Non-conformances work flow

Non-conformances work flow


Purpose

The purpose of this non-conformance process is to establish a structured approach to identify, address, and resolve issues or deviations from established standards or procedures within the organization, ultimately ensuring the quality, compliance, and efficiency of its operations. The workflow through Open, Complete, and Closed-states helps to systematically manage and track the progress of non-conformance resolution from detection to final resolution and review.

Each state in the workflow serves a very specific purpose:

Open-state

The "Open"-state is the initial phase where a non-conformance is identified and registered. During this stage, the primary objectives are to:

   - Gather information and details about the non-conformance.
   - Identify the root cause of the non-conformance.
   - Determine the corrective measures or actions required to address the issue.
   - Assign responsibility for implementing these corrective measures.
   - Initiate the process of resolving the non-conformance.

Essentially, this phase involves the detection and initial response to the non-conformance, ensuring that it is properly documented and that corrective actions are initiated promptly. 

When the corrective measures has been sucessfully implemented the non-conformance can be moved to the "Completed"-state

Completed-state

The "Completed"-state follows the "Open"-state and is the final stage in the non-conformance process, and it should involve the administration of the organization. During this phase:

   - A thorough review of the entire non-conformance process, from its initial detection to the completion of corrective actions, is conducted.
   - Administrative decisions may be made regarding the effectiveness of the process and the actions taken.
   - Documentation is archived for future reference or audit purposes.
   - Any necessary communication or reporting, both internally and externally, is completed.

This stage ensures that the organization's administration has oversight and control over the non-conformance process, validating that the issue has been adequately addressed and resolved in accordance with the organization's standards and objectives.

Closed-state

The Closed-state serves as an archive for all closed non-conformances. This means that all documentation related to the non-conformance, including details of the non-conformance itself, the corrective actions taken, verification and validation results, decisions made during the administrative review, and any reports or communication related to the non-conformance, are stored and organized systematically.

Timestamp and Action Logging

The "Closed"-state maintains a meticulous log of timestamps and actions for every non-conformance registered. This logging serves multiple purposes:

Historical Reference:
Timestamps provide a historical record, allowing the organization to track the timeline of each non-conformance, from its initial detection through resolution and closure.

Accountability:
By logging actions taken, the organization can maintain accountability. This includes recording who was responsible for each action and when it was completed, ensuring transparency in the resolution process.

Reopening Closed Non-Conformances:

One unique aspect of this Closed State is the ability to reopen closed non-conformances. This feature is crucial because it allows the organization to address situations where a previously closed issue resurfaces or is found to be inadequately resolved.

Criteria for Reopening:
Clearly defined criteria should be in place to govern when a closed non-conformance can be reopened. This could include the discovery of new information, evidence that the corrective actions were ineffective, or a recurrence of the same issue.

Reevaluation:
When a closed non-conformance is reopened, it undergoes reevaluation, which may include reassessing the root cause, reviewing previous corrective actions, and determining the need for additional or modified actions.

Documentation Updates:
While the "Closed"-state primarily focuses on archiving, reopening a non-conformance requires documentation updates to reflect the new developments and actions taken during the reopening process.

In summary, this version of the "Closed"-state primarily functions as an archive and repository for closed non-conformances. It meticulously logs timestamps and actions, ensuring a comprehensive historical record of each non-conformance. The ability to reopen closed non-conformances is a vital feature, allowing the organization to address recurring or inadequately resolved issues effectively. 


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