Smart Manufacturing and Audit Management: Opportunities and Challenges
Blog | June 20th, 2023

Smart Manufacturing and Audit Management: Opportunities and Challenges

Continuous improvement of quality is a business compulsion for enterprises across the board. Rather than responding to complaints from customers, proactively identifying issues (before it reaches the customer) and rectifying quality gaps earlier in the lifecycle help businesses improve production efficiency, reduce costs, and increase brand reputation.

One of the tools that facilitates a proactive approach to improving quality is the audit of the manufacturing processes in a systematic manner. It helps to uncover problems and implement corrective measures to ensure that the products conform to specifications and meet regulatory requirements. The manufacturing process may be owned by the brand or outsourced to a contract manufacturer. In either case, the quality is the responsibility of the brand and therefore, they are required to ensure the partners meet the quality requirements.

integrating QMS and PLM

Benefits of a Robust Audits Process

Audits can be conducted by internal teams, or external experts, or can be a mix of both depending on the complexity of the product and the processes. It may take anywhere between a day and weeks depending on the size of operations, the number of units to be audited, etc. It may be a one-time audit or an ongoing process, based on how compliant the manufacturer is. If there are repeat errors and recalls, the manufacturer will have to continuously monitor the process and address the issues. If there are few or no issues reported, the audit may be scheduled periodically, such as every quarter, half-yearly, or yearly.

Audits help manufacturers:

  • Assess the unit’s capability to meet the project requirements
  • Assess how compliant it is with statutory or regulatory requirements
  • Evaluate the facilities and their ability to meet the production, hygiene, and quality criteria
  • Evaluate the manufacturer’s processes, operations, and workflows
  • Identify areas of improvement and recommend improvements

The Auditing Process

At the time of the audit, the auditors require several aspects of the unit to be audited. These include:

  • The production capabilities
  • Working conditions, facilities, machines and their capabilities, and environmental control
  • Observing workers to assess their skills and capabilities
  • The quality system and its effectiveness
  • The management capabilities

In addition to observing the activities, interviews with the people on the shopfloor can also help get insights that will enhance the findings of the audit.

Smart Audits for Improved Efficiency with ComplianceQuest

Auditing is a very detailed process that requires the recording and reporting of the findings for further follow-up. The purpose of the audit will be fulfilled when the subsequent actions are taken to address issues identified during the process and the impact is assessed to see whether it has had the desired effect.

In a paper-based approach, some of the challenges auditors and manufacturers face include:

  • This can be very tedious and time-consuming. It can lead to duplication of efforts, and there is the likelihood of missing out on key information.
  • Retrieving documents also can become a challenge, because of which businesses struggle to make data-driven decisions.
  • Identifying the root cause of issues can be very resource-intensive and collaboration between teams located in remote locations is challenging.
  • Risk assessment, implementing controls, corrective and preventive actions, and, more importantly, tracking and monitoring progress are not easy, rendering processes inefficient and ineffective.

With an end-to-end audit management system such as ComplianceQuest, companies with smart manufacturing can leverage data to improve the audit workflow end-to-end.

Schedule Audit: Ensure audits happen at the specified periodicity by scheduling at the plant, site, and supplier level.

Prepare for Audits: Auditors can access past reports and documents to review findings, open findings, CAPAs, etc. to assess progress and ensure the corrective actions have been taken and are yielding the desired results.

Record from Anywhere, Anytime: As the audit management software is cloud-based, it can be accessed from anywhere and reports and records created on the go. In case of poor access to Internet connectivity, the software synchronizes the moment connectivity is available. This improves the accuracy of the reports. Images and videos can also be attached as supportive documents. The records can also be categorized based on the audit policies for easy retrieval and sharing.

Pre-built Report Templates: The CQ software provides pre-built report templates and enables the generation of any number of audit reports quickly and easily.

Risk Assessment: Identify risks and enable proactive quality control to mitigate them.

Collaborate and Communicate: The audit reports can be shared with the stakeholders based on relevance from within the system, improving collaboration and communication for faster and more effective action.

Reporting and Analytics: The audit data can be used for creating additional reports and running analytics for deeper insights and data-driven strategic decision-making.

integrating QMS and PLM

The ComplianceQuest Audit Management software is flexible, scalable, and configurable, enabling the creation of bespoke workflows based on the specific needs of the organization. It is aligned with regulatory standards such as ISO 9001, ISO 13485, FDA 21 CFR Part 11 and allows planning of audits around each of them to improve compliance.

The CQ Audit Management solution is integrated with the EQMS and helps to identify gaps to provide relevant training. This ensures only qualified personnel are assigned based on the standard selected.

It helps manufacturing companies be audit and inspection ready by enabling them to plan, manage changes, learn from past audits, create schedules and assign roles and responsibilities, organize data and documents, and conduct periodic internal audits. The CQ Audit Management Software helps in every step of the way, providing visibility and transparency across the entire process.

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