I have been working with a growing business in the pharmaceutical consultancy sector on a business improvement project. HTF Associates provide specialist advice, project management services and supply chain management to the pharmaceutical industry. HTF Associates are industry experts offering guidance and support in Good Distribution Practice (GDP) as defined by the EU and the MHRA which includes the implementation of quality management systems meeting GDP requirements and the provision of contract resources, including the ‘Responsible Person’ (RP) role.
The founder and Managing Director of HTF Associates was consciously expanding the business and wanted to develop the company by way of a process flow environment. He felt that as the company continued to grow, he should not have to be personally involved in every client project and he needed to feel reassured that things were happening as they should.
Following our initial discussion, we decided to implement a formal quality management system to underpin the everyday operations of the business and to provide the MD with the governance structures and assurance processes he needed as well as meeting the requirements of ISO 9001:2015.
One of the first areas of concern we identified was the due diligence process before deciding to take on a new client. Previously, the MD used an informal, undocumented checklist to gather a range of information ready for review. When we looked at the process in more detail we were able to formalise a Due Diligence process so the relevant information could be gathered by any member of the team and passed to the MD for review and a decision. This freed up his time and enabled him to take a more strategic view of potential clients and projects.
I found this project particularly interesting due to the culture of documenting everything already in place at HTF Associates – due to the high level of documentation required for their clients under GDP. My usual approach is to reduce the amount of documentation to the absolute minimum so we all compromised and met somewhere in the middle!
After completing the initial gap analysis and 6 further days on site between Oct 18 and Feb 19, we successfully passed our external audit with ISOQAR and gained certification to ISO 9001:2015 in April 2019.
The MD was delighted with this outcome as although the real driver for the project was improving the business and moving it away from people-based organisation towards a process based one, it is always nice to get a certificate!
I was delighted to receive the following testimonial from the team at HTF Associates:
Helen made the process of gaining ISO9001:2015 certification simple and effective. Her advice and support at each stage of implementation proved invaluable. We now have a QMS that is easy to follow and maintain, standardising and continually improving our company processes. We would highly recommend Helen’s excellent services to any company aiming for ISO certification. She has been a joy to work with and is extremely efficient in every challenge she takes on board. We couldn’t have asked for anyone more pleasant to work with, so on behalf of everyone in the office we would like to thank you for your time here at HTF Associates.
Direct HKW Project
6 days from to Oct 18 to Feb 19, 2 days for certification body audits Mar and Apr 19.