You're facing a quality assurance dilemma with external vendors. How do you ensure standards are met?
When your external vendors are falling short on quality, take swift action to safeguard your standards. Here's your game plan:
- **Establish Clear Expectations:** Define and communicate your quality criteria explicitly from the outset.
- **Regular Monitoring:** Implement a system for ongoing assessments of vendor outputs.
- **Foster Strong Relationships:** Work closely with vendors to understand their processes and encourage improvements.
How have you navigated vendor quality issues? Share your strategies.
You're facing a quality assurance dilemma with external vendors. How do you ensure standards are met?
When your external vendors are falling short on quality, take swift action to safeguard your standards. Here's your game plan:
- **Establish Clear Expectations:** Define and communicate your quality criteria explicitly from the outset.
- **Regular Monitoring:** Implement a system for ongoing assessments of vendor outputs.
- **Foster Strong Relationships:** Work closely with vendors to understand their processes and encourage improvements.
How have you navigated vendor quality issues? Share your strategies.
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Based on my experiences, the action plan can be as follows; Stringent Vendor Selection Process. Stringent Vendor Qualification process. Excluding in-house testing based on vendor COA should be through Risk Assessment. Stringent service agreement and QTA. Continuous monitoring and periodical assessment of supplied material quality. Risk ranking based Supplier audits. Market Intelligence about supplier performance.
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Few insights based on my experience: 1) Have regular connect sessions to understand what going well and blockers 2) Have knowledge sharing sessions as required 3) Have clarity on the expected deliverables 4) Email communication looping multiple related project members can help for transparency of work done - Product owners, Team leads, Scrum master, Dev, QA, Project Managers, DevOps etc.
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I worked closely with vendors for more than 15 years and to get quality from them the my golden rules are 1. Treat them as Business Partner not vendors which means building a trust between you and them that empowers them to talk to you openly anytime they have a doubt or make a mistake during manufacturing. 2. Clear and complete transfer of expectations, documents , procedures in the language they understand 3. Right assessment of vendor manufacturing capabilities 4. Let them own the quality of what they are manufacturing. 5. And last adequate delivery time to follow all manufacturing processes properly.
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To establish the key performance indicators (KPIs) to measure quality and adherence to timelines. Conduct regular audits and inspections to verify compliance with standards. Create a system for continuous feedback to improve processes and resolve issues promptly.
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As a consultant to Lifesciences industry, here is my insights. When managing quality assurance with external vendors in the life sciences industry, start with thorough vendor qualification and risk assessment. Ensure strong supplier agreements outlining clear expectations for compliance, testing, and auditing. Conduct regular audits to assess regulatory adherence, and utilize real-time monitoring for transparency. Maintain open communication with vendors to collaboratively address issues and implement CAPAs. Ensure vendors are aligned with regulatory expectations through training, and have escalation and contingency plans ready for non-compliance to protect product quality and patient safety.
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