Explaining the Basics of ISO Standards: CHECK
Besides products, what else should you check to keep going with quality improvements?
In this blog series, we’ve been explaining the Plan-Do-Check-Act cycle of improvement: see these articles for the other three. You can read more about planning and the PDCA cycle is on our website, Plan-Do-Check-Act.
We all know to check the product or service before it’s handed over to the customer. In our last article, DO we outlined internal QC to catch non-conforming products or services before delivery. But that isn’t the only thing to check, is it? NOPE. ISO 9001:2015 has a long list of other internal factors that we need to monitor – not just for ISO certification, but to keep up with constantly-changing business requirements. Here are some, from clause 9, “Performance Evaluation.”
Customer satisfaction: this can be from surveys, by email or phone or in person, or other personal contact with the clients. Customer satisfaction can also be determined by increases in orders, received compliments, referrals to new customers, and other means.
Information from the system needs to be analyzed, in order to determine:
conformity of products and services,
performance and effectiveness of the QMS,
whether planning has been implemented effectively,
if actions taken to address, risks, and opportunities have worked,
performance of external providers, and
need for improvements to the quality management system.
There are other matters the Standard doesn’t outline but are just as important, in our opinion:
Whether training has been effective;
Whether more training is needed;
if the environment for production of products and services is sufficient, whether in space, equipment, supplies, or other;
whether the documentation of the QMS is clear, adequate, and effective;
if the scope of the quality management system is adequate for current operations;
whether communication by leadership has been effective in setting comedy, culture and expectations;
whether customer communication has been adequate to properly plan current production, and for future requirements;
whether organizational roles and responsibilities are clearly laid out and effective;
if the quality objectives are adequate for steering the daily operations of the company;
whether the measurement system and equipment for determining conformity of products and services is adequate;
if there is sufficient knowledge within the organization for current and future operations, or if more needs to be acquired through training, hiring, or other means;
whether production planning has been adequate for current and future needs;
if design functions, whether for products, or for services or for processes, has been adequate;
and there could be many more questions, depending on the size and complexity of your organization.
Internal Audit: A Detailed CHECK of Your System
How do we find out all these questions, and even more? A through internal audit of your system, as required by Klaus 9.2.2 of ISO 9001: 2015. The internal audit is a program of its own, within your QMS,
to keep everything running in the way it should by finding out where the strengths and any weaknesses are occurring.
The internal audit program must be planned, and implemented according to the plan, by trained personnel who have the qualifications and experience to:
prepare an audit,
ask good questions,
follow the evidence they are shown to determine if further questions are needed,
decide if the evidence they are presented conforms to requirements, and
clearly and properly report all their findings to top management.
Results of the internal audits
All those findings whether conforming or not – must be analyzed to determine any weaknesses in the system, and addressed to cure those weaknesses. Simply replacing a defective part, or performing maintenance that was ignored or skipped, or re-training someone, is probably – based on our 35+ years of experience – not adequate to keep the problem from recurring. These articles on our website may be of help in determining the true cause of a problem and helping you cure it forever:
Oh, and one more advantage of good internal audits – they point out facts that can otherwise turn into findings at your annual external audit!
The next step to continue with quality improvement, is the ACT or ADJUST step of PDCA. More on that in our next and final article in this series.