PDF Archive

Easily share your PDF documents with your contacts, on the Web and Social Networks.

Share a file Manage my documents Convert Recover PDF Search Help Contact



Expert Prepping Suppliers .pdf


Original filename: Expert Prepping Suppliers.pdf
Title: https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/
Author: tdraschil

This PDF 1.5 document has been generated by PScript5.dll Version 5.2.2 / Acrobat Distiller 11.0 (Windows), and has been sent on pdf-archive.com on 11/03/2016 at 17:56, from IP address 207.250.x.x. The current document download page has been viewed 424 times.
File size: 210 KB (6 pages).
Privacy: public file




Download original PDF file









Document preview


Document

Page 1 of 6

Related Articles: 1

This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call
+1 (908) 547-2200 .

EU Notified Body Challenge:
Numbers Down, Performance
Questioned
“The Gray Sheet” Mar. 8, 2016

Printed by Mr. Norm Rabin, Maetrics LLC

Expert: Prepping Suppliers For
Surprise Audits Imperative For Device
Firms Under EU Unannounced
Inspection Scheme
By Shawn M. Schmitt / Email the Author / View Full Issue
Compliance Corner / Word Count: 1092 / Article # 01160229002 / Posted:
February 25 2016 10:15 AM

Executive Summary

Topics Covered in
this Article
Click a keyword for related
articles.
General Topics
inspections
compliance
SilverSheet
Industries
Medical Devices
Regions
Europe

Manufacturers selling product in the European Union must work with critical
suppliers to ensure they're audit-ready now that unannounced inspections by
notified bodies are standard practice in the EU, an industry expert says.
Specifically, it's important for vendors to have procedures in place that
address surprise inspections, and device firms should warn suppliers to not
turn away third-party auditors when they knock on their door. PLUS: A
detailed Q&A-format table to aid manufacturers in understanding the
European Union's new unannounced audit scheme.

Device manufacturers selling product in the European Union must work side-byside with key suppliers and subcontractors to ensure they're audit-ready now that
surprise inspections by notified bodies are standard practice in the EU, an industry
expert says.
Specifically, it's imperative for vendors to
have adequate procedures in place that

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/9/expert-prepping-supp... 3/11/2016

Document

address unannounced third-party
inspections, and device firms should
warn suppliers to not turn away auditors
when they arrive on their doorstep.
"What I'm seeing a lot is that suppliers do
not have these types of procedures.
Many of them aren't even aware of the
unannounced audits and they're being
caught completely off guard, which isn't
good for any of us," said Roberta Goode,
president and CEO of Goode Compliance
International.

Page 2 of 6

Suppliers that refuse
auditors entry to their
facilities "can lead to followup actions and potential
escalation. Your CE mark
could be in jeopardy,"
consultant Roberta Goode
says.

"Ensure that your suppliers have those procedures; but beyond that, they're going
to need some training to those procedures," she said. "It's not enough to just have
the procedures. There must be training and awareness."
Companies required to comply with the EU's Medical Devices Directive
must
undergo the surprise audits along with their suppliers. The audits, which are
conducted at least once every three years, began in April 2014.
The goal of the audits is to determine whether a device being manufactured by a
particular firm is exactly as described in its CE technical file, and that manufacturing
processes are accurate as described in procedures and work instructions. (See
sidebar, "EU Unannounced Audits: A Primer.")
A technical file is a comprehensive collection of data and documentation about a
medical device. The files are similar to FDA's requirements for US firms to develop
device master records and design history files.
A surprise inspection is separate from a manufacturer's regular-cycle audit. That
means "we're talking about the potential for a large number of audits, although I
think you'll likely see that only in the case of the highest-risk products," consultant
Goode said.
Regularly timed audits focus on quality
management systems while
unannounced ones center on device
integrity.
Goode asserts that EU "manufacturers
aren't really preparing their critical
suppliers for the unannounced audits, but
they must because everything that goes
on with their suppliers ultimately rolls
back onto the device firms."
For example, vendors can cause
headaches for manufacturers by barring
auditor access to their facilities, most
often because they have intellectual
property concerns.

EU Unannounced Audits: A
Primer
European device companies now
undergo surprise inspections of
their manufacturing processes, and
there are questions firms likely
have about the EU's new approach.
This Q&A-format table will aid
manufacturers in understanding the
new unannounced audit scheme.
See sidebar at end of article

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/9/expert-prepping-supp... 3/11/2016

Document

Page 3 of 6

"First of all, it's important for suppliers to have a contract with you, or a revised one,
which says that they cannot and should not refuse unannounced audits," Goode
said.
"But if they do, let them be aware that the auditors will complete a report providing
full details of the situation and the refusal of entry," she elaborated. "The auditors
will directly inform the notified body, and in the case of your supplier they'll also
inform the legal manufacturer. This can lead to follow-up actions and potential
escalation. Your CE mark could be in jeopardy."
Companies are encouraged to review supplier contracts. "You'll probably have to
revise them, some quite a bit, some not as much. So it behooves you to go through
your records now of your suppliers and make sure that everything is up-to-date.
This is the time," said Goode, who also urged manufacturers and vendors to
conduct mock audits.
Further, firms should compile for notified bodies a list of vendors that includes
contact names, phone numbers, physical addresses and email addresses, and the
types of products or components that are made at the supplier's facility.
Manufacturers should also note the type of language (or languages) spoken at the
facility if English isn't the native language.
Auditors "need to have proper interpretation with an interpreter, if necessary,"
Goode said. "They should also know if personal protective equipment – safety
equipment – is required to be in that facility. The facility's hours of operation should
also be noted."
Goode's comments came during FDAnews' 10th annual FDA Inspections Summit in
Bethesda, Md.

Budget For Product Testing
Because the EU's impetus for the surprise inspections is better product integrity,
third-party auditors will test devices while inspecting onsite.
Manufacturers are expected to foot the bill for the testing as part of the
unannounced audit model. That means firms will have to budget appropriately for
product testing – especially when it comes to more costly types of devices.
"You will be liable for the cost of devices
that you'll be providing to the notified
body in order to perform device testing,"
Goode said. "And if it is required that
auditors perform testing in an offsite
laboratory, for example, you will also be
liable for the cost of shipping and
transporting that product."

EU manufacturers are
expected to foot the bill for
device testing as part of the
new unannounced audit
approach.

She recommends that firms factor product testing into their yearly budget. "If your
organization isn't already doing that, it's a good idea to give a heads-up to the boss
or the CFO to budget for the cost of the tested devices."
However, "in the case where an auditor does not believe that witnessing your
testing in your manufacturing facility is adequate and wants to take it offsite to do a

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/9/expert-prepping-supp... 3/11/2016

Document

Page 4 of 6

lab test, the process will go something like this: You'll receive a separate quote from
the laboratory for that testing. You'll have to approve it, issue a purchase order and
pay for it up front because the notified body does not want to get in the middle of
that. So you'll pay for that up front, and then the testing will be done," Goode
explained.
She noted, however, that in most cases it's sufficient for the notified body to simply
witness device testing in a firm's facility, in which case there would be little to no
additional cost.
Nevertheless, "I don't want manufacturers to be caught off guard, particularly if
they're making something that's a bit more expensive," Goode said.
This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call
+1 (908) 547-2200 .
Printed by Mr. Norm Rabin, Maetrics LLC

Copyright (c) 2016 Informa Business Intelligence, Inc., an Informa Company. All rights reserved. No part of this article
may be reproduced in any form or incorporated into any information retrieval system without the written permission of the copyright owner.
Online/print subscriptions, reprints, and web posting and distribution licenses are available.
Contact us at (888) 670-8900
, +1 (908) 547-2200
, or clientservices@pharmamedtechbi.com.

EU Unannounced Audits: A Primer
By Amanda Maxwell
European device companies now undergo surprise inspections of their manufacturing processes, and there are
questions firms likely have about the EU's new approach. This Q&A-format table will aid manufacturers in
understanding the new unannounced audit scheme.

European device companies now undergo surprise inspections of their manufacturing processes, and there are
questions firms likely have about the EU's new approach. This Q&A-format table will aid manufacturers in
understanding the new unannounced audit scheme. (See companion story,"Expert: Prepping Suppliers For Surprise
Audits Imperative For Device Firms Under EU Unannounced Inspection Scheme" — "The Gray Sheet," Feb. 25,
2016.)
Question

Answer

Who conducts the audits?

Notified bodies. These are third-party certification bodies appointed by designating
authorities in the EU member-state.
Manufacturers select their notified body themselves according to which they think will be
best to audit their products. They may appoint more than one notified body. They then
receive routine audits from that notified body, but they also now receive surprise
inspections, known in the EU as “unannounced audits."

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/9/expert-prepping-supp... 3/11/2016

Document

Page 5 of 6

Are all manufacturers of
medical devices, regardless
of the risk class of their
product(s), subject to these
surprise inspections?

Any manufacturer that needs to involve a notified body to comply with the requirements
will receive unannounced audits.
of the Medical Devices Directives
Because notified bodies do not need to be involved in auditing class I low-risk medical
devices (that do not have a measuring or sterile function), these products will not be
impacted by inspections.

Are in vitro diagnostic
manufacturers subject to
these inspections?

Where notified bodies are already involved in auditing IVDs, they will also carry out
unannounced audits.
However, at present in the EU, there is no need to involve a notified body for the
majority of IVDs.

What is the legal basis for
these audits and for how long
have they been happening?

The legal basis for audits in the EU lies within the Medical Devices Directives, but it was
not put into action until after the September 2013 European Commission
Recommendation on audits and assessments notified bodies in the field of medical
devices
. However, it does not have the status of a legally enforceable document.
Unannounced audits got underway in April 2014.

How much of a “surprise” are
these audits?

Manufacturers will not know about the inspection until the auditors knock on the door.

How frequent are the surprise
audits?

At least once every third year, but more if the device is considered high-risk, if devices of
the type in question are frequently noncompliant, or if specific information provides
reason to suspect nonconformities of the devices or their manufacturer.

Where do the surprise
inspections take place?

Notified bodies may, instead of or in addition to visiting the manufacturer, visit one of the
premises of the manufacturer’s critical subcontractors or crucial suppliers.
This applies in particular if the main part of the design development, manufacturing,
testing or another crucial process is located with the subcontractor or supplier.

Do the inspectors travel
abroad for inspections? If so,
how do they keep the
inspections a surprise?

If a visa is needed to visit the country where the manufacturer is located, the contractual
arrangements should contain, as an annex, an invitation to visit the manufacturer at any
time, and an invitation that leaves the date of signature and the date of visit open (to be
filled-in by the notified body).
The contractual arrangements should also contain, as an annex, similar invitations
issued by the critical subcontractors or crucial suppliers.

What does the surprise
inspection involve?

The major focus of unannounced audits is to check whether the device being
manufactured and tested is exactly as described in the technical file, and that
manufacturing processes are exactly as described in procedures and work instructions.
If internal change control and communication has not ensured that process
improvements, changes in critical component suppliers, and new production methods
have been promptly and correctly translated into changes in the technical file, then
manufacturers should expect major nonconformities to be raised.

Do any special contractual
arrangements need to be in
place?

The contractual arrangements should foresee that the manufacturers continuously
inform the notified bodies on the periods when devices falling under the notified bodies’
certificates will not be manufactured.
Further, the contractual arrangements should cover the measures to be taken by notified
bodies to ensure the security of their auditors. The contractual arrangements should
provide for a financial compensation for the unannounced audits including – where
applicable – the device acquisition, its testing and security arrangements.

What are the implications for
manufacturers in terms of
preparedness?

. If the
Manufacturers must ensure excellent communication with their notified bodies
notified bodies arrive to do the surprise audit and the product involved is not being
manufactured that day, or there are not sufficient staff to accompany the audit team (or
not the appropriately qualified staff) then the manufacturer will need to pay the cost of
the audit and will be subject to a further surprise audit at cost at a later date.

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/9/expert-prepping-supp... 3/11/2016

Document

Page 6 of 6

Similarly, the manufacturer will need excellent lines of communication with its critical
suppliers and subcontractors for the same reasons.
The realities of unannounced audits need to be thought through and reflected in
contractual arrangements.
What can manufacturers do
internally to put themselves
in the optimum position?

They should define who in the organization has the responsibility to inform the notified
bodies and how this should be achieved. They should also operate and document
progresses, so those with responsibilities to inform other parties should be either
involved with the change process or at least be informed immediately the decision is
made.

What evidence is there that
unannounced audits work?

In 2014, notified bodies withdrew more than a thousand certificates awarded to medical
device companies for reasons including noncompliance, major nonconformities and
refusal of audit
.
The total number of certificates withdrawn was 1058, up 20% from 881 in 2013, and
up15% from 915 in 2012. Part of the reason for the increase was the impact of the
unannounced audits.

What additional impact has
been evident as a result of
surprise audits?

There has been a significant increase of about 25% in notified body staff.

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/9/expert-prepping-supp... 3/11/2016


Related documents


expert prepping suppliers
eu notified body challenge
dental firm texas 8jan16
production process control pops up most
iso 13485 update
warning letters pdf


Related keywords