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Quality and Supply Chain Consultation

Our consulting services include qualification of supply chains (including audits), country transfers, remediation activities including regulatory recalls, monitoring supplier quality and part qualification activities. We use ISO and regulatory standards to ensure compliance.


Custom consulting services

•CAPA closure
•Complaint resolutions
•Recall and advisory notifications
•QMS creation/updates for ISO
•Process Validation review (IQ, OQ, PQ)
•Sterilization process review
•Manufacturing supply chain setup

Our Supplier Quality Program



Procedures


We create and update procedures to align with your supply chain and company strategy that is compliant to standards.

Monitoring


We monitor the supply base via statistical monitoring, risk based surveillance of small to large suppliers, providing ongoing reporting.

Remediation


We help systematically resolve findings via a structured approach to identify, correct and prevent root cause via various Methodologies such as 8D, A4, 5 Ys etc.

Assessments


We conduct supplier oversight via onsite or remote review of ongoing operations to established standards by certified auditors

Part qualification


We qualifying manufacturing processes across various types of part production using a systematic process of design transfer, validations and control plans.

Latest projects

Manufacturing supply chain – Case Study

Evaluate, enhance, standardize supplier spend for Industrial equipment
commodity across NA plants. Conduct “cost” analysis of products and
RFQ process.
• Standardization of RFQ
• Data analysis for contract negotiation

• Supplier consolidation.

Supplier Audit Program– Case Study

Supplier audit program finding from registrar, internal audits, 18 months
behind schedule. No inhouse trained resources, attrition. Increasing
incoming defect rate. Audit TNL budget spent on firefighting activities
• Scope and prioritize supplier risk per ISO 13485.
• Notify, schedule, execute supplier audits per client protocol.
• Enhance client audit program with updated checklists, audit reports.
• Optimize TNL cost by trip consolidation, resource localization

• Consistency of audit report and outputs across multiple auditors.

Distributor Assessment – Case Study

New Director of distribution hired to improve distribution of company
product. High reportable events, not being documented from distribution
network, inconsistent reporting, QMS/CAPA management. Implementing
a program to manage, assess and improve distributor compliance to
company requirements.
• Multiple local distributors over 9+ countries, 7+ languages.
• Average travel time from company HQ to distributor – 22hrs

• Standardized expectations and evaluation of distributors.

Quality Oversight
On Site

Process Validation
Design Transfer

Part Qualification
Manufacturing

Supplier Audits
Assessments

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