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Case Studies

BACKGROUND

• Supplier, Organisation, Project Assessments
• Range of suppliers, projects and organisations (computerised systems, IT service providers, engineering organisations, R&D and manufacturing, pharma, medical device, biotech, cosmetics, process industries)
• Evaluation of shortfalls and risks, remediation planning
• Review and / or execution of remediation activities

OBJECTIVES

• Plan and execute supplier, organisation, project  assessments
• Train internal personnel in assessment / inspection planning, execution, reporting and risk assessment methods
• Manage assessment programme
• Conduct assessments globally
• Identify critical risks and value added remediation actions

ROLE

• Custom and off-the-shelf assessment training programmes
• Determination of business, patient and regulatory risks impacting client organisation
• Plan assessment schedule and determine appropriate form of assessment (review, on site audit, postal audit, project learning)
• Lead assessments, supporting and / or mentoring client personnel
• Facilitate risk assessments, plan remediation and support review and execution of high risk preventive / corrective actions

OUTCOMES

• Improved quality systems, processes and skills
• Improved customer / supplier relationships
• Greater leveraging of effort from internal and external supply organisations
• Improved external inspection readiness

CHALLENGES

• Understanding of audit value, reduced lifecycle costs
• Establishing consistent risk tolerance across business functions
• Remediation action follow up and closure

BENEFITS

• Utilisation of capable, experienced suppliers
• Reduced project costs, risk reduction, avoid duplication of effort, improved control over lifecycle activities
• Improved customer / supplier relationships
• Client’s self sufficient post ISL support