The Elsmar Cove Forum http://Elsmar.com/Forums/ ISO 9001, Medical Devices, Six Sigma and TS 16949 (automotive) and Business Standards Compliance Requirements en Sun, 19 May 2013 03:43:16 GMT vBulletin 10 http://elsmar.com/Forums/images/misc/rss.jpg The Elsmar Cove Forum http://Elsmar.com/Forums/ The future of 3-D Printing http://Elsmar.com/Forums/showthread.php?t=59760&goto=newpost Sat, 18 May 2013 20:09:22 GMT How 3-D Printing Could Disrupt the Economy of the Future (http://www.bloomberg.com/news/2013-05-14/how-3-d-printing-could-disrupt-the-economy-of-the-future.html) Your thoughts? How 3-D Printing Could Disrupt the Economy of the Future

Your thoughts? ]]> Manufacturing and Related Processes Marc http://Elsmar.com/Forums/showthread.php?t=59760 Case Studies of Six Sigma in Service Processes http://Elsmar.com/Forums/showthread.php?t=59759&goto=newpost Sat, 18 May 2013 14:48:31 GMT Could somebody please provide pointers to online reference material or threads in Elsmar Cove Forum on examples / case studies of six sigma in service processes? It will be helpful to get this information on both types of service processes: - Repetitive in nature (like PO generation, etc.) -... Could somebody please provide pointers to online reference material or threads in Elsmar Cove Forum on examples / case studies of six sigma in service processes? It will be helpful to get this information on both types of service processes:
- Repetitive in nature (like PO generation, etc.)
- One-off (like R&D for a new drug, etc.) ]]> Six Sigma Hemanta Bhatt http://Elsmar.com/Forums/showthread.php?t=59759 <![CDATA[Is there any "rate the auditor" done on Elsmar or anywhere else?]]> http://Elsmar.com/Forums/showthread.php?t=59758&goto=newpost Sat, 18 May 2013 14:18:35 GMT Hello there,

We've just had our re-certification audit (AS 9100) and "unbelievable" things occurred:

1. the quality manual did not include the standard clauses and the auditor was quite shocked to find that !!!
Explanation: I had updated the Manual to simplify it (remove pages of clauses copied from the standard!!) and to actually bring more value to the company. I reduced it to 18 pages from 38 and I could have reduced it even more!
I told the auditor (nicely) that there was no other provision on writing the manuals except what was required by clause 4.2.2. He accepted that but later he tried continuously to "prove" what value would bring the clauses added to the manual.

2. I added more visual aids in the manual, e.g the interaction of the processes, core processes, support processes, input, and output. It was actually the model of a business process. The auditor was again shocked and appeared not to clearly understand... asked many questions like how we audited that and others... He had prepared his audit plan according to processes chosen one year ago and it was difficult I suppose to change that (though we sent him the manual one month before the audit). We tried to be helpful and said that he could do whatever would be easier for him...

3. I prepared a risk management process for the company, with criteria and all the requirements (the company had nothing at that point). In the beginning it seemed complicated, but then we managed to reduce these criteria, and it was OK (we were able to analyse risk in ~ 5 min. Criteria: families of products based on the customer, part characteristics -new/existent part, price, difficult or not to manufacture- and the main operations). We could have reduced them even more, but did not have enough time to do it... (had just 1/2 a month to do everything!!)
When we presented the risk process the auditor was again shocked, why do we have such a complicated risk process?? He said he had simpler methods to show us. We had examples of risk done (analysed), and I was 95% convinced that he could not have raised us a non-conformance. But it's not normal for a third party auditor to act like that!!!
He could give us indications or advice and we would be more than happy to accept it, but not to force them on us, right? He should not make those types of comments...

My frustration is mainly because I am quite new to this company, and I wanted to do good things for them (lost a lot of time to prepare these, even at home and at weekends, neglected my family...) . How could I actually prove them that what I did was right? How could they trust me and not their third party auditor? In the end it was established that we would do exactly what the auditor advised, of course. :frust::frust:

I have many years of quality experience and training as a lead auditor and worked with many certification bodies before and had both types of the manuals (with and without the clauses) and nobody ever said something against...and whoever wanted to give us advice proceeded differently, not trying to impose it on us. And nobody appeared shocked of anything we had before (I even thought that maybe this auditor did not like something about me...) :(

We learn all our life and we continuously try to improve and when things like these happen, it’s like all you learn no longer makes sense... How could you, one person, new to the company, argue with the third party auditor (even a civilized argument!) when the people in that company are not trying but just to be veeeery nice with that auditor! (It should be right also to add that they are actually very nice to everybody...)

Thanks,
Michelle ]]> AS9100, Nadcap and related Aerospace Standards and Requirements MichelleN http://Elsmar.com/Forums/showthread.php?t=59758 Pest Control in Hotel Restaurant Kitchens http://Elsmar.com/Forums/showthread.php?t=59757&goto=newpost Sat, 18 May 2013 07:29:33 GMT Dear Friends, My organization is in stage of implementation HACCP Standards. An consultant recommends to immediate stop supply pest control in Hotel ‘s kitchen cause food may observe toxic. I want to know what are the alternatives? Is there any chemical for controlling pests are allowed in... Dear Friends,

My organization is in stage of implementation HACCP Standards. An consultant recommends to immediate stop supply pest control in Hotel ‘s kitchen cause food may observe toxic.
I want to know what are the alternatives? Is there any chemical for controlling pests are allowed in food production area?

Please need your help ?

Thanks ]]> ISO 22000, HACCP (21 CFR 120) and Food Safety DAWELAH http://Elsmar.com/Forums/showthread.php?t=59757 What documented procedure in this case ... http://Elsmar.com/Forums/showthread.php?t=59756&goto=newpost Sat, 18 May 2013 05:34:21 GMT When I have design and development in my process and the necessary documented procedure, and going along I decide to outsource the design and development process to an other ISO13485 company, what must I do with the documented procedure ? 1. Remove my documented procedure 2. Revise it to direct... When I have design and development in my process and the necessary documented procedure, and going along I decide to outsource the design and development process to an other ISO13485 company, what must I do with the documented procedure ?
1. Remove my documented procedure
2. Revise it to direct to the controls exercised over design and development outsourcing, which is documented elsewhere in QMS.
3. Any other opinions ? ]]> ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems somashekar http://Elsmar.com/Forums/showthread.php?t=59756 Current MRI Labeling requirement for European Union http://Elsmar.com/Forums/showthread.php?t=59753&goto=newpost Fri, 17 May 2013 23:42:22 GMT Hello,

I work at a small medical device company in the US. We currently sell an implantable device with CE Marking. I'm looking for current MRI labeling requirement for EU... Can anyone help point me in the right direction? Thanks in advance! ]]> CE Marking (Conformité Européene) / CB Scheme ehoqa http://Elsmar.com/Forums/showthread.php?t=59753 Delivering an effective and all inclusive EHS program in a Food company http://Elsmar.com/Forums/showthread.php?t=59752&goto=newpost Fri, 17 May 2013 22:25:41 GMT What is involved in delivering an effective and all inclusive EHS program in a food industry? What is involved in delivering an effective and all inclusive EHS program in a food industry? ]]> ISO 22000, HACCP (21 CFR 120) and Food Safety yeong313 http://Elsmar.com/Forums/showthread.php?t=59752 Recommended Sealing for Granite Top in a Clean Room http://Elsmar.com/Forums/showthread.php?t=59751&goto=newpost Fri, 17 May 2013 20:43:12 GMT Does anyone use granite top in the gowning room sink of a class 8 clean room ? if yes, what is recommended for sealing / treatment of the granite to eliminate porosity and loosen crystals? Thanks in advanced for all the great responses. Does anyone use granite top in the gowning room sink of a class 8 clean room ?
if yes, what is recommended for sealing / treatment of the granite to eliminate porosity and loosen crystals?

Thanks in advanced for all the great responses. ]]> US Food and Drug Administration (FDA) csterling http://Elsmar.com/Forums/showthread.php?t=59751 Has anyone purchased their powerball tickets? 17 May 2013 http://Elsmar.com/Forums/showthread.php?t=59750&goto=newpost Fri, 17 May 2013 20:03:59 GMT They say it is now 600 Million. Have you got your golden ticket yet? http://news.msn.com/us/powerball-jackpot-grows-again-to-dollar600-million?ocid=ansnews11 They say it is now 600 Million. Have you got your golden ticket yet?

http://news.msn.com/us/powerball-jac...ocid=ansnews11 ]]> Coffee Break and Water Cooler Discussions mguilbert http://Elsmar.com/Forums/showthread.php?t=59750 Specification for how to measure lengths of hose assemblies http://Elsmar.com/Forums/showthread.php?t=59749&goto=newpost Fri, 17 May 2013 19:37:55 GMT Is there any specification or standard that prescribes how to measure lengths of hose assemblies? i.e. Tape measure over the outside curve, tape measure over the inside curve, force hose into straight position from top and use steel rule, force from side, force from bottom, averages... We... Is there any specification or standard that prescribes how to measure lengths of hose assemblies?

i.e. Tape measure over the outside curve, tape measure over the inside curve, force hose into straight position from top and use steel rule, force from side, force from bottom, averages...

We have an "in shop" process that can produce consistent results, but our customer may choose to measure a different way.


Thanks. ]]> Various Other Specifications, Standards, and related Requirements Fuzzix http://Elsmar.com/Forums/showthread.php?t=59749 What things do you look for when promoting from within an organization? http://Elsmar.com/Forums/showthread.php?t=59747&goto=newpost Fri, 17 May 2013 18:29:25 GMT I work for a small (non union) manufacturing company (125 employees). Whenever a position opens up (because of retirement, resignation or termination), the goal has always been to try and fill that position by promoting from within the organization. the obvious things are taken into consideration,... I work for a small (non union) manufacturing company (125 employees).
Whenever a position opens up (because of retirement, resignation or termination), the goal has always been to try and fill that position by promoting from within the organization. the obvious things are taken into consideration, such as:

Senority
Dedication
Motivation
Experience
Work Ethics

But what other factors should we be looking at? Does anyone have some type of aptitude test that could be given or even some practical advice based on experience that they would like to share?
Over the years, some of these promotions turned out rather well, but then some......not so good.

Thanks in advance. ]]> Career and Occupation Discussions LRE67 http://Elsmar.com/Forums/showthread.php?t=59747 <![CDATA[C - What the "C" in C=0 Sample Plan means]]> http://Elsmar.com/Forums/showthread.php?t=59746&goto=newpost Fri, 17 May 2013 18:27:23 GMT Someone asked me what the "C" in C=0 meant, I thought it stood for charachteristic but someone believes that is incorrect but does not have an answeer themselves. Does anyone want to chime in?

Thank in advance. ]]> Definitions, Acronyms, Abbreviations and Interpretations QE-Bob in Wisc http://Elsmar.com/Forums/showthread.php?t=59746 Control of Monitoring and Measuring Equipment for Servicing Photocopiers http://Elsmar.com/Forums/showthread.php?t=59744&goto=newpost Fri, 17 May 2013 16:16:19 GMT I've just been reviewing notes I made during our recent external audit. The use of calibration equipment was noted in respect of test charts used to assess the output of devices (we service photocopiers) and multi meters that are used to ensure that remanufactured devices are electrically safe. My initial understanding of this line of audit was related to 7.6 - Control of Monitoring and Measuring Equipment. We maintain the calibration of the multi meters and maintain records in respect of 7.6. However, we had never considered test charts under this requirement. I have since reviewed and re-read the requirements of 7.6 and have started to wonder if we have this all wrong as the requirements refer to "determine the monitoring and measurements to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements"... does this requirement relate to the requirements determined by the customer or all requirements of the product including those not specified by the customer but necessary for the specified or intended used. ]]> ISO 9000, ISO 9001, and ISO 9004 - Questions and Discussions glenn0004 http://Elsmar.com/Forums/showthread.php?t=59744 Method Comparison Design Onput Sample Range Requirement http://Elsmar.com/Forums/showthread.php?t=59743&goto=newpost Fri, 17 May 2013 16:00:23 GMT First post, Hi y'all :bigwave:

So when writing a design input for a method comparison requirement would you include the sample range in that requirement? Or would you include it in the SOP?

Here is a simple example using slope. (I am not including other requirements and keeping this ambigious to make this example simple)

Design input - method comparison
Reference method: Predicate device
Acceptance criteria: Slope of 1.0 +/- 0.1

vs

Design input - method comparison
Reference method: Predicate device
Acceptance criteria: Slope of 1.0 +/- 0.1
Sample Range: Sample doses must span the range of 3 to 400 units


What is your opinion? Include the sample range in the requirement or leave it out since the SOP has the sample range information in it.


Cheers ]]> Design and Development - Process and Product danielschaefer http://Elsmar.com/Forums/showthread.php?t=59743 Is there a typical personality type in Quality? http://Elsmar.com/Forums/showthread.php?t=59742&goto=newpost Fri, 17 May 2013 15:30:10 GMT It's just for fun. Is there a common thread to the personalities or characteristics of ppl in the quality field? If so, what traits are most common? I've got my reasons to ask but think it could be fun too. ]]> Coffee Break and Water Cooler Discussions TPMB4 http://Elsmar.com/Forums/showthread.php?t=59742 Comparing laboratory Scope of Accreditation against internal equipment http://Elsmar.com/Forums/showthread.php?t=59740&goto=newpost Fri, 17 May 2013 13:33:11 GMT Sorry if this is a stupid question but I feel REAL clueless on this one. :confused: Had an auditor in here this week and he said I really SHOULD be verifying that the calibration laboratory I use is accredited to calibrate the test equipment I send them. I already have a copy of their latest... Sorry if this is a stupid question but I feel REAL clueless on this one. :confused:

Had an auditor in here this week and he said I really SHOULD be verifying that the calibration laboratory I use is accredited to calibrate the test equipment I send them. I already have a copy of their latest Scope of Accreditation but I am confused on what I should be comparing this against. I'm assuming I need to know what my equipment's capability is and then compare this against the cal lab's scope document? To me this looks difficult especially for items such as an oscilloscope.

Can someone point me in a direction or provide some guidance on how to address this?

Thanks! ]]> ISO 17025 and related Metrology Topics - Measurement Devices, Calibration and Test Laboratories RCW http://Elsmar.com/Forums/showthread.php?t=59740 NIST Standard for CO2 Monitor Calibration http://Elsmar.com/Forums/showthread.php?t=59739&goto=newpost Fri, 17 May 2013 13:10:01 GMT Good Morning, I have a quick question. Is there a NIST standard for Carbon Dioxide monitors ie it actually reads CO2 ppm in air? Thanks, Good Morning,

I have a quick question. Is there a NIST standard for Carbon Dioxide monitors ie it actually reads CO2 ppm in air?

Thanks, ]]> ISO 17025 and related Metrology Topics - Measurement Devices, Calibration and Test Laboratories mguilbert http://Elsmar.com/Forums/showthread.php?t=59739 Quick way to check spline pitch runout for machine operators http://Elsmar.com/Forums/showthread.php?t=59738&goto=newpost Fri, 17 May 2013 12:06:20 GMT Is there a quick way to check spline pitch runout for machine operators? We currently are placing a gage pin in the pitch dia. and picking up in 4-6 places around the circumference with an indicator. It is a slow and inaccurate method. thx. Is there a quick way to check spline pitch runout for machine operators? We currently are placing a gage pin in the pitch dia. and picking up in 4-6 places around the circumference with an indicator. It is a slow and inaccurate method. thx. ]]> Inspection, Prints (Drawings), Testing, Sampling and Related Topics leetimothyj http://Elsmar.com/Forums/showthread.php?t=59738 <![CDATA[Should Internal Audit CAPAs be kept separate from "normal" CAPAs?]]> http://Elsmar.com/Forums/showthread.php?t=59737&goto=newpost Fri, 17 May 2013 10:54:35 GMT Hi Guys, not sure if I am posting on the correct forum but I shall continue anyway. We had a Stage 1 audit for ISO13485 recently and the auditor gave us 1 Major NC, the only major :), for internal audit CAPAs not being linked to normal CAPAS. When we perform internal audits our CAPAs are... Hi Guys,

not sure if I am posting on the correct forum but I shall continue anyway. We had a Stage 1 audit for ISO13485 recently and the auditor gave us 1 Major NC, the only major :), for internal audit CAPAs not being linked to normal CAPAS. When we perform internal audits our CAPAs are attached to the audit form and are uniquley identified. I am really confused as this is what I have always done in previous lives! Is there something I am missing / not understanding?

Any advice from you good people would be appreciated! ]]> ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems Lesley1707 http://Elsmar.com/Forums/showthread.php?t=59737 Auditor approval by AABs already authenticated by another AAB from other sector http://Elsmar.com/Forums/showthread.php?t=59736&goto=newpost Fri, 17 May 2013 08:05:09 GMT Which are the standards or other requirements (Ex IAQG log) describes the requirements of transfer of auditor authentication from one AAB to another? In addition to AS9104-1 clause 10.8 and AS9104-3 clause 7.6 does any other standard asks for recognition of auditor by other AABs,if the auditor... Which are the standards or other requirements (Ex IAQG log) describes the requirements of transfer of auditor authentication from one AAB to another?

In addition to AS9104-1 clause 10.8 and AS9104-3 clause 7.6 does any other standard asks for recognition of auditor by other AABs,if the auditor is already authenticated? ]]> AS9100, Nadcap and related Aerospace Standards and Requirements Joy http://Elsmar.com/Forums/showthread.php?t=59736 CE marking for a X-ray Imaging Detector http://Elsmar.com/Forums/showthread.php?t=59735&goto=newpost Fri, 17 May 2013 06:40:31 GMT Good evening to everyone, My company has developed a flat panel detector to be used for X-ray Imaging. We would like to sell this device but we not sure about what CE marking should be. The device can have both industrial and medical applications. For the medical applications, we would... Good evening to everyone,

My company has developed a flat panel detector to be used for X-ray Imaging. We would like to sell this device but we not sure about what CE marking should be.

The device can have both industrial and medical applications.

For the medical applications, we would like to sell it to a third part manufacturer that, according to Article 12, will assembly it into a medical device system, so being himself responsible to mark the assembled system as a CE MDD.

To my company side, We would like to get a CE marking not as Medical Device avoiding so to go trough a ISO 13485 managment system and all the strict requirements that are asked for MDD.

Flat panel detectors are used a lot also in industrial applications for Imagining purpose. Can anyone help me and give me suggestions on what kind of CE marking (not MDD) is it possible to apply to the detector ?

Thank you so much ]]> CE Marking (Conformité Européene) / CB Scheme alimary15 http://Elsmar.com/Forums/showthread.php?t=59735 <![CDATA[California Food & Drug Branch require components manufacturer to obtain license?]]> http://Elsmar.com/Forums/showthread.php?t=59734&goto=newpost Fri, 17 May 2013 01:34:56 GMT Hi,

First, I'm so appreciative of this forum. Now my question: I've been told that the California Food and Drug Branch (CA FDB) requires that a manufacturer -A-(residing in California) of components that go in another manufacturer's -B- finished medical device must apply for a medical device license. This is according to the Sherman Food Drug and Cosmetics Act (see sections quoted below). I called the CA FDB to ask, and they confirmed it, about the manufacturer of components that go into another's finished device having to be licensed. To me, that seems unreasonable. I can see that finished device contract manufacturers need to apply for a license, but components? Please advise if this is true if you've dealt with CA FDB.

111615. No person shall manufacture any drug or device in this state unless he or she has a valid license from the department...

109920. “Device” means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is any of the following:...
(b) Intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in humans or any other animal.

109970. “Manufacture” means the preparation, compounding, propagation, processing, or fabrication of any food, drug, device, or cosmetic. The term “manufacture” includes repackaging or otherwise changing the container, wrapper, or labeling of any food, drug, device, or cosmetic in furtherance of the distribution of the food, drug, device, or cosmetic. The term “manufacture” does not include repackaging from a bulk container by a retailer at the time of sale to its ultimate consumer

Thank you. ]]> Various Other Specifications, Standards, and related Requirements Ichiban http://Elsmar.com/Forums/showthread.php?t=59734 CDRH Appeals Process - New FDA Guidance Document http://Elsmar.com/Forums/showthread.php?t=59733&goto=newpost Fri, 17 May 2013 01:24:51 GMT Hi All, FDA has released new guidance document from CDRH for Appeals Process. This guidance is intended to replace two earlier guidance docs as below: 1. Medical Device Appeals and Complaints: Guidance for Dispute Resolution (February 1998) 2. Resolving Scientific Disputes Concerning... Hi All,

FDA has released new guidance document from CDRH for Appeals Process.

This guidance is intended to replace two earlier guidance docs as below:

1. Medical Device Appeals and Complaints: Guidance for Dispute Resolution (February 1998)

2. Resolving Scientific Disputes Concerning the Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA (July 2001)

Regards,
Sreenu
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File Type: pdf CDRH guidance on appeal process_May2013.pdf (158.0 KB)
]]> Other US Medical Device Regulation Topics sreenu927 http://Elsmar.com/Forums/showthread.php?t=59733 CE Mark Classification for a a pulmonary function test filter http://Elsmar.com/Forums/showthread.php?t=59732&goto=newpost Thu, 16 May 2013 23:57:30 GMT We are preparing for the CE Mark. Our device, a pulmonary function test filter, seems to be both Class 1, low risk and non-sterile, and Class 2, it inserts into a body orifice (the mouth). Now, the testing can take more than an hour, off and on, but the device is not always in the mouth. If we... We are preparing for the CE Mark. Our device, a pulmonary function test filter, seems to be both Class 1, low risk and non-sterile, and Class 2, it inserts into a body orifice (the mouth). Now, the testing can take more than an hour, off and on, but the device is not always in the mouth. If we declare that our device is Class 1, could the Authorized Representative say that it is not? Could a competitor file a complaint saying that it is not? Do we have to justify our decision to declare our product to be Class 1?
Thanks ]]> CE Marking (Conformité Européene) / CB Scheme jtenrec http://Elsmar.com/Forums/showthread.php?t=59732 Convenient source for finding a listing of changes to BS EN ISO standards http://Elsmar.com/Forums/showthread.php?t=59748&goto=newpost Thu, 16 May 2013 22:44:10 GMT So the situation I'm in is having started recently with a small medical device company. We have neglected our standards library for some time (let's just say a "couple" of years). Our NB has kindly pointed out that our technical files have not kept up with the standards and the state of the art. I have about a dozen crucial standards that I need to catch up with.

Does anyone know of a convenient source for finding a listing of the changes made with the BS EN ISO standards revisions? I would really like to avoid having to read both versions side-by-side playing "spot the change". Thanks. ]]> Various Other Specifications, Standards, and related Requirements bdruthers http://Elsmar.com/Forums/showthread.php?t=59748 Free Mindmaps Tool/Software wanted http://Elsmar.com/Forums/showthread.php?t=59731&goto=newpost Thu, 16 May 2013 21:26:01 GMT HI, I like Minmaps a lot as they are a simple way to come up with several ideas. I would like to ask you if someone has a nice free software/ freeware that can share, to install, to do Minmaps usually, and daily? Thank you for the sharings HI,
I like Minmaps a lot as they are a simple way to come up with several ideas.

I would like to ask you if someone has a nice free software/ freeware that can share, to install, to do Minmaps usually, and daily?

Thank you for the sharings ]]> Quality Tools, Improvement and Analysis amiuda http://Elsmar.com/Forums/showthread.php?t=59731 <![CDATA[Strategic Planning & Management Review]]> http://Elsmar.com/Forums/showthread.php?t=59730&goto=newpost Thu, 16 May 2013 21:08:43 GMT Question ...

I'm doing Management Review as per ISO 9001 Std requirement and ... "Upper" Management is doing Strategic Planning on the side ...

Problem is : Quality Manager (me !) is not invited ... causing frustration not to participate :mad:, questionning the competence of people who is participating in it:mad:, and questions about efficiency of the management review process:mad:. For me, it's like they have a second (or even worse, a hidden) agenda.:notme:

Am I right ?:( What do you think ?:( The Human Resources Manager, a real good guy (I'm sarcastic here):mad:, has succeed to influence the Upper Management (God that they are naive!):( that individuals are part of the "Middle Management" eg Production Manager (I'm not kidding you !:mg:), Quality Mngr.:mg: and Purchasing Mngr:mg:. However, each of these persons listed has minimally a bachelor's degree and a Profesionnal title (which some of this "Upper Management" have not) and a minimum of 10 years experience.:bonk:

When asked why I do not participate (not being invited), we're told that it's because they're talking about sales ... Bull****:mad:. When some details are shown from my boss, we can see clearly that they talk about orientation involving quality, and other issues ...:agree1:

Is it me who does not understand what a strategic planning exercise is ?:bonk::frust:

I'm asking myself serious questions ... ]]> Misc. Quality Assurance and Business Systems Related Topics LesPiles http://Elsmar.com/Forums/showthread.php?t=59730 US Working Permit Requirements for European Consultants http://Elsmar.com/Forums/showthread.php?t=59729&goto=newpost Thu, 16 May 2013 19:26:17 GMT What are the requirements for Europeans wanting to work on short term contracts in the US? Thank you What are the requirements for Europeans wanting to work on short term contracts in the US?

Thank you ]]> Career and Occupation Discussions J0anne http://Elsmar.com/Forums/showthread.php?t=59729 Simplifying Supplier Evaluations for hundreds of Suppliers http://Elsmar.com/Forums/showthread.php?t=59727&goto=newpost Thu, 16 May 2013 18:55:26 GMT Hello, thank you for taking my question. We are a small aerospace distributor that basically uses hundreds of suppliers in any given year. Currently, all suppliers with 3 or more shipments are rated in three categories, On time delivery, Quality of Product, and Ease of doing business. These... Hello, thank you for taking my question.

We are a small aerospace distributor that basically uses hundreds of suppliers in any given year. Currently, all suppliers with 3 or more shipments are rated in three categories, On time delivery, Quality of Product, and Ease of doing business. These individual scores are weighted and totaled the resulting percentage is turned into a "Quality Rating" (100 -97= Excellent; 96-92 Very Good...and so on). Since we use so many different suppliers, the Quality Rating is cumulative and includes all shipments ever made by that supplier since to do otherwise it might take years for one supplier to accumulate enough shipments to get an accurate evaluation.

At a recent surveillance audit for 9120A, an Opportunity for Improvement was given to simplify our rating system and only use shipments from a supplier occurring in say, the past 6 months in our evaluations. I was told that no one uses cumulative shipments beyond that and that using every shipment ever made by that supplier was not appropriate. I contend, however, that because we sometimes don't use a supplier again for much more than 6 months, it would be very difficult to get an accurate rating on any one supplier.

So, I am confused on how to proceed. The system I use seems to work for us and I hesitate to change it however, given that Opportunity for Improvement I feel that I must at least try.

I would appreciate any thoughts on this issue. Thank you. ]]> Supplier Quality Assurance and other Supplier Issues Mary2962 http://Elsmar.com/Forums/showthread.php?t=59727 How to go about package validation on a class II, non-sterile device http://Elsmar.com/Forums/showthread.php?t=59726&goto=newpost Thu, 16 May 2013 17:23:33 GMT Hi All,
We have a class II non-sterile device ("sensor patch") that we are trying to do package validation on. the product goes into a high barrier 3"x6" pouch. I was not sure if I need to follow all the requirements from ISO 11607. we are also in process of applying for our CE mark.
Do we really need to meet all the requirements of Packaging for terminally sterilized medical devices? if not, how should we go about selecting the test cases that are required? we are thinking about conducting ASTM F-88 for seal strength and ASTM F2096 for bubble leak.
we were going to do Accelerated heat aging per ASTM F1980 after conducting the tests above.
Do we really have to conduct ISTA 2A – Environmental Conditioning and ASTM 4169 DC-13 (Typical Fed Ex and UPS shipping environment)?
any feedback is greatly appropriated. ]]> US Food and Drug Administration (FDA) rodm2001 http://Elsmar.com/Forums/showthread.php?t=59726 Decrease frequency of inspection based on results http://Elsmar.com/Forums/showthread.php?t=59725&goto=newpost Thu, 16 May 2013 17:02:26 GMT Dear Friends, i have an issue: I`m using this kind of inspection in my process: 1. in line control (automatic) 2. measurement/visual control by operator in line 3. next check by quality technician 4. randon outgoing check I collect a data. Some results are good, some not so much... Dear Friends,
i have an issue:
I`m using this kind of inspection in my process:
1. in line control (automatic)
2. measurement/visual control by operator in line
3. next check by quality technician
4. randon outgoing check

I collect a data. Some results are good, some not so much...

I would like to have some kind of statistical tool which will help
me to decide HOW many samples I have to collect on each batch size to achieve my target ppm.
I dont want AQL. it is, let say, not supported by my company.

Is there any way how to decide on ppm level how many parts to check visualy and how many to measurement ?

Or any other ideas ? Do you have some experiences with decreasing frequency of measurement ? Please come with ideas.
My self is very opened ;)

Just for information: we are speaking about automotive industry, very strict ppm levels and lot of critical characteristics (also with goverement regulations)

Thanks for support ! ]]> Inspection, Prints (Drawings), Testing, Sampling and Related Topics Michal Jahodka http://Elsmar.com/Forums/showthread.php?t=59725 I want to test quiz ISO 14001 http://Elsmar.com/Forums/showthread.php?t=59724&goto=newpost Thu, 16 May 2013 16:16:01 GMT I want to test quiz ISO 14001 who can help me to find a website to test ISO 14001 Thanks :bigwave: I want to test quiz ISO 14001
who can help me to find a website to test ISO 14001
Thanks :bigwave: ]]> ISO 14001 and Environmental Related Standards mattroilan2008 http://Elsmar.com/Forums/showthread.php?t=59724 Can Buyer stipulate that all product quality efforts be directed straight through her http://Elsmar.com/Forums/showthread.php?t=59723&goto=newpost Thu, 16 May 2013 16:06:27 GMT Good morning Covers! I've been working in the QE role for a privately-owned contract manufacturer for about 3 yrs. For at least the past decade, we've been supplying Class I disposable components for power tool medical devices to several OEMs.

We're currently struggling with implementing CAPA and related actions for one of our Customers. I've written action plans which have rec'd internal approvals, but have been unable to elicit consistent guidance. IMO, a major reason for our difficulties is that the Buyer has mandated several times that all discussion/approval of actions be routed directly through her as the primary (only authoritative?) contact. The practices/ shifting demands/ of this individual consistently deflect/ ignore our good faith efforts to propose solutions to an escalating number of complaints. This Buyer's tendency to either not respond, or set aside discussions between our respective Engineering dept. as subject to her (indefinitely?) delayed review is causing headaches from our CS rep, up to our chief onsite executive.

Frankly, I'm finding myself wishing for the interactions provided by one of our (BIG) OEM Customers. While (often very) demanding, their SQEs are an authority which definitely drive implementation/closure of CARs, and true improvement...

Do I have a right to demand a Customer SQA contact as the primary contact on these efforts?

These issues are only growing, as frankly I don't have practical authority to delay continued Production to a range of open affected p/n which is distressingly growing due to failure to close issues which, after a few contentious e-mails assigning blame for (our) problem, seem to lose urgency in the Buyer's focus in favor of "Today's" new issue regarding "Today's" hot urgent part!

Any help would be greatly appreciated; if I can solve this (personality-driven?) bottleneck I might just become the "Hero of the Day" around here!!! ]]> Supplier Quality Assurance and other Supplier Issues Roberticus http://Elsmar.com/Forums/showthread.php?t=59723 Auditing Human Resources http://Elsmar.com/Forums/showthread.php?t=59722&goto=newpost Thu, 16 May 2013 15:56:15 GMT We have a Human Resources Manager who I have never audited, it was never mentioned the last time I had a re-certification audit. Would it be necessary or a good idea to audit them. Clause 6.22 I covered when auditing the other departments. We have a Human Resources Manager who I have never audited, it was never mentioned the last time I had a re-certification audit. Would it be necessary or a good idea to audit them. Clause 6.22 I covered when auditing the other departments. ]]> ISO 9000, ISO 9001, and ISO 9004 - Questions and Discussions DougieB http://Elsmar.com/Forums/showthread.php?t=59722 Calculation of Contamination Reduction Efficiency http://Elsmar.com/Forums/showthread.php?t=59720&goto=newpost Thu, 16 May 2013 14:31:21 GMT Hi all, Our end product is recycled plastic chips, we have two end product streams from the same main stream source. One of the two streams gets an extra treatment to reduce a contaminant. On both end streams QC measurments are being carried out regarding this contaminant. Now I can see... Hi all,

Our end product is recycled plastic chips, we have two end product streams from the same main stream source. One of the two streams gets an extra treatment to reduce a contaminant.

On both end streams QC measurments are being carried out regarding this contaminant.

Now I can see clearly in the YTD data of the measurement that the treatment of one stream gives a reduction compared to the non treated stream.

Let say the non treated stream has an avarage of 100ppm spread +/- 40ppm and the treated stream has an avarage of 30ppm spread +/- 20ppm

Can I just calculate the reduction efficiency by average or is there a better way to calculate the efficiency of the reduction by using the data sets of the QC measurements, on this contaminant, of the two end streams.

Thanks for advice! ]]> SPC Monitoring and Statistical Analysis Techniques 01mercy http://Elsmar.com/Forums/showthread.php?t=59720 TS 16949 Consultants in New Delhi (India) http://Elsmar.com/Forums/showthread.php?t=59719&goto=newpost Thu, 16 May 2013 11:56:50 GMT Hello friends, Our organization has decided to go for TS 16949 certification. Can you please suggest some good consultants in New Delhi (India). Regards Lakshit Seth Hello friends,
Our organization has decided to go for TS 16949 certification. Can you please suggest some good consultants in New Delhi (India).


Regards
Lakshit Seth ]]> ISO 10019 - Consultants and Consulting lakshit http://Elsmar.com/Forums/showthread.php?t=59719 Variable Dimensions / Part of Production / PPAP Dimensional Report http://Elsmar.com/Forums/showthread.php?t=59718&goto=newpost Thu, 16 May 2013 08:27:35 GMT With PPAP dimension reports what do you do if, as part of the production process, you end up adjusting one dimension to get the others right? The adjustment is needed to make the more important dimensions/criteria right. A significant number will be just outside the tolerances. The product is... With PPAP dimension reports what do you do if, as part of the production process, you end up adjusting one dimension to get the others right? The adjustment is needed to make the more important dimensions/criteria right. A significant number will be just outside the tolerances. The product is functionally fit for purpose and would not be noticed by the customer. In fact the last measurement in the Dimension Report is not really needed.

What are the implications if one dimension gets reported as NOK in a Dimension Report? Is it better to leave of the measurement or put it in exactly as it is measured? Perhaps the tolerance is too small and the drawings need changing to reflect this? Perhaps its not worth causing the hassle and just leave it off? I'm sure some companies just make it up too. ]]> Inspection, Prints (Drawings), Testing, Sampling and Related Topics TPMB4 http://Elsmar.com/Forums/showthread.php?t=59718 Insulin Pen Injector Storage Requirements http://Elsmar.com/Forums/showthread.php?t=59717&goto=newpost Thu, 16 May 2013 07:45:34 GMT Dear Elsmar cove member, :bigwave: Our company is working on insulin pen inejctos - both reusable and disposable. We outsource the design to an external design supplier. The reusable pen injector is both metallic and plastic, while the disposable pen is only plastic. We have studied the pen... Dear Elsmar cove member, :bigwave:

Our company is working on insulin pen inejctos - both reusable and disposable. We outsource the design to an external design supplier. The reusable pen injector is both metallic and plastic, while the disposable pen is only plastic. We have studied the pen injectors of many different innovators and i found that the reusable pens should never be refrigerated, while the disposable pens should be refrigerated before use.
I can understand the requirement of the disposable pens to be stored in the refrigerator as it is because of the drup product which is integrated into the device.
Can anyone explain why the reusable pen should not be stored in the refrigerator? Is it something related to the mechanics of the device, which can affect the functionality of the device? :confused:

Thanks
Sree ]]> Other Medical Device and Orthopedic Related Topics sreeranjini http://Elsmar.com/Forums/showthread.php?t=59717 Is my Internal Audit Plan on the right track? http://Elsmar.com/Forums/showthread.php?t=59716&goto=newpost Thu, 16 May 2013 05:59:57 GMT aaaaaaaaaa aaaaaaaaaa ]]> Internal Auditing kgott http://Elsmar.com/Forums/showthread.php?t=59716 Engineering Change Management Generic Procedure http://Elsmar.com/Forums/showthread.php?t=59713&goto=newpost Wed, 15 May 2013 20:30:53 GMT Hello,

I have been researching this process and being very new to it I am getting a bit confused at times. We are a manufacturing facility that produces our own line of IBOP's and Safety Valves for the oilfield. Would anyone have a generic procedure that I could take a look at and hopefully clear this up for me? I know that it is a fairly legnthy process with the ECO, ECN, Implementation, ect. Any help would be greatly appreciated. ]]> Manufacturing and Related Processes MMINT http://Elsmar.com/Forums/showthread.php?t=59713 Scope of ISO 13485 Certification needs the word Production. http://Elsmar.com/Forums/showthread.php?t=59712&goto=newpost Wed, 15 May 2013 19:42:26 GMT Hello everyone, we are a very small company (4 people), and started as a distributor for medical devices. Meanwhile, we expanded our business and estabilished a contract with an asian manufacturer, providing 3 medical devices under our name. Also I need to say, that we do not design or... Hello everyone,

we are a very small company (4 people), and started as a distributor for medical devices.

Meanwhile, we expanded our business and estabilished a contract with an asian manufacturer, providing 3 medical devices under our name. Also I need to say, that we do not design or develop.

Now, we intent to implement the ISO 13485 and want the scope to be similiar to this: "production and distribution of...". We need the word production included in our scope.

According to the ISO 13485, is there any problem with this? Technically our company is the manufacturer.

Best regards,

Paulo ]]> ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems dampiro http://Elsmar.com/Forums/showthread.php?t=59712 Calibration and Measuring Device Labeling Requirements http://Elsmar.com/Forums/showthread.php?t=59711&goto=newpost Wed, 15 May 2013 17:38:29 GMT Just recently completed an external audit for 9001:2008 / 13485:2003 (dual registrations). During the audit it was discovered we were using a non-calibrated tape measure in our assembly process. We were not written a non-conformance however the auditor (without consulting) mentioned the use of "for reference only" stickers to be applied to devices that were used for non-critical measure of product. So... our performance review team chewed on this a while and everyone is now worried we have to label every ruler in the building (in the admin desk etc...) "for reference" and that we must determine what tolerance constitutes a 'critical measurement'.

So the questions are... Who has experience in this sort of ISO issue? How did you resolve it?
Where / how do we draw the line between guaranteeing quality customer product and maintaining a level of sanity & reason about how we label and define our system and processes?

Im curious (and new to QMS).

many thanks,
w. ]]> Quality Management Related Issues WilBryan http://Elsmar.com/Forums/showthread.php?t=59711 <![CDATA[Where are shipping & receiving processes covered under TS 16949]]> http://Elsmar.com/Forums/showthread.php?t=59710&goto=newpost Wed, 15 May 2013 16:58:57 GMT I don't know why I'm having a "brain freeze" over this, but, where are shipping & receiving processes covered under TS?

If an auditor wanted to write up something they didn't like in shipping, what clause would they put it under?

Rick ]]> ISO/TS 16949 - International Automotive Quality Systems Standard rickmcq http://Elsmar.com/Forums/showthread.php?t=59710 IRS and AP Issues - 2013 http://Elsmar.com/Forums/showthread.php?t=59709&goto=newpost Wed, 15 May 2013 15:30:47 GMT Nothing on the latest issues posted here. IRS and AP. Any thoughts? Nothing on the latest issues posted here. IRS and AP. Any thoughts? ]]> Controversial Discussion Topics mguilbert http://Elsmar.com/Forums/showthread.php?t=59709 What kind of data is expected for a PPAP Material Analysis Report http://Elsmar.com/Forums/showthread.php?t=59708&goto=newpost Wed, 15 May 2013 14:54:01 GMT Hello All,

Need help.

What kind of data is expected to be filled in for this form (please refer to attachment) ?

For dimensional items, we already have separate form, namely "Dimensional Result".

Is it something related to RoHS. In this case, then we need to break-down each part to its material for analysis on environment hazardous substances eg. Pb, Cd, Hg, etc.

Please let me know how you deal with this so far.

Thank you very much!
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]]> ISO/TS 16949 - International Automotive Quality Systems Standard whtan02 http://Elsmar.com/Forums/showthread.php?t=59708