Company insight ■
Does the supplier have a formal programme to ensure compliance with trade regulations?
Consistent quality
Suppliers with good quality systems and cultures are better prepared to meet customer needs: ■
Does the supplier have a certified quality management system (ISO 13485/ISO 9001)?
■ ■ ■ ■ ■ ■
Does the supplier have quality agreements with their suppliers?
Does the supplier have a formal supplier audit programme?
Does the supplier have a formal complaint management system?
Does the supplier have a formal controlled document management system?
Does the supplier maintain specifications with critical quality attributes?
Does the supplier have subject matter expertise in regulatory matters?
Change management
Suppliers serving regulated industries must have change management procedures as part of their quality system: ■
Does the supplier have a formal change management programme and change control procedures?
■ ■ ■ ■
Does the supplier have a formal change notification process?
Does the supplier have systems in place to identify and segregate pre- change and post-change material?
Does the supplier require change management/change notification for their suppliers?
What is the notification period for a planned change?
Corporate social responsibility Suppliers with formal CSR programmes are better positioned to avoid supply chain risks associated with legal, ethical and human rights issues: ■
Does the supplier have a formal CSR programme?
■ ■ ■
Does the programme address ethics, labour and human rights, sustainable procurement, and compliance with law?
Does the CSR programme comply with any international standards?
Is the CSR programme subject to third party review/certification?
Table 2: Examples of relative importance for purchased goods or services Relative
importance score
0 1 2 3 4 5
Examples for all non-CSR categories
Non-GMP, indirect commodity material GMP material, standard commodity GMP material, second source qualified
GMP material, available from multiple sources GMP material, alternative available, not yet qualified GMP material, sole sourced
Examples for CSR CSR not important at all
Table 1: Risk evaluation score model Criteria
Relative importance score
Industry specialisation Business continuity Consistent quality
Change management Corporate social responsibility
X X X X X
Add column for total score
Relative risk score
= = = = =
Total score
CSR somewhat important CSR is a business imperative Table 3: Examples of relative risk score for each key consideration
Relative risk score
0
1 2 3 4
5 Not focused No plan
Table 1 is a proposed risk evaluation model to assess the relative risk of a supplier according to the responses to the questions shown above. It allows the user to rank the relative importance of the five key considerations as well as the supplier’s performance against those considerations. Table 2 and 3 are examples of scoring for each consideration. Documenting the criteria for each score will drive consistency in risk assessments and allow for the comparison of the relative risk of suppliers.
Medical Device Developments /
www.nsmedicaldevices.com
No QMS, high complaint rate
No change management/ notification policies
No programme
Anyone can reduce the risk in their supply chains by first evaluating their own needs and then the key elements of their suppliers’ assurance of supply strategy. Then, supply chain professionals are able to focus their efforts on the highest risk items and suppliers in the supply chain. By incorporating a risk evaluation during the supplier selection, a more robust supply chain with fewer hidden risks can then be built. ●
www.qosina.com 37
Industry speculation
100% focused
Business continuity
Certified BCMS
Consistent quality
Certified QMS, low
complaint rate Change management
Change control & notification aligned with BPSA/BPOG
Corporate social
responsibility Documented,
third-party audited CSR programme
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