Suppliers selection

Another useful strategy is to study suppliers performance metrics based on data on delivery, quality, and agility. With this data it would be easy to create monthly supplier scorecards to assess supplier s future delivery and quality trends. 

In choosing suppliers to be included in the supply base, the buyer needs to be concerned about not only the transaction costs but also the long term strategic fit. Typically the buyer identifies, evaluates, and contracts with suppliers. Unreliable suppliers, in terms of quality and fulfillment, increase the buyers cost. In many cases, because of the suppliers capacity constraints, the buyer may need to allocate its purchase order to more than one supplier. 

In consumer products, many product safety issues have been traced back to suppliers failing to meet the buyer s requirements, resulting in dangerous lead paint in toys, unsafe car tires, and pet food containing poisonous chemicals (Spencer and Casey 2007). Production delays due to parts shortages and recalls of faulty products produced by deficient suppliers cost milhons of dollars to buyers through recalls, warranty cost, cost of inventory adjustments, and damage to reputation. 

The evaluation factors used most frequently are price, quality, and delivery. Other possible factors would be production capacity and flexibility, technical capabilities and support, information and communication systems, financial status, innovation and R D, corporate social responsibility (CSR), safety awareness, political stability, cultural congruence with the buyer, and terrorism risk. Other frequently used factors include organization structure, training and development policies, performance history, reputation, amount of past business, warranties and claim policies, procedural comphance, and return policies. 

The buyer must combine the relevant factors in a meaningful way to come up with a rank-ordering of the suppliers. Very often a linear rank ordering may not be 

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VDA 2 Quality assurance of supplies - supplier selection/sampling/quality per-... 

Supplier selection criteria and audit should cover working methods, system functionality, and GMP knowledge... 

An audit report will serve as the formal record of the audit and its findings, and is a major input into selecting the supplier and determining any necessary corrective action. To complete the quotation review exercise the pharmaceutical manufacturer (or its main contractor) should produce a formal report that summarizes the quotation compliance, the key points of the audit report, and the main benefits of each system. The chosen suppher and reasons for the supplier selection should be clearly stated. 

The major product flow variables and cost parameters associated with the material flows throughout the production network are also shown in Figure 20. Based on the assumption that a supplier with lowest landed costs is selected outside the model per raw material and site, raw material flows are not modeled explicitly. Supplier selection could however also be included in the model analogous to the extension to include make-or-buy decisions for intermediate products (cf. Chap. 3.4.3). 

It is sensible to take the attitude that it must be possible to simplify or substitute inputs. The purchasing function as a whole just has to be determined enough in benchmarking across business units and suppliers. Selecting a few products and comparing them across business units typically uncovers substantial value. 

Supplier Audits are more beneficial if they are conducted as part of the supplier selection and procurement process so that any actions arising can be progressed within a project s implementation. More than one Supplier Audit may be appropriate or necessary for a system where multiple subsystem suppliers or subcontractors are used. The Validation Plan will document which suppliers require and do not require auditing and when these audits should take place. Table 5.2 indicates when Supplier Audits are required. 

The second life-cycle phase addresses the capture of requirements and the selection of suppliers. It entails the following main activities, usually conducted sequentially User Requirements Specification (URS), GxP Assessment, Supplier Selection, and Supplier Audits. Getting this phase right is crucial to ultimate success. The issues that have to be managed can be summarized as follows ... 

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. ... 

A purchasing process that addresses compliance issues is presented in Figure 7.5. This covers supplier selection, award of contract, delivery, and validation. The process is initiated with a determination as to whether or not an audit is required. Once the need for an audit has been established, the supplier concerned should be contacted and an audit request made, explaining the context of the audit. 

Postal Audits are usually used as part of the supplier selection shortlisting process. They may recommend an audit on a supplier s premises where extra detail is required, but typically such Supplier Audits are reserved for the preferred supplier in order to confirm their acceptability from a compliance perspective. 

Definition and documentation of the business requirements for LIMS is the first step in the implementation process. These requirements are not system specific and define, at a high level, what LIMS will be expected to do for the business. The business requirements are used in defining the system requirements in the supplier selection process and in the financial justification for the system. The business case will normally be based on the ability of the LIMS to ... 

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. 

Background to the PLC installation Organization and responsibilities Validation approach and the procedures to be used Results of any supplier selection process Ongoing operational requirements for GMP Ongoing operational requirements for lEC 61508 A milestone plan... 

The URS is a very important first step as it forms the basis for the dehnition of the system, supplier selection, and the approach to validation. It should be the mechanism by which the users have the opportunity to express their needs. Dividing the needs into musts and wants provides the project team with an indication of how to weight the requirements during supplier selection. 

Where a new supplier is being selected a number of factors need to be considered and a detailed supplier selection process may be undertaken. Evaluation may consist of gathering information from various sources such as the suppliers themselves, companies who already have a system installed, and trial demonstrations. Where possible a fixed-duration trial (pilot) should be set up on site for the project team and user representatives to run through some scenarios of how the system may be used. 

The supplier selection process may result in the selection of a system that requires a lot of customization in order for it to meet stated requirements and GxP. If this is the case then a systems integration partner may be required for the implementation. The QMS of the systems integrator should also be audited to ensure that their methodology will result in a validated system. 

Contracts placed with the supplier should include provision for ensuring regulatory compliance. This is no different from the expectations for snppliers satisfying other types of snpply criteria within the pharmaceutical and healthcare snpply chain,3° 2 d regulatory authorities may request documented evidence to support the supplier selection process. 

Typically, supplier selection processes shall take account of ... 

Again the right quality is significant to the pharmaceutical industry. The supplier must understand good manufacturing practice (GMP). Supplier selection is critical. Supplier... 

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