IA Catchwords– Series 8

Not explained

Process realization activity is to be documented as per the requirements, needs of the process and the competency of the personnel. Process explanations are to be documented to ensure that the process is carried out to meet the requirements. If it is observed that the absence of such explanations had caused or potential to cause non-conformities, then it is necessary to provide explanations either in the form of documentation or visual displays.

Not trained

Training of personnel is critical to any activity. Training is to be planned both for meeting the existing process/product requirements and enhancing the competency of operating personnel. If it can be concluded that lack of training had resulted in process/product/service non-conformities, then it is important that training is identified as a means of closure of the non-conformity. in fact, "not trained" is one of the common causes of analysis, if proper RCA (Root Cause Analysis) is carried out. This is true in not only in product realization or maintenance or marketing. For example, if a company has identified that a lower hit-rate is an effect and the cause is due to inadequate training of marketing/application personnel in understanding clients requirements, then the same is to be addressed.  

QMS Data Management- Series 1

Data management includes the following

·         Identification of opportunities for data identification

·         Prioritization/classification of data in each of those opportunities

·         Identification of data to be managed

·         Planning for data management

·         Systematic arrangement for data collection

·         Data collation

·         Analysis

·         Identification and implementation of corrective and preventive actions

QMS clause No. 8, identifies Measurement, Analysis and Improvement and focuses on measurement of QMS and calls for determination of applicable methods, including statistical techniques. Data planning however starts from Cl. No. 4.1, when there is a need to monitor, measure, and analyze QMS processes. In addition, clause number 8.2.1, 8.2.2, 8.2.3, and 8.2.4 also need to be managed.

Records form a major chunk of data management. Records requirement are specified and needs to be addressed. Records provide evidence that the realization processes meet the QMS requirements. Hence, management of data from those records forms the basis of the improvements. Records could be in the form of sheer information and measurable data. Such measureable data management is what is needed in the Clause No. 8.

Data measurement

Records form the basis for data identification.

Below given are some of the areas of data measurement:

·         Process related- 5.6, 6.2.2, 6.3, 7.2, 7.3, 7.4.1, 7.4.2,7.4.3, 7.5.1,7.5.2, 7.5.3, 7.5.4,7.5.5, 7.6, 8.2.1, 8.2,2,8.2.3

·         Product/service related- 7.2, 7.3,7.4.3,7.5.1, 7.5.3, 8.2.4,

The first step is to segregate information and monitorable and measurable data from the records.

Data management includes systematic collection of data from the processes and product/service realization

Data collection is done in such a manner, that they can be collated and analysed

Designing of various formats/templates/checklists/control charts to be used for data collection play an important role. Frequency of collection and method of recording data is planned to provide adequate information on the effectiveness of the control of the process/product/service.

A poorly designed format/template can defeat the purpose of data measurement, without providing required information. Once the data is collected, a collation matrix would help in consolidating them and help in prioritizing for subsequent analysis.

A collation Matrix would typically contain data on various parameters of each process being monitored, frequency of data collection, and the source of data collected.

Data analysis would be discussed in the next article. Meanwhile, initiate data collection and collation. Any help, do not hesitate to contact. Good luck

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.

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.

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,

IA Catchwords- Series- 5

Frequency of review is not followed

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. The frequency of review is normally fixed taking into account the status and importance of the activities being reviewed and the availability of participants. Once planned, it is necessary to follow the routine. It has been observed that while Business reviews are done as per the schedule, the QMS reviews are invariably either delayed or cancelled. In order to avoid such incidences, it is suggested that the reviews are integrated with the Business reviews and/or done in 2/3 tier structure. If the reviews are not carried out or not effective, the result would be a weak system resulting in not meeting the Business Objectives.

Instructions were not available

Instructions are essential for effective planning, operation, and control of processes. They are a means by which information is passed on to carry out or test processes. They need to be clear, and unambiguous and provide Do's and Don’t's. Verification of availability of instructions to ensure process effectiveness is necessary, where the absence of such instructions would adversely affect the process performance. This includes visual, dimensional, functional, performance, comparison with standards/specifications, etc.,

Look at /Look for

"Looking at" is a powerful tool for an auditor. One looks at the documents, records, processes, people, equipment, measurements, data, etc., It is a phrase used to convey the observations in precise terms. This phrase is invariably followed by the phrase "looking for". One looks at the operations, documents, and records for conformance. In fact, it is a logical combination of observation and result.

Mapping of defect classification is not done

Defects are observed and recorded. In order to analyze the causes of defects, and identify corrective actions, they are to be prioritized. A good practice is to classify them according to their impacts on the final result. There are many ways of defect classification- such as impact-based, cause-based, results-based, process-based, product-based, customer-based, project-based, etc., The type of classification is influenced by the objective of the process/project, type of defects, and the stage of defect observation. Once the classification is done, investigation is carried out using a mapping technique. Mapping is done using techniques to identify patterns, and trends that might indicate causes.

IA Catchwords- Series- 4

 

Corrective actions are not identified

This applies to product, process and system related NCR's. Corrective actions are evolved/identified based on data collection during processing and internal auditing, periodically analyzed, identifying root causes of the problems and prioritizing them to identify corrective actions. While disposition actions addresses the immediate redressal/attending to the NCR for prevention of the specific product/process/system to go out of control, corrective actions are to be identified to eliminate the root cause and to prevent recurrence. There are many opinions on this issue. One is that for every product/process NCR, there shall be a Corrective action. Another point is that many problems may occur randomly, which may not repeat and hence such problems may not need Corrective actions. However, in the case of system related issues, for every observed NCR one may not be able to implement corrections, but Corrective action is to be identified and initiated. In the case of Customer complaints, many customers demand corrective actions for every NCR/Observation observed by them. Obviously, it needs to be addressed. Please remember that for every NCR, be it product, or process or system, there are 3 levels of addressing them- correction, Corrective Action and Preventive Action. Never gets confused between Corrective and preventive actions. While Corrective Actions prevent recurrence of problems, Preventive Actions prevent Occurrence of problems.

 

Customer complaints are not closed

Customer complaints are always causes for concern. It is imperative that these are complaints are properly recorded, irrespective of their nature. No filtering is recommended. A centralized system of recording is recommended to ensure customer focus. This recording shall ensure availability of complete details- both technical and systemic. The system shall have mechanisms for immediate redressal, including replacement, if any, and their closure to the satisfaction of the customer. The closure details shall be available along with the complaint details. Closure could be one of correction or of corrective action or both. A clear definition of the closure mechanism shall be established and documented. Closures shall be evidenced for all the recorded complaints. If it involves, the reporting the corrective actions to the customer, the same shall be evidenced. Closure shall include verification of effectiveness of the corrective actions taken by checking the elimination of the nature of the complaint. Closure actions shall include complete investigation, analysis and objective evidence of changes in the system. The absence of any one of the above would mean that the complaint is not closed.

 

Data is not being captured

Data and Measurements are the backbones of any QMS. Data capturing is essential for sustenance and improvement of the processes. Data may be available, but if not captured, the process performance cannot be measured. If one wants to know the status of any process, data capture is essential. There are many methods of data capture. It could be recorded either in soft or in hard copy. It could be automatic or manual. It could be in analog or in digital form. It could be elaboration of process parameters, performance details, personnel data, machine capabilities, specifications of products/ raw materials, delivery data, etc., In short, data capturing provides a complete snap shot of the processes. It could be vital/essential/desirable for the operations of the business. It could include both business and operational processes. If either the data captured is inadequate or ineffective, then it is necessary to review the process for improvement.