OPM Quality Setup in R12
OPM Example
Taking an example of chocolate process manufacturing where
A Finished good comprised with two ingredients as below
Finished Good- Chocolate FG
Ingredients- Chocolate Syrup and Chocolate-Water
Step#1 – Inventory Organization Parameters
Inventory - Navigation: Setup/Organizations/Parameters
Inventory Organization is a plant where the batches are produced or an organization that holds the inventory at specified locations.
Inventory organization as process manufacturing enabled
Step#2 – Inventory Item Attributes
Inventory - Navigation: Items /Master Items
Product, all the ingredients and by-products to be used for the production are defined as inventory items, process manufacturing enabled and must be assigned to the process manufacturing enabled inventory organization (ORA in this example)
Ingredients
Step#3 – Setting up OPM Quality
OPM ALL- Navigation: Quality Manager /Setup
Set up OPM Quality Management in the Quality Manager responsibility:
• Define Test Classes. Optional.
• Define Test Units. Required.
• Define Sampling Plans. Optional.
• Configure Process Quality Parameters for a particular organization. Optional.
• Define specification Version Control in the Process Quality Parameters window. Optional.
• Define Test Methods. Optional.
• Define Tests. Required.
Setup and process flow can be explained by below diagram
Step#4 – Organization as OPM Quality LAB
OPM ALL- Navigation: Quality Manager /Setup/Process Quality Parameters
Enter organization name, click on Quality Laboratory and document numbering for samples.
Step#5 – Setting Up Tests
A test helps determine a quality characteristic or attribute of an item or lot. Test data type refers to the data type or format expected for the test result.
Non-Validated Test
Numeric Range Test
List of Test Values Test
Text Range Test
Prerequisites for tests
• Enter test methods and test units.
• Enter test classes to group specific tests into meaningful set
OPM ALL- Navigation: Quality Manager or OPM ALL/Setup/tests
Test Methods
OPM ALL- Navigation: Quality Manager or OPM ALL/Setup/tests methods
Once define what kind of test method the test is. For example above test have Brix_new as a test method under which we can define precision and replicate criteria.
Test replicate – while taking samples test replicate decides if we want to have same test replicated multiple times
Test Classes
Test classes distinguish the test class depending on the item attribute. For example it can be Chemical, mechanical or temperature etc.
OPM ALL- Navigation: Quality Manager or OPM ALL/Setup/tests Classes
Test Units
One can define custom test units for the test or use the already defined test units.
OPM ALL- Navigation: Quality Manager or OPM ALL/Setup/tests units
Step#6 – Setting Up Specifications
A test helps determine a quality characteristic or attribute of an item or lot. Test data type refers to the data type or format expected for the test result.
Specification
Item specifications identify a target or ideal result for each quality test performed by listing test requirements that specify these characteristics or attributes. When you complete the initial quality setup and then combine tests and test methods to design specifications. The specifications entered are used to compare against actual test results from samples taken. For range-validated tests, define the minimum and maximum acceptable range values for the test as well as the out-of-specification action to be performed when a test fails.
Using Item Specification Validity Rules
The Validity Rules for Item Spec window lets you define the validity rule type as inventory, WIP, customer, or supplier for item specifications
Depending upon the validity rules one can define specifications at various stage of the manufacturing process for example during the mixing or on the line and final sample when finished good is ready.
I am defining two specifications in this example intending to take sample at WIP level when the manufacturing in process and other sample as Inventory which will be taken when the finished good is produced.
The specification Validity Rile decides weather will be WIP/Inventory type.
WIP Specification-
OPM ALL- Navigation: Quality Manager or OPM ALL/Specifications/Specifications
To take the WIP sample I need to define the specification which can take samples taking OPM batch and batch lot number into consideration.
Click on Validity rule of above screen.
And then click on new.
Click on production and enter recipe name it will select formula and routings then.
Save the record close the screen and come back on specification screen.
Approve the status
Approve the specification by clicking Actions-Change status
And then change the status to Approved for General Use
Once Specification is in approved for general use status then only you can change the status of the validity rule.
Open the validity rule and change the status by actions-change status.
Inventory Specification -
Intention to have inventory specification is wanted to take a sample once a finished good is produced so under the validity rule I am not entering batch details and also making lot as optional by which I could able to take sample only on Finished good item.
Please note the replicate, it shows the number of times the test needs to be taken.
Save the specification and change the status of it as approved for general use.
Click on validity Rule, on the inventory tab click on lot as optional also you can mention the certificate of analysis report at the end of Finish good which can outline the analysis parameters.
Step#7 – Samples
Sampling supports quality inspection of materials during various points in the supply chain. Sample collection at events such as receiving, batch creation, batch step release, production yield, and lot expiration
Samples are also created as part of a stability study for a particular item. Samples are sent to a quality laboratory organization for testing. You can take multiple samples from the same source, and their collective disposition can be used to control and update other processes in the supply chain.
Sample Group
Sample groups are groups that share common sampling information.
For example, if the sampling plan requires three samples, then the first sample record has a sample instance of one of the three samples required. Each time a sample is added to a sample group, the total samples required increases by one, and each new instance is numbered appropriately in the series. When you use the Get Spec function, you can also create a new sample group instead of adding the new sample to an existing sample group
Once all setup is in place we can then take the samples.
OPM ALL- Navigation: Quality Manager or OPM ALL/Samples/Item Samples
Select Source as WIP, select the batch number and select the lot number. Click on Get Spec you shall see the WIP only specification available.
Save the Sample.
Click on results and enter the results values depending on the values you enter and if it falls within the range the evaluation will be set to accept.
Inventory Sample
Note the source as Inventory.
Note here – not entering any batch number. As we have made lot as optional in the validity rule sample is not asking for lot number.
Sample Dispositions-
Sample disposition can be changed manually by Actions - select Change Disposition
Disposition summary
Change from Planned to:
· Pending
· Retain
· Cancel
Change from Pending to:
· Cancel
· Retain prior to the sample being saved.
Change from Retain to:
· Pending in anticipation of sample analysis.
· Cancel to terminate analysis.
Change from In Progress to:
· Accept with Variance if results are recorded, and at least one result is in an experimental error region, or out-of-specification. However, the sample approver must accept this variance.
· Reject if results are recorded and at least one is not acceptable.
· Cancel to terminate additional analysis.
Change from Complete to:
· Accept if results are recorded and acceptable, and sample results are within the limits of the specification.
· Accept with Variance if results are recorded, and at least one result is in an experimental error region, or out-of-specification. However, the sample approver must accept this variance.
· Reject if results are recorded and at least one is not acceptable.
· Cancel to terminate additional analysis.
Change from Accept to:
· Accept with Variance if results are recorded, and at least one result is in an experimental error region, or out-of-specification. However, the sample approver must accept this variance.
· Reject if results are recorded and at least one is not acceptable.
· Cancel to terminate additional analysis.
· Change from Accept with Variance to:
· Reject if results are recorded and at least one is not acceptable.
· Cancel to terminate additional analysis.
Change from Reject to:
· Cancel to terminate additional analysis.
Step#7 – COA Report
Finally run the certificate of analysis
This explains the OPM Quality setups.
Thanks,
Ajay
