If you work in a Life Science company, be it medical device, pharmaceutical, biotechnology, nutraceutical, or within other industries, you will understand the importance of maintaining the highest industry standards right through the life cycle of your product – from the ideation stage to the end-user.
A crucial component of this life cycle is the “supplier”.
Not only will you conduct supplier qualification to choose the best supplier to meet your needs, but also, it is a regulatory requirement that the parts, ingredients, services, etc., provided by suppliers or third-party vendors meet your company’s specifications and are compliant with relevant regulations.
Let us say that your medical devices company manufactures, amongst others, positron emission tomography (PET) scanners. PET scanners have four main components – the frame/gantry with the detection apparatus, the patient table, the detector/camera system, and the computer system. Your company has to ensure that all the basic components that are supplied, for manufacturing each of the main components, are up to industry and regulatory standards. This means that your supplier should qualify for your requirements.
In this article, we will take a look at the requirements for supplier qualification, the process, as well as how to automate supplier qualification-related processes.
But first, let’s cover the basics:
- What is Supplier Qualification?
- Why is Supplier Qualification Important?
- What Are the Requirements for Supplier Qualification?
- Supplier Qualification Process
- How to Digitize and Automate Your Supplier Qualification Processes?
What is Supplier Qualification?
Supplier qualification is the process by which your company will choose the correct supplier/third-party vendor for components/raw materials/services based on your requirements and regulatory protocols.
Supplier qualification means that you need to thoroughly evaluate candidate suppliers and third-party vendors as per your requirements, and then choose the best supplier or third-party vendor. These are regulatory requirements.
Let us take the PET scanner example. During the COVID-19 pandemic, your regular supplier of isotopes closed shop, and you were left with a major predicament. In haste, you choose a new supplier for the isotopes. Unfortunately, you do not go through the regular thorough evaluation process for selecting a supplier. This may result in a scenario wherein the isotopes are substandard. Hence, you run a risk of your PET scanners not functioning properly, with resultant misdiagnosis, customer complaints, regulatory agency visits, and a whole lot of other troubles.
To avoid such incidents from happening, you will choose your supplier after the due process.
Why is Supplier Qualification Important?
As a Life Science company that researches, develops, manufactures and sells products that directly affect humans, you will have to maintain the highest industry and regulatory standards at each step of the life cycle of your products. This means that you will, without a doubt, choose the right supplier after a thorough supplier evaluation and qualification process.
Hence, supplier qualification is important to ensure business continuity, reduce risk and consistently ensure that your products are of the highest standard.
According to Good Manufacturing Practice (GMP) regulations, supplier qualification is a crucial part of the validation process before choosing the right supplier for your company. It means that supplier qualification is not a recommended protocol, but also a regulatory requirement.
What Are the Requirements for Supplier Qualification?
Supplier qualification provides assurance that your supplier will consistently furnish the materials/components that your company requires in accordance with international current GMP regulations.
EU – GMP Guideline Chapter 5 states the following:
- 5.27 states that “The selection, qualification, approval, and maintenance of suppliers of starting materials, together with their purchase and acceptance, should be documented as part of the pharmaceutical quality system…”.
- 5.28 states that “The quality requirements established by the manufacturer for the starting materials should be discussed and agreed with the suppliers….”.
- 5.29 states that “Audits should be carried out at the manufacturers and distributors of active substances to confirm that they comply with the relevant good manufacturing practice and good distribution practice requirements…”.
- 5.45 states that “The selection, qualification, approval, and maintenance of suppliers of primary and printed packaging materials shall be accorded attention similar to that given to starting materials”.
Chapter 7 (EU- GMP Guidelines), section 7.9 states the following:
“The Contract Acceptor must be able to carry out satisfactorily the work ordered by the Contract Giver such as having adequate premises, equipment, knowledge, experience, and competent personnel”.
For medical devices organizations selling their products in the EU, sections 7.4.1 (Purchasing process), 7.4.2 (Purchasing information), and 7.4.3 (Verification of purchased product) of ISO 13485:2016 are relevant for supplier qualification:
- 7.4.1 states that “The organization shall document procedures to ensure that purchased product conforms to specified purchasing information”.
- 7.4.2 states that “Purchasing information shall describe or reference the product to be purchased, including as appropriate”.
- 7.4.3 states that “The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchasing requirements”.
In a nutshell, before commencing with the supplier qualification process, your company will identify and spell out all regulatory requirements that concern materials, components, and services that you will require from a supplier or third-party vendor.
Next, your company will plan and execute the necessary audits, wherein you need to demonstrate compliance with the selected supplier in accordance with your requirements.
After signing the contract with a supplier or third-party vendor, your company will need to evaluate the supplier’s compliance as per regulatory requirements.
It should be noted that if the supplier wishes to make any changes that will affect the GMP status or the production and testing parameters of your products, they will notify you before making changes.
Also, the supplier will notify you immediately if they discover any deviation (or non-conformance/complaint) that can affect the services they provide to you. These deviations should be appraised and necessary actions are taken.
Recommended Reading: What are Current Good Manufacturing Practices (cGMP)?
Supplier Qualification Process
While the supplier qualification process is a regulated mandate and your company will need to audit candidate suppliers before finalizing the best supplier based on your requirements, please note that all suppliers need not go through this process.
The supplier qualification process is dependent on the criticality of the supplied item and the effects that these items may have on the quality of your manufactured products.
Many companies continue to manage their systems, including the supplier qualification processes, manually. But, if you implement QMS software you will be able to efficiently streamline the entire supplier management activities of your company.
Supplier Management module by SimplerQMS provides the tools you need to digitize and automate your supplier-related tasks such as supplier selection, evaluation, qualification, and monitoring.
You may continue using a manual approach or you may have incorporated QMS software.
Either way, the same supplier qualification life cycle approach typically applies.
This approach is called the QUEST Approach:
- Question – define requirements and develop questions
- Understand – compile candidates and assess capabilities
- Evaluate – evaluate candidates and identify the best one
- Site audit – perform a comprehensive site audit
- Track – re-qualify suppliers on a routine basis
Let us look at each of these in more detail.
1. Define Requirements and Develop Questions
First of all, you will need to understand your requirements for the products you are planning to manufacture. You will define and document these requirements, and, then develop questions for potential candidates.
You will need to know their:
- Production and technological capabilities
- Delivery and cycle times
- Quality standards and certifications
- Customer service standards
All likely questions must be framed by experts from relevant departments in your company. This task is crucial, and one person or a small team will not suffice.
2. Compile Candidates and Assess Capabilities
Once you have defined and documented your requirements, the next step is to engage with potential suppliers to determine whether they wish to partner with your company.
Interested potential suppliers will need to explain how they can provide your requirements along with relevant documentation to back up their claims. Additionally, you may request these potential suppliers to provide appropriate samples for evaluation.
It is important that your list of shortlisted potential candidates is a reasonable number, say around 5. This will make it easier for you to evaluate each one.
3. Evaluate Candidates and Identify the Best One
In this step, do a thorough evaluation of the top 5 candidates that you had shortlisted in the previous step.
Compare your requirements with the capability of each candidate to meet them. By a process of comparison and elimination, you will identify the top candidate for your needs.
4. Perform a Comprehensive Site Audit
After you have identified the top candidate, plan and execute a complete audit. This can be either on-site or off-site and will depend on what service or product you require from the supplier.
Do ensure to do a meticulous audit of the potential supplier. If it is a non-critical requirement, an off-site audit will suffice. On the other hand, for critical requirements, an on-site audit becomes essential.
After the audit, evaluate the results and then go ahead and accept the supplier (or reject).
5. Re-qualify Suppliers on a Routine Basis
Great! You have now chosen the supplier, and the supplier qualification process is complete.
However, you will need to re-qualify your suppliers periodically. This will tackle both pre-approved audit corroboration steps and any potential lacunae observed in previous audits.
The timing of these audits depends on the criticality of the products or services provided by the supplier, and their credentials on regulatory compliance.
How to Digitize and Automate Your Supplier Qualification Processes?
If you are still maintaining a manual system, you will find it difficult to ensure that your suppliers and third-party vendors are prioritizing product quality and regulatory compliance.
This problem is solved when you have a dedicated Electronic Quality Management System (eQMS) that allows you to maintain all supplier quality data and documentation in one place like SimplerQMS.
SimplerQMS supplier management software module allows you to store your supplier documentation, plan your supplier quality audits, link suppliers, supplier findings, CAPAs and provides a clear overview of all your documentation. Furthermore, the software solution simplifies both supplier corrective action requests and supplier qualification processes, all in one place.
A crucial component for any Life Sciences company is the supplier. You need to choose your suppliers carefully based on your requirements and per regulatory requirements.
The QUEST approach will help you in qualifying a supplier for your company.
With a dedicated electronic system such as the SimplerQMS supplier management software module, you can maintain all supplier documents in one place, plan supplier audits, link suppliers, and much more.
If you are interested in streamlining your supplier-related processes we recommend you book a personalized demo and talk to our specialists.