How should I approach REACH, CM, etc. as a job shop?

Tyler

Involved In Discussions
#1
I work for a very small job shop in the aerospace industry. Lately we have seen an increasing number of requests for REACH, CM, etc. declarations. I need help determining how best to manage compliance to these regulations.

As a job shop, we don't do any of the design ourselves. In a world that is fair, I would expect the designers to manage the compliance of their products, but that is not reality. Instead, we are tasked with trying to determine the chemical makeup of their products; a task I do not feel qualified for. To the best of my knowledge, the only area of concern with the products we manufacture is the special processes used (e.g., chem treat, passivation, anodize, paint, etc.). However, it is very difficult (if not impossible) for me to determine the compliance of our products for the following reasons.
  • All outside processing is outsourced. We don't buy the specs for the special processes we have performed so I don't know what chemicals are used in the process.
  • Since I have a very limited knowledge of these processes, I have no way of knowing if the process renders the product non-compliant with regulations. For example, we have a lot of products chem treated with hexavalent chromium, but I have no way of knowing if the hexavalent chromium is integrated into the material in excess of 0.1% of the weight of the product. My guess is it probably doesn't, but that's just a guess and I don't want to operate on assumptions.
I have tried asking our processors for this information but they have not been very helpful. They gave me information about the product(s) they use, but didn't tell me whether it contained an SVHC or integrated an SVHC into the product.

As a small job shop with limited resources, how would you advise we approach compliance, especially considering the lack of help from our suppliers. Are there resources out there that provide compliance information on common materials and special processes?
 
Elsmar Forum Sponsor

greatwhitebuffalo

Starting to get Involved
#2
Can you "flow down" those requirements to the external vendors by stating the processes must be compliant to the required regulation when you generate the PO? We handle it that way and request that the certification states compliancy.
 
Last edited:

Tyler

Involved In Discussions
#3
Can you "flow down" those requirements to the external vendors by stating the processes must be compliant to the required regulation when you generate the PO?
Not always. Sometimes we get these requests after the products have already been purchased. Only a few customers have specified that products must be REACH compliant on their contracts.

Even if I flowed down these requirements, I am not confident that I would get honest answers from my suppliers. It is surprising that so many of our processors seem to have no compliance programs in place. They are all NADCAP approved processors too.
 

Ninja

Looking for Reality
Trusted Information Resource
#4
Been there...we charged for REACH declarations and sent the part/material out for testing (fee was testing cost plus).
Whether or not your resources are limited, flowing the cost of compliance to your customer makes it a wash for you...it's just another product you sell, price accordingly.
Never once had a customer push back... HTH

It's best if you speak real time with the compliance officer on the customer end first...that way there is no surprise when you say "you want a cert for a $2MM assembly, so we have to build another one just for testing...that will cost $2.5MM with shipping, testing fees and insurance."
...then ask them what they propose as a functional balance.
 

Tagin

Trusted Information Resource
#5
There are companies (e.g., Assent Compliance, Greensoft) which provide the service of doing the compliance legwork: chasing down vendors for declarations, maintaining a database of this information, combining that data into something you can use for a declaration to a customer and so on. But they are not cheap services, and if your vendors are unresponsive to you, then hiring an external company won't help anyway.

The chemical analysis route makes sense, as long as you can reliably get your vendors to agree that they will not change any of the chemicals or materials used in the product you analyze. From the sound of it, its not clear if they would tell you if they changed any of the materials from batch to batch.
 

Tyler

Involved In Discussions
#6
Been there...we charged for REACH declarations and sent the part/material out for testing (fee was testing cost plus).
I like that. However, it would suck if we promised our customer a REACH compliant product only to discover after testing that it is not compliant. Seems like you would need to know ahead of time whether it is compliant.

The chemical analysis route makes sense, as long as you can reliably get your vendors to agree that they will not change any of the chemicals or materials used in the product you analyze. From the sound of it, its not clear if they would tell you if they changed any of the materials from batch to batch.
I do not think my suppliers would notify me of changes to chemicals used in their processes. As I said in my original post, we are a small aerospace manufacturer so most of our business is with other small aerospace companies.

I feel like the lower tiers of the aerospace supply chain tend to fly under the radar (no pun intended). So far, no one seems to be taking these regulations very seriously. Perhaps it is because the focus has been mainly on the first and second tier suppliers? Either way, these requirements now seem to be landing (again no pun intended) at the lower levels of the supply chain.

On a somewhat separate note, what do you do if you discover something is not REACH compliant? As it stands, I know that some chem treated parts are not REACH compliant; they deposit a small amount of hexavalent chromium onto the product. However, I found this communication on the use of hexavalent chromium in aerospace. The following excerpt is taken directly from that communication.

"There are several upstream applications for Authorisation that cover generic uses of chromium trioxide, as well as for specific aerospace and defence uses of chromium trioxide and other chromates. These applications were completed by the following consortia or other applicants (click link for additional information) to allow use of chromates by downstream users."


I highlighted in bold the part that stuck out to me. It sounds like even though chem treated products aren't REACH compliant, they are covered by an already existing authorization. Does that sound right? Is that how REACH works? Can you benefit from someone else's authorization? If so, do I need to reference the authorization for my customer? Or do I just need to declare the SVHC and let them figure it out?
 

optomist1

A Sea of Statistics
Super Moderator
#7
I urge you to seek out and complete courses on each...I recently completed several courses....they are worth the time and effort...as these topics are not necessarily simple...

Cheers Optomist1
 

Tagin

Trusted Information Resource
#8
I highlighted in bold the part that stuck out to me. It sounds like even though chem treated products aren't REACH compliant, they are covered by an already existing authorization. Does that sound right? Is that how REACH works? Can you benefit from someone else's authorization? If so, do I need to reference the authorization for my customer? Or do I just need to declare the SVHC and let them figure it out?
On the page following that quote, it states a number of conditions that have to be met to continue using that chemical. So, it sounds like if you meet those conditions that chemical can be used in aerospace products. Whether or not your customer will accept a chemical covered by an upstream authorization is dependent on the customer. I'm not in aerospace so I'm not familiar with what difficulties that could present for your customer.

This "spec creep", as we call it in our company, is a problem: products that were designed years ago by the customer are suddenly now being given a requirement to meet all these compliance specs - ROHS, REACH, POP, BPR, CA PROP65, etc. If we can't get a compliance declaration from upstream, we just inform the customer. It was wishful thinking, at best, for them to assume such product would be compliant, and we as much tell them that.
 

Ninja

Looking for Reality
Trusted Information Resource
#9
I like that. However, it would suck if we promised our customer a REACH compliant product only to discover after testing that it is not compliant.
FWIW, it's easy to maintain REACH compliance in my experience...as long as you don't intentionally add stuff that crosses the line, and perhaps spot test areas of high risk.
We made material out of a starting powder...we had the incoming powder tested for Pb upon receipt...then didn't intentionally add non-compliant stuff...never came close to failing on the final product.

Again, work together with your customer, the solution is likely easier than you currently fear.
 

Tyler

Involved In Discussions
#10
I urge you to seek out and complete courses on each...I recently completed several courses....they are worth the time and effort...as these topics are not necessarily simple...
Do you have any suggestions?

FWIW, it's easy to maintain REACH compliance in my experience...as long as you don't intentionally add stuff that crosses the line, and perhaps spot test areas of high risk.
The only problem is we are a build to print manufacturer; we don't control the designs. To be fully REACH compliant I need to know the chemicals used in the special processes and/or materials specified. I can't do that without the help of my vendors. What further complicates things is figuring out how to determine if something exceeds the 0.1% weight limit for SVHCs. For example, I don't know how much hexavalent chromium is deposited onto our parts when they are chem treated. Right now I am erring on the side of caution and just telling our vendors when an SVHC is present.

I think for now, my approach will be to request safety data sheets from my vendors, screen the chemicals by CAS number, and report any SVHCs that are used in raw materials or SVHCs that are added in coating/finishing processes. Thoughts?
 
Thread starter Similar threads Forum Replies Date
V Is there an approach to define the "must 'or' should" in supplier audits? US Food and Drug Administration (FDA) 2
V Implementation of a QMS - Should I use a Preventive Action approach? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I Poll: Should auditors promote the process approach? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 331
W What is meant by Process Approach Auditing and What questions should be asked? Process Audits and Layered Process Audits 11
M Supply and Delivery - How should I approach the work for a specific process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Crusader Process Approach beef - Registrar says that we 'should' use the process approach General Auditing Discussions 20
E Please help! ! I AM FRASTRATED SO MUCH! Should inactive ingredient be included in the unit formula if it is removed during the manufacturing process? US Food and Drug Administration (FDA) 0
I IEC 60812 or ISO 14971 for PFMEA? What should we use? ISO 14971 - Medical Device Risk Management 3
qualprod Do sum of results of quality objectives should met a high level goal? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
F Should I perform several Gage R&R for every caliper to cover all specs range of use? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
E Opening meeting for Third-Party Audit--Who should say what? General Auditing Discussions 22
8 MSA--Should I Use Parts or Gage Pins? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
B Should I buy IEC 62304:2006, IEC 62304:2006/AMD 1:2015 or both? EU Medical Device Regulations 1
W "Accurate to ±2%" means "64% of measurements should be within 2% of the actual value"? US Medical Device Regulations 4
H Should we stop inspecting a part if its never been rejected? Reliability Analysis - Predictions, Testing and Standards 6
D What distributor requirement should we (manufacturer) require from the Distributor? EU Medical Device Regulations 0
M Should there be another column in the Optimization section (step 6) of AIAG-VDA DFMEA form? FMEA and Control Plans 1
C By when should harmonized standards be complied with? EU Medical Device Regulations 5
W Strategy for determining which components from a system should be "ME EQUIPMENT" -- home healthcare environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
B Documented information - Should be controlled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Is engineering a process and should it have its own process turtle? IATF 16949 - Automotive Quality Systems Standard 7
P Which MDCG Document should I use for PMS Plan and PSUR? EU Medical Device Regulations 2
M Who should quality representative report to? ISO 13485:2016 - Medical Device Quality Management Systems 5
H When should the first PSUR be issued? EU Medical Device Regulations 5
I If i do not want to be an initial importer should i register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
O Should a Covid vaccine and testing policy be included as part of ISO9001 or AS9100 risk management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B UKRP to what level should you audit Class I Technical Documentation? UK Medical Device Regulations 0
C When should you quit programming? Job Openings, Consulting and Employment Opportunities 9
C Should resolution be included in uncertainty budget for digital caliper or micrometer calibration? Measurement Uncertainty (MU) 5
Ed Panek External Standards List - Should this document include previously revised standards? ISO 13485:2016 - Medical Device Quality Management Systems 4
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A Should I take an online course for a career in Occupational Health and Safety? Career and Occupation Discussions 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
S Which Sampling Plan(s) Should I Use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 13
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Master Samples - What should we be keeping? IATF 16949 - Automotive Quality Systems Standard 9
G Supplier delivered recent PPAP, should he deliver yearly layout inspection? IATF 16949 - Automotive Quality Systems Standard 7
John Broomfield Should ISO 9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 70
A Capability Study - in the beginning of your career what should you have known about the tool Quality Tools, Improvement and Analysis 11
J Should Loading and Unloading be Included in Cycle Times? Lean in Manufacturing and Service Industries 14
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4

Similar threads

Top Bottom