questions related to a process, and it takes less than 15 minutes to complete. This synchronizes with the Plan-Do-Check-Act approach and emphasizes the need for a quality-first approach across all processes or 'layers.'

The focus of LPAs is not a comprehensive audit but to narrow down on a few critical, high-risk items, thus accelerating the audit process.

How to Perform Remote Audits Effectively?

Quality and safety leaders can leverage next-generation EQMS and EHS solutions to conduct effective and useful remote audits. However, an auditor looking to perform remote audits must know these seven areas -

1. Leadership team's commitment and involvement to remote audit seriously and preparation as it would for a regular audit.

2. Understanding the complexity of the processes based on industry and nature of business operations, size of the organization, and the number of locations to be audited.

3. Information on the existing controls to assess the current health and safety success and the gaps that need to be filled

4. Gathering layouts, documents, and processes as part of pre-auditing requirements.

5. Establish communication protocols.

6. Details of the audit process and goals.

7. Employee engagement by gathering their input and ensuring all concerned parties know their role in the process.

ComplianceQuest's Audit Management Solution

To improve quality and safety within the organization, ComplianceQuest offers an Audit Management solution as a part of its EHS platform. The audit management solution is part of both EQMS and EHS solutions. It can integrate seamlessly with document management, training, management review, permit-to-work, incident management, inspection, supplier, environment, and reports and dashboards to manage quality and safety.