Quality Nonconformance - something went wrong in production!!!

AAAAGGGGHHHHH, something went wrong in production!!!

We had a recent quality nonconformance in production. The nonconformance fell across a procedure within our Production and Service provision. Our quality system captured this and our nonconformance process was activated to take care of this, but I also thought of it as a good opportunity internally to conduct some peer mentoring with our technical manager as well as using the experience to create an article.

So let us begin, when a company finds itself outside of compliance or its regulatory boundaries, it must get the problem under control before continuing business. Most companies have a goal to satisfy their customer base, and the ISO 9001 standards are in place to ensure that this goal is met. Therefore, nonconformity to these standards may result in unhappy customers.

?? Tip – A nonconformity is?‘‘the failure to meet one or more of the existing requirements in ISO 9001:2015 standard.’’

So, a call to action must be just that, a call to get the violator moving back toward the original standard. Time is often money and even safety in these circumstances, so your instructions must be clear and concise to ensure customer requirements are met.

?? Tip – A quality nonconformance is more than a ?bump in your quality path, and this is your opportunity to correct and improve the issue to prevent future occurrence.

In manufacturing, the Clause 8.5 (Production and Service provision) of the standard is where it all happens. This clause is divided into a number of sub-clauses, each of which are important. So, you need to study and understand each sub-clause to determine how your operation complies. Given the complexity and demands around production processing, failure here to establish solid foundations will create regular non-conformance which is risk-prone to a ‘domino-effect’ of failures in the process whilst trying to achieve your customer requirements.

Let us look at the most complicated, this being: 8.5.1 “Control of Production and Service Provision.” Essentially, the clause is asking that production be performed under “controlled conditions” to ensure quality. The clause then provides some minimum requirements for what “controlled conditions” must include. At this point, you need to understand and differentiate between your operation and your service providers — who have very different “controlled conditions”?

Let’s focus on our operation conditions which must include, as applicable:

1._The availability of documented information that defines the characteristics of the products to be produced, the services to be provided, or the activities to be performed and the results to be achieved.

Neil’s Comment: The “Results achieved” may be a significant additional requirement for some organisations. As example your current documented information (work instructions / procedures) may not contain this requirement.

2. The availability and use of appropriate monitoring and measuring resources.

Neil’s Comment: “The availability and use of appropriate monitoring and measuring resources” This is to emphasise the fact that monitoring may be being carried out by personnel as well as by equipment. (See also article 7.1.5 Monitoring and measuring resources.)

3. The implementation at appropriate stages of monitoring and measurement activities to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met.

Neil’s Comment: There is an explicit requirement for “the implementation at appropriate stages of monitoring and measurement activities.”

4. Appropriate infrastructure and environment for the operation of processes.

Neil’s Comment: “Appropriate infrastructure and environment” expands on the previous ISO 9001:2008 requirement of “suitable equipment”. (See also article 7.1.4 - Environment for the operation of processes.)

5. The appointment of competent persons, including any required qualification.

Neil’s Comment: “Competent persons” are referred to as throughout the standard, to emphasise competency rather than just qualification of personnel. Competency can mean activities in demonstration of a software application or on-the-job training.

6. In instances where the resulting output cannot be verified by subsequent monitoring or measurement, the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision.

Neil’s Comment: “In instances where the resulting output cannot be verified by subsequent monitoring or measurement.” These are sometimes referred to as “special processes.” For these processes, the standard requires the process itself to be initially validated and then periodically re-evaluated.

?For example: Through initial process capability studies and subsequent ongoing controls such as Statistical Process Control (SPC.) Examples of “special processes” may include: Coating, plating, heat treatment, moulding, soldering, sealing / gluing etc.

7. The implementation of actions to prevent human error.

Neil’s Comment: “The implementation of actions to prevent human error” can be addressed by applying various methods

• Ensuring personnel involved are competent as per point 5, by having the appropriate abilities, knowledge, skills, training and equipment available.
• Investing in a culture of right-first-time and communicating the importance of “getting it right”.
• Adopting a risk-based approach when designing processes involving human input. (i.e., use of tools such as Failure Mode Effects Analysis.) This may result in a reduction on human inputs through careful specification of equipment to be used in the process, including automation or reengineering.
• The employment of Poke-Yoke (a fundamental lean mistake proofing tool) devices and methods can be use in both product and service-based processes. e.g: Non-contact process parameters are outside of acceptable limits and alarms are triggered for personnel dealing directly as line control.
• Reducing process variation through tools such as Process Capability Studies / ongoing Statistical Process Control and Gauge Repeatability and Reproducibility (Gauge R&R) studies. i.e.: By minimising opportunities to “get it wrong,” resultant errors can be reduced.

?8. The implementation of release, delivery and post-delivery activities.

Neil’s Comment: All steps must be defined and controlled as follows;

• Release: Any final inspection and test requirements / authority to release.
• Delivery: Shipping / Transport / Collection arrangements.
• Post-delivery activities: Warranty, servicing, spares, end of life recycling requirements etc. (also consider 8.5.5 Post-delivery activities.)

?A lot of repeat language does appear in 8.5.1 which reflects that in 8.1, as well as other clauses in the standard. For example, 8.5.1 again is insistent that you provide resources, a notion that has been addressed numerous times already, earlier in the standard. You might already have addressed and met the conditions required already, or maybe not, but its inclusion is repeated as a ‘safety net’ mechanism built into the standard. Personally, i think it is a good thing.....

?? Tip - If you look to think of 8.5.1 as a memory jogger: a list of things to check and re-examine?before?you commence work on a given works order or next contract.

?How can you glean the benefits from ISO 9001:2015?

When implemented properly, Clause 8.5.1 should result in the following benefits being achieved for your Organisation:

• Each work order that hits the production floor, or each project that launches, should have all the necessary information, resources, assigned personnel, competence and instructions on hand in order to work efficiently.
• Personnel responsible for the work will know exactly what they are supposed to be doing, competent in their application, with knowledge of what the product or service requirements are, and how to ensure the quality of their work.
• “Human error” is finally called upon and addressed in this clause, and organisations can leverage this to create inventive methods to reduce nonconformities due to human error like mistake proofing, which is simply a system designed to prevent inadvertent errors made by workers performing a process.

In Summary

It seems like quite an exhaustive list, and it is, but because you have worked through previous sections of the standard you already have the required background information available to comply with this requirement, you just need to put it into place.

You need to plan the production of your products and services, and during production, identify and then trace the status of the product or service. Protect and look after customer-owned product and materials. Preserve the product or service once you have produced it. Ensure you support the product or service once supplied. During this whole process manage any changes that are needed.

So, the secret to implementing this clause within your QMS is not to get down 'into the roots' of the individual requirements but to keep the big picture in focus. If we can do that, then all the process requirements will be met and any nonconformance identified should be isolated, captured and remedied for future success.