Processes

Processes are a powerful option for QMS Events. QMS Processes essentially are a series of predefined QMS events as defined by the ISO Standard, in particular for ISO 13485 and FDA’s QSR (Quality System of Regulations, sections related to medical devices).

These ISO defined processes show the various events, in sequence, that need to be completed to meet the requirements of the ISO Standards. They are selected by either the project manager or the user and simply dropped into the project at the appropriate point. The QMS process then automatically fills in all the subsequent tasks, reporting, workflows, managers, users and thresholds and triggers that are required, by the ISO standard. As one QMS Process defined event is closed, the next is automatically triggered and initiated and this continues until the Process is complete - all in accordance with the ISO Standard. When a QMS process is used, you can be sure it meets all the compliance requirements for that process.

The Processes are only available to PTOs and Managers. The Processes are not available in private projects.

The Processes must be approved before they could be used in Project Management Module by an adequate person through appropriate approval workflow.

Example

In the following, we are going to demonstrate how to work with Processes.

Let’s say, the case is the following in our company: The management plans to start the procedure for determining, providing and maintaining the work environment that is required to achieve conformity to product requirements. The process covers the following issues: Health, cleanliness and clothing of the personnel, possibilities for adverse events, description of the special environment conditions, and control of the contaminated or potentially contaminated products. The CEO of the company (in our example: John Smith) is creating work instructions for each unit or department. In this case, according to ISO 13485, the CEO will initiate ‘P-640 Work Environment Process’. This is the flow chart of the P-640 Process:

 

John Smith is going to go to the Project page and start ‘P-640 Work Environment Process’. Please follow the steps below described in our example.

Please go to the Project Management module by clicking on the 'Project' icon in the sidebar on the left side. Select your project you want to work in, and click on ‘Processes’ in the left side menu.

Step 1:

  1. In order to complete QMS Processes properly, please check out if you are a member of the responsible System Roles/Groups according to the flow chart (e.g. Unit Manager, CEO, QMS Manager etc.).


    In our example, John Smith is a CEO user, which means that he is member of the CEO System Role/Group. He will be assigned a number of QMS Issues according to the flow chart. To view the Groups which you are member of, please go to 'Settings' > 'People' > 'Users' > Look for your user name and click 'Details'. On the next page you can view the Groups you are member of.



    To view the members of any System Role/Group, please click on Settings in the sidebar, click on People on the top of the page, and select Groups/System Roles in the left side menu.

     
  2. In Processes, please scroll down to ‘P-640 Work Environment Process’. To view the flow chart of the Process, click on the 'Preview File' button ('eye' icon) in front of the 'Start' button.



     
  3. Click on ‘Start’ to start the Process. In the next window, confirm with ‘OK’. Now, a sequence of QMS issues is being started automatically.



     
  4. In 'Issues' of the project, we can see that a Process type Issue, ‘P-640 Work Environment Process’ is created by John Smith.



     
  5. For this Process Issue, the ‘Create Work Instructions for Work Environment in Each Unit or Department’ Task type sub-task is created. The sub-task is assigned to the Unit Manager user (in our example John Doe is Unit Manager).


     
  6. According to the flow chart, in parallel, a Process is displayed in the QMS module in the specific project. Inside that Process a QMS Event, ‘P-630-A Infrastructure – Equipment Problem Report Process Initiated’ is created. Processes are ordered horizontally by date.


     
    • To go to the Issue details page of the Process, please click on the subject of the Process.




       
    • To see the details page of a QMS Event or a QMS Decision, please click on the QMS Event or on the QMS Decision.




       
  7. On the details page of ‘Create Work Instruction for Work Environment in Each Unit or Department’, you find the ‘T-002 Work Instruction Template’ attached.


     
  8. Please follow the instructions in the flow chart. Complete the relevant sections in the form. Rename the document to the following format: WI-00X-XXX.


     
  9. In order to proceed with the Process, click 'Edit' on the details page of ‘Create Work Instruction for Work Environment in Each Unit or Department’.
  10. In the ‘Edit issue’ window, click on ‘Add attachment’ to select and upload the form. Set the Status to 'Closed' and click Update. According to the flow chart, Step 1 is completed here.

Step 2

  1. Please scroll down to the 'Parent Issue' section on the details page of the Task and click on the parent Process Issue ('Work Environment Process').



    A new QMS Decision, ‘P-640 Approval – Approve Work Instructions’ sub-task is created, and it is assigned to the CEO (to John Smith), according to the flow chart.



    The QMS Decision is displayed in QMS 'Processes' and in 'QMS Issues'.





    You can view all Process steps or only QMS steps on the Process details page, by clicking on 'Show all steps'.


     
  2. The CEO goes to the details page of ‘P-640 Approval – Approve Work Instructions’.  


     
  3. He is reviewing the attached form, and now he needs to make a decision whether to approve it or not.
  4. Click 'Approved' or 'Declined'  according to your decision. Optionally, add comments.
  5. According to the decision, there can be two cases.

 Case 1: Work Instructions declined

  1. The CEO clicks on ‘Declined’. Optionally, he can add  comments. Click OK.
  2. According to the flow chart, the Process continues with Step 1.


     
  3. The Work Instructions are declined by the CEO, the Status of the previous ‘Create Work Instructions for Work environment in each unit or department’ Issue is automatically set to 'Reopened'. When you are done working on the Issue, close it.


     

Case 2: Work Instructions approved

  1. The CEO clicks on ‘Approved’, and click on 'OK'.
  2. When the Work Instructions document has been Approved, Step 2 is completed according to the flow chart. 

Step 3

  1. A new QMS Event ‘Process: P-640 Work environment Process ended’ is created.  The Process and Step 3 is finished automatically. To view finished Processes in the project (i.e. Processes in 'Closed' Status), go to the QMS 'Processes' page and check the 'Show finished processes' checkbox.




     
  2. On the details page of the finished Process, you can see that the Status of the ‘P-640 Work Environment Process’ is set to 'Closed'.