The article explains how to perform an Assessment in the new Assessment Workflow

1.  Enter Assessment Details

1.  Enter Assessment Details

1. Date: The date this assessment is to be completed.

2. Main Contact: This is the main contact person at the Supplier for this assessment.

3. Completed By: Select the person who is completing the assessment.

4. Position: The job position of the person completing the assessment.

2. Complete Data Collection

2. Complete Data Collection

Both the Doclist and Checklist shown are generated from the program applied. If any Corrective Actions are selected they will generate in the next stage.

1. Requirement: What is to be done. In the case of a Doclist this will typically require the upload of a Document. In the case of a Checklist a question would need to be answered.

2. Download Response Document: In order to download and complete a response document, simply click the document icon next to the Requirement details. The download should start automatically.

3. Review Date: This column is added for the Doclist grid only. When the review date occurs, an automatic document review will open up and notify both the supplier and customer about the out-of-date document that needs to be re-uploaded. The review date can be set manually by typing or by using the calendar feature provided.

4. Upload Response Document: Once a supplier has finalized the documents required by the customer, they will click “Add File” to upload. Any files that attached here will now go automatically to the “Documents” module.

5. Report: An optional field for any additional notes or comments.

Note: Once the supplier clicks “Save & Submit” they are not able to edit the documents they have uploaded as at this stage they will have been sent to the Documents module. Until such a time as the Supplier is ready to Submit their documents they can use the Save button to save their work.

3. Complete Nonconformance & Corrective Action stage

3. Complete Nonconformance & Corrective Action stage

This section expands on the Corrective Actions selected in the Data Collection stage above. The user completing the assessment must add:

  1. Comments / Observations: Add any comments / observation made with regards to the Non-conformance / Corrective Action:
  2. Category: The level of importance assigned to the non-conformance.
  3. Responsible: Who is responsible for the Corrective Action.
  4. Due Date: The due-date that the Corrective Action is to be completed by.

4. Add a Risk Assessment – Absence of Control

4. Add a Risk Assessment - Absence of Control

This stage is used to conduct a preliminary risk assessment of the Supplier or Material.

1. Hazards: Select any Hazards associated with the material.

2. Risk: Assign the level of Risk associated with the Hazard.

Note: If the Risk is High / Medium, and the Model Details have been completed in the Assessment Program, the Assessment will proceed to the next three stages below. If the selected risk is None / Low, the Assessment will skip these stages and proceed to the final Approval stage at the bottom of this page.

3. Advanced Risk Determination: Select if the user wishes to use the Advanced Risk Determination method instead of manually selecting the risk as outlined in Step 2 above.

5. Determination of Control

5. Determination of Control

This stage is designed to allow you to determine what kind of control might be required for this Supplier or Material. The decision tree can be designed in the Risk module and can guide you towards determining the most appropriate kind of control for the Supplier or Material.

The output of the decision tree will either be Control Required or Control Not Required, according to how you have designed the Decision Tree. If there is no Control Required then the assessment will skip the next two stages and go to the final Approval stage.

6. Add a Control Plan

6. Add a Control Plan

Note: If you have already predefined Control Models in the RISK module then they can be selected by clicking Add Control shown above. A number of System Control models are also available and which have been prepared according to FSMA requirements.

1. Control name: The name which describes the activity e.g. auditing.

2. Control limit: The specific point at which the product may become unsafe e.g. temperature in the case of a heat treatment control.

3. How: The control measure or procedure is conducted.

4. Responsible: Person who is responsible for ensuring the control measure is conducted as per specification and schedule.

5. Frequency: How often the control measure needs to be conducted e.g. every two years in the case of audits.

6. Corrective Action: The action to be taken in the event that the critical limits are not met.

7. Records: The record where the data and evidence supporting the fulfillment of the control is maintained.

8. Verification: The activity that confirms that all the elements of the control are in place, adequate and capable of producing safe and legal food.

7. Conduct Risk Assessment – Presence of Control

7. Conduct Risk Assessment - Presence of Control

Now that you have established the controls required for this particular Supplier or Material it may be possible to adjust the Risk in the presence of these controls. In this case only the Probability of the Risk should change and not the Severity.

8. Approval

8. Approval

1. Score: Final Score which is automatically calculated if there is a score associated with the Rating.

2. Result: State whether the result is a Pass or a Fail.

3. Rating: Assign the final rating.

4. Status: This is where you determine whether the Supplier or Material is Approved and should show up on your Approved Supplier List. It is possible to leave this field empty, in which case you may wish to conduct a further Assessment or an onsite Audit.

5. Scope of Approval: If required you can select the Scope of Approval. This allows you to limit or further define the Scope of Approval for the Supplier or Material. For example, you may want to approve Suppliers / Materials based upon certain conditions e.g., temporary approval, specific category approval, for a particular region or group of plants etc.

6. Summary: A summary of the Assessment is automatically created by the Assessment Program.

7. Responses: Displays the number of responses from the Checklist in the Assessment.

8. Report: Make any final notes or observations in the Report section.