Nonconformity

Nonconformity in terms of ISO 9001 is defined as the failure to meet one or more requirements that are outlined throughout the mandatory clauses. To get more into detail on the topic, nonconformity can refer to the requirements of a regulatory body, the organization itself, or even the customers of the business.

Failure to meet one or more requirements

Requirements of ISO, business procedures, or customers

Nonconformity can be anything from the company’s individual procedures to the quality standards that must be upheld in order to satisfy the customer base. In the event that there are any violations of ISO 9001, there are a few actions that should be taken thereafter.

A major non-conformance is something that could cause a significant failure of your businesses' intended operations and objectives. It could be a failure to implement a key requirement of your Standard, the absence of it altogether, or a failure to maintain conformance

 A minor nonconformity is defined as an incident that does not meet the ISO 9001 requirements, but that does not have any major consequences. This means, that the nonconformity will not result in a failure or majorly weaken your QMS. Examples of minor nonconformities are, failure of a few personnel to correctly follow a process, or a single incident of not having proper paperwork for inspecting equipment.

1. Management Review

Management review is akin to getting your car serviced every year even when there are no overt signs of problems. Management reviews are generally conducted quarterly and present an opportunity to review the company’s existing quality policy as well as set new objectives for the rest of the year. New objectives can be invaluable for minimizing non conformance.

Product changes, new requirements, new processes, change management etc. are all reviewed. The management review process can identify and correct any current or incipient deficiencies before they might be revealed by an audit or incident. Routinely reviewing the organization’s process helps spur continuous improvement. A system should be in place for implementing any resulting plans for improvement or corrective action and verifying their effectiveness.

2. Review

A review is usually a ‘senior management’ exercise. Keeping this in mind, it’s important to conduct a similar exercise with the actual employees who are involved in the day-to-day process. These employees have an in-depth understanding of various processes and how they are related. They have vast knowledge about the product and more importantly about past non-conformance issues. They very well could have been first to respond to a crisis and would have played a crucial role in analyzing the situation and solving an issue. On the flip side, this discussion could reveal a knowledge gap crucial to fixing non- conformance. An end-to-end understanding is crucial in setting up new objectives to minimize non-conformance. Also, understanding the process followed by lower-level employees could highlight pain points and provide key insight into potential areas of non- conformance, those which cannot be identified in a management review or audit.

3.Internal Audit

An audit is simply another form of testing i.e. comparing things as they are to how they ought to be. Internal Audits need to be scheduled at regular intervals to check whether the quality system conforms to requirements and to ensure the system’s efficacy. Unlike an external audit, all the processes need not be audited at the same. Internal audits can be conducted as a series of smaller audits, with different processes audited at different times. The frequency of audit can also be set depending on the process in question. With changing internal and external dynamics, the criteria for the audit can be decided prior to the audit rather than the planning stage. Any previous findings, past audit conclusions, and pre-defined questions all become valuable data. Observations raised during internal audits could be classed as preventive actions as they can suggest improvements within the system to prevent non-conformances from occurring in the future.

4.Feedback

While all customer complaints are recorded and must be actioned, customer feedback also plays a role in minimizing non-conformance. Feedback from customers helps to understand potential non-conformance issues and is an opportunity for improvement. Customer suggestions may prevent any issues from being raised in the future. Negative as well as positive feedback is valuable data. Spending time to analyze could help spot trends and patterns. Feedbacks help to dig into the root cause of the issue which may not always be obvious (else it would have been picked up in audit testing). Understanding the root cause can help differentiate a temporary lapse from a process flaw.