How do I manage unplanned deviations in Grand Avenue Software?

Owned by Ann Ivey
Last updated: Feb 25, 2024
3 min read

Grand Avenue Software does not have a dedicated workflow for unplanned deviations (also called process deviations or incidences). As a workaround, the NCM module can be modified to use for this purpose.

Positives

Negatives

Positives

Negatives

  • Workflow is close to what is needed for process/procedure nonconformities

  • Configurable fields can be used to make the workflow a better fit for process/procedure nonconformities

  • Provides a path to create a CAPA Request if needed

  • The name “Nonconforming Material” does not convey that there can also be process/procedure nonconformities

  • NCMRs do not have an out of the box “Root Cause” field

  • For a process/procedure nonconformity, the Disposition Plan and its associated tasks may be extraneaous.

NCM Report Configuration for Process/procedure Nonconformities

Configuration

Suggested Values

Configuration

Suggested Values

Add NCM Report coding field for Nonconformity Type (OPTIONAL if needed to distinguish between NCMR types for metrics purposes)

Material/Product/Part, Process/Procedure

Add NCM Report extra data field for Root Cause

<open text field>

Add to Product Disposition Locations

N/A - Process/Procedure

Add to Product Disposition Codes

N/A - Process/Procedure

Add to NCM Report Entry Defect Code

Process/Procedure

If desired, add an NCM Review Board

Process/Procedure Nonconformity Review Board

Add Part to Parts Database

Part #: 999999 Part Name: Process/Procedure

Process Steps

Submit NCM Report

  1. Enter the Description of the process/procedure nonconformity (applicable only to GAS 16.1 and later releases).

  2. Enter special Part Number 99999 for “Process/Procedure” as shown below.

image-20240225-215311.png

  1. Enter the Correction in the Containment Description/Plan field as shown in the example below.

  2. Enter the Root Cause if it is known at this point. The field is required at this step, so enter “TBD” if the root cause is not known; it will be filled in later.

  3. Select Nonconformity Type “Process/Procedure” if that field has been configured.

image-20240225-210319.png

  1. Add an entry in the Disposition Plan following the example below and click “Save.”

  1. Answer the Process Impact questions and click “Save.”

  2. Click “Save and Proceed to Signoff”

  3. Sign off to submit the NCM Report.

Propose Disposition Plan

  1. Document any investigative activities in the NCM Activity Log.

  1. If the Root Cause was previously TBD, enter the root cause found during the investigation.

  1. If the Disposition Plan’s Disposition Code field is not already filled in, select “N/A - Process/Procedure.”

  2. Click “Save.”

  1. Click “Save and Proceed to Signoff.”

  2. Select the applicable NCM Review Board for process/procedure nonconformities.

  1. Set an Approval Due Date, specify whether a CAPA should be initiated, and click “Sign Off.”

Formal Review

A review board approves the process/procedure nonconformity description, root cause, and correction.

Assign Disposition Task and Implement Disposition

  1. If there is no product to disposition, assign the Implement Disposition task to yourself and sign it off as shown below.

  1. Sign off the Assign Disposition Tasks task.

Review Disposition Results

If there is no product to disposition, click “Save and Proceed to Signoff.”

Close NCM Report

If the report looks correct, click “Proceed to Signoff.”

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