SBS - The best value in QMS software

Virtual Office and Multi-Site Registration: Including the FedEx Registration

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#11
Subject: Re: ISO 9001 Certified Virtual Office /../Andrews/Dey/Kozenko
Date: Thu, 8 Jul 1999 15:58:23 -0600
From: ISO Standards Discussion

From: Write9000
Subject: Re: ISO 9001 Certified Virtual Office /../Andrews/Dey/Kozenko

> By failing to meet a contract [requirement], for example by delivering
>late, one is not amending the contract. One is failing to meet it.
>
Pat:

I agree completely, and to put it in the "lingo" of contract professionals, failing to meet a delivery date is in fact a default of contract, for which there are two different types of remedies (for the purpose of our discussion List): (1) legal remedies and (2) quality system remedies.

This is all I have to say about "legal" remedies:

The last time I read any of the fine print on any of the providers of express (that is, "one day") delivery service providers' packages and bills of lading, I found exculpatory language to the effect that the service provider would only apply "best efforts" to the intended "overnight" delivery...

The remainder of this post is about quality system remedies...

At first, the exculpatory language of the contracts people made me angry. I wanted to believe that my company's twenty bucks could somehow GUARANTEE overnight delivery. Then I gave some thought to my company's own personnel, and the fact that, converted into light bulbs, some of them couldn't illuminate the crawl space underneath my basement stairs (relative position in the management organization notwithstanding...).

What we're actually dealing with here is the "degree of risk" that ISO (9001:1994) talks about in Clause 4.14, Corrective and Preventive Action, which in part I quote:

"Any corrective or preventive action taken to eliminate the causes of actual or potential nonconformities shall be to a degree appropriate to the magnitude of the problems and commensurate to the risks encountered."

Now I'm going to risk offending a lot of list readers, and put that statement of the Standard into a business perspective meaningful to Fed X (and I don't even work for Fed X, but it's a great opportunity to applaud the Standard as written...)

If I were the CEO of Fed X, I wouldn't care if YOUR package didn't get delivered on time, truly...

I would care if perhaps, a THOUSAND packages sent from your "sending location" did not get delivered on time. And why is that?

My reasoning would be this: It's totally absurd to believe that every package taken to any Fed-X counter in any location everywhere every day is going to reach its intended destination on time (that is, tomorrow...) and anyone who believes this of any express carrier is not living in the real world... My experience as a contracts manager taught me that cover letters for Bids and Responses to RFP's and RFQ's for public agencies (with totally strict bid-date received-by deadlines) should contain the text, "This Proposal may have been received in duplicate original(s)..." and that several (two, and perhaps more than two...) providers of express delivery services should be used (even for USPS bids, and don't think that part of quality is funny...).

You learn to think this way the first time one of those so-called "express" delivery service providers fails to meet your intended contractual requirements, and your bid for (say) $20 million in professional services is not even considered because it arrived a day late (and, of course, everyone knows the business development VP is going to hand you one "original" of the bid at 8:30 pm the day before it's due, knowing full well that the express shipment stations for any express services all close at 9 pm at the airport, which is 20 minutes away...); and when you find out your bid is not even being considered, you not only have to explain it to the President, VP Operations and the VP Business Development, you also have to try to continue to work with the people who's lives were in that Proposal... who won't be going to that "next job" that you could have won, but for the failings of the express delivery service provider... It's called "quality planning" where redundant delivery of duplicate originals makes all the sense in the world... (hands clapping for subClause 4.2.3).

But it's confusing to the express delivery service provider, who only cares if (pick a number here...) 99.4 or 99.5 per cent of the contracted "express" deliveries arrived on time. Because to the express delivery service provider, the number you picked is "ok" and it's certainly commensurate with the "risk" which is:

(Thinking now as the CEO of Fed-X again...) "...in order to improve performance from 99.4 percent to 99.5 percent on-time overnight delivery, it will cost the company 8 billion shareholder dollars, since (for example) clerks would (then) need to be 4 year degree holders, as opposed to (now) high school graduates... certainly not "commensurate with the risks" since, if the company DOES NOT spend that kind of money on a miniscule performance metric improvement, the company will still be in business tomorrow and so on ..."

Now let's see that Standard requirement one more time:

"...shall be to a degree appropriate to the magnitude of the problems and commensurate to the risks encountered..."

to which I can only add, [applause...] and [Thanks, Pat...].

David Kozenko
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#12
Subject: Re: ISO 9001 Certified Virtual Office /..//Kozenko/Andrews/Kozenko
Date: Thu, 8 Jul 1999 16:02:29 -0600
From: ISO Standards Discussion

From: Write9000
Subject:RE: ISO 9001 Certified Virtual Office /..//Kozenko/Andrews/Kozenko

> I think that, indeed, we are required to track customer complaints - in
> order to be able to utilize the information in the corrective/preventive
> action process(es).

Ethan:

In the old timey Westerns, there are "blinders" on the horses' eyes, and I never wondered what those blinders were for until my daughter started up the Equine ladder (now toward the US Olympic Team I might add... beaming not too much...).

When you "handle effectively" you might (for example) be swatting a tennis racquet at thousands of "bounced at you" golf balls. It may develop on bad days into a formidable task, but it can be done.

One step further, when you have to "track" all those golf balls after you've hit them (or in simpler terms, if you have to track all those complaints after you've addressed them, the term "addressed" not intended to connotate that which a golfer does...) then you've introduced a new three-dimensional layer of self-imposed responsibility that may or may not be useful.

A mere "Yes I hit them all back" may be completely sufficient, in lieu of a GPS logistics report about where they all stopped after you hit them.

The Standard requires "handle effectively" which you can decide for yourself is more like the former (which, one racket or two, is not tracking), or the latter (which is tracking), or anywhere in between (that is, don't track the golf balls but track the tennis balls...).

David Kozenko
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#13
Subject: Re: ISO 9001 Certified Virtual Office /../Ostrander
Date: Fri, 9 Jul 1999 11:47:42 -0600
From: ISO Standards Discussion

From: sasmith13 - fedex.com (Shirley Ostrander)
Subject: Re: ISO 9001 Certified Virtual Office /Ostrander

FedEx is, in fact, certified WORLDWIDE. According to an ISO9000 training class I went to recently, our ability to be certified worldwide was due in large part to our computer systems that allow us to not only 'see' a package as it travels through our network, but it allows us to provide information and procedural changes in near real-time. In addition, we have a satellite broadcasting network that reports daily on how we did every night, if there were any plane delays and why. An auditor who comes to Memphis can see (and audit) any FedEx location worldwide. While auditors do spot checks around the world, our operation is certified as a whole, not station by station.

Understand that I'm not an ISO9000 expert for FedEx and I've not worked directly with any of the auditors that have come to Memphis. While I cannot provide specific details of the above information (because I don't have them), if there is interest I will try to find someone and a phone number that would be in a position to answer questions.

Shirley Ostrander
Personnel Information Systems Analyst

(OH, and yes we were the first service company to be certified worldwide...we were certified through Lloyds)
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#15
After reading through this entire thread again for the first time in a while, I now can confidently say that I have figured it out. Not only can a big company BUY a registrar, but obviously the RAB is up for sale as well. Ken Cogan states:
In this unique case, the RAB did approve the unusual approach used by the Registrar.
Duh. If you're big enough you can buy what you want. Even an ISO registration. I go along with Phyllis where she says:
I would be extremely cautious of using the Federal Express example for doing virtual offices. Their cetificate is a joke.
Yes - I agree. FedEx's certificate IS a JOKE. It was bought and paid for one way or another. Ken Cogan says FedEx is a 'special' case because if its systems. I say it was and is a special case as they have a certificate without having to comply as most companies do. One could say their registration makes a mockery of ISO registration.

But I'm not surprised. I have seen a lot of big companies get away with 'unnoticed' majors which stood out like a sore thumb during audits. Not just in ISO, but in QS as well.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#16
Virtual Registration

This is just a reminder that self-declaration is not the only way to 'keep costs low'. You can 'buy' your requirements in one way or another...

:thedeal:
 
J

JodiB

#17
ok, my dander is up!

My cloak is off, I reveal that the registrar I worked for is the one who certifies FedEx and not only that..but I am the one who managed the account. It is total BS to say that the field offices were not visited- because I personally coordinated the visits worldwide and know damn sure that they were not only visited but that all customer complaints to us as their registrar were forwarded to the auditors to follow up on.

Yes, they have a worldwide approval. Was our sample size large enough? I won't tell you the details, but I assure you that we used mega manpower every 6 months. Even during the busy holiday periods when they carried a large temporary employee basis.

Ken, if you are the Ken Cogan that I know, then you should have looked into this before answering. It is a worldwide approval. Although I agree that some of your other points were valid.

That's all I will say on this matter.:frust:
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#18
Lucinda,

Your response is appreciated. Both sides of the story bring the truth into focus. Now we have some feedback from 'the other side of the fence'.

I admit, only through this discussion, this thread has disturbed me for a long time. One of the disturbing parts is the idea of a sample. I've never had a registrar agree to a 'sample' locations with the sole exception of multiple sales offices reading from the same corporate manual. They want to see every nook and cranny. Every building. I guess my question would be how big does a company have to be before a company can get a 'dispensation' to sample as opposed to looking at every facility.

Again, thanks for giving us some of the facts and reality! :thedeal:
 
U

Unregistered

#19
It's standard

Registrars have a table that conforms to RAB guidelines that gives the "sample" size. For companies with 5 or fewer locations, you look at every one - annually. Not necessary to see every one on the initial audit. Typically you would look at HQ plus one or two locations depending on how many you have. For 5, probably HQ plus 2. Then pick up HQ and the other two on the first surveillance visit. But it also depends on the type of activities at each site, the number of employees at each site, etc.

For more than 5 locations, you use the sample table. Rule is to always visit HQ, then the additional locations as indicated on the table. A registrar always reserves the right to visit more than the required minimum number to address problems at a particular location or for other reasons. But the customer will sure yell if you do it! Many people have said in this forum, "change registrars if you don't like them or what they do". There are some registrars who work very hard to maintain the quality of their work and their integrity, and they will tell you to go ahead and take your business elsewhere if you won't let us do our job the way we think is necessary.

I handled many large, complicated multinational client accounts, and we used the sampling scheme that visited the majority of sites each 3 year certfication period. If we insisted on visiting every site, it would have been extremely expensive and cumbersome for the client, and would not have added any value. Don't forget that the registrar visits HQ every time and reviews internal audit reports. That is his eyes and ears for the sites he doesn't personally visit. Sometimes key personnel from sites that aren't being visited this go-round can come to HQ and sit with the auditor and bring information/paperwork with them. With a robust quality system, there is a measure of confidence on the part of the registrar that the company isn't hiding anything. This kind of confidence isn't "bought" by the client. If a registrar smells something funny, there is definitely some further action taken. It doesn't go unnoticed.

We also had the odd clients who actually insisted that we exceed the minimum and spend more time or visit more sites, or look harder to find problems. FedEx was one of those.

I witnessed many individual approvals rolled up into larger corporate approvals. It was the general trend and approvals got larger and larger with more and more sites tagging on. These sites usually had maintained a prior certification, so personal independent attention had been paid to them prior to the "sampling" scheme that was put into place after rolling into a larger approval. Continued close scrutiny simply wasn't necessary, with corporate assuming the QMS oversight role.

I am happy to share what I can from my experience on the "other side of the fence". Don't be afraid to knock registrars, because I understand and share some of the general frustrations expressed here. And it also gives me the opportunity to clear up a misconception that may have been frustrating you.:)
 
Thread starter Similar threads Forum Replies Date
S Distinction between a critical supplier and a Virtual manufacturer EU Medical Device Regulations 2
L IATF external audit virtual (remote) IATF 16949 - Automotive Quality Systems Standard 13
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 4
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 4
P Best Global Option to become an OBL/PLM/Virtual medical device brand in 2020 Other Medical Device Regulations World-Wide 2
GStough WCQI Virtual Conference May 6, 2020 Coffee Break and Water Cooler Discussions 1
D Virtual Documentation via Master Flow Chart? Process Maps, Process Mapping and Turtle Diagrams 4
V CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing Other Medical Device Regulations World-Wide 3
D Certifying a "virtual" company with zero employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S ISO 13485 scope of certification - We are a virtual manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
M Informational MHRA – Virtual manufacturing of medical devices – Updated guidance Medical Device and FDA Regulations and Standards News 1
dgrainger MHRA guidance on Virtual manufacturing - version 2 EU Medical Device Regulations 1
M Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation Medical Device and FDA Regulations and Standards News 0
J Virtual Manufacturer and CE Marking EU Medical Device Regulations 8
M Virtual Manufacturer vs Reseller (Medical Devices) EU Medical Device Regulations 0
TheMightyWife Virtual Manufacturer v Medical Device File (NB audit) EU Medical Device Regulations 12
N Own brand labelling/virtual manufacture of IVD's EU Medical Device Regulations 2
S Virtual manufacturers/OEM - CE/ISO requirements EU Medical Device Regulations 7
B Virtual Manufacturer / OBL ISO Requirements Other ISO and International Standards and European Regulations 3
M Audit Mandays for OBL/Virtual Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
W Virtual Manufacturer and Risk Management ISO 14971 - Medical Device Risk Management 3
I MHRA - Virtual Manufacturer Document Requirements EU Medical Device Regulations 2
K Quality Manual for a Virtual Company (Medical Device) Quality Management System (QMS) Manuals 2
P Qualification of pest control service in a "virtual manufacturer" ISO 13485:2016 - Medical Device Quality Management Systems 3
P How to add Voip features (ring group, virtual receptionist) into Cisco SIP PBX in C#? Medical Information Technology, Medical Software and Health Informatics 1
J FDA Compliant Quality System for Virtual Manufacturing (IVD Medical Device)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
W ISO 13485 - The use of virtual offices (everything is sub-contracted) ISO 13485:2016 - Medical Device Quality Management Systems 4
MarilynJ6354 American Global Standards Virtual Registrar ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A American Global Standards Virtual Cert Program for ISO 9001 Registrars and Notified Bodies 12
M Environmental Protection Virtual Event - 2010 Miscellaneous Environmental Standards and EMS Related Discussions 0
Stijloor Virtual Reality Tour of the Basilica of Saint John Lateran Travel - Hotels, Motels, Planes and Trains 3
K Virtual DMIS vs. PC-DMIS - Help needed Calibration and Metrology Software and Hardware 3
Wes Bucey SAE Virtual Job Fair - May 19, 2010 Career and Occupation Discussions 2
Q ISO 13485 Design Control Procedure for Virtual Manufacturer wanted ISO 13485:2016 - Medical Device Quality Management Systems 8
kisxena Transferring a validated software platform to a virtual server Software Quality Assurance 8
V ISO 9001 Virtual Audits - Ways to audit remote locations such as design centers General Auditing Discussions 6
T CMM Reverse Engineering Scannning 3-D - IMS Impact with 4.8 version Virtual DMIS Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
RoxaneB Are You Interested in Coming for a Virtual Walk? Coffee Break and Water Cooler Discussions 130
I Virtual Manufacturing and ISO 13485 - Cardiovascular products ISO 13485:2016 - Medical Device Quality Management Systems 7
Govind Virtual Audit by Internet or Electronic Communication - Do you have any success? General Auditing Discussions 11
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
E Consultant with Office 365 experience Consultants and Consulting 2
B Can we be ISO 9001 certified without a physical office? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Watchcat Office of In Vitro Diagnostic and Radiological Health (OIR) De novos 2018 Other US Medical Device Regulations 1
S Tracking laptop movement inside the office IEC 27001 - Information Security Management Systems (ISMS) 7
tony s An organization's Internal Audit Office certified to ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
M Remote Office only has Invoice Function - Audit Needed? IATF 16949 - Automotive Quality Systems Standard 0
T SPC in Insurance Back Office Operations Service Industry Specific Topics 4
L Computer stations unlocked - Office Stations vs Production Stations Supply Chain Security Management Systems 4
5 Advice for a new EMS at a small, office-based company ISO 14001:2015 Specific Discussions 3

Similar threads

Top Bottom