3 Vital Questions To Ask Your Medical Machining Suppliers15th Mar 2021
Procuring subcontract precision engineering for medical device components can be a minefield. Sourcing the right fit for your supply chain is far from easy because of the sheer number of players out there.
Many claim to be specialists in their own particular sphere of CNC machining (while still taking on plenty of non-core work). And you will know from experience that some precision engineers are more precise than others.
1. How Do They Go Above And Beyond Their ISO Certifications To Guarantee Quality?
ISO certifications should make the job of sifting contenders easier. But sadly that is not always the case.
Sometimes a supplier can tick the right accreditation box but still not deliver the expertise and experience you’re searching for. Or conversely, you may wrongly rule out a potentially excellent supplier simply because they lack a certain certification.
You need to dig deeper. Here’s how…
ISO 9001 – The Essential Certification
ISO 9001 should be an absolute requirement. Rule out any company that fails to offer the required documented processes and traceability. If a supplier is not certified to this seemingly ubiquitous quality standard then forget them – they do not merit serious consideration.
ISO 13485 – Desirable But Don’t Let It Distract You
ISO 13485 seems like an obvious ‘must-have’ for any precision engineering company involved in medical device supply chains. But beware! While it is the standard for medical OEMs, barely any CNC machining company seems to have it. Even a machining company with a strong specialism in the medical sector will have clients in other sectors too. So, while they do not have ISO 13485, they may have satisfied other equally stringent certification criteria.
AS9100 – A Strong Indicator Of Quality And Consistency
AS9100 – the aerospace quality certification that enhances ISO 9001 – is a strong indication that a supplier takes quality and consistency very seriously. AS9100 is more rigorous than ISO 9001 (as is the automotive standard TS 16494). AS9100 has strong criteria with regard to First Article Inspection (the design verification and design history file, the formal method of providing a reporting measurement for each component in an assembly).
But again beware – there are machining suppliers without AS9100 that will outperform companies that have this accreditation. You should ask these important questions:
- Are any of the supplier’s regulated clients so confident in their quality inspection processes that they have awarded them ‘ship to stock’ status? (bypassing inspection at Goods In)
- If so, how long has the supplier held ship to stock status?
- What does their NCR history look like?
- Does the supplier show commitment to quality and perform 8D investigations for both internal and external non-conformance?
2. How Rigorous Are Their In-House Inspections? (Do They Ship To Stock?)
It’s vital that you ask your prospective suppliers whether they ship to stock for any existing clients.
CNC machining companies that are trusted to ship to stock must have the highest level in-house inspection procedures. This is essential if they are to deliver consistently high levels of quality. Without rigorous in-house inspections, they would not be allowed to bypass Goods In quality checks.
For that to happen without a well-regarded accreditation such as AS9100 speaks volumes about the high levels of quality and consistency at the supplier concerned. And the trust that their customers place in them as critical component machining partners.
In the high-mix subcontract CNC machining environment, companies that ship to stock are meticulous in their inspections. Self-inspection and buddy checking for approval are not enough. Expect to see conscientious production staff supported by a dedicated inspection team that is focussed on quality to the point of obsession.
CNC machining is a precision process – unlike finishing (an artisan process) – but it is still highly dynamic and fraught with variables such as cutter deflection, cutter wear, batch-by-batch changes in materials, temperature fluctuations and the human factor.
For that reason, painstaking inspections and robust, validated processes are absolutely essential. And ship to stock status is a good real-world guarantee of that. Proof positive.
3. What Does The Supplier Think Of Your Processes? (Can You Help Yourself By Helping The Supplier?)
You’re scrutinising CNC machining companies to ensure they’re demonstrating best practice. Guess what? They’re watching you closely too.
At a certain level within the industry, procurement professionals tend to concentrate on the immediate future (while also troubleshooting and firefighting in the present).
CNC machining companies operate in a high-mix, dynamic and fast-paced industry. Their customers (large and small) experience stocking issues; there may be overlooked or urgent requirements, sudden changes in priorities. It persists 24/7/365.
So CNC machining companies admire buyers and specifiers who:
- plan the year ahead
- look beyond the immediate horizon
- anticipate requirements based on developments further down the pipeline.
This tends to happen more often at larger firms and corporates; it’s less common among smaller clients. So when it does happen, it helps suppliers to deliver the reassurance and peace of mind that professionals crave. This builds trust and stability in the partnership.
And that’s what it’s about: trust and stability. Yes, you want CNC machining at a good price. But you also need:
- improvements in quality – underpinned by the guarantee of consistency
- responsive deliveries – every time, like clockwork
- security of supply
- added value in the design process – solving the problems you didn’t know you had
- a stress-free partnership – no hassle.
This blog post is part of a three-part guide to reviewing your CNC machining procurement. The free guide covers:
- what to look for in your new CNC machining suppliers
- traditional methods of sourcing suppliers – and why they don’t always work
- key questions you should ask CNC machining companies
- why you should demand rigorous in-house inspections (and not just rely on certifications)
- good practice in procurement (looking further ahead).
Get Penta Involved
Penta Precision is ISO 9001:2015 accredited for quality assurance. Our experienced engineers can alert you to potential design and engineering issues before they become costly, time-consuming and stressful.
Trust in Penta to maintain quality and consistency through tried and trusted validated processes:
- We communicate well
- We take care at each stage
- Our service is consistent.