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Supplier Selection

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Product Range and Production History ... Assess product specifications for ... Product problem reporting system. Product recalls. ORG Procurement vs QA ... – PowerPoint PPT presentation

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Title: Supplier Selection


1
Supplier Selection
  • July 2002
  • Case Study Model for Pre-Qualification

2
Supplier Pre-qualification
  • Selection criteria
  • Judgement of GMP compliance
  • Certificate of Pharmaceutical product, that
    includes a GMP statement
  • Production Licence
  • Product Range and Production History
  • G.M.P. audit by a qualified person (pharmacist)
    at each manufacturing site
  • Suppliers economical and historical background
  • Check references given by supplier

3
Product qualification
  • Assess product specifications for compliance to
    IDA and international standards
  • Assess stability studies
  • Verify quality of sample in IDA laboratory

4
  • Verify the source of approved raw material
  • Document all requirements in an IDA product
    specification
  • IDA label and leaflet design
  • 1. Product specification
  • 2. Product label

5
Characteristics of Product quality
  • Chemical characteristics
  • Physical characteristics
  • Stability
  • Packing
  • Labeling
  • Information (leaflet)
  • Bio-availability

6
Contract specifications
  • The required quality is documented in contract
    specifications by
  • IDA product and packing specification
  • minimum shelf life at delivery
  • certificate of analysis
  • quality of the export cartons
  • these specifications are part of the contract

7
Verifying the Quality of Shipped Drugs
  • Certificate of analysis
  • Sampling and physical inspection of each batch
  • Laboratory testing, 30 of batches are
    re-analysed at the Agency
  • More then 15 of IDAs overhead is spend on QA/QC

8
Maintaining and monitoring Product Quality
  • Appropriate storage condition
  • Appropriate transport conditions
  • Product problem reporting system
  • Product recalls

9
ORG Procurement vs QA
  • The main objectives of IDAs purchasing
    department are to ensure that
  •     The correct products of the quality defined
    by IDAs QA department,
  •     in the correct quantities,
  •     at the lowest possible integral cost price
  • are available to current and future clients.
  • IDA Purchasing
  • department
  • Procurement Process
  •  
  •  
  •  
  • Specifying Supplier Contract
    Ordering Monitoring
    Problem solving/
  • Selection Management
    Contract Control after care
  •  

10
Vendor Rating Systems
  • Are an instrument to measure supplier
    performance.
  • Should be part of an integrated Supplier
    Selection and Evaluation System which should also
    include product, process, (quality) system and
    financial assessment.

11
  • Should be designed to identify problem
  • areas and measure the impact of
  • corrective actions
  • Are in principle most effective when
  • used/designed to improve supplier
  • performance over a long(er) period of
  • time and/or as a tool in pre-selection
    processes.

12
  • Should only include objective and measurable
    criteria and/or include measures to eliminate or
    minimize subjective influences. Suitable criteria
    are price, product quality and delivery
    performance.

13
  • Can, especially if not computerised, be very time
    consuming. When designing/
  • introducing a Vendor Rating System you
  • should be aware of the Complexity
  • Monster. Complex systems are difficult if
  • not impossible to maintain.
  • KEEP IT SIMPLE!

14
Example Vendor Rating System
  • The following performance indicators/weight
    ratios are used in measuring supplier
    performance.
  • Indicator Criteria
    Weight Max.
    value Max. score
  • Timely delivery Ordered vs. actual
    40 100
    40
  • Competitiveness Pricing and/or availability
    40 100 40
  • Quality of delivery Export cartons,
    documentation,
  • C/A shipping documents,
  • invoice etc.
    10 100 10
  • Quality of Average response
    time,
  • Communication quality of submitted offers
    etc. 10 100 10
  • 100 100

Should a problem with product quality occur this
will obviously supersede all above mentioned
indicators.
15
  • Score Conclusions
  •  
  • 80 to 100 Excellent performance. Actions may
    be defined on non-critical indicator(s) only.
  • 70 to 80 Above average performance.
    Actions may be defined based on critical
  • indicator(s).
  •  
  • 60 to 70 Average performance. Improvements
    required on critical indicator(s).
  • 40 to 60 Below average performance. Firm
    commitments towards improving indicated
    shortcomings required. Performance closely
    monitored. Repetitive under performance
    necessitates use of alternative supplier(s).
  •  
  • 0 to 40 Unacceptable. No orders granted
    until sufficient measures are taken to
    guarantee improvements.

In case a zero score is reached on one of the
indicators, this will lead to a (temporarily)
disqualification
16
Delivery Performance Report
17
Example of Final Scores
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