IA Catchwords- Series 7

No records maintained

Records are the results of operations. Records demonstrate results and compliance achieved QMS standard identifies 20 records to be maintained. They provide evidence of successful completion of the QMS processes. If there is no evidence of records being maintained as per QMS and if it is observed that there is a need for records maintenance for any of the processes even when not specified, then it is essential to ensure the same.

No specific methodology defined

QMS defines process of value addition to achieve specific planned results. In order to achieve consistent results, processes/activities need to be controlled. One of the methods of controlling is to define a methodology. In the absence of the same, results are likely to be misleading and one cannot be sure for the achievement of the specific targets, specifically in the implementation of monitoring, measurement, analysis and improvement- one of the examples of specific methodologies is - measurement of customer satisfaction. QMS also specifies use of statistical techniques as one of the methodologies

Not documented

Documentation is the heart of the QMS. The Standard calls for documenting a quality policy, quality objectives, a quality manual, 6 mandatory procedures , 21 records and procedures for effective planning, operation and control of the processes. These documents are intended to address the various requirements of the QMS. While there can be no two opinions on an auditor " looking for" the mandatory documents and records, the identification of "documents and records determined to be necessary to ensure the effective planning, operation an control of the processes" is crucial for the organization. Even when a document exists for controlling the processes, if it is not brought under the purview of the QMS and controlled, it is not acceptable and considered to be "not documented". The document shall adequately describe the activities of the process and in such a manner "operable" by the process owner and the team.

Not effective

This statement is "all-pervading" and an "effective tool" for an auditor. An auditor shall verify the

· documents, records, processes- such as planning, operation, monitoring, controlling, etc.,

· activities- such as data collection, collation, reviewing, recording, authorising, communicating, , etc.,

· operating personnel-for understanding, applying the skills, and knowledge, performing on the machines, etc.,

· maintaining the machines, etc.,

Measurement of effectiveness is done under 3 major categories- results, time, and effort. If it is observed that there is a lack of focus and improvement in any of the above, then it can concluded that they are "not effective". For example, even if parameters of a process are recorded routinely and correctly over a period of time to meet the output requirements, it can be considered "not effective", if the same has not yielded any opportunity to improve the process.

Not effectively monitored

Monitoring is an important activity to verify if the process/activity is being carried out as per the defined /documented requirement. Monitoring is the first step towards process improvement. Monitoring is needed to demonstrate conformity to the product requirements, conformity of the QMS and conformity to the processes. Effective monitoring must lead to a definite and defined process improvement. Monitoring shall be followed by collection of data, collation of data and subsequent analysis. These shall include use of various statistical techniques. Records maintained at various processes shall form the basis of verification of effective monitoring.

Not established

QMS standard uses various standard nomenclatures such as - defined, determined, established, etc., Establishing involves, setting up or creating. It could be a procedure, a record, or a process. Establishing includes the setting up of the process, understanding by the operating personnel and stabilization/standardisation.The process is said to be "not established", even if any one of the criteria given above is not met with.

Not evidenced

Evidencing includes Documents, records, and the Practices and these shall be carried out as per the defined standards, and practices. Evidencing is the proof of completion of an activity. "Not evidenced" shall include absence, incompleteness, or uncontrolled, unless specified so. Evidencing can be done either physically or by electronic media. For example, Video-conferencing record is acceptable as an evidence of a review.