Notification of Supplier Change: Records to Keep After Receiving the Email

Receiving Change Notice vs. Making a Decision

We received an email from the supplier stating, "The manufacturing location will change.
There will be no changes to the drawings and delivery specifications."
The purchasing manager relayed this information, and parts made at the new location are expected to arrive next month.

At this time, what actions need to follow within the company?

The mere fact of receiving the email does not mean that a change has been reviewed.
It is essential to establish whether a review manager has been assigned, what products the parts are used for, whether the premises of existing evaluations are maintained, and when the changed products will start arriving.
Only then does it become a usable record in actual operations.

This document presents MedQraft's practical recommendations for handling supplier change notifications.

This does not mean that the same testing, auditing, or approval procedures should apply to all changes.
The specific level of control should be determined according to the product's risk, nature of the change, contract, and company procedures.

Distinguishing the Scope of Reference Guidance

Section §3.4 of the GHTF/SG3/N17:2008 Supplier Management Guidance outlines the perspectives for agreeing on the responsibilities and management of manufacturers and suppliers.
Change management is also an area to consider during agreement and addresses the procedures for assessing changes in validated processes and determining the need for revalidation.

This document serves as non-binding guidance, and the text cites regulatory standards and specifications at the time of publication without directly transposing them to the current legal obligations or the latest regulatory provisions.

The table below and the examples provided are not translations of the original forms but are created to explain the practical flow.
Additionally, IMDRF has published a Consultation on Revision of Supplier Management Guidance.
The distinction between the announcement of public consultations and the issuance of final documents must be made, and this document does not present the contents of the revision as definitive requirements.
The date of material verification is September 19, 2026.

Finding the Boundaries of Changes at the Acceptance Stage

In the first review, it is advisable to confirm “why it changes” and “exactly what changes.”
Depending on whether the supplier’s assertion of the same specifications refers only to the dimensions in the drawings or also includes materials or process conditions, the subsequent questions will differ.

Below is a self-created example for organizing acceptance records.
You can simply supplement the necessary items in your company's existing change management form.

Confirmation Area	Question	Examples of Related Documents
Change Details	Is the difference between before and after specified specifically?	Comparison table, revision history of drawings, process description
Target Identification	Is our part number linked to the supplier’s number?	Purchase specifications, part lists, supplier part number comparisons
Scope of Application	What products, inventory, and orders are affected?	List of products used, inventory and order status
Timing of Application	Can the first changed lot and shipment schedule be identified?	Supplier lot information, transition schedule
Review Basis	Is there any supporting documentation for sameness or suitability?	Evaluation reports, comparison results, inspection records

Instead of leaving undisclosed information as blank, consider indicating the status as "Pending Supplier Confirmation".
If the request date and responsible person are included, it will clarify who is responsible for the next actions.

It is important not to arbitrarily input completion dates or record expected information as confirmed facts.

Fictitious Case: Same Drawings, Just a Change of Processing Location

The following is a hypothetical situation for illustration only, not a case of an actual client.
The supplier of processed parts used in medical devices has notified us that they are moving the production location from A to B.
They assert that the part number and dimensional tolerances will remain unchanged.

The development manager can review what characteristics and conditions were covered in the existing evaluation.
The quality manager may inquire about differences in processing and inspection methods at the new location compared to existing management details.
The purchasing manager can check the delivery schedule for the changed parts and the plan for depleting existing inventory.

In a small organization, it’s better to keep different review perspectives separate, even if one person takes on multiple roles.
For instance, if the supplier’s documentation only includes the dimensions of the drawings, it is necessary first to assess whether this encompasses the whole set of items our team needs to verify.

If additional confirmation is necessary, organize and request clarification on which items and why they are needed.
Conversely, if existing evidence sufficiently covers conditions following the change, they can explain its applicability and review the possibility of avoiding unnecessary retesting.

It is crucial not to jump to conclusions like “since the location has changed, all items must be retested” or “since the drawings are the same, there is no impact.”
The core of the record should be what differences were discovered and what evidence led to the conclusion.

Documenting Review Results Along with Application Conditions

When the review concludes, it is important to have a detail that someone else can execute, rather than just a simple checkmark.
Distinguish whether the materials are insufficient, if additional confirmation is needed for potential application, or if it has been determined that it can be applied within the review scope.

Record Elements	Self-generated Example
Review Subject	Supplier notification number, affected parts, conditions before and after change
Support Used	Report number and revision, verified items, review scope
Remaining Items	Requested materials, purpose of additional confirmation and responsible person
Decisions and Conditions	Applicability status, conditions to be completed before application, decision-maker
Confirmation of Application	First changed lot, identification method for incoming goods, results of confirmation and record locations

Be sure not to confuse the review status with the allowable status.
If there is only an indication of “under material review” and it is unclear how to handle the incoming changed products, then purchasing schedules and quality judgments may move differently.

In cases where hold or conditional processing is needed, the management method should be determined according to the company's authorization rights and material handling procedures.

The necessity of reporting or obtaining approval for regulatory changes is a separate issue from the completion of the supplier review.
Verify the current requirements for the product and market, and connect that judgment with the responsible review if necessary.

Linking First Lot and Documents After Implementation

After the review, verify whether the conditions written in the review records were actually applied at the site.
The supplier indicated that they would convert starting next month; however, existing production may arrive later, or the changed products may arrive sooner than expected.

This is why it is essential to match actual lot or product identification information rather than simply distinguishing based on calendar dates.
If there is a need to differentiate inventory before and after the change, warehouse and production sites must be able to utilize that distinction.

If purchase specifications or inspection guidelines have been amended based on the review results, be sure to check that they are reflected in the documents that the responsible person actually uses.
Determine whether the initial incoming confirmation is sufficient or if observation for a certain period is necessary based on the nature of the change and review results.

For related information, refer to the document revision linked to the point of use.
This will help in preventing the issue of leaving documentation conclusions trapped within the document repository.

Exposing Unverified Areas When Data is Insufficient

There may be situations where the supplier cannot immediately provide all documentation.
In such cases, rather than concluding with a brief reply of “no issues,” it is better to outline what has not been verified and why that information is necessary for judgment.

Consider potential options such as additional explanations, limited access to documents, and alternative justifications, but do not assume that documentation not provided exists.
Even under tight schedules, it should be clear within the company's procedures who can make decisions regarding applicability and what conditions must be met.

The goal is not to increase the number of record forms.
Examine whether there are any discontinuities between the acceptor, reviewer, decision-maker, and confirmation of applications for the specific notification received.

Even if one person is responsible, if the stages and bases are segregated, it will be easier to explain decisions later.

Questions to Check Within Our Company

• What changes is the supplier supposed to notify, when, and to whom?
• Is the notification received by the purchasing manager appropriately communicated to the designated reviewer?
• Are the supplier's claims and the evidence verified by our team distinguished?
• Is the status of additional materials visible to the responsible person?
• Does the decision to apply lead to the first changed lot, purchase information, and usage documents?

If there are any challenging answers among these five questions, it can be a good starting point to follow the flow regarding a recent change.

MedQraft’s QMS consulting collaborates with organizations to review the necessary scope based on the procedures and records they use.

You can check the support scope in the QMS consulting information.

The reference materials include the aforementioned GHTF final document and IMDRF consultation notice regarding the revised guidance.
The tables, fictitious cases, and questions in the text are authored by MedQraft and do not replace the suitability judgments of specific products or the licensing conclusions of individual markets.