When Manufacturing and Supplier Quality Process Improvement is performed – it’s critically important to get it right…the first time.
I think you’ll agree with us when we say: it’s REALLY hard to search for Quality problems across the entire organization, then implement corrective actions – while also managing your daily responsibilities.
“We wanted to update and improve our Intended Use Validations at Hawkins for both COTS and Custom developed applications. Included in this effort was the Electronic Signature (21CFR Part 11) validation of our internally developed system supporting our QMS.’
‘We brought Advantu’s Process Experts on board. They quickly conducted assessments of several Hawkins’ systems and efficiently identified Intended Use Validation (IUV) gaps that needed to be resolved in support of our validation efforts. Additionally, we were provided a plan of action to close the identified gaps.’
‘Advantu’s team was extremely professional, knowledgeable and enjoyable to work with. Their deliverables were completed professionally and provided the foundation for the next steps in our IUV process. We look forward to our continued relationship with Advantu’s experts.’”
Nancy Hegdahl
Quality Manager
Hawkins, Inc.
RA/QA Expertise to help you implement and advance your quality culture.
We provide the third party objective analysis and corrective support you need – while you stay focused on getting products built and shipped on time.
No more surprises! Whether BioPharma or Medical Devices – keep the quality of your products consistent while delivering them on an extremely reliable schedule.
Manufacturing and supplier quality process improvement is the solution to your customer satisfaction challenges.
For example:
One of our biotech clients wanted to add an Instrument to their GMP workflow for large scale manufacturing, but they didn’t have the knowledge or resources necessary to accomplish the task.
Gap Analysis
Our process quality expert recommended a gap analysis, which enabled us to review all their QMS (R&D/Manufacturing) procedures, documentation and processes. Afterwards, he worked with the client to produce a thorough risk-based implementation plan, with items listed by order of priority.
Corrective Actions
Our team went to work, implementing all the corrective actions, and the client was able to successfully add the instrument to their GMP workflow; additionally, all of their processes & procedures were updated for compliance with FDA and International Standards. This included ensuring the proper Verification of Effectiveness (VOE) step is part of the CAPA process.
Success
Now they have everything in place so, if an FDA audit should occur they’ll be able to sail through with flying colors. Additionally, they have high confidence their product will exhibit world class quality because of their newly updated ‘best practices’ processes.
Value Added Benefits to you!
Click: Manufacturing- Complete Harmonization with R&D
- CMO Vendor Agreements which Protect your company
- Fully understand your Vendor’s financial analysis
- Awareness of your Vendor’s Cybersecurity
- Improve communications by closing Gaps associated with silo’d organizations
- Increase market share with higher quality products shipped on time
- Dramatically improved (consistent) parts quality
- Reliable ‘on time’ parts & materials delivery
- Avoid downtime with enhanced reviews and inspections – mapped to expectations
- No Surprise Policy – mutually predetermined responses to common challenges
In the age of outsourcing, drug and device manufacturers depend on their suppliers for critical activities, making them vulnerable to potentially devastating quality issues.
Additionally, many manufacturers continue to operate under the false assumption that by handing over duties to suppliers, so too go the responsibilities for maintaining regulatory compliance. This is wrong.
Although it’s in a suppliers’ best interests to keep themselves to a high standard of quality to attract clients, the regulatory burden rests on the company receiving their products or service.
Manufacturing quality is equivalent to supplier quality, in that, it’s ultimately the responsibility of the originating drug and device manufacturer to meet FDA quality standards for their products. If you are working with a contract manufacturing organization (CMO) then you know there are unexpected negative impacts to customer satisfaction, your company’s reputation and ultimately your market share – when things go wrong.
Monitoring and managing quality is extremely important when outsourcing anything that could potentially impact your product.
Highly Effective Gap Analysis
Wanna’ know quickly if your Manufacturing and/or Supplier Quality Processes are 100% effective and fully compliant? Here’s the deal:
Have Advantu conduct a Gap Analysis.We can reveal the blind spots and help you avoid a devastating problem tomorrow – by mitigating the hidden risks today.
We want to help bring your processes to best practice status – so you can enjoy increased confidence with your delivered products.
Click on your area of responsibility:
Manufacturing
Because more and more companies are outsourcing their manufacturing operations, it’s becoming increasingly important for leaders to establish (and constantly improve) their quality management systems, in order to ensure harmonization across research and development and manufacturing so no quality gaps occur.
Let Advantu’s experts improve the quality, clarity and completeness of your GMP workflow by implementing/updating the following:
Medical Device
- Good Manufacturing Practices (GMP)
- Contract Manufacturing Organization (CMO/CDMO)
- Vendor Selection & Management
- Do their capabilities meet all your needs
- Vendor Agreements
- QA Functions clearly defined before project starts
- Develop a technology transfer package
- Vendor Communications
- Total transparency & clarity is essential
- Vendor cGMP Manufacturing Capabilities
- Intellectual Property Protection
- Planning for Surprises (create predefined actions to most common hurdles)
- Mutually agreed upon contingency plan
- Communications with FDA (clearly defined responses from client, vendor)
- Vendor Selection & Management
- Contract Manufacturing Organization (CMO/CDMO)
- US and International Harmonization
- Optimizing Processes through Continuous Improvement with a Process-Risk based Training Plan
Pharmaceutical
- Good Manufacturing Practices (GMP)
- Contract Manufacturing Organization (CMO/CDMO)
- Vendor Selection & Management
- Do their capabilities meet all your needs
- Vendor Agreements
- QA Functions clearly defined before project starts
- Develop a technology transfer package
- Vendor Communications
- Total transparency & clarity is essential
- Vendor cGMP Manufacturing Capabilities
- Intellectual Property Protection
- Planning for Surprises (create predefined actions to most common hurdles)
- Mutually agreed upon contingency plan
- Communications with FDA (clearly defined responses from client, vendor)
- Vendor Selection & Management
- Contract Manufacturing Organization (CMO/CDMO)
- US and International Harmonization
- Optimizing Processes through Continuous Improvement
Supplier Quality
Because cost control is critical to corporate profitability, the FDA is placing an even greater emphasis on manufacturers to control activities and materials provided by their suppliers. Each organization is responsible to ensure their suppliers provide materials and services that are fit for purpose throughout the product lifecycle, from product development through commercial distribution. In fact, regulatory agencies are focusing on supplier management through risk-based quality controls and open communication between the procuring organization and supplier.
Why does this matter?
The FDA (and other international regulatory agencies) specify that the contracting organization is ultimately responsible for the quality of purchased material and that the contract facilities are considered an extension of the manufacturer’s own facility.
In order to ensure the highest product quality, Advantu promotes a risk-based approach to qualifying, managing and auditing third party providers.
Are you curious about the Secret to long-term process improvement? Training! Training! Training!
It’s the best way to keep everyone informed and up to date on the latest regulations. Not only how things should be done, but why.
Want to know if your Supplier Quality Process is up to speed? Have Advantu perform an Audit!
Medical Devices (21 CFR Part 820)
Per the FDA, all medical device companies marketing products in the United States must have a Quality Management System that satisfies the requirements of Part 820. Specific to suppliers, this regulation establishes Purchasing Controls (Section 820.50), which require manufacturers to develop and maintain procedures that ensure all purchased or otherwise received products and services adhere to a specific set of requirements.
According to the FDA in 21 CFR Part 820.0, “establishing” means to define, document, and implement. Regarding Purchasing Controls, thorough documentation (written or electronic) is absolutely essential.
Why is This Important?
Supplier Evaluation and Monitoring. Review existing vendors and evaluate their capabilities to scale-up without compromising Quality.
Why?
Here’s a case in point.
A recent client experience with Supplier Quality exposed a subtle gap that is not specifically called in the regulation. In this case the client had a supplier that was perfectly qualified to build their small volume prototypes and had an acceptable Quality System. But after production started they learned (through their defect monitoring) that the supplier was not cut-out for full scale production in larger volumes, so they were forced to change suppliers late in the game which cost them time and reduced quality.
Our Focus:
- Supplier Quality / Supplier Management Systems
- Purchasing & Supplier Quality Agreements
- Supplier Evaluation
- Supplier Monitoring (auditing)
- Supplier Documentation
- Supplier Communications
- Supplier Quality Agreements
- Supplier Quality Certification
- Purchasing & Supplier Quality Agreements
BioPharma (Q10 Pharmaceutical Quality System Guidance)
Per the FDA, this guidance extends quality systems responsibilities for drug makers to the activities they outsource. One particularly important clause states that contract givers “should be responsible for assessing the suitability and competence of the contract acceptor to carry out the work required.”
It also states that all responsibilities for quality-related activities between the two parties “should be specific in a written agreement.”
Beyond this, all drug manufacturers must ensure that any product they deliver to the market is neither adulterated nor misbranded due to the actions of a contracted facility, but rather due to the labeled drug manufacturer, because all companies (virtual or otherwise) are ultimately responsible for the products they deliver to the market.
Following a risk-based approach for supplier quality management is the formula for success – here are the key actions included:
- Conduct a comprehensive risk assessment
- Perform a supplier audit
- Monitor, document, and review supplier performance
- Establish appropriate written quality agreements
The Goal is to establish a complete and thorough, documented process.
- Supplier Quality / Supplier Management Systems
- Purchasing & Supplier Quality Agreements
- Supplier Evaluation
- Supplier Monitoring (auditing)
- Supplier Documentation
- Supplier Communications
- Supplier Quality Agreements
- Supplier Quality Certification
- Purchasing & Supplier Quality Agreements
Advantu’s FDA Process Experts are experienced performing Manufacturing and Supplier Quality Process Improvement
- Our Process
- GAP Analysis
- Improvement Path Report
- Implementation of Corrective Actions
- Confirmation of Desired Goals Successfully Achieved
Our team can perform a Gap Analysis to identify and recommend QMS Process improvement areas, prioritize the improvement areas and develop short term, intermediate term and long term plan to ensure your QMS processes are clear, easy to understand and address “Common Sense Compliance”.
Challenges teams face:
- Lack of process knowledge
- Inconsistency with documentation
- Gaps in their QMS due to Silos within their Organization
- Need to demonstrate equivalence with predicates
- Not providing all of the expected testing
- Lack of knowledge regarding differences between verification and validation
- Underestimating risk management requirements
- Incorrect formatting of required documentation
- Incomplete or not-easy-to-understand QMS processes
- Major disconnects between R&D and Contract Manufacturing
- Lack of thorough vendor/sub vendor agreements with Suppliers
- Missing or incomplete Training Plan across the organization
WHY WAIT
If you’re experiencing these quality challenges – we know you’re under a lot of stress.
Here’s the good news – our experts have been helping teams address and systematically resolve these issues for decades – we can help you overcome your challenges and transition into a highly productive organization, capable of delivering quality products (on time) on a consistent basis.
It’s a straight forward process, and we think you’ll agree – the earlier you start, the earlier you’re on the path to a highly improved process with a newly energized team – armed for success!
Contact Us Today!
