Optimizing Manufacturing Process Design: How ComplianceQuest’s Connected Cloud-based PLM Solution Helps

One of our clients, a medical device manufacturing company, was facing delays in its product development lifecycle due to the back and forth at the design stage. The concern was that every time a change was made, it had to be reviewed and approved. After sending the email with the revised document, someone from the design team had to follow up constantly with the reviewer to make sure they reviewed and approved the design.

The quality leader who mentioned this also told us about how for an earlier version of the product, the purchasing department had placed the order against an older design file. Luckily, a chance conversation with the design team helped them spot the mistake and send the right purchase order.

This is not an uncommon sight in manufacturing companies relying on a mix of manual and electronic systems on a legacy platform. Some of the common challenges such companies face include:

• Emails get lost or forgotten
• Version control becomes a challenge
• Reviews and approvals get delayed
• Change management is a nightmare

This lack of visibility can lead to a high rate of nonconformance and noncompliance, resulting in poor quality of products, increased customer complaints, and warning letters from FDA, not to mention recalls. All these add to costs and time delays and need to be addressed early to minimize issues later.

A cloud-based, end-to-end product lifecycle management (PLM) system can help manufacturers to integrate the processes, increase visibility, and automate reviews, approvals, and change management.

The right PLM solution can facilitate better collaboration between the design, development, and manufacturing teams, have better control over BOM, reduce risks of nonconformance and non-compliance, and improve quality across the manufacturing process.

Some of the benefits can be summarized as:

• Improved real-time collaboration
• Accelerated innovation
• Lower cost of production
• Improved version control
• Better change and risk management

The Challenges in Product Development Lifecycle

The product development lifecycle encompasses a series of steps right from ideation to designing, development, manufacturing, marketing, and obsolescence. A major part of iterations and revisions happen in the ideation and design stages as this is where the product specifications, the objectives, and the performance parameters are decided.

A variety of tools and solutions such as mechanical computer-aided design (mCAD), electrical design automation (EDA/eCAD), and product data management (PDM) software are used to create and maintain the design files. Often, these systems do not talk to each other, creating data silos. The lack of visibility between the different stages of development leads to delays and rework in creating bills of materials, approved manufacturer lists, engineering change orders, assembly instructions, quality processes, and so on. Often, suppliers and teams involved in downstream processes are not part of the review process. Therefore, if there is a change initiated at this stage, it can cause further delays and add to costs.

As businesses work with globalized teams, the complexities get further compounded, needing greater visibility.

Advantages of a Cloud-Based PLM Solution

A cloud-based product development life cycle management solution such as ComplianceQuest makes the process more efficient, provides greater flexibility and visibility, and facilitates collaboration and communication from within the system. It reduces the scope for errors by enabling version control and accelerating reviews and approvals through notifications and alerts. All stakeholders can access BOMs, AMLs, etc., and access the latest version of these documents with ease.

It helps optimize manufacturing process design in the following ways:

Optimization #1 - Unified View of Records

All the relevant records pertaining to a design, such as mechanical, electrical, and software, are available in a centralized location. This ensures interoperability and visibility and traceability, improving productivity, minimizing errors, and lowering associated costs.

Optimization #2 - Effective Change Management

Automated alerts and notifications facilitate the sharing of changes, reviews, and approvals faster and more efficiently. The engineering changes and revision controls are automatically reflected in the records related to parts and BOMs, thereby enabling teams to access current designs with version control.

Optimization #3 - Efficient Collaboration

As the supply chain goes global, with design and development happening in remote corners of the world, gathering inputs and feedback can be made simpler and more efficient in a cloud-based system. Permission-based access to relevant documents from anywhere, anytime, improves the speed and efficiency of collaboration between teams located in disparate geographies. This can help leverage expertise regardless of location, reduce nonconformances, mitigate production risks, and improve quality.

Optimization #4 - Increase Compliance

Regulations require documentary evidence for finished products. A centralized repository of all documents with an audit trail improves compliance while ensuring adherence to specifications and tracing back to the root cause in case of any issues.

Optimization #5 - Faster Time to Market

In a highly competitive world, first-mover advantage plays a key role in keeping ahead of the competition. When the product lifecycle becomes efficient, manufacturers can strengthen their competitive advantage, streamline processes and data sharing, and avoid delays and confusion, leading to shorter product development cycles.

Optimization #6 -Improve Product Quality

Quality is at the core of competitiveness and brand building. Cloud-based PLM optimizes processes, integrates workflows, and improves visibility. This helps with ensuring conformance and compliance and facilitates continuous improvement of the quality management system. As PLM addresses risks and change management at an early stage and enables feedback integration, the efficiency and effectiveness of the processes improve and ensure high quality.

To know how you can optimize your manufacturing process design with ComplianceQuest, request a demo: https://www.compliancequest.com/product-lifecycle-management-plm/