In my previous article entitled ‘Strategic Planning & QMS’, I discussed how strategic planning provides framework and directing inputs to Quality Management System (QMS). Now in this article I shall explore on different types of QMS documentation and steps to define QMS.
A Quality Management System (QMS) contains various types of documents also called as artifacts.
Quality Policy Manual is a top level document that describes the role of QMS in achieving the Quality and is aligned to organization’s strategic plan (Mission, Vision, Values, Goals and Objectives). This document provides a basis on setting up objectives to be achieved by implementing QMS.
Processes/Procedures are sequence of interdependent tasks when performed using specific inputs generates desired outputs (e.g. Requirements Process). Documenting a process ensures its standardization. This means that the process is followed uniformly by different users and hence yields to the outputs which are comparable and hence its performance can be analyzed.
Records (Templates/forms/checklists/Reports) are tools to implement processes.
- Templates/forms are used to ensure that information is uniformly collected and documented that is necessary and sufficient at every instances of its usage. (e.g. Requirements Specification template used for understanding and analyzing requirements).
- Checklists used during reviews to ensure that all the required points are reviewed and documented. (e.g. Requirement Analysis Checklist)
- Reports document the details and summary of the activity performed. It provides basis for further discussions, reporting and analysis. (E.g. Project Reports, Review Reports, etc.)
Guidelines are suggestions to determine certain task. Guideline document is intended to facilitate streamlining of that activity being implemented at several occurrences. E.g. Testing Guidelines.
Standards are industry proven low level mandates that helps in implementing the process in effective and efficient manner. E.g. User Interface Design Standards.
Steps to define QMS are depicted in the below diagram.
Categorization of processes and sub-processes may be at organizational level or at project level. Schematic diagram of Inter-process dependencies should be clearly framed.
Process definition model may be chosen as suitable e.g. ETVX (Entry Task Verification eXit), SIPOC (Suppliers, Inputs, Process, Outputs, and Customers). In addition to process implementation tools like templates/ checklists/ reports, software tools may also be used to facilitate efficient implementation. E.g. Using Project Management Software – Teamwork Projects for managing projects.
Maintenance of QMS documentation deals with periodical updates in the QMS based on feedbacks and process performance analysis. It helps QMS to improve continually.
All the documents under QMS need to be organized in structured manner which can be easily located as and when needed by users.