Now that we have an understanding of what your company needs in order to have a successful custom medical cart project, we can delve into how your suppler quality management contributes to this process.
As with most major projects, every company will have its own methods and processes for evaluating effective supplier quality. The first step for any company is the pre-auditing process.
Initiating Supplier Quality with Your Custom Medical Cart Manufacturer
Ideally, a designated quality person will help qualify a medical manufacturer and should have some background knowledge on this company. When the project gets to the concept stage (or sooner), you can do one of two things:
1) Send an agenda of what you'd like to audit for the future onsite audit.
2) Send a survey to your medical cart manufacturer and set a deadline so you have time to review it.
When you receive the completed survey from your custom medical cart manufacturer, look for gaps and compare the results with a company you are familiar with (this could mean comparing their answers with your company's). Given the amount of information involved with this process, we strongly advise sending a survey to your manufacturer first.
What to Expect for an Onsite Tour
The onsite audit should take place when your custom medical cart project gets to the engineering or prototyping stage. Check out our Road Map infographic to see how this aligns in the custom medical cart process.
Those who opt to send an agenda will have to gather information and process documentation, participate in the walk-through, check necessary machine preventive maintenance, PPMs, employee competency and certification history, and try to fill in any missing gaps. Tours such as this generally take longer, and in some cases may last up to a couple days, requiring additional travel expenses.
Companies who send a survey beforehand will also have time to review any and all process documentation needed to further qualify their custom medical cart manufacturer. This leaves time on the tour to fill in gaps of information, distinguish any red flags and ask additional questions. The onsite tour should take you through the step-by-step process your manufacturer follows from order to shipment.
Onsite Audit Checklist
|
Section Name |
What to check |
ISO |
ISO 13845:2016 |
|
Human Resources |
Pick an employee and check to see if they have training records saved and that they have a recertification program |
7.2 & 7.3 |
6.2 |
|
Internal Audit |
Make sure the company has an internal auditing program. Check the schedule and check that the audit results are recorded |
9.2 |
8.2.4 |
|
Infrastructure |
Preventative maintenance on machines: review plan and records. |
7.1.3 |
6.3 |
|
Control of monitoring and measuring equipment |
Control of monitoring and measuring equipment: calibration schedule, records and view equipment to check dates on equipment |
7.1.5 |
7.6 |
|
Planning of product realization |
Make sure the company has a documented plan on how to produce the part, verification activities, and records of these activities and employees know how to access this information. |
8.1 |
7.1 |
|
Purchasing |
Check the companies purchasing process, verification of purchase orders sent, materials received etc. Verify that the company has an approved vendor list and that they are only ordering from approved vendors. |
8.4 |
7.4 |
|
Control of design and development changes |
Make sure the company has a documented process for design/engineering change approval and records. |
8.3.6 & 8.5.6 |
7.3.9 |
|
Order entry to shipment |
It’s always good when performing the onsite audit to learn the company’s order entry to shipment process. Makes sure during the Order Entry to shipment process the company can easily see where the product is in the process. |
Multiple |
Multiple |
***The information in this checklist details where you can find these clauses in the International Standard ISO 13845:2016 and ASQ/ANSI/ISO 9001:2015, respectively.
At HUI, we thoroughly understand not only the custom medical cart process from concept through shipping, and we have an intimate knowledge of how to maintain effective supplier quality and related audits. So, if you have a design in mind, contact us today, and we’ll have your project underway.
