CAPA – Corrective and Preventive Action

As one of the most common problem management best practices, CAPAs (Corrective and Preventive Action plans) help organizations maintain ISO and other compliance standards. Our solution allows users to trigger CAPAs via failed audits, incidents, or ad hoc requests. If the action item owner is away while the action item has been assigned to him, our system may automate an escalation request. After a given number of days, the task may automatically be sent to a different role of equal responsibility. Additionally, an action item owner may request one extension on his action item, as per the company’s business requirements.

CAPA and Action Item Assignment – As CAPA is being created, a manager may add multiple AIs (action items) that define specific criteria such as AI name, owner, action type, and priority, etc. in the Create CAPA form. AIs are assigned to specific resources with specified deadlines and levels of priority. Action item owners collect and store action item evidence on completion. Process owners can, in turn, indicate their progress throughout these CAPA endeavors, review and approve AIs, and give their electronic signatures.

Control Testing

Add and Execute Test: Users are capable of adding and executing tests. All information that had been entered into the test definition form will populate the Execute Test form, enabling all auditors or other testers to review vital information pertaining to their test. Information such as prerequisites, scheduled date and due date, frequency and sample size are available to the user executing their test. As they execute their tests, they create test samples and assign each one an overall grade of pass or fail, determining the strength and status of the control, overall. During a review cycle, a manager may view, edit, or add sample results. If your company is undergoing two audits at once, for example, ISO 9000 and COBIT – their similarities allow you to leverage one test result for the other audit! Furthermore, pre-defined tests may be altered and reused at your discretion to fulfill your business needs. Interfacing’s solution can hold all audit history and results in our repository!

Evaluate and Approve Test Sample: The “Yes/No”, “And/Or”, and “Pass/Fail” buttons can help users determine sample effectiveness and accuracy easily and quickly. Users are able to add multiple samples without exiting the “Add Sample” window, adding a layer of automation to their evaluation process. To ensure a high degree of accountability and create a way to clarify inconsistencies, users can establish responsibilities by role and view all stakeholders involved in the audit approval cycle.

Complete Review and Audit Trial: Our Audit Review form displays all inherited audit information, as well as a dropdown to grade the audit result overall (pass/fail). The form also features a dropdown that triggers an automatic escalation to CAPA by selecting yes or no. We’re also aware that even though an audit may assume a passing grade, it could still require the CAPA process! Lastly, our Audit Report provides drilldown report visualizations that enable users to view all calculated metrics and data related to an audit instance (e.g. status of each associated test, adequacy and effectiveness of each test, auditor responsible for each test, etc.).

Incident Management

Effective IcM (Incident Management) is crucial to prevent any hazard that can potentially harm an organization’s operations, services, and reputation. Interfacing allows users to build a panoramic IcM process, from creating incident ad hoc, conducting incident investigation, performing root cause and risk analysis, setting multiple review and approval cycles, to triggering CAPA process based on failed analysis.

Incident Tracking & Investigation: Using an automatically generated tracking code, users can effortlessly follow up on incident request at any step in the process. Incident-related graphs and documentation can also be easily generated from data that captures additional specificity. From an incident form, incident investigators are able to inherit all information entered at previous stages of the incident process. Any user with the proper security and status may view all details of the incident, trigger an escalation to CAPA if needed, and submit an incident sign-off complete with an electronic signature once the investigation has been concluded.

Incident Review & Report: Our incident review option includes all fields inherited from the initial incident form (e.g., tracking code, location, analysis, investigation, etc.). Users are capable of triggering process-loop backs if a form is rejected upon review, adding validation on fields to prevent a form submission without a signature, and setting multiple approval cycles that may precede any form submission step. A user with proper security may drilldown into the details of an incident report to view subsets of relative information as well as expose and consult all related CAPA and IA details.

Interfacing is here to assist you with the always evolving changes to compliance requirements that need to be addressed immediately. We lead the way to corporate transparency with our easy to deploy and comprehensive digital integrated management system solutions for all your compliance, risk and process management needs.