6 Steps to Make Inspections Effective for Continuous Quality Improvement

Businesses encounter quality-related risks across various stages of the production process. This could be due to factors such as deviations in incoming raw materials, human errors, temperature-related factors, change management issues, or even changing regulatory requirements.

One of the most effective methods to identify gaps in quality is inspection. It is a proactive approach towards quality management where potential quality issues can be identified and addressed before they become a real problem. A robust inspection process is critical to identify systemic risks earlier on in the lifecycle, playing a key role in the process of

• Reducing product recalls
• Preventing regulatory issues
• Reducing Cost of Quality (CoQ)
• Ensuring customer satisfaction

A Case in Point

One of our customers, a medical device manufacturer, trusted the suppliers of one of their key raw materials and had not been conducting inspections diligently. There were no issues, probably because the supplier was doing their part in terms of quality processes. When an additional supplier was onboarded, the raw materials were not inspected as it was not part of the process and the manufacturer probably expected the same quality standard from the new supplier as well.

This led to the final product not meeting the performance criteria. Though the error was caught in the final random check before reaching the market, the entire tracing of the root cause and taking corrective action took time. The product had to be scrapped and the inspection reinstated till the quality of the raw materials from the new supplier was assured. This led to higher costs, wastage, and time delays. Had it not been caught at the final stage, it would have led to erosion of brand reputation and probably an FDA warning as well.

Therefore, businesses need to ensure that any quality issue is addressed at an early stage and must conduct regular inspections to identify potential risks.

Planning the Inspection Management Process

Create a fool-proof inspection process across the production lifecycle and remember the following:

• Inspections at Every Stage: If an error enters the supply chain, then with each step, the cost of correcting it becomes higher. This makes early detection important and inspection can ensure this. For instance, when the raw material is received from a supplier, inspecting it is a critical step in ensuring that they meet the specifications and there are no deviations. Overall, inspections are a must at the following three stages:

• Incoming raw materials
• During production & manufacturing
• Finished goods inspection

• Automate the Process: Inspections are a detailed process of many steps. The data gathered during the inspection can not only help correct existing problems but also provide a view of potential issues and enable informed decision-making. Using digital transformation technologies such as cloud, IoT, and AI/ML can improve outcomes.

Key Benefits of Inspections

A quality inspection is a preventive measure that helps detect potential defects and ensure that customers only receive products and services that perform as expected. In our conversations with quality leaders, we found that businesses that conduct regular inspections in their manufacturing units see the following benefits:

• Correct and consistent quality
• Uncover production-related inefficiencies at an early stage
• Minimize wastage, scrapping, and recalls
• Lower cost of production
• Improve resource optimization
• Reduce Cost of Quality (CoQ)
• Increase brand reputation

6 Best Practices for Conducting Effective Inspections

Conducting inspections must also be process-oriented to be effective and to enable uncovering of existing and potential issues along the production line. It must be comprehensive and must integrate the following steps to deliver the expected results - which is, to determine quality issues at an early stage:

Step #1 - Document Quality Standards

The organization needs a clear quality statement that drives the policy and processes. It guides the quality management processes to be followed by the quality teams, suppliers, and other stakeholders. It is used as a reference to create quality checks during inspections and audits and ensure that right from the raw materials to the different production processes, all comply with the SOPs. It also helps to demonstrate the organization’s commitment to quality culture.

Step #2 - Create Simple Inspection Workflows and Metrics

Inspection workflows must be easy to understand and implement. In business with medium to large set-ups, there may be many units and many different elements that need to be inspected. Therefore, the workflows must be comprehensive and broken down into multiple parts for being implemented with minimal training. While improving the effectiveness of the inspection process, it will also reduce the inspection time cycle. Establishing metrics for different parameters will also help inspectors identify deviations quickly.

Step #3 - Define Control Procedures for Quickly Fixing Issues

Use past data and trends to identify common issues that can be fixed quickly, without much rework. The quality issues identified during the inspection must be segregated and categorized for improving resource utilization as well as address issues quickly for faster time to market without compromising on quality.

Step #4 - Perform Preventive Maintenance of Inspection Equipment

Calibrating the inspection equipment is as important as preventive maintenance of the production equipment. This will improve equipment accuracy and efficiency and also ensure consistent product quality.

Step #5 - Start at the Source

Often, inspections are conducted on the final product. However, if there is nonconformance or defects, it will mean tracing back to the root and reworking, leading to scrappage and delays, not to mention additional costs. Instead, performing inspections right at the start can lower the risk of low-quality products and scrap later. It will also help identify problems early and address them effectively.

Step #6 - Train the Inspection Teams The inspection teams need to understand regulatory requirements, quality standards, and the need for inspections. This will help them perform their duties correctly and effectively. Inspections involve not only inspecting the premises but also interviewing the workers, observing their activities to ensure standardization, reporting, follow-up, communicating, etc. Therefore, training must be comprehensive and empower the teams with the required skills. This will ensure adherence to processes and greater compliance.

Automating Inspection Workflows with ComplianceQuest

Businesses that use a cloud-based inspection system find inspection lifecycle management more efficient and effective. Right from scheduling the inspection to making notes, sharing it with the relevant stakeholders, ensuring implementation of necessary action, and monitoring and tracking the impact of these actions can be automated. This helps ensure that the inspections are effective in achieving the goal of continuous improvement and risk identification and reduction.

A cloud-based solution such as ComplianceQuest helps businesses plan and automate the inspection workflow by providing features that make every aspect of the inspection process efficient. Some of the features include:

• Scheduling Inspections: Inspections need preparation as the inspectors need to understand what they are inspecting and all that needs to be done during the inspection at the chosen site.
• Checklists: To ensure all elements are covered during the inspection, it is important to have a checklist. A standardized, pre-built checklist can help inspectors ensure all standard elements are covered. They can be customized for unique needs as well.
• Record and Document: The inspectors can record interviews, and take and attach images and video to the inspection records, thereby providing the required information with greater accuracy and evidence. This is not aimed at blaming anyone but in ensuring that errors are corrected in an efficient manner.
• Management Review: The inspection documents and records provide the top leaders and the quality team with data needed to make informed decisions on the continuous improvement of quality management.
• Training: The data also helps the managers understand skill gaps and plan the necessary training to equip the team with the required knowledge and skills to improve the quality of processes.

Further, ComplianceQuest Inspection Management Solution is integrated with other quality management functions such as risk management, change management, complaint management, and supplier management. This provides greater visibility into operations, helps improve the quality of inspections, and in turn, uses the data gathered during the inspection to improve all aspects of the operations. The CQ EQMS is also aligned with the leading global standards such as ISO, thereby improving compliance.

To know more about CQ Inspection Management, visit: https://www.compliancequest.com/inspection-management-software/