Certification on ISO 9001 and other quality standards is vitally important in most organizations. Not only does certification ensure that your processes are designed and implemented properly, – it also sends a strong signal to customers and other external stakeholders that your company is committed to quality excellence, and that you’re meeting the goals that you set forth for your quality in your organization.
ISO 9001 sets forth a range of requirements that organizations must fulfill to be in conformance with the standard. When a company fails to meet one of these requirements, – for example, when it fails to recognize or define a problem, determine its root cause, or take appropriate action a problem to prevent him from reoccurring,
– a finding of nonconformance may result.
Nonconformance implies that something is amiss with the company’s quality management procedures. It’s an indication that something needs to be rectified with respect to a process, a product, or the quality management system itself. It may also result from processes that are simply not being followed properly.
Conformance is typically verified by way of an external audit, – but instances of nonconformance might also be uncovered by internal audits, customer complaints, or routine testing processes. In fact, it’s far better to discover an issue yourself, – as that will typically happen earlier than it would in the case of an external audit. When problems are discovered early and proactively addressed, it puts your company in a stronger position to pass external audits with flying colors.
In this article, we will discuss four important measures that your organization can take to increase conformance readiness, starting with the annual management review process:
#1: Initiate a Management Review
Regardless of the products, processes, and systems, you have in place today, – things will inevitably change. Although your existing systems should include measures to accommodate those changes, – it is nevertheless good practice to perform a more comprehensive evaluation of your quality management systems and processes on a periodic basis.
The management review process provides an opportunity to reassess your organization’s existing quality policies and to set objectives for the coming year. Most companies perform a formal management review of quality procedures, processes, and metrics on an annual basis, – but it may be helpful to initiate a management review at other times throughout the year, – particularly during times of significant change.
Areas subject to review may include changes to processes, product design, or the company’s product portfolio; as well as any new requirements that may have emerged as a result of changing customer expectations, legal or regulatory requirements, or changes to internal company policy. In any event, the management review should be comprehensive in nature and should follow a well-defined and clearly documented checklist.
Very often, the management review process will uncover potential deficiencies before they turn into actual problems. At the very least, this exercise contributes to the process of continuous improvement, enabling the organization to proactively discover potential weaknesses or areas that can be made more efficient or effective.
To get the most out of a management review process, it helps to have a clear handle on your organization’s quality KPI’s. Having effective efficient, and accurate, data collection systems in place will help to keep the management review focused on facts rather than opinions, – and will provide a foundation upon which the organization can measure and monitor expected results.
#2: Perform a Ground Level Review
While the management review process typically happens annually and is fairly comprehensive in nature, – it often makes sense to perform a more focused evaluation with front line personnel, – the people who work in the trenches every day designing, manufacturing, and testing the product, as well as the people who interact directly with the company’s customers.
A ground-level review may be performed at any time, – but it may be prompted by changes to products, systems, or processes; or by customer feedback or other indications that product quality may be at risk. While a management review tends to involve senior-level employees, the ground-level review engages workers who have a more intimate knowledge of the specific tasks, machinery, and procedures that go into making the company’s product. In this respect, such a review process can often reveal knowledge gaps or deficiencies that might not have been identified in a management review.
This is also a good time to ask whether front-line employees have the necessary tools to do their job thoroughly and efficiently. QMS systems that rely on paper-based data collection, for example, typically require more effort and are less accurate than mobile phones, tablets, or other digital devices that can be easily carried around the shop floor. By understanding employees’ needs, quality managers can put systems in place to empower workers to be more efficient and accurate.
#3: Perform an Internal Audit
Whereas external audits are performed by independent third parties, – internal audits are initiated by management to test whether the company is following the systems and processes that it put in place as part of its overall quality management plan. External audits tend to be a big deal. They require substantial management attention, they are often fairly extensive in their scope, and there can be significant consequences in the event of a finding of nonconformance.
Internal audits, on the other hand, serve as a kind of self-regulation process. If management discovers an instance of nonconformance, they can initiate the appropriate corrective action. Moreover, internal audits need not cover extensive territory; it’s entirely reasonable to stage multiple internal audits that are more limited in scope.
As always, it’s extraordinarily helpful to have the right systems in place for collecting data and making it available for analysis.
#4: Collect & Analyze Customer Feedback
By taking a proactive stance toward customer feedback, companies will be in a strong position to establish their conformance to quality standards. When strong systems are in place to receive customer feedback with respect to nonconformances, then to assign root cause analysis, corrective action, and preventive action according to automated workflows; quality managers can ensure that nothing falls through the cracks.
To do this well, it’s important to have systems in place that allow for the efficient collection of customer feedback, clear assignment of responsibilities, and as much automation as possible.
Organizations that perform these four tasks well will be in a strong position to defend their processes and practices when external audits occur. An effective QMS system is the common ingredient that is necessary to effectively implement all four of these strategies. At Intellect, we develop quality management software that enables organizations to systematize data collection and analysis and to automate workflows, giving quality managers full control of the information that matters most. To learn more about our QMS software and our platform for “extreme configurability”, contact us today.
Now that you've learned about the 4 ways to increase conformance readiness, learn about the best QMS software solutions, “Improving your Organizations' Culture of Quality with ISO Standards”.