Defining QMS

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.

qms_document_types

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.

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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.

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Strategic Planning & QMS

“Create and publish to all employees a statement of the aims and purposes of the company or other organization. The management must demonstrate constantly their commitment to this statement.”    Deming (Point 1 of Deming’s 14 points for management)

In this article, I shall discuss strategic planning and its importance in establishing Quality Management System (QMS).

Strategic Planning: Strategic planning is a management activity that collectively defines organization’s perception of success, focus and priorities and set directions to accomplish them. Thus strategic planning helps an organization to focus and prioritize its efforts towards achieving desirable success.

strategicplanning-qms-paint

Mission: Mission statement reflects ‘Why’ we exist as an organization. It forms a mental image of the organization. It is a clear and concise statement that describes organization’s purpose, reason of existence. It reflects its present state.

Vision: Vision statement reflects ‘Where’ we want to be in future. It describes the desired state of the organization in future.

Values: Values of core beliefs and priorities of an organization to which it is committed in any circumstances. Mission and vision statements should be aligned to the organization’s core values.

Mission, Vision and values statements should be well framed and well understood by all the employees in the organization as they inherently guide goals, conduct and operations of the organization.

Goals: Organizational goals, aligned to mission and vision, are generic set of desired achievements.  They set a clear futuristic path towards what it has to accomplish.

Objectives: Objectives are specific set of achievable tasks towards accomplishing goals. These objectives when achieved collectively help organization to reach their goals. Objectives should be specific, measurable, attainable, realistic, time bound.

All of the above elements of strategic planning provide framework and directing inputs to QMS.

Quality Policy: It is a policy statement defined in the QMS that states the quality objectives and expectations towards it, directions to focus on achieving quality and underlying responsibilities.

Quality policy is defined jointly by management and quality experts and needs to be thoroughly understood by all the employees.

By establishing and implementing QMS, jointly aligned to strategic planning and quality policy, these quality objectives are measured and hence continually improved. This ensures that organization is continually improving and progressing towards its defined mission.

Therefore QMS provides a framework to the organization to ensure that organization’s efforts are focused and positively leading towards achieving its vision.