Navigating Certification Process of Ex Product – Challenges of CoC Part2 – QAR/QAN
In our previous blog post, we introduced the fundamental concepts of IECEx certifications, particularly focusing on the Certificate of Conformity (CoC). We explored the importance of product testing (ExTR) and the role of manufacturers in ensuring product safety and compliance.
Now, we delve deeper into the next crucial phase of the CoC process: Factory Audits (QAR/QAN).
What is CoC and How to Get It? Part1 Summary
First, let’s summarize our previous blog post shortly. It outlined the three primary types of IECEx certificates:
Certificate of Conformity (CoC),
component certificate, and
unit verification certificate.
The CoC is the most complex and involves type testing and factory assessments to ensure product consistency. In contrast, the unit verification certificate is less stringent, requiring only a unique identifier for each unit. The ATEX Ex Product certificate, similar to the IECEx unit verification certificate, does not include manufacturing information. This blog post will delve deeper into the process of obtaining a CoC, including the required test reports and factory quality assessments.
In the Part1 blog, we detailed the Product Testing (ExTR) part of the CoC with common mistakes, and what the Manufacturer does under this phase. Check the blog in this link, if you are interested in the topic.
Factory Audit (QAR/QAN)
First, let’s clarify what QAR and QAN are meant:
Quality Assurance Notification (QAN) under ATEX and
Quality Assurance Report (QAR) for IECEx.
Ensuring the ongoing safety and reliability of your Ex Products requires more than just initial type testing (ExTR). A robust quality management system is essential to maintain consistent production standards. Both the ATEX and IECEx schemes mandate regular factory audits (QAN/QAR) to verify that your manufacturing processes comply with explosion protection requirements. These audits assess your quality management system, production processes, and product conformity. By adhering to these rigorous standards, you can guarantee the safety and performance of your Ex Products and maintain compliance with ISO 9001, IEC 80079-34, and other requirements.
Preparation for QAR/QAN
The two most important parts, that you need to draw up and revise:
Your Company and production process documents
Your manufacturing location and production line.
These have to be taken into account even under your product designing and test sample manufacturing phase too. If your designer is enough considerate, they will create the product with the requirements of the related standards.
Documents – Ex Authorized Person
The Ex Authorized Person’s role is the most important at Ex Product. Every organization must assign this role in their system to a capable person. The responsibilities and authorities of Ex Authorized Person are detailed in IEC 80079-34. Based on those requirements you as the manufacturer update your ISO 9001 related documentation.
Production Preparation for Ex Product
From a component arriving at the warehouse to shipping your end product needs to be reviewed. There are special requirements related to Ex Products. The two critical points at Ex Product manufacturing are the following:
Identification: Your Ex Product related components, material, tools, and process steps must be easily distinguishable during every step of the manufacturing.
Traceability: based on product serialization you need to identify and prove every Ex related component, material, and process step was produced in accordance with the related standards.
Common Mistakes of Preparation
Based on our over-a-decade of experience the most common weak points of the preparation for QAR/QAN Audit are:
The Ex related information in the company documents is not structured, and coherent, can not be seen clearly which paragraphs related to the requirements of the standard.
The role of the Ex Authorized person is not detailed to the appropriate depth.
Lack of knowledge about the documents that need to be submitted for QAR/QAN.
Missing or insufficient labelling at storage and production lines.
The Ex related process steps and calibrated tools are not identifiable.
Ex related employee’s training evidence does not contain every required information.
Internal Production Process Audit
Internal Production Process Audit is connected to the previous and the next chapter too. The first step is: based on your production processes you create the Process Audit form. Then you organize the audit timeline with the manufacturing location and make the process audit. The internal audit is based on this form, you check at least one product production from components arriving till the shipping of it. In case of any non-conformity it must highlighted in this form and the manufacturing location must take action to eliminate it. This filled form is one of the submitted documents for QAR/QAN certification.
The QAR/QAN Audit
The prepared document pack needs to be submitted to the Certification Body. They check it and after that, the date of the audit will be set. The Certification Body will do mostly similar audit as your Internal Production Process Audit: they check at least 1 product manufacturing process from the start to the end. They will ask for evidence like
training and calibration records,
real-time assembling,
traceability, or
organization-related documents.
If you make a detailed and efficient internal audit no problem can come up during the QAR/QAN audit.
Common Mistakes of QAR/QAN Audit
The non-conformity during your internal audit is not resolved until the QAR/QAN Audit.
You do not make a fully detailed internal audit, so during the QAR/QAN Audit, you will realize unexpected non-conformity.
Lack of evidence during QAR/QAN Audit.
In conclusion, important to do a successful and detailed Internal Production Process Audit before you submit the documentation pack to the Certification Body. The best if you can identify any problem before the Certification Body.
Delivery of Your CoC
After your product passes the ExTR tests successfully and your QAR/QAN audit has taken place your product will become an Ex Product with a Certificate of Conformity (CoC). It takes some time for the Certification Body or Bodies (ExTR and QAR/QAN process can done by different Certification Body) to issue the certificate. With the CoC in your hand, you will finally be able to manufacture and sell your Ex Product with a certification number and string.
Do you need experienced and professional help to get your CoC, Product Testing, or Factory Audit?
We have extensive experience in internal production audits
We can support or optimize your documentation based on requirements of standards
We can help you get your certificate flawlessly
Let us know, we are here to help!
