Working with your partners in the business: Regulatory

Working with your partners in the business: Regulatory

I recently talked about the relationship with the Packaging Technologists/Engineers. In this blog I discuss working with the Regulatory function. I talk through the regular interactions, the key information they provide the team and their responsibilities, and the role of senior sponsors.

The Regulatory organisation has many touch points with the Artwork service team

Whether it’s a launch program, a large safety data change or a company-wide project, the group the Artwork Service team are probably speaking to most often, will be the Regulatory team. Each company varies, but its why, in many cases, the location of the Artwork Service team is close to the Regulatory group and why the reporting is sometimes also aligned.

In a launch program, the Regulatory group will be providing the content and timescales for each market. The Artwork team will be communicating with different parts of the Regulatory organisation, the central team as well as the regulatory contacts in the markets, and sometimes separate safety teams. Most packs are required to be changed on a frequent basis and the Regulatory group, as well as triggering the changes, provide the guidance on the phasing.

Regulatory are involved throughout the process, providing the core text and the review and approvals of the artwork brief and the final artwork.

Reducing the frequency of pack changes is only possible if good communication exists, so such changes can be ‘bundled’ together. Achieving very short lead-times for launches, post approval, are only enabled through close cooperation.

It is important the Regulatory team are clear on their roles and responsibilities

The Regulatory team advice on timings can vary in quality but the one area which they cannot get wrong is the core text content. The old adage ‘garbage in, garbage out’ is applicable here and unfortunately I have worked with companies who have made great improvements with their artwork process but the step change we normally see has been hampered by poor quality of text input.

Responsibility for the content, translations, and the review and approval processes must be very clear if you are to achieve excellence in the labelling and artwork process.  It‘s hard but the Regulatory contact in the affiliates can be easily forgotten in the process redesign so it important to involve them, understand their issues and then pick up their points, tailoring the SOPs and training material accordingly.

Good sponsorship will set up the project for success and enable further progress

I always ensure Regulatory have a strong presence on the project steering committee. It is vital changes required are owned by this group, as they ‘touch’ so much of the process. It is only through good senior sponsorship, with a reach to the whole regulatory organisation, globally, will you design a process with the potential to be world class. Post implementation, a senior Regulatory figure must be part of the Governance team to ensure the improvement in the process continues.

In my next article I will talk about the part played by another key group – Planning.

To help you in your Artwork Improvement Program, you can also find useful information in my book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities


Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email.

For more information on artwork, go to our free download section.