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The importance of quality and ERP systems by Peter Newbould, Quality Assurance / Regulatory Affairs Manager

Are you getting the most out of your business management systems?

After successfully completing our ISO 13485 recertification audit we were happy to receive a wide range of positive comments from our followers on the successful implementation of our ERP system from Access Factory Master and the controls it provides.

We went live with Access Factory Master at the start of 2021. The system was scoped, reviewed, and implemented by our Managing Director Iqbal Bahia and the senior management team; with the ethos of bringing our business system requirements and quality systems together in one place.

During an audit you want to be able to access all the required documentation and show the relationship between these. Being able to clearly link a customer’s order to an internal works order and show the full traceability to raw materials is a must.

The benefits of ERP and quality integration

The ability to be able to do this with just a couple of clicks, without the need to search through folders full of paper copies or window folders with missing files or miss labelled files, can never be underestimated. Access Factory master, if scoped and implemented correctly, does this with ease.

This makes the audit process quick and easy and provides confidence to the auditor that the processes covered are under control.

Running our quality system embedded in our ERP system is not just an auditing tool or a better method of holding and capturing production documentation and information. It also provides a valuable tool in measuring and reporting Key performance indicators giving an extra dimension for improving the business.

Being able to report our delivery performance, supplier performance, and internal performance alongside costing reports allows us to focus our efforts in areas that require any improvements. This makes the development of the business clear and concise without any ‘smoke and mirrors’ that can cloud some business KPIs.

Using the system to capture process improvements

In addition to the above areas, we can use the system to capture process improvements from areas such as audits and health and safety actions. Corrective and preventative actions are now concise and detailed and are also integrated with the ‘5 why tools’ to help define root causes.

The effort made embedding these quality tools are invaluable as a Quality Manager. Simple tasks such as managing our calibration system have been greatly improved from a spreadsheet to a fully integrated system. The system tracks all our calibration needs from a tooling register to all calibration certificates. This identifies the equipment that is due for calibration and can even report on the number of times the gauges have been used and the batches it has checked.

Encouraging growth and development

All too often, businesses can stifle growth and development as the basic tools required are not open to all. The information required to act is locked in a spreadsheet limited to one department or the data is not trusted. Using one system to cover all of our requirements enables that information to be used across the entire business and was one reason why Access Factory Master was picked above other systems.

All of this combined provides a very strong platform for us to improve the business and move forward with the confidence required in our sector.

Meeting MDR and MDD requirements

As many of you out there in the medical device sector understand, the documentation and system controls are extensive to meet both the MDR and MDD requirements. Having all those controls and ease of access in one system supports the role of a quality manager at Kirkstall Precision. Being able to develop our systems and not worry about the daily requirements means the quality systems can provide the value added tools a successful business requires.

It would be great to hear from all you quality managers or quality engineers in a similar position.

Do your business systems provide the quality tools you need? What limitations do you find covering the quality and regulatory requirements from a system point of view?

Our aim is to provide an uncompromised service and product to our customers on time at the right cost, and our approach to integrating our quality system with our ERP system is just one example where the Kirkstall Precision Team is leading the way.

To find out more about our quality procedures or our ability to meet MDR and MDD requirements, email our Managing Director Iqbal Bahia at: