9.1 Monitoring Measuring & Analysis [ISO 9001 Procedure]

Purpose

The purpose of this procedure is to establish and define the roles and responsibilities for detailed monitoring, measurement, analysis and performance evaluation.

The process includes recording and tracking progress against identified actions and targets, which provides the mechanism for safety assurance that ensures our safety processes and systems can effectively manage our safety risks. Where assurance cannot be given, it provides an opportunity for prompt intervention and action planning.

The 3 Subclauses of Monitoring, Measurement, Analysis, and Evaluation

Under clause 9, there are three subclauses:

• 9.1.1 – General
• 9.1.2 – Customer Satisfaction and
• 9.1.3 – Analysis and Evaluation

9.1.1 General

Under the general section, the company must determine what processes need to be monitored and measured. To guarantee valid and auditable results, the monitoring, analysis, measurement, and evaluation methods need to be predetermined.

Alongside that, it must also be determined:

• When the monitoring should be performed
• When the monitoring results should be analyzed
• When the monitoring results should be evaluated
• Evaluate the performance and effectiveness of the QMS
• Retain all documents as evidence of all determining results

The company also needs to determine the following:

• What needs to be monitored?
• What needs to be measured?
• What methods were selected for monitoring/measuring/analysis/evaluation to ensure valid results?
• Will the company consistently be able to produce measurable and repeated results?

A company's needs are likely to change over time. The monitoring objectives will need to be adjusted from time to time to keep the data and results valid.

As the company grows, new measures and procedures must be developed and implemented. Regular reviews help to show the effectiveness of the QMS. The focus of your processes should be on process conformity, product conformity, service conformity, and continuous improvement of QMS effectivity.

What Does The Measurement Process Involve?

The measurement process involves the physical measurement of product characteristics.

The measurement and data analysis processes for your company QMS should consider measuring resources and methods like:

• Computers
• Computer software
• Time
• Statistical Tools
• Workforce

The measurement process usually involves physical measuring. This includes using;

• Predetermined measuring tools according to industry standards
• Taking samples at predefined intervals during production

If all measurement processes are not fully recordable, you can use the company's knowledge of:

• Technology
• Customer requirements
• Manufacturing processes

This will help you determine which measuring methodology to apply to each process and include them in your QMS.

Verifying product characteristics can be applied through statistical methods and process parameters that include:

• Control charts
• Variation analysis
• Pareto analysis
• Capability studies

The relevant personnel needs training in methods, measuring tools, and analysis.

9.1.2 Customer Satisfaction

Customer satisfaction should be monitored to determine to which degree their expectations and needs are being fulfilled. The methods for obtaining this information need to be determined by the QMS.

Methods of measuring and monitoring the way customers perceive your company can be done through:

• Physical customer feedback through meetings
• Customer surveys
• Warranty/Guarantee claims
• Compliments/Complaints
• Dealer reports

Producing high levels of customer satisfaction is an essential metric tool for gathering real-time information to improve your QMS processes and products. Each customer will have different needs, so you will have to use additional measures and controls to measure and analyze the data.

Defining Customer Satisfaction Indicators

Your company must have a clearly defined process for defining customer satisfaction indicators. This process should also include:

• The frequency of data collection
• The method of data collection
• A summarization
• A review of the data
• An evaluation of the data
• Actions on how to improve
• The required timeline for the remedy
• Whose responsibility it is, and
• The follow-up with the customer

To continuously improve customer satisfaction, you will need to review customer feedback and trends constantly. This will be your baseline for both internal and external clientele.

9.1.3 Analysis and Evaluation

Your company should use the appropriate data and information gathered by monitoring and measuring to evaluate the conformity of the following:

• Products and services
• The degree of customer satisfaction
• The performance of the QMS and
• The effectiveness of the QMS
• The effectiveness of implemented planning
• Actions were taken to address opportunities and risks
• The performance of external service providers
• The need for the QMS to constantly improve within

Subclause 9.1.3 has a new requirement set out, and that is to evaluate the effectiveness of actions taken to address any and all risks and opportunities. This subclause requires that:

• Your company uses the evaluation and analysis to evaluate the degree or level of customer satisfaction
• The results of your analysis are used to evaluate product and service conformity
• The data should be analyzed to provide supplier information
• The analysis results are used to evaluate the performance of external suppliers, vendors, or retailers

To do a proper analysis, you will have to collect data that relates to the effectiveness, efficiency, and performance of:

• Products
• Services
• QMS processes
• Production outputs
• External service providers
• Supplier performance
• Use of resources
• Cost of poor quality
• Customer satisfaction

The best evaluation is done when you collect data year over year and do a trend analysis. This will identify opportunities for improvement, determine long-term processes, and determine corrective actions that need to be executed for any negative trends.

What Is The Role Of Management?

The role of management is to continuously review the data and analysis done by the Quality Management team.

All methods of collecting data should be recorded and filed in a manner that allows for transparency and auditing and provides transparent processes for the following:

• Sorting and classification of the data are pertinent
• The type of data collected
• The use of appropriate systems and data gathering techniques and tools
• The assignment of responsibilities and authorities to review and correct
• Competency and training in the use of data analysis and tools
• The timeline for data collection, action, and remediation