Since 1991 Industrial Technology Systems Ltd (ITS) has undertaken over thirty vendor audits. The majority have been carried out on behalf of customers to ensure that their suppliers adhere to their quality requirements and the requirements of the regulatory bodies. Examples of the vendor audits undertaken by ITS are outlined below.
An audit was requested by Rhone-Poulenc Rorer (RPR) prior to them placing a purchase order with AB Precision (Poole) Ltd for the supply of an Automatic Function Test Machine for use in the production of metered inhaler (MDI) aerosols products at its Holmes Chapel manufacturing site.
Bespak’s purchasing of two machines from Mikron prompted the need for a vendor audit. Bespak is aware of the increasing importance of validating the software content of these machines and they wanted to ensure that Mikron was capable of maintaining satisfactory quality levels when designing and building the two current and any future machines. The study concentrated on the features of Mikron’s structure and work processes that could have affected the quality of the machine’s software.
A vendor audit was carried out for Becton Dickinson (BD) as part of the process of validating the ATEQ’s Type ‘F’ microprocessor based Leak Test instruments. The audit addressed the supplier’s quality system, concentrating specifically on the servicing aspects of the business.
Becton Dickinson (BD) was undertaking a project at Swindon associated with the introduction of up to fourteen new injection moulding machines. Krauss Maffei Kunststofftechnik GmbH (KMK) in Germany, in conjunction with Krauss Maffei UK (KM UK) were chosen to build, supply and support a range of injection moulding machines.
Prior to the decision, an audit took place at the Munich, Germany offices of Krauss Maffei. The intention of the audit was to determine whether quality activities and related results complied with planned arrangements; and to determine their effective implementation within the Krauss Maffei organisation.
Becton Dickinson (BD) required a label printing system and KTP Ltd were identified as a capable supplier. The intention of this audit conducted by ITS was to ensure that quality activities and deliverables complied with BD’s arrangements and requirements, and to determine their effective implementation within the KTP organisation. The audit took place at KTP’s Beverley offices.
BD was considering the purchase of a Statistical Process Control (SPC) package from Nicollet Process Engineering (NPE) for use with their plastic injection moulding system. The intention of this audit was to determine, investigate and analyse the procedures and methodologies used by NPE in the design, development, implementation and support of the SPC package. The audit took place at NPE’s office in Minnesota, USA.