Process variation refers to the natural differences or deviations that occur within a process. In any process, there are numerous factors that can influence the outcome of the final product/service, including variations in raw materials, equipment, environmental conditions, and human factors. These variations can result in slight differences in the characteristics of the products/services that are being delivered.

Process variation can be classified into two main types:

1. Random Variation: This type of variation is caused by random and unpredictable factors that are inherent in the process. Random variation cannot be eliminated entirely but can be controlled through statistical process control (SPC) methods.
2. Systematic Variation: Systematic variation is caused by identifiable and predictable factors within the process. These factors may include equipment calibration errors, changes in raw material properties, poor training, or fluctuations in environmental conditions. Unlike random variation, systematic variation can often be identified and corrected to improve the consistency and quality of the final product/service.

Managing process variation is essential for maintaining product/service quality and consistency. Techniques such as statistical process control (SPC), Six Sigma, and process optimisation are commonly used to monitor and reduce process variation, ensuring that products/services meet specifications and customer expectations.

How can ISO 9001 help?

ISO 9001 is a quality management standard that provides a framework for organisations to establish, implement, maintain, and continuously improve their quality management systems (QMS). While ISO 9001 itself does not directly address process variation, implementing its principles and requirements can help minimise process variation indirectly in several ways:

1. Standardised Processes: ISO 9001 emphasises the need for organisations to define their processes and procedures. By standardising processes, organisations can reduce variation by ensuring that everyone follows the same steps and methods for performing tasks. This consistency helps minimise the likelihood of errors and deviations within the process.
2. Risk-Based Thinking: ISO 9001 promotes the concept of risk-based thinking, which involves identifying potential risks to quality and implementing controls to mitigate them. By systematically identifying and addressing risks that could lead to process variation, organisations can proactively minimise its impact on product/service quality.
3. Continuous Improvement: One of the core principles of ISO 9001 is continuous improvement. Organisations are encouraged to regularly monitor their processes, collect data, analyse performance, and implement corrective actions as necessary. Through this process of continual improvement, organisations can identify and address sources of variation, leading to more consistent and predictable outcomes.
4. Supplier Management: ISO 9001 requires organisations to evaluate and control their suppliers to ensure that purchased products/services meet quality requirements. By selecting reliable and competent suppliers and establishing clear quality criteria, organisations can reduce the risk of variability in the products/services that they supply, which can contribute to process variation.
5. Training and Competence: ISO 9001 emphasises the importance of training and competence for personnel involved in the quality management system. Well-trained employees are better equipped to perform their tasks consistently and accurately, reducing the likelihood of errors and variations in processes.
6. Measurement and Monitoring: ISO 9001 requires organisations to establish performance indicators and monitor key process parameters. By measuring process performance and analysing data, organisations can identify trends, deviations, and opportunities for improvement, allowing them to take corrective action to minimise process variation.

Overall, while ISO 9001 does not specifically address process variation, its focus on standardisation, risk management, continuous improvement, supplier control, employee competence, and performance measurement can help organisations effectively minimise process variation and improve overall product/service quality.

Do you need help with achieving ISO 9001?

Talk to us today. Our consultants can guide you through the process, providing advice and templates to ensure that you’re on the right track. We will help you to avoid non-conformities with ISO 9001 and set you up for success.

For more information on ISO-Cert Online’s services or to discuss your requirements please contact us on 0333 014 7720 or email info@isocertonline.net.

Of all the ISO standards available, you’re most likely to have heard of ISO 9001. It’s the standard relating to quality management systems (QMS) and is by far the most popular. In fact, our expert consultants support businesses to achieve ISO certification every day of the week. And, in this blog, we are sharing some of the persistent non-conformities with ISO 9001 (the issues which prevent businesses from meeting the requirements set forth in the standard) as a guide to follow when preparing for a quality audit.

Typically, non-conformities with ISO 9001 are identified through internal and external audits, routine inspections, or other forms of assessment. They appear in your processes, your products, and services, and even in the actions of your employees. Furthermore, they are categorised as either a minor-conformance or a major non-conformance.

• A minor non-conformance would describe a situation which does not comply with ISO 9001 requirements. However, it may be a one-off occurrence and/or it’s doubtful that it would have a serious bearing on either your QMS or your day-to-day operations.
• A major non-conformance reflects either a repeated minor non-conformance or a single situation which falls short of the standard’s requirements. In this case, your QMS would be affected, and you could even face operational downtime because of the incident.

When non-conformities are detected, it’s vital for organisations to take corrective actions to address the root causes and prevent their recurrence. This process is a fundamental aspect of ISO 9001. Resulting in continually improving the effectiveness of the quality management system.

Most common non-conformities with ISO 9001

Depending on the size, operations and industry of your business, the nature and severity of non-conformities can vary widely among organisations. Below are the most common examples of non-conformance, with guidance on how to manage them before they cause you serious problems:

1. Failure to understand the context of the organisation:
   ISO 9001 requires that the organisation identifies and understands the needs and expectations of its interested parties. While many businesses will know (or think they know!) this information through experience, not many will take the time to analyse the data, so that no one is missed out in terms of who needs to be communicated with, on what topics and when.
2. Failing to understand the customer’s requirements:
   A proper understanding of the what the customer wants (and expects) is critical to any business. Failing to do this will lead to inefficiency and wasted time (and money). It also has a direct impact on an organisation’s credibility.
3. Inadequate documentation and record management:
   An essential element of any audit is being able to provide the relevant evidence. So, stay on top of maintaining and updating documented procedures, policies, and records as required by ISO 9001. Also, make sure that you store these safetly so that they are available for review. Incomplete or inaccessible records or documentation just won’t cut the mustard.
4. Lack of process control:
   Without the correct monitoring and measuring, you will experience inconsistencies, errors, or deviations from established procedures. Not only will this undermine your QMS, but you may fail to meet your clients’ requirements. Worse still, you risk a product recall or operational downtime as you reset your production processes – all impacting on your productivity and efficiency.
5. Lack of control over the working environment:
   In order to carry out work effectively and efficiently, employers must give employees a workplace that is fit for purpose, as well as the correct equipment to do the job (which is safe to use), and appropriate training. A poorly maintained workplace and/or equipment will not only lead to poor quality but may also cause harm to the environment or human health.
6. Insufficient or poor training:
   How can your employees perform their role effectively if they haven’t been adequately trained or are not qualified? By introducing a training programme and maintaining training records, you will be able to equip your staff to conduct their work and support the business’ customer satisfaction objectives.
7. Non-compliance with customer requirements:
   Meeting customer needs is at the heart of ISO 9001. It’s important to meet product specifications, such as measurements or delivery schedules in line with customer requirements. Failure to do this, could result in an unhappy customer. Additionally, you may find that your reputation takes a hit as word spreads about the poor quality of your product or service.
8. Inadequate corrective and preventive action:
   Continuous improvement is the cornerstone of ISO 9001. So, when issues crop up – and they will! – don’t bury your head in the sand. Make an action plan to address and resolve them in a systematic and timely manner. Always document any corrective actions as a record that you have taken steps. This evidence will be extremely valuable in an audit.
9. Poor supplier management:
   Although your business may be performing well, have you stopped to think about the impact on your business if one of your key suppliers let you down or even went out of business? The repercussions of supply chain problems can reach your customers very quickly. But by close control and monitoring of your suppliers, you can become more resilient to these risks. Start by agreeing your business’ requirements, creating, and maintaining a supplier database, assessing supplier performance, and producing a list of measures to counter any supply chain risks or interruptions. This will help you to safeguard the quality of your product or service.
10. Lack of customer feedback: One of the most valuable exercises a business can conduct is gathering customer feedback. It serves to gauge sentiment about different areas of your business. It also provides insights which can direct you to publicise the things you’re doing well. And, whilst receiving negative feedback is uncomfortable, it’s the most effective way to understand how you should improve your products or services.
11. Inadequate risk and opportunity management:
    Another essential part of any QMS is a robust programme of risk management. Without this, you are likely to fail to identify and mitigate risks that could affect the quality of products or services. Likewise, the standard also requires that the organisation identifies and plans for possible opportunities (as well as risks).
12. Non-compliance with legal and regulatory requirements:
    A fundamental consideration for any business is compliance with the applicable laws, regulations, and industry standards that affect its operations. Make sure that you are compliant to avoid fines and penalties. And document that you adhere to requirements, providing relevant supporting evidence.
13. Ineffective internal audits:
    No auditor worth their salt goes out of their way to find faults! On the other hand, a string of audits which don’t identify either minor or major non-conformities could also be seen to have no value. By developing a culture of continuous improvement, you will embrace rather than fear opportunities to develop or enhance the status quo.
14. Internal and external communication problems:
    As they say, communication is key. And inadequate communication (internal or external) can lead to misunderstandings, errors, and lapses in quality. Examples of strategies which can support effective communication include regular 1 to 1s with staff, weekly team meetings, summarising action points and responsibilities from meetings, taking time to listen, being open to feedback, giving positive feedback, using the right technology for your business and teambuilding or project work to draw different departments together. Effective communication has many benefits both for your employees and the quality of your product or service.
15. Lack of leadership engagement:
    ISO 9001 requires that top management show their commitment to, and support for, a QMS. Businesses where there is little involvement – or worse, awareness – from top management are unlikely to have embedded a culture of quality. This is likely to raise questions about whether employees have appropriate guidelines to follow, are regularly encouraged to take quality-focused actions, talk about quality within their roles, and see strong examples of prioritising quality.

Looking at this list of non-conformities with ISO 9001 highlights how valuable this standard can be for your business. The benefits of implementing a quality management system don’t stop at just tightening up your processes; they reach across all areas of your business and can significantly improve your operations, your product or service, as well as the experience you give to your customers.

Do you need help with achieving ISO 9001?

Talk to us today. Our consultants can guide you through the process, providing advice and templates to ensure that you’re on the right track. We will help you to avoid non-conformities with ISO 9001 and set you up for success.

For more information on ISO-Cert Online’s services or to discuss your requirements please contact us on 0333 014 7720 or email info@isocertonline.net.