The Client: A Fortune 100 multinational automaker

Overview

As a leading manufacturer of branded footwear and performance leathers, this company markets millions of pairs of uniform boots and shoes every year around the globe.

With its prime customer as the Department of Defense (DoD), the company has tremendous focus on product and process quality. Compliance with ISO 9000 indicates its consistent use of documented, standardized procedures to produce the products, as processes that are under control are more likely to yield defect-free products. Thus, ISO 9000 assures product uniformity and conformance to buyers' specifications. The quality unit has the charter to establish and monitor division-wide quality processes for ISO compliance to meet rising quality standards from DoD.

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Solution

Today, quality management at the company has taken a different shape and form, with much less energy being spent on making the process work. The focus has shifted to improving quality metrics that are visible across organization. MetricStream CAPA Management solution has tied together all the loose ends of the CAPA process by providing an automated and transparent environment. It allows employees to capture problem data from anywhere in the operation, conduct investigation to determine the root cause, manage the entire preventive and corrective process, implement changes and ensure that the problem is resolved effectively.

"MetricStream had provided a comprehensive yet simple to use solution. And simplicity was important as we did not want something overly technical and complicated" says a Senior Quality Management System Analyst leading the project.

Any user can access the solution from her desktop and initiate a CAPA based on an exception such as a material nonconformance or a process variance and assign it to an owner with a due date. A notification is sent to the owner, the quality manager and the head of quality with a link to the case in the system. The assigned owner can accept that CAPA with the given dues date or change the due date. Alternatively, the owner can reject the CAPA, in which case the quality manager can decide if that CAPA can be terminated or needs to be executed. The owner can also reassign the CAPA to someone else who needs to address it. The entire process is automated with the information flowing as per predefined workflows.

The owner is tasked with the responsibility to conduct the root cause analysis and come up with a resolution action plan within the published due date. Upon completing the investigation, the CAPA owner can enter his findings and the proposed action plan into the system and route it to the quality unit as well as mark courtesy copies to any other departments that may be affected. "Anyone who is affected by the CAPA can add comments or provide inputs allowing wider participation which was difficult to achieve earlier", explains the QMS Analyst. The quality head evaluates the analysis and plan for approval or rejection and the response is sent out to all affected parties along with any comments.

The biggest change is the visibility quality managers now have into the system. "Not very long back, tracking CAPAs was a huge challenge", recalls the QMS Analyst, "we'd be faxing documents and waiting for responses in trying to figure out where a CAPA was and why it was late." With MetricStream application, each case can be easily tracked as it moves from one stage to the next.

"Escalation management has been another area of great benefit. Earlier, we had to involve supervisors to speed up processes but now the application automates triggering of escalations", explains QMS Analyst. "At 12 noon on the due date of a CAPA, system sends out an escalation message to the owner and to the supervisor, letting them know that the CAPA was due today."

"Flexible reporting was another key factor in our selection of MetricStream", says QMS Analyst. At a click of a button, managers can access reports showing open CAPAs, closed CAPAs, recent CAPA activities. Scheduled reports such as CAPAs past due or due in the next 10 days reach quality managers desktop automatically. When heading for a meeting, quality managers can quickly run and print the CAPA dates overview report, a short summary with the date history of a CAPA and make the discussions more productive. CAPA findings and remarks report is a quick refresher on what a CAPA was about; ability to search and associate related CAPAs helps in doing trending and avoiding duplication.

"In the paper-based system, we had to physically move around papers and files; and only one person could work on a case at a time", says QMS Analyst. MetricStream provides a collaborative environment where anyone can access any information anytime (as long as they are authorized) and team members in different locations can work simultaneously on a case.

Challenge

The year 2004 saw a dramatic increase in the demand for the business due to the rise in military activity. The traditional manual and paper-based mechanisms being used to manage the processes was falling way behind scale at which the business was operating. Quality documents were being controlled using complicated and unwieldy spreadsheets and CAPAs were managed manually. It was difficult to manage and track the paper trail for a specific corrective action and to ensure that a corrective action was implemented. If a stage involved multiple participants, there was no easy way to collaborate and work on a CAPA simultaneously. In addition, there was no way to track the status of an issue and knowing where a case has been bottlenecked.

Moreover, the quality managers and the executive management had no measurable data to evaluate the quality processes. There was a complete lack of visibility into review cycle times, open CAPAs, repeat issues, average closure times, etc. limiting the ability to view trends for proactive preventive actions and making it nearly impossible to get process improvement metrics.

The company concluded that the basic quality infrastructure had to be upgraded to support the business growth. Automating the CAPA process was imperative to ensure continued ISO compliance and avoid a DoD audit failure.

Why MetricStream was Selected?

Rich CAPA capabilities along with deep overall quality management functionality

Multi-site web-based access with central control

Flexibility to support customer's specific workflow requirements

Low total-cost-of-ownership

Ease-of use without a steep learning curve

Benefits

  • Efficiency:
    The customer has seen the average issue resolution time go down by over 15% as the automated workflow takes CAPAs through the prescribed lifecycle without any delays. Email notifications and a task list on the users' homepage keeps pending tasks on top of the mind improving responsiveness and active participation.
  • Visibility:
    With MetricStream, the customer has 100% traceability of CAPAs. The status of any corrective action is visible across the organization making CAPA management a predictable process. Visibility into trends has given the quality unit the ability to undertake more frequent preventive actions. The ease with which the users can access and search the records has also substantially increased, driving the adoption of the solution.
  • Data-driven:
    CAPA process performance metrics are now available and provide a sound basis for ongoing continuous improvement. Quality issues are now proactively identified, tracked and resolved and decisions are based on hard facts and metrics. The powerful analytics and reporting capability with graphical dashboards allows managers to adopt a data-driven approach to quality processes.

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