What are some best practices for standardizing a process to ensure that multiple 3rd party vendors consistently deliver a quality product, i.e., clinical reports, to an organization running clinical trials? Saving Changes...
Peter RapinSubject Matter Expect; Project Delivery| Independent ConsultantOntario, Canada
Jan 10, 2023 8:32 PM
Replying to Stéphane Parent
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Your suppliers should work within your framework. If you have quality standards, they should be part of the contract at the same level to which you are beholden.
You hold suppliers to your standards in your contracts, communications and payments.
However, your standards may not apply to your suppliers. If you're in the business of manufacturing widgets and you retain a Design-Build contractor to provide infrastructure to increase your capacity, your widget quality management will have no impact on design and build of the expansion.
Your contract should specify quality standards equal to or better than industry standard for such services and compliant with your service provider's internal and claimed quality requirements.
The request for proposals should include not only costs and delivery but also a commitment to quality management and discussion as to how this will be achieved. Saving Changes...
Vijay SuryavanshiProject Manager - Engineering| RECARO Aircraft SeatingPlantation, Fl, United States
The clinical trials must adhere to FDA regulations 21CFR part 50 and 56. Your company can tighten the regulations that the FDA has to maintain good quality standards by developing your own specification.
In the aviation industry, we use the FAA regulations and most companies have their own internal specification as well. Also, aviation uses AS9100 as a Quality standard (bench mark).
The regulatory authorities (FDA in your case) expect the industry to focus on developing quality systems during the planning and conducting of clinical trials. Such systems depend on the development and implementation of standards for each clinical trial process. The quality system requirements include:
Personnel roles and responsibilities Training Policies and procedures Quality assurance and auditing Document management, record retention, and reporting Corrective and preventive action (CAPA) There are four types of errors likely to occur in clinical trials: Design, procedural, recording (both random and fraudulent), and analytical. The quality system should deal with each of these.
The sponsors are also advised to apply risk management principles to effectively target resources to activities that present a greater risk to data integrity and human subjects’ protection.[6] There is also a need to define controls to prevent errors, identify potential problems, and intervene before the problems become serious.
The improvement in the quality of clinical trials requires the use of the systems approach, tools, and models.
The FDA recommended a four-step systems approach, as follows:
Say what you do Do what you say Prove it Improve it.
PS : Please read this research paper where Quality of clinical trials is considered a moving target whose link is below for more details.
During the bidding, you may request from each supplier to arrange a physical sample to make a preliminary assumption about what the quality will look like during delivery. Requesting sample will have 3-in-1 advantages: 1- will check the speed of delivery 2- will check how the sample is being packed (this will reflect on the supplier culture, mentality, QA/QC procedure, etc.) and 3- to check the final quality of the product.
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1 reply by Peter Rapin
Feb 20, 2023 2:36 PM
Peter Rapin
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Keeping in mind that 1) speed of delivery, 2) packaging, and 3) quality of the sample may not reflect the the final product as sample may (and usually are) special production runs to impress the potential customer.
Furthermore, it may not be feasible to ask for a sample - a 10,000 m2 warehousing facility, a 5000 watt generator, a service contract, a computer program, etc.
Saving Changes...
Peter RapinSubject Matter Expect; Project Delivery| Independent ConsultantOntario, Canada
Feb 20, 2023 1:40 PM
Replying to Omar Haddad
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During the bidding, you may request from each supplier to arrange a physical sample to make a preliminary assumption about what the quality will look like during delivery. Requesting sample will have 3-in-1 advantages: 1- will check the speed of delivery 2- will check how the sample is being packed (this will reflect on the supplier culture, mentality, QA/QC procedure, etc.) and 3- to check the final quality of the product.
Keeping in mind that 1) speed of delivery, 2) packaging, and 3) quality of the sample may not reflect the the final product as sample may (and usually are) special production runs to impress the potential customer.
Furthermore, it may not be feasible to ask for a sample - a 10,000 m2 warehousing facility, a 5000 watt generator, a service contract, a computer program, etc. Saving Changes...
Vijay SuryavanshiProject Manager - Engineering| RECARO Aircraft SeatingPlantation, Fl, United States
This is where the concept of risk transfer to vendors becomes important. Terms and conditions must be embedded in the P.O placed to the vendor for these risk coverages.
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1 reply by Peter Rapin
Feb 20, 2023 3:20 PM
Peter Rapin
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Completely agree that the procurement process includes risk transfer. However the pricing reflects this risk transfer and when you get something 'cheap' it usually means that the supplier is short changing quality and will ultimately deflect the risk back to the buyer by not accepting any rejections of product supplied. "You got it at discount, what did you expect?"
Saving Changes...
Peter RapinSubject Matter Expect; Project Delivery| Independent ConsultantOntario, Canada
Feb 20, 2023 3:00 PM
Replying to Vijay Suryavanshi
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This is where the concept of risk transfer to vendors becomes important. Terms and conditions must be embedded in the P.O placed to the vendor for these risk coverages.
Completely agree that the procurement process includes risk transfer. However the pricing reflects this risk transfer and when you get something 'cheap' it usually means that the supplier is short changing quality and will ultimately deflect the risk back to the buyer by not accepting any rejections of product supplied. "You got it at discount, what did you expect?" Saving Changes...
