2022 ViewPoint Espresso report on Quality

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ViewPoint Espresso report on audit findings

Quality management systems # 1, May 2022


Pulse Check 2022 The Espresso report is turning its focus to audit findings. What are companies struggling with these days? Where are the most common failures and root causes? Throughout this mini-series, we will check how companies do in the following areas:

Quality (May 2022) Environment (July 2022) Safety (September 2022)

In the case where the area is a recurring ViewPoint Espresso topic - we will, when possible, compare data to reveal any changes over time. Our objective is to provide insight on what enterprise risks may be top of mind for companies around the world. 2

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Setting the scene

Topic in focus

ISO 9001 chapters analysed:

How to read this report

What did we find?

This time around, we look at risks and opportunities for companies with a quality management system certified to ISO 9001.

4. Context of the organization

• The report shares insight on the distribution of findings and nonconformities overall and per chapter.

• Companies struggle most with chapters 7 Support and 8 Operation.

What are the issues that cause companies most problems and thus what are the areas that should be at the centre of attention and improvement efforts? Analysing audit data from all quality management system audits performed by DNV in 2021, we take you on a deep dive through the chapters, clauses and subclauses of ISO 9001.

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5. Leadership 6. Planning 7. Support

8. Operation 9. Performance evaluation 10. Improvement

• You first get an overview of the percentage (%) of companies with findings and non-conformities and how these are distributed across the chapters. • Then we look more closely at the distribution of findings and nonconformities for each chapter, revealing the areas with which most companies struggle.

• The data upon which the analysis is based is extracted from Lumina™, DNV’s management system certification performance benchmarking tool.

• In chapter 7, clauses specifically covering resources and competence cause the most concern. Moreover, out of the top 10 non-conformities, 3 relate to sub-clauses in this chapter. • A staggering 1 in 2 companies record at least one finding related to chapter 8. Clauses specifically covering external control and production & service provision record the most findings. Among the top 10 subclauses with the most findings 4 fall into chapter 8. • Particular attention should also be paid to chapters 6 Planning and 9 Performance evaluation, as well.


Quality – Overview

Distribution of findings and non-conformities per chapter

• For ISO 9001 certified companies, findings are most frequently found within: • Chapters 7 Support and 8 Operation, where approximately 56% receive findings and, for about 20% of the companies these are nonconformities. • The runner ups which are chapters 9 Performance Evaluation and 6 Planning, with 45.3% (13% with nonconformities) and 36.1% (8% with nonconformities) of the companies receive findings, respectively. • In the next sections, we will dive further into each chapter and connected clauses and sub-clauses.

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Quality – Distribution of findings and non-conformities

Chapters 4 Context of the organization & 5 Leadership

• Chapter 4 Context of the organization does not register the highest frequency of findings. • However, almost 9% of the companies do have findings related to clause 4.2 Understanding the needs and expectations of interested parties. • Close to 10% receive findings related to the more traditional clause 4.4 Quality management system and its processes. • Chapter 5 Leadership represents key clauses aimed at ensuring an effective management system. Even so, it has the lowest frequency of findings. Overall, only 10% of companies have findings within chapter 5. • The clause with the highest rate of findings in this chapter is 5.3 Organizational roles, responsibilities and authorities (almost 5%).

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Quality – Distribution of findings and non-conformities

Chapters 6 Planning & 7 Support

• In chapter 6 Planning, it is 6.1 Actions to address risks and opportunities that causes the most issues. This is also the ISO 9001 clause with the second highest frequency of findings overall. • Companies seem to still struggle with the implementation of a systematic approach or methodology that not only enables effective identification of risks and opportunities but also defines actions as input to the quality management system planning. • Chapter 7 Support has the most frequent findings.

• In particular, clause 7.1 Resources rates high with 32%. The findings here relate to two subclauses in particular: 7.1.5 Monitoring and measurement resources to verify the conformity of products and services and 7.1.3 Infrastructure required for operating the company’s processes. • Clauses 7.2 Competence covering provision of competent resources and 7.5 Documented information are areas where companies frequently need to improve, as well. 6

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Quality – Distribution of findings and non-conformities

Chapters 8 Operation & 9 Performance evaluation

• Chapter 8 Operation, which is at the core of ISO 9001, is where companies record the highest rate of findings. More than 1 in 2 companies ends the audit with at least one finding here. • Clauses 8.5 Production and service provision and 8.4 Control of externally provided processes, products and services, which relates to purchasing and outsourcing, are areas where approximately 25% receive findings that require improvements. • Chapter 9 Performance evaluation pose challenges for a number of companies, as well. • Especially, clause 9.1 Monitoring, measurement, analysis and evaluation, which covers determination of what, how and when to analyze and evaluate results, is an area where approximately 25% receive findings.

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Quality – Distribution of findings and non-conformities

Chapter 10 Improvement

• Chapter 10 Improvement looks at the continual improvement of the quality management system and its performances over time. • Although this chapter overall does not have the highest frequency of findings, we see that clause 10.2 Non-conformity and corrective action, i.e. the management of these, is an area where almost 20% of companies are still struggling to meet the requirements.

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Quality – Distribution of findings and non-conformities

Top 10 issues at subclause level

• Further analysis of the sub-clauses for each chapter provides an aggregated Top 10 view for both findings and non-conformities. • Subclause 7.2.0 Competence tops the list of most common findings. Not surprisingly 7 out of 10 sub-clauses can be found in chapters 7 and 8. • The most common non-conformity is sub-clause 8.5.1. Control of Production and Services. It is closely followed by 7.1.5 Monitoring and measuring resources and 7.2.0 Competence. Also among the Top 10 most common nonconformities 7 out of 10 are found in chapters 7 and 8.

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Methodology and sample 2021

This Espresso report is based on quality management system certification audits to ISO 9001 performed by DNV in 2021, covering all industry sectors.

This report is based on more than 100,000 audit findings from 25,000+ companies worldwide.

25,000+

The data stems from Business Assurance customers in DNV and does not claim to be statistically representative of companies worldwide.

Want to know more? The data analysed in the survey is an extract from the Lumina™ App, DNV’s intelligence benchmarking suite.

Adding insight from DNV’s Self-assessment suite and Boost My Audit provides further insight.

The app provides you more in-depth high-level statistics on failures for any given standard, peer and internal benchmarking, and trend line analysis. This insight supports detailed planning of improvement paths and measurement follow up, for example.

The self-assessment suite measures your standard understanding and management system readiness. Boost My Audit helps focus internal and external audits targeting improvement efforts on critical areas.

Access is available to all DNV customers. Read more about our digital tools or contact us directly for more information or tool activation.

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