This chapter covers the following topics:
Following is a requirement that customers have for tracking nonconformances:
Yes. Upon identifying a nonconformance, suppliers should document, evaluate, segregate (where practical) and disposition the nonconformance in accordance with the defined nonconforming material control process. Oracle Manufacturing Execution System (MES) for Process Manufacturing provides the toolset for rapid identification and tracking of manufacturing nonconformances.
Capture and Process Material and Resource Nonconformances
Written procedures for production and process control are designed to assure that critical materials such as drug products have the identity, strength, quality, and purity they claim to have or are represented to possess. Oracle Manufacturing Execution System (MES) for Process Manufacturing helps ensure that written nonconformance procedures, including any changes, are drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. Electronic records are maintained with electronic signatures so that these process control procedures are followed in the execution of the various production and process control functions. Tasks are documented at the time of their performance. Any deviation from the written procedures is then captured, recorded, and an appropriate disposition is assigned.
Unexpected events that adversely affect the manufacturing process and quality of the finished product can occur in any controlled production environment. These nonconformances must be tracked in the Control Batch Record (CBR). Quality departments analyze nonconformances as part of for their Corrective Action and Preventive Action initiatives (CAPA). To document the complete manufacturing batch record, evidence of nonconformances must be included in the CBR. Oracle Manufacturing Execution System (MES) for Process Manufacturing helps you manage nonconformance in the batch manufacturing process.
Nonconformances observed during the following events are tracked and recorded in the CBR and are used for analysis by Quality Control for CAPA. When there is nonconformance from the Master Batch Record (MBR), a window displays the following details:
Time the event occurred
Batch number, product produced
Phase of the batch where the event occurred
Specific details of the incident or observation, including:
Date of the nonconformance
Level of criticality
Individual who logged the issue
Type of nonconformance
Target value (not required)
Actual value
Preliminary cause
Reason code or severity code
Remarks
Links to standard operating procedures for managing nonconformance
Required follow-up steps with signatures of responsible operators and supervisors
Classify nonconformances as either critical or noncritical. Specify the actions to take after a nonconformance is recorded. For example, critical nonconformance is signed off by a quality control manager, while the production supervisor signs off noncritical nonconformance.
If additional follow-up and analysis documentation is created, then it is associated with the batch and incorporated into the CBR. Display the SOPs that link to a specific type of nonconformance.
Each nonconformance is identified by a nonconformance number and is available for viewing from the CBR.
Log a dynamic nonconformances during the batch execution process by assigning nonconformance severity, priority, and nonconformance ownership.
Oracle Manufacturing Execution System (MES) for Process Manufacturing tracks manufacturing nonconformances caused by such things as batch material quantity changes, item substitutions, resource substitutions, as well as any ad-hoc operator observations, such as power interruptions. Notifications of any nonconformances are automatically routed electronically to those who need to review and approve or disapprove continued processing. This includes all appropriate nonconformance details and electronic signature information so that batch status can be determined and appropriate actions can be taken. Batches with unapproved critical nonconformance events are now allowed to proceed to a closed status until all critical nonconformance events have received an approval disposition.
If batch material quantities are changed or substituted in the manufacturing process, then a nonconformance is recorded manually in the Oracle Process Manufacturing Process Execution application by choosing Log Nonconformance from the Actions menu. This can occur when the dispense material workorder is modified to change dispense quantities prior to staging material for addition on the shop floor. It can also occur when batch scaling is required to correct for material discrepancies.
This is a critical nonconformance. It must be authorized by the quality manager. Notifications of this nonconformance are sent to individuals who need to review and approve or disapprove the continuance of batch processing.
If resources are changed during batch production, then a nonconformance is recorded. By definition, a resource is anything of value, except material and cash, required to manufacture, cost, and schedule products. Resources include people, tools, machines, labor purchased from a supplier, and physical space used in the manufacturing process.
Resource nonconformances are defined as:
Resource substitutions in the batch manufacturing process that were not previously defined as acceptable alternates.
Resource failures and performance issues
This is a critical nonconformance and must be authorized by the quality manager.
A workflow approval process is available to make disposition on nonconformance. The post disposition actions such as putting a batch on hold, changing grade, and so on are manual.
Refer to the Oracle Quality User's Guide for details.
A collection plan and rules are seeded for Oracle Manufacturing Execution System (MES) for Process Manufacturing. Nonconformance e-records and associated e-signatures are part of the Oracle E-Records store for each event tracked. You can log nonconformances at the following batch levels:
Batch
Batch operation step
Batch operation step activity
batch operation step activity resource
Navigate to the following window or pages to log a nonconformance from the:
Batch Steps window in the Production Supervisor responsibility of the OPM Process execution application.
Batch page, Batch Details tab of the Operator Workbench.
Batch Operation page of the Operator Workbench:
Batch Details tab
Batch Details tab, Step
Batch Details tab, Step, Activity
Batch Details tab, Step, Activity, Resource
Process Instructions page of the Touchscreen Workbench.
From here, you can log a nonconformance from the batch, step/operation, activity, or resource level.
Prerequisites:
Set up nonconformance tracking in the Oracle Quality application.
Refer to Setting Up Nonconformance Tracking for additional information.
Identify the batch, operation, step, activity, or resource where the nonconformance occurred.
To log a nonconformance from the Batch Steps window:
Navigate to the Batch Steps window.
Select the Step and Operation where the nonconformance was observed.
Choose Log Nonconformance from the Tools menu. The Enter Quality Results window displays.
Verify the Collection Plan, Owner and Enter By User fields. You can only select a collection plan that has a current effective date. If a default collection plan has been specified, it is automatically selected.
Click Enter. The Update Quality Results window displays.
Enter the Nonconformance Number.
Enter Nonconformance Source as INPROCESS. Required.
Enter a brief Description of the nonconformance. Required.
Enter a Detailed Description of the nonconformance. Required.
Click Update.
To log a batch nonconformance from the Operator Workbench:
Navigate to the Operator Workbench.
In the Operator Workbench, find and select a batch or batch operation.
In the Batch or Batch Operation page, select the Batch Details tab.
In the Actions field, select Log Nonconformance.
Click Go.
The Quality Plans page displays.
Continue entering the batch nonconformance as described in the following task To enter a nonconformance:.
To log a batch step nonconformance from the Operator Workbench:
In the Operator Workbench, find and select a batch operation.
In the Batch or Batch Operation page, select the Batch Details tab.
In the Operations region, select a step.
In the Select Step field, select Log Nonconformance.
Click Go.
Continue entering the batch step nonconformance as described in the following task To enter a nonconformance:.
To log a batch step activity nonconformance from the Operator Workbench:
After selecting a batch step as described in the preceding task To log a batch step nonconformance from the Operator Workbench:, in the Activities region, select an activity.
In the Select Activity field, select Log Nonconformance.
Click Go.
Continue entering the batch step activity nonconformance as described in the following task To enter a nonconformance:.
To log a batch step activity resource nonconformance from the Operator Workbench:
After selecting a batch step activity as described in the preceding task To log a batch step activity nonconformance from the Operator Workbench:, in the Resources region, select a resource.
In the Select Resource field, select Log Nonconformance.
Click Go.
Continue entering the batch step activity resource nonconformance as described in the following task To enter a nonconformance:.
To log a nonconformance from the Touchscreen Workbench:
Navigate to the Touchscreen Workbench.
Search for a batch.
Refer to Searching for Batches.
Touch, tap or press Details to view process instructions for a batch or batch operation step.
If you are viewing process instructions for a batch in the Batch page, touch, tap or press Log Nonconformance.
If you are viewing process instructions for a batch operation step in the Batch Operation page, select the level to enter the nonconformance:
Batch/Material
Step
Activity
Resource
Touch, tap or press Log Nonconformance.
Continue entering the batch step activity nonconformance as described in the following task To enter a nonconformance:.
In the Quality Plans page, click Enter Quality Results for a collection plan.
The Add Data: Enter Results page displays.
Verify the Plan Name and Process Batch Number.
In the Nonconform Severity field, select the severity level.
(Optional) In the Detailed Description field, describe the nonconformance.
(Optional) Click Attachments to add an attachment.
(Optional) Click Add Another Row to add another nonconformance.
Click Apply.