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Implementation of Quality Management System

Implementation of Quality Management System in Dispensary Establishments

Part-2: Establishing the Process Documentation

In the previous part, we learned how organizations define their goals and objectives as directions and basis of performance measurement. Goals and objectives in the enterprise level which have broader scope and longer time frame are itemized into departmental and individual goals and objectives, with more specific scope and shorter period.

Question arises on how we bring the whole organization into doing the intended activities to achieve the objectives. Part-2: Establishing the Process Documentation (also known as Quality Documentation in ISO 9001:2008) will briefly review a simple method to build and deploy a documentation system which will help to accomplish that.

What is Process Documentation?

Process Documentation produces a set of documents which describe how a process is performed. According to ISO 9001:2008, there area four classifications of document in the QMS, they are;

Manual is the main document at the highest level, which defines the quality policy and or-organization objectives (see Part-1 for policies and objectives setting). This document describes how a company controls its activities to ensure quality products and services produced.

Procedure is a document that describes a process flow and its supporting elements. The purpose is to explain clearly how an activity is carried out.

Supporting documents are another type which contains specific additional information of a procedure. Various form of this document includes work instruction, table, reference, drawing, or forms/worksheet.

Records are document generated from conducting a process. Example; Blank form of Purchase Order (level3), after being filled-in, signed, and executed, will become a record of Purchase Order (level 4).

Preparing a Process Documentation

A famous saying related to documentation says, ”Write what you (should) do, do what you write”. Yet, how do we write all that we should do? How detailed is detail? How do we ensure we have addressed all the important aspects?

Remember one of the principles of Quality, "Do it right from the beginning" From the hierarchy above, we shall begin by composing a good Manual document. We may use the ISO 9001 standard or other models as a basis to develop the outline. Noteworthy is, Manual should be able to describe the processes that exist in the organization and the relationships between processes with a brief but thorough manner.

There are many sources that can be referred when determining the outline of the Manual. However, a Manual should at least contain:

(1) who we are (incl. vision, mission, organization structure)

(2) what we do (incl. our processes and activity)

(3) how we deliver quality product/services by meeting the requirement

(4) what we want to accomplish (incl. quality policy, objectives, strategic goals)

(5) how we make continuous improvement and accomplish the goals

Once we define that, we will be able to determine the business processes at the enterprise level, along with the relationships between processes, related personnel, as well as the critical factors. Business processes are usually written in the form of diagrams.

From the picture above, we can see how an enterprise-level Business Process Map defines the Procedures, by reducing Processes into Sub-Processes, and subsequently derive a list of procedures. Therefore, if the organization makes the earnest efforts in constructing the Manual, ensuring that it truly reflects the organization attributes, then the lower-level documents will certainly lead to comprehensive process control with emphasize to the critical factors.

Benefits of Process Documentation

Process documentation provides well-written information which articulates strategies and objectives in a systematic and comprehensible manner. It points out an overall understanding of the organization, required resources, methods of coordination, personnel, development policies, management requirement, etc.

Some may say,”There’s a lot of business that can flourish without any documentation at all”. That might be true (in case of organization consists of less then five persons with no regulatory adherence), but documentation system is a powerful instrument of alignment, both vertically (management to personnel) and horizontally (among departments and divisions). As a general rule-of-thumb, organizations with more personnel will have more complexity in communication, thus a well-laid document is even more mandatory. Document containing explanation on how things are done will improve communication, enable everyone to work together toward common goals. Management will benefit from consistent work performance and predictable results, while team members benefit from increased confidence and a clear sense of achievement. (Rosariwaty Tedjokoesoemo)