The FDA is not only the regulating agency for this market, it is also a storehouse of information.
Today’s post is short on text, but packed with authoritative links to the materials available on the FDA website.
Small Business Guide to FDA This .pdf document was last updated on 10/7/2008 and provides contact information as well as an overview of the Federal Register / publication of proposed regulations process.
Design Control Guidance for Medical Manufacturers Because design controls must apply to a wide variety of devices, the regulation establishes a framework that manufacturers must use when developing and implementing design controls.
Current Good Manufacturing Practices (cGMP) Rule links (on FDA website).
Don’t confuse hardness and hardenability. Hardness is a material property. Hardenability is a way to indicate a material’s potential to be hardened by thermal treatment.
Hardness is resistance to penetration. Hardenability describes how deep the steel may be hardened upon quenching from high temperature. The depth of hardening is an important factor in a steel part’s toughness.
The brinell test uses a 10mm hardened steel (sometimes carbide) ball and various levels of force applied over a specified time. The softer the material, the deeper the penetration, the wider the impression.
The width of the impressions is measured optically and averaged. (Wider impressions mean the ball penetrated deeper, thus, the material is less hard.) The Brinell hardness number is calculated by dividing the load applied by the surface area of the indentation. Prior to today’s direct reading instruments, the measured indentation diameters could be looked up on a reference chart and the corresponding Brinell hardness number given.
The Rockwell test is similar, but uses different forces and either a smaller ball indenter (Rockwell B scale ) or a diamond indenter (Rockwell C scale).
Hardenability- Jominy Test
In the Jominy test, a standard specimen is heated then water quenched from the end, and a series of rockwell hardness tests are taken in 1/16th inch increments along the length of the specimen. Jominy test measures potential depth steel will harden.
It is the influence of the steel’s chemical makeup (Carbon and Alloying elements) that determine how a deeply a grade of steel will transform to martensite for a particular quenching treatment. This means that for each grade being heat treated, mechanical properties are a result of cooling rate (quench). An excellent web page on this can be found here.
So what of the difference between hardness and hardenability? Hardness is resistance to penetration under specified conditions of load and indenter. Hardenability is the ability of a steel to acheive a certain hardness at a given depth, upon suitable heat treatment and quench. Hardness can be measured in steels in any condition. Hardenability presumes that the steels will be heat treated to acheive a targeted hardness at a given depth.
One is an actual property, one is a measure of potential.
And now you know.
Web resources: Gordon England Thermal Spray Coatings Farmingdale State College School of Engineering Technologies.
False: Preventive Maintenance (PM) is too costly.
False: Its cheaper to fix it when it breaks, rather than before hand.
False: Preventive Maintenance is just about routine maintenance. They knew about Preventive Maintenance in 1965. False: Preventive Maintenance (PM) is too costly.
Actually, unscheduled equipment downtime is what costs you. Your people are being paid, but there is no production. Taking a machine down for PM makes no economic sense either. This is pretty simple to understand. However, to minimize the costs of ‘doing PM’, when you do your PM makes a difference. The scheduling of PM to take advantage of equipment idle time is key to keeping it economically feasible. PM should be accomplished on lunchbreaks, during changeovers, or on back turns. Every minute that a machine resource is scheduled, it should be producing; PM should be scheduled for when it’s not.
Here’s my ‘Lunchroom Test’ of your PM program. If I go into your lunchroom at lunchtime, and your operating people and your maintenance people are eating together, YOU NEED A PM PROGRAM! While the equipment is not being operated, it should be under the loving attentions of your maintenance specialists. Maintenance is the job of the operator you say? Well then show me the documentation of what they do. Each shift. Every day. Documentation, not just checkmarks. And when they do it… False: Its cheaper to fix it when it breaks, rather than before hand.
I don’t know about your customers, (actually, I think I do know a little bit…) but I sold steel to companies just like you- in fact to some of you- who told me that they got ZERO PPM and 100% ON TIME from their ordinary suppliers…
So presuming that your equipment doesn’t go out of statistical control before it fails (anyone care to place a bet?) the fact is that you are still vulnerable to missing the customer’s expectation of 100% on time when you have an unplanned equipment failure. And if you built in extra leadtime, well, the lean boys have a name for that too. (Muda) What is the cost of premium freight to make up for an unplanned machine failure? What is the cost of overtime for operators to make up the shortfall? Or the cost of retooling another machine just to keep the schedule? What is the cost of the lost production time on that unit or cell?
When we compare these costs to those of giving the machine over to the PM boys for a few minutes over lunch, or after production… this is an easy economic decision to make. False: Preventive maintenance is just about routine maintenance.
Oil changes. Greasing bearings. PM is just a fancy way of saying routine maintenance. WRONG! With just a little bit of imagination, using available and not so expensive tools, PM can identify troubles before they become failures. Non-contact thermometers can help you determine the changing thermal behavior of bearings, motors, relays, and other electrical equipment as they begin to deteriorate. Sending out gearbox oil for elemental analysis to your supplier can tell when critical parts are beginning to fail. Vibration analysis can identify machinery ready to fail. I used these techniques in a cold drawing mill for steel, they can work for you too. But having these tools and techniques available isn’t enough. You have to actually use them.
Now is a good time. Between shifts. While operators are on break or doing a changeover. On ‘off shifts’. On weekends. Now is the time. Not when your customer calls to tell you he’s really in a bind, and needs you to expedite next month’s releases moved up to this week too.
I told you about my steel mill PM successes. What is the best Preventive Maintenance tool or technique that you have applied in your precision machining shop? And how did it save you?
If you can’t prove it- don’t say it… but when opinion is called for, base it on facts and outline them as the basis for your judgement.
Keep in mind that all external documents should be considered to be read by outside parties including hostile legal counsel, and competitors. And archived and retrievable- anywhere, anytime, worldwide- thanks to Google. Confidential privacy advice courtesy of Google.
Here’s an ironic example : note the “confidential sponsors only” status on the bottom of this slide from a presentation posted on the world wide web. Note the last bullet point: Issues Management: Privacy as a key topic. Physician, heal thyself!
My 3 guidelines are to make certain that your writing is therefore:
Strictly focused. Stick to the topic of concern. No “subject creep.”
Veracity incarnate. If any aspect is uncertain, give the reader guidelines so that they may make appropriate inferences.
Necessary. The people who will be receiving your work are busy too. Is it absolutely necessary that they get your document? Ask “Why?” 5 times. Remember, like the slide above, it could end up on Google forever.
As Santayana once observed, “It is helpful for a system of philosophy to be substantially true.” Truth may not be an adequate defense to certain readers, (it may in fact be hostile to their intentions). But as precision manufacturers, we stand nowhere if not on the facts and data.
The WTO just handed China a 460 page ruling regarding how the country handles American books, movies, and music. Here is a 9-page .pdf of the conclusions and findings. Dispute DS363 (here’s a summary) has at its core how the Chinese distribute and ‘protect’ from piracy American creative works in that country. So why should precision machine products manufacturers care about how the Chinese “distribute Hollywood movies, books, and music?”
“Sometimes the law defends plunder and participates in it. Sometimes the law places the whole apparatus of judges, police, prisons and gendarmes at the service of the plunderers, and treats the victim – when he defends himself – as a criminal.”- John Frederick Bastiat
Reason 1: Intellectual property rights are at the root of every bit of legitimate commerce. It isn’t just Hollywood movies being pirated across the pacific. Industrial designs, machined parts, counterfeit products are legion from the country whose premier, Hu Jintao, Mr. Obama will soon host.
Reason 2: This is the portent of the authentic test of President Obama: his dealings with Hu Jintao next month at the G 20 Summit in Pittsburgh Sept 24-25, 2009. Will he execute the appropriate remedial actions against the Chinese violations recognized and confirmed by due process via the WTO, and ITC, protecting American jobs and interests?
Before that Pittsburgh meeting, the administration must rule on a recommendation by the US International Trade Commission to impose up to a 55% tariff on Chinese Tires. We’ve been following the Cheap Chinese Tires deaths cases since our ethics class at Walsh University in July of 2007. These issues have been around for a long time… the current cheap tire row is a suit filed by the USW who charged that the flood of cheap Chinese tires had resulted in massive loss of jobs.
Is Obama as wise as Solomon? Will he stand up for American interests? How will he, as one of the world’s leading debtor executives- respond to his legal responsibilities to enforce the trade laws with China, perhaps his largest creditor?
Will he deliver the remedy won by the USW against Chinese dumping, in light of his need for cooperation from China, a leading purchaser of US Treasuries? Or will he acquiesce, complicit in the plunder of American intellectual property rights and jobs?
After 8 years of nonfeasance on the China Currency Issue out of Washington D.C., we’re wondering. Could this be a Change? “The worst thing that can happen to a good cause is, not to be skillfully attacked, but to be ineptly defended.” John Frederic Bastiat
Watch these China cases for a glimpse of our industry’s future. And an understanding of what the current administration thinks of manufacturing.
Does a precision machinist really need 12 hammers? Hammer time!
We were stunned to see this collection of hammers from a ‘precision machinist’s’ tool box at a recent auction. Not in the photo is yet another rubber hammer, even larger than the biggest shown here. I’m thinking millwright, not precision machining from this view. Check out the hacksaw and pipe wrenches.What do you think? Do you have more big hammers in your tool box than a city girl has shoes in her closet?
It’s okay guys. Time to tell.
