Which organization is more like yours — A or B?

A.) FDA regulations will choke our business. Requirements, changing all too often, generate extra work and mountains of paperwork. FDA auditors have no understanding of our business, and appear intent on slowing or shutting us down. We prepare for site visits in fear that some unknown discrepancy will earn us a warning letter.

Our production is not like other types of manufacturing. Based in biologics, it is unpredictable, more of an art than a science. We try to minimize reporting deviations, because the paperwork burden they generate is a distraction from what we must do here. Our deviation reporting is designed to satisfy the inspectors.

B.) Compliance audits provide useful insights about what we can improve. Our business is run to maximize production efficiency. It is easy to document deviations, which is part of our systematic approach to continuously improving our operations. We proactively search for performance that deviates from our standards. We effectively prioritize the deviations we detect, assigning corrective action teams to find cause, develop solutions and manage risks when we make changes.

There are probably no organizations that warmly view FDA audits. But in the current economic downturn, there is a growing need to reconcile these two perspectives in order to control costs and build new levels of efficiency. Much of the management effort directed toward FDA compliance reflects this tension. Often, the emphasis is on taking action — any action — to reduce attention from the FDA.

Resource efficiency and compliance are not opposing forces. In fact, using systematic techniques to conduct and document investigations, implement corrective and preventive actions (CAPAs), and reduce operator error can help most healthcare manufacturing organizations improve compliance, cut costs and achieve superior business results.

Systematic Corrective Action

We propose a proactive model for achieving current good manufacturing practice, or cGMP, and quality systems registrars, or QSR, compliance. cGMP and QSR will help in managing resource-efficient processes to provide predictable, documented results. At its core, systematic corrective action is an approach for managing the CAPA to ensure that deviations are identified and resolved so that output standards are met, or preferably, exceeded.

The challenge is that a systematic approach requires a level of discipline seen in few organizations. Complex management systems, sometimes belabored by the perceived conflict between compliance and efficiency, often work against, rather than for, effective action. Information systems are designed to manage the information flow by tracking each relevant document to meet FDA requirements. However, few systems make the vital leap between managing compliance documentation and improving business performance.

Using process thinking helps organizations link CAPAs to operations systems and helps make the leap from compliance to business results. Since 1958, the gold standard in the effective resolution of issues has been Kepner-Tregoe’s four FDA-recognized processes: situation appraisal, problem analysis, decision analysis and potential problem analysis.

Issue Identification

Efficient and compliant issue identification requires early recognition to minimize the growth of the issue, good definition to minimize inappropriate responses and then a punctual response to minimize the spread of the issue.

When people in your organization report non-conformances:

  1. How useful is the information they provide for understanding the scope and impact of the non-conformance?
  2. How useful is the data for tracking and trending incidents over time?
  3. How useful is the data for prioritizing non-conformances and determining appropriate next steps?

By using Kepner-Tregoe’s problem analysis process, clients are provided with a framework for clarifying and documenting non-conformances accurately and concisely.

Issue Prioritization

Prioritization begins with an accurate assessment of the deviation based on clear criteria, which balance regulatory and business needs, and effective routing to ensure a timely response, based on clarity of protocols. Relevant information and clarity of communication should drive both appropriate escalation and planning of the approach to the investigation.

When people in your organization gather to determine how to address non-conformances:

  1. How often are there differences of opinion about the appropriate next steps?
  2. How long does it take to determine the appropriate next steps?
  3. How frequently do people struggle with allocating limited resources to competing priorities?

Situation appraisal is a logical framework for identifying and prioritizing issues. It helps with bringing order and clarity to a complex environment, setting priorities and planning actions to resolve each concern. This is especially important at the operations management level in identifying high-priority and costly issues that require action. Effectively prioritizing resource utilization is one of the most important elements in a well-functioning corrective action system.

Issue Containment

Effective containment requires interim actions and contingent actions to limit the spread of any potential problems associated with the non-conformance.

When people in your organization initially react to a non-conformance:

  1. How timely are their responses?
  2. How appropriate are their responses?
  3. How well do their responses limit the spread of the non-conformance and its effects on your organization and your customers?

Potential problem analysis helps people efficiently identify measured responses to a non-conformance, and any potential problems or effects that might result.

Moreover, potential problem analysis involves avoiding risks inherent in the solution, and anticipating risks that may arise from implementing a containment action and planning appropriate action before they become reality. Preventive and contingent actions are established to minimize risks, while promoting and capitalizing actions are established to extend benefits.

Issue Investigation

A good investigation leads to true cause. When people in your organization conduct investigations:

  1. How often do they get to true cause?
  2. How much time is spent gathering relevant data vs. documenting speculations?
  3. How well do their investigations explain the logic used to determine cause?

Problem analysis is finding the root cause of deviations, and investigating the cause or causes of failure. When something goes wrong, the question is, why? Problem analysis provides a powerful logic for understanding the root cause of performance deviations. Corrective action that drives business value rests upon a foundation comprised of an effective, systematic logic for finding root cause.

Investigation Approved

Approvals should be based on clear criteria and support the performance system. When people in your organization present investigations for approval:

  1. How many review cycles are required for approval?
  2. What information is provided to investigators to help them improve their investigations?
  3. How are people encouraged to complete thorough investigations?

Kepner-Tregoe’s approach to managing performance is based on the experiences of effective leaders who know that setting clear expectations for performance — and then helping employees achieve that performance — are the keys to sustaining a competitive advantage. The approach centers on a five-component model (situation, performer, response, consequences and feedback) that has been consistently re-validated since its inception and provides a practical, useful framework for understanding human performance.

CAPA Selection

A good CAPA is the best-balanced CAPA chosen to meet the detailed needs of the specific non-conformance. When people in your organization recommend CAPAs:

  1. How often do CAPAs provide actions to remove true cause?
  2. How often do CAPAs recommend actions to prevent re-occurrence?
  3. How often do the recommendations address any risk associated with the CAPA?

Decision analysis is selecting the best solution for the deviation by making choices between alternative corrective actions. It is also concerned with selecting the action that best meets agreed performance objectives, while managing the risks attendant to any change. Alternative actions may be known, or a new solution must sometimes be created. Senior management is often involved in sanctioning the actions that are adopted.

CAPA Implementation

There are two important aspects to implementation: prioritization and scope management by the leadership team, and then effective implantation by the project team.

When people in your organization implement CAPAs:

  1. How well/often are CAPAs delivered on time, on cost and on performance?
  2. How often do CAPAs overlap?
  3. How often does scope change?

Project management utilizes resources wisely to implement value-added change. A good plan provides objectives that decision-makers can use to prioritize changes and identify overlapping changes.

Potential Problem Analysis is avoiding risks inherent in the solution and anticipating risks that may arise from implementing a corrective action and planning appropriate action before they become reality.

CAPA Approved

As with investigation approvals, CAPA approvals should be based on clear criteria and support the performance system. When investigations and CAPAs are closed:

  1. How well is efficacy confirmed?
  2. How well is ongoing monitoring established?
  3. How well are the efforts of team members appropriately acknowledged to encourage people to complete thorough investigations and implement appropriate CAPAs?

With acceptable standards in place, monitoring and reporting can compare planned performance with actual performance. Effective monitoring and reporting precisely specifies the nature of deviations, including their identity, location, timing and magnitude. In addition, information about distinctions between successful and unsuccessful production operations must be effectively documented. The critical objective is identifying, on a short interval basis, all meaningful deviations between planned and actual performance.

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