The Elsmar Cove Forum http://Elsmar.com/Forums/ ISO 9001, Medical Device, and TS 16949 (automotive) and Business Standards Compliance Requirements en Thu, 17 May 2012 05:22:46 GMT vBulletin 10 http://elsmar.com/Forums/images/misc/rss.jpg The Elsmar Cove Forum http://Elsmar.com/Forums/ <![CDATA[Has anyone used "Paradigm 3" software?]]> http://Elsmar.com/Forums/showthread.php?t=54566&goto=newpost Thu, 17 May 2012 05:11:20 GMT Has anyone used the software "Paradigm 3" to control their Quality, or other, Management System?

Any feedback, hints or tips?

Thanks :) ]]> Quality Tools, Improvement and Analysis Meggsy http://Elsmar.com/Forums/showthread.php?t=54566 What is clause ISO9001:2008 for Acc/Rej Criteria and Verifying QA process http://Elsmar.com/Forums/showthread.php?t=54565&goto=newpost Thu, 17 May 2012 04:20:14 GMT All,
May I like to know which clause of ISO9001 for I want to input relevent clause about QC .
Acceptance & Rejection Criteria
Are acceptance & rejection criteria specified for different
process parameters and product tested by IPT?
Have you prepared overall inspection test plan covering
referance of work instruction, acceptance criteria,format and
parameters tested for different types of products for
incoming
inprocesss
and final stage of inlspection?
Verifying
Are you inspecting/verifying all the critical products
new develpments products or
purchased materials?
How any records are kept for the same?
I wonder am I put cluse 8.2.4 , right?
Are you testing raw materials?How?




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]]> Internal Auditing THEERANART http://Elsmar.com/Forums/showthread.php?t=54565 Procedure on How to Calibrate a External Micrometer http://Elsmar.com/Forums/showthread.php?t=54564&goto=newpost Wed, 16 May 2012 23:28:28 GMT Complete procedure according to standards. Complete procedure according to standards. ]]> ISO 17025 and related Metrology Topics - Measurement Devices, Calibration and Test Laboratories Dearbace http://Elsmar.com/Forums/showthread.php?t=54564 Traceability Requirements for Computer Hardware Equipment under ISO 13485 http://Elsmar.com/Forums/showthread.php?t=54563&goto=newpost Wed, 16 May 2012 21:22:53 GMT Hello, After a recent TUV inspection my firm received a letter stating that the requirement for tracking assets such as laptop computers hasn’t been met. Could someone please help me understand where this is stated in ISO 13485? The only computer related requirements in ISO 13485 have to do... Hello,
After a recent TUV inspection my firm received a letter stating that the requirement for tracking assets such as laptop computers hasn’t been met. Could someone please help me understand where this is stated in ISO 13485? The only computer related requirements in ISO 13485 have to do with software, and not the actual hardware itself. Since all employee computers have unique identifiers which are recorded at the time of distribution, it seems redundant to have to address this all over again. I would like to understand where this requirement comes from and how we can demonstrate compliance with it.
Thank you in advance for sharing your wisdom! ]]> ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems FongPi http://Elsmar.com/Forums/showthread.php?t=54563 SPC Newbie looking for Excel Spreadsheet formula for a sample size of 40 components http://Elsmar.com/Forums/showthread.php?t=54562&goto=newpost Wed, 16 May 2012 20:55:27 GMT Help, our company is new to having to do any type of spc but a new customer is requesting spc on some parts we are doing for them, does anyone have any excel spreadsheet formula for a sample size of 40 components that i can have a look at.......:notme: Help, our company is new to having to do any type of spc but a new customer is requesting spc on some parts we are doing for them, does anyone have any excel spreadsheet formula for a sample size of 40 components that i can have a look at.......:notme: ]]> Capability, Accuracy and Stability - Process, Machine, etc. f1guru http://Elsmar.com/Forums/showthread.php?t=54562 Animal Tissue (Pericardium) Engineering Process Control http://Elsmar.com/Forums/showthread.php?t=54561&goto=newpost Wed, 16 May 2012 17:27:46 GMT Hi, Can someone describe a general description of the process control (what to control and how) of the engineering of animal tissue, that is from tissue (pericardium) from porcine there is a decellurization of all the living cells and dna of the animal tissue, however the process maintains a... Hi,

Can someone describe a general description of the process control (what to control and how) of the engineering of animal tissue, that is from tissue (pericardium) from porcine there is a decellurization of all the living cells and dna of the animal tissue, however the process maintains a structure (scaffold)that allows the patients cells to regenerate on it. It is a medical device implant.

Any considerations of the critical aspects to look in supplied material (what to specify as acceptance criteria), during process and final product acceptance criteria.

Any thoughts on this it will be much appreciated,

england ]]> US Medical Devices (21 CFR part 820) England http://Elsmar.com/Forums/showthread.php?t=54561 Documents vs. Forms - Is there any difference? http://Elsmar.com/Forums/showthread.php?t=54560&goto=newpost Wed, 16 May 2012 16:54:01 GMT Hello, I have recently taken on the ISO responsabilitys at my company. After reveiwing the QMS, I found that we have 56 different documents and/or forms. And I have a few questions. 1) Is there an actual difference between calling something a form or a document? (The former Quality Manager... Hello, I have recently taken on the ISO responsabilitys at my company. After reveiwing the QMS, I found that we have 56 different documents and/or forms. And I have a few questions.

1) Is there an actual difference between calling something a form or a document? (The former Quality Manager calls them both names throughout the QMS manual)

2) Do all forms / documents require a document number and revision level on them?

3) Do I need document numbers and revision levels on printed documentation generated from our MRP Sytem? (i.e. PO, packing slip, RMA, etc...)

Most of these forms / documents are redundent and I plan on removing or modifying as many as I can to decrease the amount we have.

Thank you
Griff23 ]]> ISO 9000, ISO 9001, and ISO 9004 - Questions and Discussions Griff23 http://Elsmar.com/Forums/showthread.php?t=54560 <![CDATA[How to Show "Date/time" Data Graphically in Minitab Please?]]> http://Elsmar.com/Forums/showthread.php?t=54559&goto=newpost Wed, 16 May 2012 15:22:17 GMT Hi guys,

I want data that shows alarms going off at particular time/dates.

How can I best show this on Minitab? Scatterplot seems a good way to go, but I just a get an irregular line of dots - it doesn't look too good!

A sample of the data is:

05/01/2012 12:01
05/01/2012 12:01
05/01/2012 12:02
05/01/2012 12:02
05/01/2012 12:02
05/01/2012 12:02
05/01/2012 12:04
05/01/2012 12:05
05/01/2012 12:06
05/01/2012 12:06
05/01/2012 12:08
05/01/2012 12:09
05/01/2012 12:10
05/01/2012 12:10
05/01/2012 12:14
05/01/2012 12:15
05/01/2012 12:17
05/01/2012 12:17
05/01/2012 12:21
05/01/2012 12:21

Each time/date is when an alarm goes off - I just want to show, graphically, how often alarms are sounding and if more than one goes off at once, so I can spot trends and see if there are less alarms sounding after process improvements.

Thanks for any help! ]]> Using Minitab Software timmywimmy http://Elsmar.com/Forums/showthread.php?t=54559 Major NADCAP Magnetic Inspection Nonconformance - How to answer it? http://Elsmar.com/Forums/showthread.php?t=54557&goto=newpost Wed, 16 May 2012 12:22:30 GMT "2 compliance jobs were inspected to technique instruction that require a coil shot on each individual component whos L/D ratio is less than the 2:1 minimum. The techniques do not require the use of extenders to increase the L/D ratios."

i know (because we've checked) the parts were magnetized, i know the root cause (the techique instructions are approved by the former level 3 in the method, and the new level 3 has not revised them)
i dont know if this could be an acceptable route cause for NADCAP.

any advice in how to answer this one?

:thanx: ]]> Nonconformance and Corrective Action coman http://Elsmar.com/Forums/showthread.php?t=54557 ISO/TS 16949 Cl 7.5.1 a) - Characteristics of the Product - Need Clarification http://Elsmar.com/Forums/showthread.php?t=54556&goto=newpost Wed, 16 May 2012 12:04:36 GMT Hi all May someone explain me about the requirement of clause 7.5.1 a): *the availability of information that describes the characteristics of the product*, What is information that describes the characteristics of the product? What are the most typical ways to make production information... Hi all
May someone explain me about the requirement of clause 7.5.1 a):
the availability of information that describes the characteristics of the product,
What is information that describes the characteristics of the product?
What are the most typical ways to make production information available?
Thanks all ]]> ISO/TS 16949 - International Automotive Quality Systems Standard morteza http://Elsmar.com/Forums/showthread.php?t=54556 <![CDATA[Determining the "Detection" Number Component of the FMEA RPN]]> http://Elsmar.com/Forums/showthread.php?t=54555&goto=newpost Wed, 16 May 2012 10:17:50 GMT Here's the scenario...

Failure Mode: Cap Weld Bead Off Center
Effect of Failure: Damper Leak
Potential Cause: Torch Position Off Location
Prevention: Torch Position Check (at Start up and Re-Teach)
Detection: Leak Test
Visual Check of work piece (100%)
Tensile Strength Test (at Start up and Re-Teach)
Weld Penetration (at Start up and Re-Teach)

The Question is what is the "Detection" component of the RPN?


The are multiple checks for this cause...how do you determine the number when that is the case? ]]> FMEA and Control Plans GoKats78 http://Elsmar.com/Forums/showthread.php?t=54555 Frequency of Re-Testing Working Standards (Secondary Reference Standard) http://Elsmar.com/Forums/showthread.php?t=54554&goto=newpost Wed, 16 May 2012 09:48:01 GMT Hi, I have read all guidelines from ICH Q7, Annex 3 WHO, EU GMP etc to find the timeline of re-testing of a working standard. All guidelines mention that there should be periodic re-testing of the working standard against the primary reference standard ( supplied by official pharmacopoeia).... Hi,

I have read all guidelines from ICH Q7, Annex 3 WHO, EU GMP etc to find the timeline of re-testing of a working standard.

All guidelines mention that there should be periodic re-testing of the working standard against the primary reference standard ( supplied by official pharmacopoeia). However they do not state the time line e.g., yearly, 2 year or so.


May I ask for the assistance to know, ''what should be the frequency of working standards re-testing ?''.

Many thanks in advance. ]]> Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and other related Regulations) jayeshs82 http://Elsmar.com/Forums/showthread.php?t=54554 <![CDATA[Corrective Actions - Communication Management & Tools]]> http://Elsmar.com/Forums/showthread.php?t=54553&goto=newpost Wed, 16 May 2012 09:11:20 GMT Hi all, I want to ask a few specific questions here regarding the issues I face managing the CA process. Some of them are already answered on this forum but I have additional questions which I will make clear. *- How do you manage communication by mail with i.e. a customer?* Our company... Hi all,

I want to ask a few specific questions here regarding the issues I face managing the CA process. Some of them are already answered on this forum but I have additional questions which I will make clear.

- How do you manage communication by mail with i.e. a customer?
Our company uses a DB app with a standard format, the problem is that in the "attachement part" mailings are followed up and the result is that the formal parts of a CA in this form are not writen down anymore as if "it's all in the mails". How to change this and still be able to archive mail communication?

- How do you deal with people that are responsible but do not go into the details?

- What tools do you use to analyze and identify actions i.e. 8D reports.
Much CA's can be handeled just by reporting in a standard simple template (root-cause, action taken, corrective action to implement). Big issues usually need a 8D investigation. That leaves me with all the issues that are in between does anyone have a "light 8D" template or some other alternative?

- When reporting (CAR, 8D) or any other CA related report, do you apply any structure in reporting to secure a logical followup of actions over time?

Thanks all for your input! ]]> Preventive Action and Continuous Improvement 01mercy http://Elsmar.com/Forums/showthread.php?t=54553 Seeking to learn English Video and Suggestions - I am Chinese http://Elsmar.com/Forums/showthread.php?t=54552&goto=newpost Wed, 16 May 2012 08:20:16 GMT hi, everyone, nice to meet you! i find this forum occasionally and very useful for me; i come from China and now i have been working wireharness manufacture and act as quality engineer, in charge of establish and maintain system incluing ISO9000, ISO14001, EICC etc; and conducting inner... hi, everyone, nice to meet you!

i find this forum occasionally and very useful for me;

i come from China and now i have been working wireharness manufacture and act as quality engineer, in charge of establish and maintain system incluing ISO9000, ISO14001, EICC etc; and conducting inner audit and management review; and handling quality discrepancy with responsibilities dept and so on!

however, i want to communicate with everyone fluently that are so diffcult as my english not well!

therefore, i don't know anyone can provide some learning english video;
if it is relate to quality training& quality tools training&daily life communication method that would be better!

i will be appreciate if you can provide any idea! and also i hope to make friend with you, if you have interested pls add skype:flyengle-sheng!

many many thanks! ]]> Coffee Break and Water Cooler Discussions ssz102 http://Elsmar.com/Forums/showthread.php?t=54552 Sample Size based on Process Capability Indices (Pp/Ppk)? http://Elsmar.com/Forums/showthread.php?t=54551&goto=newpost Wed, 16 May 2012 06:56:34 GMT One of my customers told me that one of his customers has shown him a paper which provides sample sizes depending on process capability indices (Pp/Ppk). With this method appropriate sample sizes for process validation could be picked out of a table (without further knowledge about mean, variation,... One of my customers told me that one of his customers has shown him a paper which provides sample sizes depending on process capability indices (Pp/Ppk). With this method appropriate sample sizes for process validation could be picked out of a table (without further knowledge about mean, variation, tolerance limits, etc.)

A colleague said that there are "rumors" an interesting paper has been published in which this method is described in detail. (Unfortunately he doesn't know who the author is or where this paper was published and I couldn't find anything in the www).

AFAIK the sample size for Pp/Ppk could be determined based on the accuracy of process capability indices (width of confindence intervals for Pp/Ppk with respect to max. type I error alpha / confidence level 1-alpha), but I haven't seen a method for sample sizes in process validation which takes both error types into account (maximal tolerable risks for type I & type II error / alpha & beta).

Hopefully someone in the Cove could provide further informations about this "sample size based on Pp/Ppk"-method!

Regards,

Barbara :bigwave: ]]> Capability, Accuracy and Stability - Process, Machine, etc. Barbara B http://Elsmar.com/Forums/showthread.php?t=54551 Quality System followed/executed in the Consumer Electronics Industry http://Elsmar.com/Forums/showthread.php?t=54550&goto=newpost Wed, 16 May 2012 01:52:54 GMT What is the Quality System followed/executed in the Consumer Electronics Industry ? What is the Quality System followed/executed in the Consumer Electronics
Industry ? ]]> Various Other Specifications, Standards, and related Requirements QE http://Elsmar.com/Forums/showthread.php?t=54550 AS9101 Process Effectiveness Assessment Report/Nonconformance Record Review Modules http://Elsmar.com/Forums/showthread.php?t=54549&goto=newpost Wed, 16 May 2012 01:23:27 GMT I am sure other OASIS registered members have received the following email: ---Quote--- To: ICOP Accreditation Bodies and Certification Bodies From: Rick Downs The message below is going out to all individuals that have taken the AATT course. We wanted to make you aware of this guidance... I am sure other OASIS registered members have received the following email:
Quote:
To: ICOP Accreditation Bodies and Certification Bodies
From: Rick Downs
The message below is going out to all individuals that have taken the AATT course. We wanted to make you aware of this guidance module as it will help clarify many questions regarding the completion of PEARs and NCRs resulting from certification audits for 9100/9110/9120:2009.
Thank you,
Rick Downs

IAQG Sanctioned Training Team Chair
The International Aerospace Quality Group (IAQG) is proud to announce the launch of the IAQG 9101 Process Effectiveness Assessment Report (PEAR) and Nonconformance Record (NCR) Review module. This module will be offered free of charge to all current and future IAQG Platform users who paid or will pay for the 9100 Online Component. It is available to English Platform users at this time. To access the module, please go to www.iaqgtraining.com and login with your email and password. You will find the module listed directly on the main screen after you login.
In an effort to improve the overall effectiveness of 9101 audit reporting, the IAQG formed an IAQG Other Party Management Team (OPMT) Audit Report Review Sub-Team. The team was tasked with reviewing completed 9101:2009 audit reports and providing feedback to stakeholders in the ICOP process.
The PEARs and NCRs provided in the online training module are actual PEARs and NCRs that were previously uploaded into the OASIS (Online Aerospace Supplier Information System) database, although references to the actual suppliers and auditors have been removed. The PEARs and NCRs have been reviewed by the IAQG OPMT Audit Report Review Sub-Team in conjunction with the 9101 Sector Document Representatives (SDRs) and the IAQG Document Representative (IDR).
The comments and recommendations were developed and reviewed by the Sub-Team, Sector Document Representatives (SDRs) and International Document Representative (IDR) for 9101 in order to provide clear, sanctioned feedback to ICOP stakeholders. It is important to note, that in most cases, the Sub-Team is not stating the PEAR is incorrect but rather it can be improved. However, it is clear the information recorded, in some examples, is simply insufficient and does not meet the intent of the 9101 standard. Included in the online training module are examples of what would be considered a best practice in completing the PEAR and NCRs.
]]> AS9100, Nadcap and related Aerospace Standards and Requirements Sidney Vianna http://Elsmar.com/Forums/showthread.php?t=54549 Resources for creating Process Validation Procedures http://Elsmar.com/Forums/showthread.php?t=54547&goto=newpost Tue, 15 May 2012 23:07:35 GMT Up until now, we have taken an exception, in ISO 13485, to process validation, on the premise that we do not have any "special processes" whose output cannot be verified by subsequent measuring and monitoring. We have passed all of our ISO audits with this being the case.
Now, however, we are getting a lot of customers who don't care about that, and are insisting that we perform Process validation (IQ/OQ/PQ) for their products anyway. I should say, at this point, that we are a contract manufacturer of components for medical devices. We do not make any actual devices here.

What I'm looking for, is a good resource (book/website, etc.) to help me put together procedures, protocols, forms, etc., having had virtually no experience, thus far, with any sort of validation activities. I need to have the whole system completed, and ready to roll by the end of June.

Any help at all would be greatly appreciated! Thanks! ]]> Qualification and Validation (including 21 CFR Part 11) cubix rube http://Elsmar.com/Forums/showthread.php?t=54547 EASA Regulatory Requirements for Electronics Contract Manufacturer http://Elsmar.com/Forums/showthread.php?t=54546&goto=newpost Tue, 15 May 2012 21:14:52 GMT Hi, I work for an electronics company that manufactures products to customer requirements. We are certified to AS9100C, excluding the design clause as we are a contract manufacturer. I have recently been approached with a question relating to our compliance with the requirements of the EASA... Hi,

I work for an electronics company that manufactures products to customer requirements. We are certified to AS9100C, excluding the design clause as we are a contract manufacturer. I have recently been approached with a question relating to our compliance with the requirements of the EASA (European Aviation Safety Agency).

My question is, as a contract manufacturer must we comply with the requirements of the EASA or indeed the CAA (Civil Aviation Authority), as we are based in the UK, or is this covered by our customers.

Thanks in advance, ]]> AS9100, Nadcap and related Aerospace Standards and Requirements JoCam http://Elsmar.com/Forums/showthread.php?t=54546 Micrometer Parallelism and Flatness Calibration Requirements and Specs http://Elsmar.com/Forums/showthread.php?t=54545&goto=newpost Tue, 15 May 2012 20:37:34 GMT I'm going to re read the following document (ASME B89.1.13-2001 Micrometers) but my question is...

Is there a requirement that the Flatness and Parallelism needs to be verified during a calibration event?

If so is there an Industry Standard that states this?

Is there a document that lists a general tolerance for Flatness and Parallelism or is this still going to mfg. specific?

Thanks ]]> ISO 17025 and related Metrology Topics - Measurement Devices, Calibration and Test Laboratories CLaurenceH http://Elsmar.com/Forums/showthread.php?t=54545