An enterprise’s reputation and profitability are directly tied to the perceived quality of company’s products and services. While quality issues inevitably surface in every organization, lack of rapid and effective resolution methodology that addresses the problem and prevents recurrence almost certainly inhibits their ability to ensure customer success and sustain profits. In regulated life sciences industry, CAPA related FDA audit findings are the largest source of FDA citations. Frequently companies face following challenges with managing quality issues:
- Manual and disparate departmental systems: Homegrown systems that use spreadsheets or Access database or manual paper-based systems have managed quality issues at the departmental level. Such systems fail to address systemic quality problems that cross departmental boundaries, failing to address the root cause of problems.
- Lack of enforcement of best practices: While enterprises might have defined best practices for problem resolution, their existing tools lack the ability to enforce these best practices. This leads to overlooked, misidentified, or mishandled issues. Without alerting and escalation capabilities, companies fail to drive an issue to closure in a timely fashion.
- Lack of cross-enterprise collaboration: Not only must departments collaborate with each other to identify and resolve systemic issues, they must also work together with suppliers and customers to identify the root cause and prevent recurrence. Manual processes that use e-mails, spreadsheets and documents to collaborate with suppliers and customers loose central visibility, leading to wrong resolution of issues.