Common use of Process Capability Clause in Contracts

Process Capability. 10.1 Certificates of analyses (COA) and/or Certificate of Cleanliness (for tankers) and/or Certificate of Conformance (COC) (equipment and consumables) The supplier’s certificates will confirm that the raw materials/tankers/equipment/consumables meet the Distell specification. The certificate will contain the actual results obtained from testing and/or inspection performed as part of the quality control of an individual batch of the raw material and/or individual tanker/equipment/consumable. The minimum requirements for the certificate are drawn up per material category by Distell. IMPORTANT: ▪ The certificate should accompany every delivery note and be e-mailed to the relevant site Quality Manager prior to the delivery, or as otherwise agreed with the relevant Distell site. ▪ Agents, brokers and distributors are to ensure that all data requirements are met per source plant, and are ultimately responsible to ensure compliance to Distell specification and other requirements. Agents, brokers and distributors shall ensure that the approved source as well as the contact details of the agents, brokers and distributors are clearly indicated on the Certificate of Analysis. It is important that the specification limits reflected on the certificate are aligned with that of Distell. True values must be displayed on the certificate. The process capability demonstrates the repeatability and consistency of the supplier’s manufacturing process relative to Distell’s requirements, in terms of specification limits per the set parameters. Process capability assumes that the process is centred on the target value (aim specification). Process capability measures process variation with respect to the allowable specifications and consider the location of the process average. Distell expects all the suppliers to have the necessary process measurements in place to detect process deviation, in order to rectify proactively. Process control measures should be able to demonstrate quality consistency and allow the prevention and/or removal of non-conforming material prior to the delivery to Distell. Distell requires the supplier’s compliance to a process capability of Cpk >1.33 for each parameter. Suppliers that cannot meet the stipulated process capability and can substantiate it with good reason(s), may apply for exception for that particular material parameter at Distell Supplier Quality Management, where after an investigation will be launched by the relevant Supplier Development Consultant with support from Group Procurement, Centre of Excellence, Innovation and the supplier. Business decisions from these investigations will be communicated to relevant role players. It is the supplier’s responsibility to ensure that materials are fit-for-purpose. Fit-for-purpose meaning: Well-equipped and/or well suited for its designated role or purpose as to be used by the consumer.