Supplier evaluation

Introduce into the selection process the supplier evaluation and audit findings regarding GMP and validation requirements for personnel qualifications, working methods, level of documentation, and in-built system functionality... 

When purchasing configurable software, it is often the practice to evaluate the criticality of the application to the regulatory operation, in order to determine if a supplier evaluation is warranted and feasible. If a supplier evaluation is not warranted or feasible, the rationale for this must be documented and retained with the system validation documentation. As in the previous case, the end user is responsible for ensuring that the program is suitable for its intended purpose when used in a regulatory environment. 

Defined specifications, supplier evaluation, established controls,... 

Supplier evaluations should assess a number of factors including ... 

These factors should be assessed for each supplier being considered, so that the best balance of business fit and compliance can be achieved. An example supplier evaluation matrix is provided in Figure 7.4. Of course, identifying a clear winner in the selection process is seldom clear-cut, and the winner rarely meets all the selection criteria. Some pharmaceutical and healthcare companies weigh the importance of various factors and for the outcome compare the sum totals for each supplier. A summary of the supplier selection process applied to larger systems should be retained for possible subsequent inspection. ... 

The third review level examines the document sets for particular computer systems identified in the hrst review level. Validation Plans and Validation Reports are typically among the first documents to be inspected. If the review of a computer system is not superhcial, the main life-cycle documents identified in Chapter 4 may be inspected. The inspector is likely to ask to see evidence of system specification and qualification, supplier evaluation, data maintenance, change control, training, and security. Sometimes inspectors will ask for supplementary information to be sent onward to them if they are seeking clarification of an issue. 

Scope of Validation The boundaries of the validation project must be defined to ensure that there is full coverage. For example, will the analytical equipment or Chromatography Data System interfaces be validated as part of the project, will Supplier Evaluations be required, etc. It is very important at this stage to determine what is within the scope of the LIMS Validation Plan and what will be validated under other associated Validation Plans. The validation of the implementation of processes and information management within the laboratory should be managed as a cohesive whole to ensure that all parts of the LIMS are developed and validated to the appropriate standards. This may be achieved by the use of a Validation Master Plan (VMP) for all the laboratory processes and information management. The Validation Plan for the LIMS and any associated plans for other interfaced systems would be referenced in and be under the control of this VMP. 

It is essential to conduct a Supplier Evaluation of the proposed LIMS Supplier and Integrator (which normally includes a Supplier and System Integrator audit) as part of the supplier selection process. This evaluation must be conducted prior to placing an order for LIMS as it may be the case that there are some major concerns regarding the ability of the supplier/integrator to deliver LIMS that meet the customer s quality standards. 

Category 5 (custom algorithms and interfaces) Evaluate the need for supplier evaluation on developer of custom code. Base test case development on function risk assessments account for lower reliability of custom code in defining risk criteria. 

Commercial Off-The-Shelf (COTS) Products Versions of products that have been commercially available for at least 6 months and are widely used. Beta releases of products that are still under supplier evaluation and COTS products specifically customized (rather than configured) for application are excluded from this definition. [Defined for this book.]... 

Any realistic QC function must therefore have a policy of supplier evaluation which will ensure that the capability of the supplier matches the requirements of the customer. This is all that can be requested of a supplier, but while assessing the capability it is essential that the customer is equally thorough in stipulating the quality requirements. 

Supplier evaluation can usually be subdivided into three categories new project with existing supplier, new supplier, and new project with new supplier. 

In the second example, the supplier evaluation meeting was attended by just a couple of the supplier s sales representatives, who said they really did not want the business aiyway. As a result the customer immediately moved the business to a new supplier. The supplier s CEO was not happy about the decision. He knew they could have received the business for all of North America as well as Europe and Asia for this customer. The CEOs of the two companies met on the golf course and the supplier tried... 

Supply base reduction Product rationalization Supplier attributes Interviews Supplier selection Supplier evaluation... 

Procedures governing assessment of new suppliers, evaluations of raw materials, supplier audits, TSCA premanufacturing notification, waste management, and preparation of specifications, labels, and MSDSs. 

Procurement Planning and Control Procurement planning and control defines the procurement quantities and dates of parts, assembly groups, and products that need to be purchased. Therefore, the order quantity calculation determines the quantities to be purchased based on the secondary requirements and generates the orders. Later, the supplier evaluation is based on the criteria quality, compliance with delivery dates, prices, and supplier conditions. 

IV.45. Supplier evaluation procedures as part of the procurement process should ensure that only suitably qualified suppliers are selected and used. The selection of suppliers should be based on their evaluated and documented capability to provide items or services in accordance with the requirements of the procurement documents, and should take account of the type of product and its impact on the quality of the final product or service. Appropriate records of evaluation and supplier selection should be maintained. 

Akarte, M. M., N. V. Surender, B. Ravi, and N. Rangaraj. 2001. Web based casting supplier evaluation using analytical hierarchy process. Journal of the Operational Research Society. 52 511-522. 

Chen, C.-T., C.-T. Lin, and S.-F Huang. 2006. A fuzzy approach for supplier evaluation and selection in supply chain management. International Journal of Production Economics. 102 289-301. 

Supplier selection - specification of desired supplier attributes, and indication of their relative importance, often through a supplier evaluation model (Figure 4.3). 

Supplier Evaluation None Subjective ratings Some metrics Systematic ratings... 

Improving first sample approval percentages while working with buyer Improving supplier evaluation processes... 

Team Learning. We perform supplier evaluations of new potential suppliers and of existing suppliers who ate deemed critical and whose performance requires improvement ... 

Supplier selection and purchasing. This deals with procurement of materials and services that are needed from suppliers to satisfy customer demand. The problem includes such issues as identification of materials and services needed, supplier relationships (i.e., supplier selection, contract negotiation, supplier evaluation) and execution of procurement operations. 

Design and construction adapted to adhesive technology and assembly methods Checking and specifying correct method of substrate preparation in consultation with adhesive and paint suppliers Evaluation of test phase, making any design changes that may be indicated Implementation of quality assurance system... 

Routroy S., 2008, Decision Framework for Supplier Evaluation and Selection in Supply Chain, ICFAI Journal of Supply Chain Management, 5(3), pp. 19-32. 

Many researchers have investigated supplier evaluation criteria and selection methods. Supplier selection is a multiple-attribute decision-making (MADM) problem (Karimi et al. 2014). Among various methods, the widely adopted methods... 

As seen in Fig. 5.6, the results from the supplier evaluation are then incorporated into the framework and classifled according to bad, good or excellent... 

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