QMS and ISO 9001 for a Single Person Machine Shop

jobshop · Sep 7, 2016

Hello,

this is my first post, sorry for the immediate questions.
I own a small machine shop, where its just been me as the only employee, for 16 years.

A main customer of mine is in the process of getting ISO certification. I've been doing machining work for them for 15 years and now I may need to get some sort of quality program developed.
My first question is, what quality records will I need to support customer certifications?
I do not do any designing, everything is strictly from their drawings.

How will I make this work when there is one employee (me)?
What is the minimum I can get away with having to support their needs?
Thru the 15 years I've been doing business with them, I can honestly say that my quality record is outstanding. What kind of PITA am I in for?

Thank you for your time and guidance.

Jim

Greg Peckford · Sep 7, 2016

Hi Jim,

I know that this can seem like a daunting task but putting together a quality system doesn't have to be a huge headache. You likely already have many of the processes in place already for how you conduct your business, now you will need to do a little formal documentation to back it up. This does not have to be complex documentation with lawyer big business talk. All you need are some simple processes mapped out to show your clients how you manage your operations.

For instance, you do not perform any in house design work, that part is easy, no process required, but you do need to show how you obtain your manufacturing drawings and specifications from your customers and how you track and maintain those documents once in your control. How do you ensure that you have the most up to date rev? (i.e....We maintain a spreadsheet of project documents and when a new revision is available the client will forward this document, We will replace the existing document with the new rev and supersede the old one.) Your a one man shop, lets not over complicate your process. All you need to do is show that you have a system in place to control your processes. How do you order, receive and store materials? Do you have a process to ensure that you have batch numbers for your stock so that you can maintain traceability. Again don't over complicate it, simply maintain a documented procedure of what your process is so that, if say a new hire were to do the task could they follow your documented process and do the activity.

Your client will tell you what they need exactly from you so once you have that info simply map out your process for each activity and how you control it. Like I said you already do the process, just formalize it but keep it within the scope and context of your business.

I hope this helps a little.

oldmanian · Sep 7, 2016

Jim,
You say you may need to get certification, has the customer asked you to do this? Our company has some sub contractors that do not and have no intention of becoming certified and we accept that. We do inspection on the work they supply and so far we have had no major dramas with these suppliers.
If the customer asks you to go down this road as a one man band you may have to look at having a consultant come in one day a month to carry out compliance checks.
In the minimum you may need to keep inspection records of work performed and keep certificates on the materials used. you may already be doing these things just not as part of a "system"
There are a lot of covers who have a lot more knowledge than I on this and I will be interested in their input.
Good luck

jobshop · Sep 7, 2016

Greg and Ian, thanks for helping me out. Its an overwhelming situation. I'm a hands on person, i keep rates low because i don't do a lot of paperwork. I keep at it, i feel this is gonna slow me down a lot. I'll do what i need to do to keep going but i'm no rocket scientist...half of this stuff makes zero sense to me.

I get their file, quote it, usually get the job, get materials precut from a vendor. Design and build fixuring, Order tooling, develop programs, set up and quality check thru the run, clean. Sometimes send out for plating or anodizing and deliver.
Its simple really. I will admit my program labeling and filing has been lacking over the years. I blame that on zero time and 1,000's of parts. I now do mainly short run production of around 40 part numbers, with many having 4+ ops, so it isnt bad. I can refile everything in a couple days if needed.
I dont even have a current in process quality check sheets, but can get one made up. I do a first part inspection and then usually rechecked features based on tolerance zones.

The thing that upsets me is that they gave me no notice. I got a supplier evaluation form emailed to me.
Under the heading 'quality management system'

Are quality records available to support customer certifications? Yes - No
Quality assurance contact:

'Design Information'

Do procedures cover the release, change and recall of design and manufacturing information, including correlation of customer specifications? Yes - No

Do records reflect the incorporation of changes? Yes - No

Does quality control verify that changes are incorporated at the effective points? Yes - No

Is the control design and manufacturing information applied to the procurement activity? Yes - No
Is there a formal deviation proceedure? Yes - No

Thats pretty much it.
Would be nice if they allowed me to only record work peice quality records, such as that sheet that i need to make.

The kicker is that a engineer there told me to jist fill it all in yes and send it. Well, i did and now i dont feel its right, especially with 'design information', since i wont be doing any kind of design. I emailed the manager and told him he may need to discard the form i just sent in and i can resend with his thoughts as to what i'm able to do and what to check yes to.

Ian, no, the customer has not asked me to do this. I just feel that with this form thats what they are pushing. Im sure they wont be doing inspections for me , but when ensembling and testing their machines they would quickly find out upon assembly if one of my parts were defective. They test final product before its sent out.

Greg Peckford · Sep 7, 2016

Jim, lets keep this in perspective here. Its your client that is striving for certification and therefor it is up to them to adhere to the requirements of the ISO standard. They in turn are required to ensure that their subcontractors are maintaining a level of quality satisfactory to their standards. In other words you are an extension of their quality program. You yourself are not bound to the requirements of the ISO 9001 standard.

Now that being said, your client may no longer be able to allow you to not maintain quality procedures, material control and inspection activities going forward. You said you are able to develop an inspection traveler for your production work. Your first step would be to implement this so that you can provide some proof of quality control to your client going forward. Your design control department is your client as they control all design and development including change management activities which are then passed down to you in the form of a revised drawing. All you need to do is show how you obtain those drawings and how you control, as well as how you are notified of any changes in design that occur during the manufacturing process. If you make any changes in the manufactured materials how do you show this on the finalized drawing (Redlined or as -built). This may never be done in which case you do not need a process for this.
As for the procurement activity, how do you know what to order? You order based on the drawings and spec sheets supplied to you by the client, correct? This is how you control the design and manufacturing in the procurement activity. I think if you develop a traveler/checksheet to reflect your manufacturing, inspection and quality control activities and also show tractability to your stock materials you will cover a lot of what they are asking for.

Keep in mind that a lot of these requirements are general and do not reflect the activities of every business or scope of operation. You are not expected to develop processes for something that does not apply to you.

Coury Ferguson · Sep 7, 2016

jobshop said:
Greg and Ian, thanks for helping me out. Its an overwhelming situation. I'm a hands on person, i keep rates low because i don't do a lot of paperwork. I keep at it, i feel this is gonna slow me down a lot. I'll do what i need to do to keep going but i'm no rocket scientist...half of this stuff makes zero sense to me.

I get their file, quote it, usually get the job, get materials precut from a vendor. Design and build fixuring, Order tooling, develop programs, set up and quality check thru the run, clean. Sometimes send out for plating or anodizing and deliver.
Its simple really. I will admit my program labeling and filing has been lacking over the years. I blame that on zero time and 1,000's of parts. I now do mainly short run production of around 40 part numbers, with many having 4+ ops, so it isnt bad. I can refile everything in a couple days if needed.
I dont even have a current in process quality check sheets, but can get one made up. I do a first part inspection and then usually rechecked features based on tolerance zones.

The thing that upsets me is that they gave me no notice. I got a supplier evaluation form emailed to me.
Under the heading 'quality management system'

Are quality records available to support customer certifications? Yes - No
Quality assurance contact:

'Design Information'

Do procedures cover the release, change and recall of design and manufacturing information, including correlation of customer specifications? Yes - No

Do records reflect the incorporation of changes? Yes - No

Does quality control verify that changes are incorporated at the effective points? Yes - No

Is the control design and manufacturing information applied to the procurement activity? Yes - No
Is there a formal deviation proceedure? Yes - No

Thats pretty much it.
Would be nice if they allowed me to only record work peice quality records, such as that sheet that i need to make.

The kicker is that a engineer there told me to jist fill it all in yes and send it. Well, i did and now i dont feel its right, especially with 'design information', since i wont be doing any kind of design. I emailed the manager and told him he may need to discard the form i just sent in and i can resend with his thoughts as to what i'm able to do and what to check yes to.

Ian, no, the customer has not asked me to do this. I just feel that with this form thats what they are pushing. Im sure they wont be doing inspections for me , but when ensembling and testing their machines they would quickly find out upon assembly if one of my parts were defective. They test final product before its sent out.

Jim,

Here is my opinion on this:

If they want you to complete this Survey, it is mainly for their records of performing some type of Supplier Evaluation.

Are they the same company that you have done work with for the past 15+ years? If so, go back to their Buyer, and explain to them the same thing you have explained here.

If they still want you to either be in compliance or Registered to ISO9001, then explain to them that this will increase my costs which in turn will increase what you charge them. :notme:

Most customers realize that one-man shop does not have the resources to manage and maintain a Compliant/Registered ISO9001 System.

But, this is my opinion on this.

jobshop · Sep 7, 2016

Thank You Greg-

I'll get to making that QC traveler and updating my customer part program files so they are in order. Maintain all current hardcopies of drawings.
Get a filing cabinet for incoming vendor documents. Will i need to send material certifications in with my parts, or file them?

Thanks again.
I'd have contacted them on this but i know they are having an outside source put it together. Ill be talking with the manager tomorrow.

Greg Peckford · Sep 7, 2016

If they require the material certs then supply them, otherwise keep them in your own records for your own tracking and should they ever request them. They are going to have a lot of new requirements that I am sure they are not even aware of at the moment so you never know what they will require from you later on. If unsure...file it!

jobshop · Sep 7, 2016

Coury,

Thanks for the reply!

Yes, this is the same shop, since 2001. I've done tons of work for them...especially the last 10 years. They have grown exponentially and me not 1 iota, but i've always been a great supplier to them. I would think they would want to keep me, but as you know sometimes we're outgrown. My ambition was kinked many years ago when i found i had a serious illness.

I dont get along too well with the purchaser... she doesnt like me for some reason, i deal directly with the manager and the engineering staff. I'll be talking with the manager tomorrow. There is a person who is heading up the ISO dept, i dont know who that is.

Thanks again

oldmanian · Sep 7, 2016

Jim,
with Material certs and inspection records we scan every one of them and store them under the customer name then the parts number then the order number and date. This saved us 4 filing cabinets of paperwork. We are occasionally asked to send certs if they want ROHS compliance proven however this is rare.

QMS and ISO 9001 for a Single Person Machine Shop

jobshop

Greg Peckford

oldmanian

jobshop

Greg Peckford

Coury Ferguson

Moderator here to help

jobshop

Greg Peckford

jobshop

oldmanian

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