Introduction

Controlled documents are documents that must undergo formal review and formal approval, controlled distribution, controlled modification and controlled storage and access.

They are critical in ensuring compliance, standardization, and quality within an organization. 

Controlled documents are commonly used in industries where compliance with regulations, standards, or internal policies is critical, such as in pharmaceuticals, aerospace, manufacturing, and healthcare sectors. 
Examples include standard operating procedures (SOPs), quality manuals, safety protocols, and technical specifications.

To facilitate the Controlled Documents creation and management process, we offer in ENOVIA the capability to use a questionnaire while creating a new Controlled Document.

The questionnaire serves as a systematic tool to automatically identify the necessary approvers, templates, and classifications based on user responses when creating controlled documents. The questionnaire aims to enhance the efficiency and accuracy of the controlled document management process while ensuring compliance with organizational standards.

Questionnaire in 'Controlled Document Management' App 

The 2024X GA release introduced a new web application, called 'Controlled Document Management', which is available with 'Quality Document Author' role (QUC) 
that is available on both on premise and on cloud environments. 

In this blog, I will explain how to work with Questionnaires in the 'Controlled Document Management' application. 

Types of Questionnaire:

In 'Controlled Document Management' app, we support two types of questionnaire:

• Creation Questionnaire 
• Approval Questionnaire

The process of creating both types of Questionnaire is the same, yet their usage is different and will be detailed later in the blog.

Create a questionnaire: 

The questionnaire provides the framework to automatically identify: required approvers, 
templates and classifications for Controlled Documents based on user responses 
to each question. 

The Questionnaire consists of root questions and sub questions.

Root questions:

For each root question, select a response option:

• Yes\\No
• Classification - select one library class
• Other – type in the optional responses that the user can choose as an answer.

Sub questions: 
For questions with a response option of 'Yes/No' or 'Other', you can create sub-questions.
The appearance of the sub-question depends on the answer the user will provide to the parent question. 

Assign related data: 
You can assign the following as related data to a root question or to a sub question:

• A person – this person will be responsible to approve the controlled document. 
• Controlled document template – this template will be used while creating the controlled document (relevant only for Creation Questionnaire)
• Route template – this route template will be used to instantiate an approval route to approve the controlled document. 
• Library class – the controlled document will be classified in this class.

The related data depends on the answer you provide to the question.

Activate the Questionnaire:

1. Promote the Questionnaire to 'Active' state, to make it available for use.
2. Associate the Approval Questionnaire with a Controlled Document Template.

Create a Control Document based on Questionnaire: 

As explained above, we support two types of questionnaires. 
The table below describes the different use of both types:

	Creation Questionnaire	Approval Questionnaire
When is it recommended to use each questionnaire?	When the Controlled Document Template is not known in advance, and is chosen as a result of answering a question.	When the Controlled Document Template is  known from the beginning.
What is the main purpose of the questionnaire?	To choose the appropriate Controlled Document Template	To choose approvers and classify the document into a library class
What types of Related Data can be assigned to a question?	Controlled Document Template  A person / Route Template  (as approvers) Library Class	A person / Route Template  (as approvers) Library Class
When is the Questionnaire used?	When creating a new Controlled Document From Questionnaire	When creating a new Controlled Document From Template
At what stage in the process of creating the document are the questions answered?	The questions are answered during the creation process of the Controlled Document.	The questions are answered after the creation process of the Controlled Document. Note: In this case, it is possible to re-start and re-submit an approval questionnaire if the document has not reached Frozen state.

The answers provided to the questions are stored and accessible, ensuring traceability of the decisions made. 

Examples:

The following examples illustrate the creation and the usage of Creation Questionnaire in more detail:

Example #1

Depending on the response to the question, the controlled document will be created based on the corresponding template and will be classified in the appropriate class.

Example #2

Depending on the response to the question, (yes/no) a sub question will appear or not. 

Then, depending on the response to the sub question, the controlled document will be automatically connected to the corresponding approval route when reaching the Frozen State.