Regulation Workflow Diagram



An out-of-the-box workflow of Document forms consists of these steps:

  • Draft 
  • Approval
  • Approved


Regulation Form Sections and Fields



  1. Identification Details Section



Fields

Field Explanation

Title

  • Must be filled before submitting to the next step. 
  • Define a short description of a document.
  • A free text field for a short description of a document.

Regulation Version

  • Define a short description of a document.

Regulatory Agency

  • Define the agency that published the Regulation. 

Regulation Status

  • Allow selection from a dropdown field with the following out-of-the-box options: Compliant, NA, Non-Compliant

Document Type

  • Must be filled before submitting to the next step.
  • Define the type of the document.
  • Allow selection from a dropdown field with the following out-of-the-box options: Contract, Drawing, Form, Job Description, Policy, Procedure, Record, Regulation, Specification, Work Instruction

Number

  • Must be filled before submitting to the next step.  
  • Define the unique document number which identifies the document. 
  • The system automatically generates with the following format: DOC-XXXXX where XXXXX is the next sequential number.  

Revision

  • Define the revision number if a document is being up-versioned. 
  • Automatically generated with the starting number being one and incremented each time the document is up-versioned.

Created Date

  • Define the created date of a document. 
  • Allow selection from a calendar, by default set to the current date.

Next Review Date

  • Define the next review date after the document is approved.
  • If the Next Review Date is specified, an email reminder shall be sent to the 'Author' of the document when the Review is due. 


  • Automatically set to the two years from the current date (for a new record) but allows selection from a calendar.

Is the Regulation Applicable?

  • A checkbox with two options: Yes and No
  • Define if the Regulation applies to the company.

License Required 

  • A checkbox with two options: Yes and No
  • Define if there is any licensing required for the Regulation

Monitoring Required

  • A checkbox with two options: Yes and No
  • Define if monitoring is required for the Regulation.

Notification Require? 

  • Define if notification is required for Regulation.
  • A checkbox with two options: Yes and No

Additional Details regarding Regulation

  • Define additional details for a regulation
  • A free text field

Overall Actions Required

  • Define overall actions required for Regulation
  • A free text field

Author

  • Define the author of the document.
  • Allow selection from all available users in the system and by default set with the currently logged in user.

Effective Date

  • Define the date the document goes into effect.
  • Allow selection from a calendar.

Approvers

  • Define the document approvers.
  • Allow selection from all users in the system.
  • The Approval task shall be assigned to these users by default.

Reviewers

  • Define the document reviewers.
  • Allow selection from all users in the system. The Review task shall be assigned to these users by default. 

Notification List

  • Define the list of users who receive a notification when a document is approved.
  • Allow selection from all users in the system. 

Document Category

  • Define a logical group of a document for categorization.
  • Allow selection from a list of options:

4 Context of the organization: 4.1 Understanding the organization and its context

4 Context of the organization: 4.2 Understanding the needs and expectations of interested parties

4 Context of the organization: 4.3 Determining the scope of the quality management system

4 Context of the organization: 4.4 Quality management system and its processes

5 Leadership: 5.1 Leadership and commitment

5 Leadership: 5.2 Policy

5 Leadership: 5.3 Organizational roles, responsibilities and authorities

6 Planning: 6.1 Actions to address risks and opportunities

6 Planning: 6.2 Quality objectives and planning to achieve them

6 Planning: 6.3 Planning of changes

7 Support: 7.1 Resources

7 Support: 7.1.1 General

7 Support: 7.1.2 People

7 Support: 7.1.3 Infrastructure

7 Support: 7.1.4 Environment for the operation of processes

7 Support: 7.1.5 Monitoring and measuring resources

7 Support: 7.1.6 Organizational knowledge

7 Support: 7.2 Competence

7 Support: 7.3 Awareness

7 Support: 7.4 Communication

7 Support: 7.5 Documented information

8 Operation: 8.1 Operational planning and control

8 Operation: 8.2 Requirements for products and services

8 Operation: 8.3 Design and development of products and services

8 Operation: 8.4 Control of externally provided processes, products and services

8 Operation: 8.5 Production and service provision

8 Operation: 8.6 Release of products and services

8 Operation: 8.7 Control of nonconforming outputs

9 Performance evaluation: 9.1 Monitoring, measurement, analysis and evaluation

9 Performance evaluation: 9.2 Internal audit

9 Performance evaluation: 9.3 Management review

10 Improvement: 10.1 General

10 Improvement: 10.2 Nonconformity and corrective action

10 Improvement: 10.3 Continual improvement

Department

  • Define the department the document belongs.
  • Allow selection from a list of options:  Administration, Customer Service, Sales, Quality, IT, Human Resources, Marketing, Manufacturing.
  1. Approved Attachment Section





Field

Field Explanation

Approved Document

  • Define the approved record. 
  • PDF version will be generated if the draft task's draft attachment is docx, doc or excel. 

Location of Regulation

  • Define the location of Regulation 


  1. Compliance Assessment Section




Field

Field Explanation

Section/Heading

  • Define the compliance assessment section/heading.
  • A free text field

Clause

  • Define the clause of the compliance assessment.

Required Actions

  • Define any required actions for the compliance assessment.

Status

  • Define the status of the compliance assessment.
  • A checkbox with the following out-of-the-box options: Compliant, NA, Non-Compliant.