ISO 9001-Clause 8.4 & Clause 8.5
Clause 8.4 Analysis of data
ISO 9001 Requirement
The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data shall provide information relating to
a) customer satisfaction (see 8.2.1),
b) conformity to product requirements (see 8.2.4),
c) characteristics and trends of processes and products, including opportunities for preventive action (see 8.2.3 and 8.2.4), and
d) suppliers (see 7.4).
You must collect and analyze QMS data that relate to the effectiveness and efficiency of products, services, QMS processes, production output, supplier performance, use of resources, cost of poor quality, customer satisfaction, etc. Do year over year trend analysis to determine longer-term progress, identify opportunities for further improvement or prioritize correction action for negative trends. Many organizations have wonderful systems for collecting data, but do a poor job in sorting, summarizing and presenting this data for decision-making. You must sort and summarize the data you collect into things gone right and things gone wrong and present them separately. Management can then focus on continual improvement of things gone right and take corrective action on things gone wrong. Your process for data collection and analysis must address the type of data to be collected, how it should be sorted and classified, use of appropriate information systems and data gathering tools and techniques, assignment of responsibility and authority to review and act, competency and training in use of tools and data analysis, that the data is gathered, analyzed and acted upon on a timely basis.
A summary of QMS performance data must be included in your periodic management review. Compare trends in quality and operational performance against your business plans, competitors and industry benchmarks, where practical. Focus on key customer-related trends to prioritize prompt solutions to problems, to determine longer-term planning for performance improvement, and to enhance customer satisfaction. Performance indicators to measure the effectiveness of processes for data collection and analysis may include reduction in cycle time to gather and evaluate data, reduction in inaccurate and incomplete data, increase in improvement opportunities obtained from data analysis, etc.
Clause 8.5 Improvement
8.5.1 Continual improvement
ISO 9001 Requirement
The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
The focus of this clause is on continual improvement of the QMS and not on product. Continual improvement of product is addressed in clause 5.6.3b. and 7.1a. Continual improvement is defined as a recurring activity to increase the ability to fulfill requirements. The ‘ability to fulfill requirements’ refers to both conforming as well as nonconforming products/processes. Conforming processes can be further improved, and nonconforming processes must be improved by taking corrective action to prevent recurrence. Recurring activity refers to the quality improvements includes quality policy and objectives, audit results, analyses of data, etc. The continual improvement process can be conducted by:
- Significant breakthrough projects that either revise or improve existing processes or lead to new processes. These are usually done by cross-functional teams outside routine operations (Business Process Re-engineering).
- Small-step ongoing improvement activities conducted by personnel within existing processes (Kaizen Events).
Use of continual improvement tools includes:
- Quality Policy – If you recall clause 5.1 required top management to establish the quality policy and clause 5.3.e required them to review it for continuing suitability. Changes in product, customer base, organization ownership, management, technology, QMS standards, etc., may require changes to your quality policy and objectives. As a tool for continual improvement, it requires top management to review and understand these changes, make changes, if necessary, to the quality policy and objectives and use these changes to continue further improvement of the QMS and customer satisfaction.
- Audit Results – Results of product, process and QMS audits usually provide many opportunities to improve QMS effectiveness and efficiency. Opportunities may relate to communications, information systems, processes, controls, use of resources, technology, etc. The management representative must report these opportunities to top management as included as part of the management review agenda. They can also be reported and reviewed at regular operational meetings, etc.
- Other Audits – Besides product, process and QMS audits, you might find it very productive to conduct financial, health and safety, environmental, technology, product profitability, social responsibility, information and communication systems audits.
- In using ‘analyses of data’ as a tool for continual improvement, use the things gone right and things gone wrong approach to classify your data for decision-making.
- Examples of situations which might lead to improvement projects include: machine set-up, die change, machine changeover times, cycle time, scrap, non value-added use of floor space, variation in process parameters, less than 100% first run capability, process averages not centered on target values, testing requirements not justified by accumulated results, waste of labor and materials, difficult manufacture, assembly and installation of product, excessive handling and storage, etc.
Useful tools that are often used to continually improve, include: capability studies, design of experiments, risk analysis, SPC, supplier evaluation, test and measurement technology, theory of constraints, overall equipment effectiveness, technology, benchmarking, analysis of motion/ergonomics and error-proofing. Ensure that personnel applying these tools are competent and trained. Performance indicators to measure the effectiveness of the continual improvement process may include quality objectives being met sooner than planned, achieving and exceeding business and quality objectives, improved efficiency in use of resources, cost reduction, improved product quality, etc.
8.5.2 Corrective action
ISO 9001 Requirement
The organization shall take action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements for
a) reviewing nonconformities (including customer complaints),
b) determining the causes of nonconformities,
c) evaluating the need for action to ensure that nonconformities do not recur,
d) determining and implementing action needed,
e) records of the results of action taken (see 4.2.4), and
f) reviewing the effectiveness of the corrective action taken.
Corrective action is action taken to eliminate the cause of a detected nonconformity to prevent recurrence, whereas preventive action is action taken to eliminate the cause of a potential nonconformity or other undesirable situation, to prevent occurrence.
You must have a documented procedure for your corrective action process which must address the following control requirements:
- Identify detected nonconformities that relate to your products, QMS processes, resources, suppliers and outsourced work, product shipped to customers, customer complaints, cost of quality reports, and things gone wrong reports.
- Define your process for identifying nonconformities and consider using appropriate problem-solving tools to determine the underlying root cause(s) of the nonconformity
- Problem-solving tools may include analysis of failure mode, capability studies, correlation diagrams, data collection, fishbone diagram (Ishikawa diagram), histograms, Pareto analysis, probability charts, stratification of data, graphic representations, etc. Ensure that personnel applying these tools are competent and trained.
Actions taken to eliminate the cause of nonconformity must flow from your problem-solving activity. Actions may involve changes to product, process, resources, documentation, controls, etc. or any combination of these. Conduct follow-up tests to determine whether these actions have indeed eliminated the cause(s) of the nonconformity and prevented recurrence. You must keep appropriate records of these actions and follow-up activities. You must monitor your corrective action records on an ongoing basis, for any recurrence of the nonconformity you took corrective action on. If you found that the problem has occurred again, then perhaps your analysis of root cause may have been incorrect or incomplete. Keep appropriate records of all corrective action steps. Ensure timely completion of any open corrective action or be prepared to provide evidence to justify its continued open status. Make your corrective action records available on request to customers and provide a summary report for management review. All nonconformities may not necessarily result in corrective action. Evaluate the significance of nonconformities in terms of their impact on operating costs, cost of nonconformity and its correction, product performance, safety, dependability, regulatory requirements, affect on customers product and processes, any other risks, and customer satisfaction. Consider using cross-functional teams in such decision-making, including the involvement of your organizations designated customer representative. Performance indicators to measure the effectiveness of the corrective action process may include reduction in – cycle time for correction actions, problem re-occurrence, open corrective actions, costs, and improvement in QMS productivity.
8.5.3 Preventive action
ISO 9001 Requirement
The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.
A documented procedure shall be established to define requirements for
a) determining potential nonconformities and their causes,
b) evaluating the need for action to prevent occurrence of nonconformities,
c) determining and implementing action needed,
d) records of results of action taken (see 4.2.4), and
e) reviewing the effectiveness of the preventive action taken.
Corrective action is action taken to eliminate the cause of a detected nonconformity to prevent recurrence, whereas preventive action is action taken to eliminate the cause of a potential nonconformity or other undesirable situation, to prevent occurrence. Sources of information for finding potential QMS nonconformities include analyses of data, audit results, cost of quality reports, quality records, service reports, supplier performance, customer satisfaction feedback, management review records, and lessons learned from past experience, SPC charts and analyses.
You must have a documented procedure for your preventive action process which must address basically all of the explanation points and tips covered under the corrective action process. While preventing potential quality related QMS nonconformities is our focus, it might be very useful to think of preventive action in a wider context, i.e. the entire business. Think in terms of actions needed to prevent loss of market share, loss of product profitability, loss due to lack of product diversity, loss of business opportunities due to lack of capacity, inadequate or older facilities, inadequate or inefficient production equipment, technology or information systems, loss of key or competent personnel, inadequate business financing, inadequate staffing, etc. These issues may have far more serious consequences than QMS issues. Consider a process that involves developing a business plan based on gathering relevant research data on these issues, use of appropriate risk evaluation and management methods, developing proactive strategies and action, monitoring and reviewing performance against the business plan. This would constitute the ultimate preventive action process. Preventive action also includes applying successful corrective action solutions to other similar products, processes and sites where there may be the potential for the same nonconformity to occur. Use error-proofing methods across similar products, processes and sites, wherever cost effective and feasible, to prevent recurrence or avoid occurrence of nonconformity. Performance indicators to measure the effectiveness of the preventive action process may include reduction in – cycle time for correction actions, problem re-occurrence, open corrective actions, costs, and improvement in QMS productivity.
For Clause 8.4:
- What data is collected and how is it done? How is it analysed?
- What analysis techniques are used and who decides which to use?How often is each method used (frequency)?
- How often is data analysis done? Who does it?
- Is analysis done on: Customer Satisfaction data? Product and Service monitoring and measurement results? Process/Product/Service trend results? Supplier performance data?
- How reliable are the sources of data that are used for the analysis?
- Were any actions taken as a result of the analysis?How is feedback obtained from Customers? What is the structure/format that is used? Does it provide information on how Customers perceive the organization’s performance?
For Clause 8.5:
- Is there any evidence of business performance improvement within the past 12 months?
- Is there any evidence of product/service quality improvement within the past 12 months ?
- Is there any evidence of quality management system improvement within the past 12 months ?
- What can initiate a Corrective Action (CAR)? How many CAR’s were issued in the last 12 months? How many were closed (make sure to review how investigation of the causes was done)? How many are still open (for how long, why are they still open)?
- What can initiate a Preventive Action (PAR)? How many PAR’s were issued in the last 12 months? How many were closed ( make sure to review how investigation of the causes was done )? How many are still open (for how long, why are they still open)?
|Example of Procedure for Corrective and Preventive Action|
|Template for Corrective and Preventive Action|
Evidence/Implementation document ( Not mandatory but helps in fulfillment of requirement):
For Clause 8.4:
- Customer surveys
- Non-conformance reports
- Supplier evaluation
- Internal audits
For Clause 8.5:
Continual Improvement Register
|Example of format for Continual Improvement Plan|
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