I'm close to retirement and have set up a one man machine/mold shop for extra income. I have the CNC machines, lots of inspection tools and a few small orders. However, checking with a few potential customers it has become clear that if I want to expand my customer base, I will need to have a Quality system in place and a manual. Where does one start? I see a number of manuals posted here but I'm not seeing any for a small machine shop specifically. This is all new to me even though I've worked in the machine and mold shop industries for the last 30 years.

Welcome to the Cove!

Rather than copy the manuals, I suggest you flowchart your process starting from quote/receive order stage till shipping.

There are six mandatory procedures which are generic to almost any company and you probably can find examples here.

Download the manual that seems to fit your application and ask questions in this forum.

A manual does not have to be complicated. It must however reflect what you do.

I would recommend that you read through most of the ISO 9000 posts.

Good luck,

Danny

Hi Moldcore, welcome to the Cove! :bigwave:

I did a Google search (key words "quality manual job shop" and found a site with samples for you to look at. http://www.link1.com/mod_documentation.html

Some people buy "canned" manuals, which I don't recommend because they are often laid aside as irrelevant. It's better to make your own manual, describing what you do, based on ISO 9001 (or equivalent) as a template of sorts.

Manuals don't have to be complex, and tons of documents aren't needed. A work instruction can be a flow chart, and even a job order that has handling, material and fabrication instructions, specifications and dimensions on it. A Google search of your own (use three to five key words in your searches) can reveal several examples that you can use to decide upon the manual style you prefer. But manuals can be a lot of work and confusing for those without much experience with such things. Technical writing can be very tedious!

Some outfiits, like this one, help you make the manual by customizing documents according to your needs and practices. http://www.eq-usa.com/Documentation%20Program%20Details.htm#DD1

If you are to be satisfying clients with your QMS, you'll probably want to hire a consultant to do the periodic internal audit because you can't audit what you personally do. You might consider asking some, and discover they have some manuals in their own tool boxes; they could perhaps assist you with your formatted QA manual.

I want to stress that you should have as large a part in this process as you are comfortable with, because it's your system and the manual should say what you do, not try to do what's in some foreign-looking book thing.

I hope this helps!

Jennifer

Welcome to the Cove :bigwave:

You have the opportunity to validate quite a bit of what I've told folks that a small single person operation can do to meet QMS requirements. You'll not need to generate a ton of documentation or any of the garbage that clutters up other organizatuions. Keep it simple as Jen said and flowchart your basic process. There is a ton of stuff here. There are also a couple of small QMS manuals that folks here have provided you could most readily adapt to suit your needs.

Don't, don't, don't get some consultant to "help". You can get pretty much all the help you need here. If you can find someone, lets say from a local ASQ group or from an organization that has a QMS in place that will volunteer to help you if you get stuck, use 'em as a sounding board. If a customer requires some kind of 3rd party validation of your QMS get someone with verifiable competency, who won't charge an arm and a leg (we can help you with that I'm sure).

In this site we have literally a ton of attachments, that you can freely use at no cost, that can be used as excellant templates for developing what you need.

Remember, you can keep it simple.

Welcome to the Cove :bigwave:

...Don't, don't, don't get some consultant to "help". You can get pretty much all the help you need here. If you can find someone, lets say from a local ASQ group or from an organization that has a QMS in place that will volunteer to help you if you get stuck, use 'em as a sounding board. If a customer requires some kind of 3rd party validation of your QMS get someone with verifiable competency, who won't charge an arm and a leg (we can help you with that I'm sure).

In this site we have literally a ton of attachments, that you can freely use at no cost, that can be used as excellant templates for developing what you need.

Remember, you can keep it simple.Randy is correct and I should either withdraw my consultant blurb or add: the problem with consultants is that it is so hard to find one who will work hard to keep it simple for you, not work hard to make a fee. One can't always be sure the consultant is really good before paying the fee. It is too easy to think of the manual like a product you buy.

I once scared off a client by quoting a large price to write his quality manual for him. His old manual was clearly not being used, or else he simply had no idea regarding the system he was soon to be audited on as a Department of Defense contractor.

I didn't get that client, but I believe he was better off for it. The man ended up going to his local university for help, and received it--I hope he had a lot of hands-on involvement in the manual's creation.

You might also check out your local university if the Cove doesn't have all the information you need--but like Randy said, there's an awful lot of good stuff available here!

In another thread I just gave a poster direction to a book I have in my own library. Perry L. Johnson did a pretty good job of describing the who-what-when-where-why's of ISO 9000 in "ISO 9000: The Year 2000 And Beyond". I have the 3rd Edition.

The book includes a sample self-assessment and simple generic quality manual.

While information on this forum is bountiful and free, I mention this book because some people like to have something tangible to learn from, and ISO is pretty much the default structure for quality manuals. The book, or one like it, is bound to be available in a good book store like Borders et.al.

[QUOTE=moldcore]checking with a few potential customers it has become clear that if I want to expand my customer base, I will need to have a Quality system in place and a manual./QUOTE]

Danny K gives good advice.
You obviously have your own particular techniques and methods of obtaining a contract, procuring parts/materials and, processing and checking your working pieces from design requirements to completion and delivery.
This being said moldcore, your current techniques and methods are what shall constitute the genesis of a so called "Business Manual".
The techniques and methods you currently use, are your processes and procedures, write these down and you have the beginnings of your business Manual.
Of course this is the simplified approach, however it's clear as a one man business: you may be potentially asked by your clients, to merely conform to the intents of a stipulated business or technical standard requirement.
It is best (and advised) practice though to, consider adopting the overall intents of a business model such as ISO 9001.
It really depends on your client base of course. Being near retirement, you may wish to stay under the proverbial radar of stipulated requirements by clients. The job pieces you process may merely have specified tolerances as a stipulation to a standard.
It's a judgment call you have to make based on time and business commitment constraints that say, in reality you are a one man business offering a niche service.
good luck.
Wallace.

However, checking with a few potential customers it has become clear that if I want to expand my customer base, I will need to have a Quality system in place and a manual. Where does one start? I see a number of manuals posted here but I'm not seeing any for a small machine shop specifically.

This stuff was all new at some point to each of us. You may not have found a manual that was specific to a machine shop, but some of the manuals posted will help you determine what needs to be in your own manual. You really can keep it simple. Others have already said it -- start with a flow diagram of your process. You can probably get all the details on a few pages. Then you really just need a few other documents and you are all set with a defined quality system. The old adage -- "say what you do, and do what you say" fits here. Let us know if you want more details!

Another nice little book about the ISO 9001 quality system is by Herbert Monnich, and is called ISO 9001 for Small and Medium Sized Businesses.

I have several one-person operations.....all face similar hurdles and challenges. The Standard is different (ISO/IEC 17025 or ISO/IEC 17020 instead of ISO 9001) but the challenges are exactly the same.

Management review and internal audit are the two most difficult parts. For internal audits you must be independent to the degree possible.....but in a one-man show that is not possible, so the trick is to set up the internal audit scheme so it is at once simple enough to use, thorough enough to actually tell you something, and objective enough to allow you to "divorce" yourself from the normal process so you can review the operations.

Management review has the same challenge. It is simply stepping back and taking a formal look at the operations of the shop at a higher level. Lots of folks overlook that and read more into it than should be there.

Both management review and internal audit are tools for you to monitor your operations.....they do not control the operations, only take the pulse.

As a machinist you already know the value to calibrations.

Make sure you document what your customers want in a way that is both complete and easy to understand when you look at it later.

Define what constitutes a complaint. Every organization receives positive and negative feedback, but not all negative feedback is necessarily a complaint. Establish some easy parameters to decide what truly is a complaint.

Just a few pointers. Hope they help.

Hershal

Wow! What a great site! All your responses have been great and very informative. The biggest hurdle I face at the moment is time, so the suggestion of keeping it simple is the most attractive at the moment. I plan on jumping into this process full time in a few weeks when I hope time will be more available.

A couple of questions have come up:

One customer has asked that I have a calibration system of ISO 10012-1. Where do I find this spec and others like this?

Is ISO 900X certification overkill for a one man job shop where the manufacturing process is never the same from day to day? One friend suggested I get the certification and in the process the Quality manual will evolve from that. Is that getting the cart before the horse?

Thanks all.

ISO 10012 may be available from several sources, such as Global Documents. I have used them before.....a little pricey but reputable organization. 10012 is a guide but does give good information to help set up and control your calibration program. Another document you might check is ANSI/NCSL Z540-1-1994, available from NCSLI (http://www.ncsli.org)

The first part is Guide 25 which won't really concern you, but the second part (from about Section 10 if I recall) is the old MIL-STD-45662A, and like 10012 has good guidence in managing a calibration program.

Remember, even though the finer points of the process change day-to-day, the basic parts are the same: define the customer needs and make sure you can meet the needs, control of the equipment, control of the process, use appropriate methods, make sure the work is good. That is where to start the definition for a 9K registration, should you decide to seek 9K.

Hope this helps.

Hershal

Wow! What a great site! All your responses have been great and very informative. The biggest hurdle I face at the moment is time, so the suggestion of keeping it simple is the most attractive at the moment. I plan on jumping into this process full time in a few weeks when I hope time will be more available.

A couple of questions have come up:

One customer has asked that I have a calibration system of ISO 10012-1. Where do I find this spec and others like this?

Is ISO 900X certification overkill for a one man job shop where the manufacturing process is never the same from day to day? One friend suggested I get the certification and in the process the Quality manual will evolve from that. Is that getting the cart before the horse?

Thanks all.

I'm afraid that in our zeal we denizens of the board may be missing certain points. First, If you are a one person business, with a few small contracts, don't even THINK about certification. The cost is simply not worth it. Since you are the entire staff, no one can fault the internal communications, training, procedures or any other internal issue, so long as it does not effect product output.

As for Calibration, check for the nearest calibration lab. Then either have your tools checked by them, or purchace a nice set of gage blocks and have them calibrated by the lab and check your tools against the calibrated blocks.

As far as a Manual goes, I think there is some good advise in earlier responses. But I still think it's overkill in your case. Flowchart your processes (what you do) and include inspection steps (i.e. general checks and final checks) Then create a mission statement at the beginning and your good to go.

The ISO 9000 model is good for even small businesses, but I draw the line at a 1 man operation. How do you audit 1 person? How does a one man shop perform management review?

James

A couple of questions have come up:

One customer has asked that I have a calibration system of ISO 10012-1. Where do I find this spec and others like this?

Is ISO 900X certification overkill for a one man job shop where the manufacturing process is never the same from day to day? One friend suggested I get the certification and in the process the Quality manual will evolve from that. Is that getting the cart before the horse?

Thanks all.

I also vote for oursourcing your calibration to a local cal house. Most do a wonderful job, and provide you with the certificates and even the reminder letters each year.

ISO registration is definitely a big deal for such a small shop. Hopefully your friend meant that you would apply for a registration audit with a registration firm, and they would tell you what you needed to do before scheduling the audit. Then the manual, procedures, etc. would need to be done before you could schedule the audit. You may be able to get what you need by simply using the ISO 9001 standard as a guide for your quality management system (QMS). To my previous post, your manual could be the whole explanation of the work processes used there. Start with the process map/flowchart!

Wow! What a great site! All your responses have been great and very informative. The biggest hurdle I face at the moment is time, so the suggestion of keeping it simple is the most attractive at the moment. I plan on jumping into this process full time in a few weeks when I hope time will be more available.

A couple of questions have come up:

One customer has asked that I have a calibration system of ISO 10012-1. Where do I find this spec and others like this?

Is ISO 900X certification overkill for a one man job shop where the manufacturing process is never the same from day to day? One friend suggested I get the certification and in the process the Quality manual will evolve from that. Is that getting the cart before the horse?

Thanks all.
Your friend is indeed placing the cart before the horse. A quality manual is needed for registration. They evolve, but only to the extent that is practical for your evolving business needs.

I wouldn't go for registration anyway. I think that's overkill for a one-man show. I mentioned ISO because it takes the guesswork out of what to cover, what to say in a manual.

The manual is little more than a means to tie together your processes--descriptions of how you will manage essential quality-related elements (you'll have several, probably including these examples: for quotes/contracts, calibration, how you will check up to see if things are being done as you'd planned, and how you will manage defects and your customer complaints, if any).

A work instruction may be needed to do some particular task that influences quality. A job order for a particular run of products is a perfectly good work instruction; no need for redundancy for the sake of being thorough!

I do encourage you to look through a book or two on the subject, and look at a sample manual, or two or so. They needn't be involved. The example in Johnson's book is 32 pages, 6"x9".

How far you want to go depends on external influences like your customers, industry and regulations, and internal influences like your comfort level and ability to maintain the documents and structures you do decide on. You'll have some choices to make.