Building Quality Management Systems for Sites and Sponsors: Root Cause and CAPA

Question 1

Quality Control

Answer 1

The component of a quality management system that ensures performance is meeting pre-determined requirements.

• Many of the standards that must be met are set externally, such as regulatory requirements and GCPs. External quality control by the sponsor’s monitors checks for compliance with these requirements.
• Other requirements such as protocols and SOPs are set internally, and should be monitored by internal quality control activities.

Question 2

Quality Improvement

Answer 2

• a cycle that is repeated throughout your clinical trial and is often depicted with the P-D-C-A cycle, which stands for Plan, Do, Check and Act
  
  1. quality planning section covers the ‘Plan’ portion
  2. quality control covers the ‘Do’ and ‘Check’ portions
  3. quality improvement covers the ‘Act’ part of the cycle. That is, this is where you take action to fix the problems that are uncovered with quality control.
• Handles the problems that your quality control identifies
• measures your performances against the applicable requirements and helps you figure out how to make a process work better.
• focus on improving the work process

Question 3

Quality Assurance

Answer 3

involves periodic assessments of a trial’s processes. It’s done to confirm that the right people are doing the right things in the right way.

• Quality assurance should be performed by someone who’s not directly involved with the work that’s being assessed.

Question 4

Quality Improvement vs. Quality Assurance

Answer 4

• both aim to detect and fix problems using the same Plan-Do-Check-Act cycle.
• Key differences:
  
  1. Everyone on a project team conducts quality improvement activities, while only objective observers should conduct quality assurance activities
  2. Quality improvement uses the same P-D-C-A cycle, but does so repeatedly throughout the duration of the trial. Quality assurance activities, are more periodic in nature, occurring at pre-specified times or when an issue arises that needs a thorough investigation. Problems are not identified in real time so it’s often too late to implement any improvements to the process.

Question 5

ALCOA-C

Answer 5

A - Attributable: it’s obvious who created the record and when

L - Legible: the document can be easily read and understood

C - Contemporaneous: the documentation is done in a timely fashion. It also means that all initials and signatures are dated on paper-based documentation. In the case of electronic documentation, it means that all signed data are dated. Changes should be traceable, should not obscure the original entry and should be explained if necessary (e.g., audit trail).

O - Original: the record is the original source document, not a photocopy.

A - Accurate: the information is recorded correctly

C - Complete: Both parties, researchers and investigators should aim for accurate and complete source documentation

Question 6

Risk Management

Answer 6

Identifying the things that pose a risk to patient safety and data integrity. Those identified risks then need to be analyzed in terms of how likely they are to occur and what their consequences would be.

• A plan is then put in place to avoid, reduce, and tolerate those risks through risk-based decision making.

Question 7

Corrective and preventive actions (CAPA)

Answer 7

The corrective actions are the steps you take to fix the root cause of it, while preventive actions are those things that are done to avoid the problem from happening again.

• The amount of detail that’s appropriate for CAPA documentation will depend on the amount of risk that an issue poses to the quality performance standards.