Medical Device Link.

CRISIS MANAGEMENT

The speed and complexity of operational change associated with accelerating innovation are the distinguishing characteristics of modern manufacturing. Add globalisation, competitive pressures, growing customer demands and intense regulatory scrutiny, and the innovative manufacturer is faced with a growing challenge of realising profit from innovation. The challenge is clear:

• Innovation is accelerating.

• Innovation induces variability.

• Variability diminishes predictable, consistent high quality.

• Quality problems pose brand risk to the company and erode market share and revenue growth.

• Quality problems reduce efficiency and increase cost.

• Diminished revenue and increased cost remove profit from innovation.

Manufacturing executives consistently identify the production of high-quality products as a top strategic objective. They know high quality is the best predictor of sustained corporate health in terms of market share, customer loyalty, profit margins, efficient strategic asset utilisation and low brand risk exposure. These relationships are shown in studies presented in a recent eBook series from Camstar, which develops enterprise manufacturing execution systems. The books can be downloaded at www.camstar.info/eBook.

Figure 1. The innovation lifecycle and value chain. (click image to enlarge)

To address the product quality problem, industry has invested in business, supply chain and product lifecycle technologies to move forward. However, these investments focus either on the innovation lifecycle or the value chain (Figure 1). This separation reinforces silos and fragments quality across the global enterprise. These “chains” intersect at manufacturing operations—the point at which product quality is realised (or not)—an area that has historically received relatively little technology investment.

Closed-Loop Quality

The closed-loop quality approach unifies collaborative design, planning, supply, manufacturing and customer experience through an enterprise closed-loop quality process that accelerates continuous improvement and continuous innovation. Camstar offers a model for closed-loop quality.

Closed-Loop Model for Advancing Product Quality

Figure 2. Figure 2. Closed-loop model. (click image to enlarge)

The model (Figure 2) assumes an underlying enabling technology that unifies the IT infrastructure of the globally distributed enterprise. The core capabilities needed to advance product quality in this model are as follows.

Design

• Leverage past and current performance data to design for quality and avoid repeat design mistakes.

• Analyse data from engineering runs to improve design.

• Align product design with the process to design for manufacturability and service.

• Update risk analysis (design FMEA) based on actual manufacturing and use occurrence plus severity.

Plan

• Develop the process plan concurrently with product design to optimise manufacturing ramp-up.

• Leverage past and current process capability plus capacity performance to optimise manufacturing and supply processes.

• Enable a seamless engineering change process to speed implementation and reduce errors.

• Update risk analysis (process FMEA) based on actual manufacturing and use occurrence plus severity.

Manufacture

• Automatically control Man, Machine, Method, Material and Measure at each step of the manufacturing process to enforce the design.

• Audit the process and collect quality characteristic data to analyse the as-manufactured record for improvement opportunities.

• Gain global visibility into manufacturing and quality events to uncover trends and relationships driving nonconformances.

• Systematically alert operations to trends that lead to nonconformances.

Use

• Track field quality issues to improve product performance and understand containment requirements.

• Understand service data that suggest quality problems and improvement opportunities.

• Gain “field performance” traceability to track quality issues back to root causes and related products.

Learn

• Monitor performance in real time across the product quality lifecycle for early warnings.

• Use advanced analysis of past performance to optimise product design, process design and manufacturing controls.

• Understand global implications and relationship of local events.

Improve

• Gain immediate access to contextual data to uncover root causes of failures.

• Eliminate root causes of quality issues by driving corrective and preventive action plans to product and process design changes.

• Implement a global process for corrective and preventive actions that includes relationships among local and global events.

The elements in the approach are not new, but until now the enabling technology to support the theory has not been available. Today we can unify the technology landscape within the global enterprise. The results are clear: Companies that align their talent with a closed-loop quality process and an enterprise technology built to support it are able to bring innovative products to market faster and at consistently higher quality than their competitors.

Camstar’s eBook Chapter 2 shows cross-industry examples of companies in various stages of realising Camstar’s closed-loop quality model. The results are encouraging to industry, and to individuals who work tirelessly to advance product quality.

Karim Lokas, VP Product Strategy

Camstar Systems Inc.

www.camstar.com