IA Catchwords- Series- 6

No Clarity

Auditing process calls for clarity of thoughts, observation, and presentation. Thoughts are converted into questions, to elicit answers. A clear thought helps to observe, assess and question. Once the answers are elicited, clarity in identifying the non-conformances and arriving at what could be the process problem becomes easier. Auditors shall clearly distinguish between trivial many to the focused one problem. Clarity in recording and answering questions to the auditors is another important factor, to prevent wrong assessments during auditing. There shall be clarity in the various documents/process instructions used in order to sustain the process and to ensure obtaining consistent results. Many of the non-conformances observed are due to lack of clarity in understanding the process objectives.

No conclusions have been arrived at

Reviews and Meetings are essential for sustenance and growth. Discussions take place on the various issues pertaining to customers, operations, and business. Top Management conduct these meetings to identify and resolve those that had been pending due to decisions from the top management. Once planned, it is necessary to follow the routine. It has been observed that while the QMS reviews are being done, records of such reviews invariably do not provide responsibility for taking further actions, target dates for completion, specific actions and decisions to prevent the problem from recurrence, etc., Either it is a problem of recording or decision-making. In order to prevent such incomplete records, it is suggested that tailor-made templates are used for recording. A detailed planning is essential to design such templates, to cover all the agenda points needed. Further, data presentation in such reviews shall be focused to identify actions and solutions, and not merely as a raw data, without analysis. A combination of data analysis and attitude shall play the trick.

No controls

Process Control is an important activity. For any process, controls are to be established to obtain consistent outputs and results. Controls are of 2 types- specifications and processes. While specifications are given by the process design, control limits are given by the acceptance criteria for operations. No controls, means either operationally not meeting the limits, or the limits are not established. It may also mean that the limits are established, but not monitored and controlled, meaning thereby, that the process output has not been consistent. It could also mean that there is no process measurement in place to monitor and control. QMS standard calls for documents for effective planning, operation and control of processes. If any of the processes has gone out of control due to absence of documents identifying controls to be established calls for measurement, then they need to be brought under control.

No planning

Planning is a basic requirement for establishing and maintenance of QMS. QMS standard has identified Planning under the following categories- Documents to be planned for effective operation and control of processes, QMS planning at the organizational level (strategic/operational), process planning for product realization, planning of design processes for realizing the product design, planning of production/service, and planning of monitoring, measurement, analysis and improvement of processes and product. These are mandatory. However, under product realization planning, functional planning would help to achieve the functional objectives and measurement objectives. A comprehensive planning encompassing functions, resources, and operations, would go a long way to achieve the corporate and functional objectives. An auditor needs to spend considerable time in assessing the formulation of plans for arrangements, resources, and intervals, resulting in expected results, records, and documents. A few of the examples of Plns are Quality Plan, Control Plan, Sales Plan, Production Plan, Training Plan, Design Plan, Calibration Plan, Testing Plan, Material Procurement Plan, Design Verification and Validation Plan,