Table of Contents



Introduction

You might have a customer complaint or a problem with a supplier's delivery.  The Non-Conformance management area provides a structured way to communicate with your suppliers, collect root cause analyses and implement preventative actions.


To create a Non-Conformance, select “Site Actions” from the left-hand menu. Once the page has loaded select the 'Non-Conformances' tab to view existing non-conformance or to create a new one select 'Create New Action' from the top menu and choose 'Create a Non-Conformance'.


The module has been designed to follow a standard workflow that should be familiar to any ISO27001 or ITIL based incident management process.

 

The module has several key concepts:

  • Non-Comformance Details > Record all details and descriptions of the Non-Conformance that has occurred to inform your suppliers.
  • Investigation Summary > Suppliers responding to Non-Conformance can enter an investigation summary along with evidence to provide details of the steps taken
  • Root Cause Analysis > The root cause analysis allows the supplier to provide information on the cause of the Non-Conformance along with being able to attach evidence
  • Corrective/Preventative Actions > Allow your suppliers to enter corrective & preventative actions to highlight the steps to take/taken. All corrective and preventative actions are approved at the customer level. They can also be raised against the supplier from the customer level
  • Non-Conformace Approval > Set the status of the Non-Conformance to ‘closed’ once you have resolved and accepted all the analysis and actions declared by your suppliers.



Raising a Non-Conformance


1.The first step is to raise a new Non-Conformance. From the main menu, beneath the 'Tools' section, select 'Site Actions'.




Once the page loads ensure that the 'Non-Conformance' tab is selected as below:




2.The first step is to raise a new Non-Conformance. From the main menu, select “Create New Action” and then click the ‘Create a Non-Conformance' button displayed above the counts.




3.

Each Non-Conformance consists of the following fields:

  1. Name > Enter a unique name to identify your Non-Conformance 
  2. Severity > Enter the severity level from the drop-down options (minor, major, critical)
  3. Non-Conformance Date > Record the date and time that the Non-Conformance occurred
  4. Non-Conformance Type & Sub-Type > Declare the Non-Conformance type to categorise and report against
  5. Repeat Non-Conformance > Select from the Y/N option to state if this Non-Conformance has occurred before
  6. Non-Conformance > Provide details and attach multiple files in relation to the Non-Conformance
  7. Affected Site(s) > Select the sites that are affected by the Non-Conformance
  8. Assignee > Assignees and the Non-Conformance creator are the only users who can close or edit the details.




4.Now that you have provided the Non-Conformance details, you can send this to your supplier to provide a response. Select 'My Supplier' then search for the supplier site in the fields shown below and then enter details about the affected product – such as BBE date or batch number to help the supplier with their investigation. Alternatively, you can select your own company to provide a response.

The following fields can be completed;

  1. Associated Site > Select from the list of companies/sites within the Authenticate Directory for whom you wish the Non-Conformance to be associated with
  2. License/Registration number 
  3. Recipient > Select a specific recipient from the contacts list available or add the details of the individual that is required to respond to the Non-Conformance
  4. Response Due Date > Specify the date and time for which you require a response from your supplier
  5. Product Details > Here you can enter details for the product in question. If you have access to the product mapping feature, then you will also be able to select from your products. 
  6. Purchase Order Number > Add Purchase order number for the product
  7. Best Before Date > Enter the best before date for the product related to the Non-Conformance
  8. Batch Number > Record the batch number to better identify the potential products affected
  9. Quantity Affected > Specify the quantity affected by the non-conformance
  10. Outcome > Set an outcome for the product whether it was Accepted or Rejected
  11. Share with Companies > This allows you to share the Non-Conformance information with other companies such as your customers or a third party.




5.After providing these details, when you send the Non-Conformance, this will create an e-mail that will go to the recipient details selected/provided.





Supplier Response


1.The recipient selected when raising the Non-Conformance will receive an e-mail that will provide them with the details of the Non-Conformance and the required response date and time.

When logging into their company profile, they will have a task open on their dashboard.




2.Once the supplier selects ‘View Non-Conformance’, they will be taken to a single page showing them the full details of the Non-Conformance raised along with access to download and view any evidence attached.

Suppliers can enter the following details;

  1. Investigation Summary > Details of the high-level investigation to understand the Non-Conformance raised
  2. Root Cause Analysis > Details of the root cause of the problem/issue raised and the circumstances for which it occurred
  3. Corrective Actions > Suppliers can add corrective actions to prevent the Non-Conformance from re-occurring in the short term. Corrective actions are not generally the final solution but focused on immediate prevention.,
  4. Preventative Actions > Suppliers can add preventative actions to demonstrate how they will eliminate the cause of the Non-Conformance longer term

Attachments and evidence can be added to both the investigation summary and root cause analysis.

Evidence can also be added to corrective/preventative actions once the supplier has indicated that these have been set as ‘complete’




3.

Once the supplier has completed all the necessary details, they can send the Non-Conformance back to the customer who has raised it.


A supplier can reject a Non-Conformance by providing a comment as to why they believe that the Non-Conformance is unfounded.





Reviewing a Non-Conformance Response


1.

Once the supplier has completed their response to the Non-Conformance and returned this to the customer, a task will appear on your homepage indicating that a response has been provided for review.

There are various stages of approval for the Non-Conformance response:

  1. Root Cause Analysis > The information provided by the supplier requires approval

  2. Corrective/Preventative Actions > Each corrective action entered by your supplier requires an ‘approval’



2.You can also add additional Corrective & Preventative actions to send back to the supplier to complete if there are further actions that you need them to do to resolve/further prevent the non-conformance.

3.Once the non-conformance response is reviewed and approved, the non-conformance can then be set to ‘closed’.

Corrective/Preventative actions can remain open even if the status of the non-conformance has been set to 'Closed' (this may be that you set longer-term preventative actions for the future that cannot yet be resolved)



Non-Conformance Dashboard


1.The Non-Conformance module can be accessed via the top navigation. Here you can manage and review the status of all Non-conformance raised against suppliers.

The top counts identify;

  1. Total Non-Conformance > The total number of Non-Conformances raised
  2. Open Non-Conformance > The total number of Non-Conformance still requiring a response/review
  3. Non-Conformance in the last 30 days > A count of the Non-Conformance in the past 30 days highlighting an increase/decrease from the previous 30 days
  4. Closed Non-Conformance > The total number of closed/resolved Non-Conformance



2.

Filters can be applied to search for/ analyse Non-Conformance by;

  • Name
  • Status
  • Supplier
  • Severity
  • Affected Site
  • Type
  • Outcome
  • Assignee
  • Date Range From / To




You can also access information on Non-conformance for a specific supplier on their profile page.


On the suppliers’ company profile, all Non-Conformance will be shown with the current status provided. All users within your organisation can view all aspects of the Non-Conformance. (Only the creator of the non-conformance and assignees can add/amend data in a raised non-conformance)





Non-Conformance FAQ's


Who is notified when I raise a Non-Conformance?

When you raise a non-conformance, emails will automatically be sent to notify the recipient selected. There will also be an e-mail sent to the assignees selected from your internal user list to notify them of the non-conformance.



Who in my organisation can see the Non-Conformance?

All users of your platform have access to view the non-conformance dashboard and all non-conformance raised against a supplier (via their company profile). Only the user that has ‘raised’ the non-conformance or assignees that have been added can approve, add actions, and close the non-conformance



What if the non-conformance is unfounded?

When the supplier receives the non-conformance task, they can ‘reject’ the non-conformance and provide a comment back to you as the reason for why they believe this to be unfounded