Setting Up and Using Operator Certification

Understanding Operator Certification

You can use Operator Certification to ensure that only certified operators perform the tasks performed in your implementation of MES for Process Manufacturing. By defining and enforcing certifications, proficiencies, and competencies, you can help meet the regulatory requirements of the FDA 21 CFR Part 211, and comply with other regulatory requirements such as OSHA. Use Operator Certification to define which certification, competency, and proficiency each task in MES for Process Manufacturing requires. Operator Certification validates each task during execution, and allows you to override the requirements.

Operator Certification helps assure that only certified operators perform critical tasks, and eliminates many errors that result from insufficient training or competency. Each time an operator performs a transaction, Operator Certification assures that the operator is certified to do so.

Operator Certification System Dependencies

Operator Certification in MES for Process Manufacturing requires that you implement portions of Oracle HRMS. Oracle HRMS stores information pertaining to each employee who uses MES for Process Manufacturing. You define each certification, competency, and proficiency in Oracle HRMS, and track these three elements for each employee in the HRMS application. Using Oracle Learning Management, a Learning Administrator can reference each certification and competency within a training course, and then each Employee can complete the required certification using Oracle Self-Service Learning Management.

To use Oracle HRMS to enter employee data, see the Oracle HRMS Enterprise and Workforce Management Guide.

To use Oracle HRMS to define each certification, competency, and proficiency, see the Oracle HRMS Workforce Sourcing, Deployment, and Talent Management Guide .

To use Oracle Learning Management to reference each certification and competency within a training course, see the Oracle Learning Management User Guide.

Associating a Certificate or Competency with an Item, Resource or Transaction

To set up Operator Certification in Oracle MES for Process Manufacturing, you use the Operator Certification - Create Object window to associate Items, Resources and Transactions with Certificates and Competencies. If you set up a certification requirement for an Item or Resource, and for a Transaction using that Item or Resource, then before the operator performs the action, be aware that the certification will have to be verified twice.

To associate a certificate or competency with an Item, Resource, or Transaction

  1. Navigate to the Operator Certification-Create Object window.

  2. Enter or search for and select an Organization. Required.

  3. Select either Item, Resource, or Transaction from the Object Type list. Required.

  4. Click Override to override the certification or competence.

  5. Select a specific Item, Resource or Transaction from the Item, Resource, or Transaction list.

  6. Click Go to open up a list of existing objects, or click Create to create a new one.

  7. In the Competence Criteria region select either Certification or Competence from the Type list.

  8. Select the appropriate Certificate or Competence for the Item, Resource, or Transaction. Required

    Note: Certificates and Competencies must exist in Oracle HRMS in order to be selectable here.

  9. Enter or search for a Proficiency rating.

  10. Enter a Start Date for the certification or competency. Required.

    You can also enter an End Date for the competency.

  11. Click Apply.

Overriding a Certificate or Competency requirement

During dispensing, if an operator does not have the required certificate or competency to manage the item, then a qualified person must give approval for the operation to continue. Only certain requirements are eligible for override. If a certificate cannot be overridden, then an error message explains that the competency or certificate is mandatory.

To override a certificate or competency requirement:

  1. Enter your Username. Required.

  2. Enter your Password. Required.

  3. Enter any necessary Comments.

  4. Click Override.