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“The Journey to Quality Excellence” Personal Care and Product Council Alexandria, VA. 10/25-26 /16 the Good & the Bad…and there is only 92-hours in a day
“The Journey to Quality Excellence”
Personal Care and Product Council
Alexandria, VA. 10/25-26 /16
the Good & the Bad…and
there is only 92-hours in a day
Topics
o a thought or two on risk management
o domestic / global supply chain challenges
o a note or two regarding your audit
considerations
o computer system challenges
o a sprinkling note on leadership, and
omy greatest fear
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…but first, a thought to share
“We are what we
repeatedly do. Excellence,
then, is not an act but a
habit.”
- Aristotle 384 BC - 322 BC
aka - back in the day
•
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Absolutely everyone enjoys some refreshment with select
readings from the US Code of Federal Regulation
However, I will NOT be discussing any
CFR cites…
You can read the CFR at your leisure
from your copy that’s on the night
stand…AND,
If it’s there…you really need to
consider introducing yourself to
somebody and getting a life!
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Risk Assessment/Management –
Consider your most recent audit
1. Show of hands – how many of you folks have performed
a Risk assessment/evaluation of some manner?
2. Or, have A Quality Unit w/other
departments that performs a Risk
assessment/evaluation of some manner?
3. Here’s a rhetorical question; You pick
your area/subject/topic. What was the
outcome of your Risk assessment/
evaluation?
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Consider back in the day an audit
consisted of what?
“A planned, independent, and documented assessment to determine whether agreed-upon requirements are being
met”. – ASQC 1994
“A systematic and independent examination to determine whether quality activities and related results comply with
planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve.”
- ISO 10011 Guidelines for Auditing Quality Systems
yada, yada, yada – Seinfeld TV Episode 1997
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Fast forward to today -
Challenges of Globalization: Risk Factors
More outsourcing of manufacturing overseas Greater complexity in supply chains Increasing volume of imported products Imports coming from countries with less well developed
regulatory systems Greater opportunities for economic fraud Multinational corporations and other companies must
consider the risks of contracting and outsourcing across borders
◊ “Effective Leadership for a Robust Quality System” - CHPA: Manufacturing Controls Seminar New Brunswick, NJ - October 13, 2010
CDER Office of Compliance CDER Deb Autor, Esq.
…and, mindful
“The more complicated the design problem, naturally the more difficult the solution and hence the more likely that some details and features may be overlooked,
Only to have their absence come to the fore after the thing is manufactured or build and put to the test of use.”
“Failure is central to engineering”…“Every single calculation that an engineer makes is a failure calculation. Successful engineering is all about understanding how things break or fail”.
Success through Failure the paradox of design
Henry Petroski, Princeton University Press, 2006
…we do have a challenge or two
“It is very difficult for an organization
to see the truth about itself.
those inside a box can seldom see
what is happening within it.
it usually takes someone looking from
the outside in to produce useful
evaluations.”
Management f-Laws
how organizations really work
Triarchy Press, 2007 - Russell L. Ackoff
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Mindful of the challenges and your audit,
have you ever had that feeling…
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We
need a
bigger
boat
How do we address the challenges
An effective Quality Systems (QS) is crucial
this assists to sustain compliance and the needs of
consumers and healthcare professional
for sure, implementation and maintenance; though
this fundamentally requires informed and committed
leadership
“Effective Leadership for a Robust Quality System” –
CHPA: Manufacturing Controls Seminar New Brunswick, NJ, 10/13/10
CDER Office of Compliance, Deb Autor, Esq.
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How many of you folks do not
have a computer?
Computer Systems are an integral part of our
personnel and business lives
No one is immune
We rely on their daily
use and proper operations
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Being mindful
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The “average American is now exposed to
254 different commercial messages in a
day”
- “Tipping Pont” 2000-2002
Malcolm Gladwell
Computer based systems (CBS) monitor
and/or control various production
operations, Quality Control testing and the
obtain a myriad of data / measurements /
messages that makes our daily lives…
Less challenging Yes / No
More challenging Yes / No
That said…a brief note on automation
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“Automated flight controls in airline cockpits have
become so reliable that safety experts say pilots
could become inattentive to rare malfunctions that
can lead to crashes.”
USA Today -
August 23-25, 2013
How many of you flew here?
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Purpose – This advisory circular (AC) provides information and guidance concerning
controls for managing information systems that generate and store records used in
the manufacture of products and parts.
Computer Generated and Stored Manufacturing and Quality System
Security Principles of Electronic Record Systems
1. User Identification 2. Authentication of User 3. Principle of Least Possible Privilege
a) Read only access
b) Insert or Write Access Authorizations
c) Change / Delete Access Authorizations
d) Security Access Authorizations
4. Auditing Mechanisms 5. Protection of Software & Hardware
destruction
“Pilots NO-NOs” - USA Today 8/23/13
“Airline pilots are required to perform duties only for safety operating an aircraft while flying below 10,000 feet during takeoff, landing and taxing. Prohibited behavior:
Engaging in unnecessary conversation with other pilots or
flight attendants
Eating meals
Ordering galley supplies
Filling out payroll records
Pointing our sights of interest”
- Source FAA
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Wall Street Journal - 11/22/13
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“The FAA’s move on Thursday underscores a growing industry-government consensus that pilot
training must change further to cope with evolving risks, particularly flight
crews’ increasing reliance on cockpit automation.”
“…the consistent theme is that the role of pilots is changing”
“…training programs need to be refreshed and refocused to take advantage of new research and
technology.”
…and then there is the…Wall Street Journal Monday, May 16, 2016
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“Pilots…unintentionally altered some touch screen settings on a computerized takeoff calculator; mistakenly entering the wrong takeoff parameters; data integrity issues – programing long been identified as major hazard; Carrier told investigators about nine other ‘known anomalies / limitations’ of the software; The manufacturer urged operators to catch data entry mistakes by requiring an independent computation made by both pilots”
…which gets me to consider
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Similar to the concern with Airline
Pilots and flight automation, have
we become so automated and
due to the automation we have
e.g.,
1.inadvertently become less attentive
and
2.maybe diminishing our knowledge of
the day-to-day routine operations as
well as technical skill sets
…with lessons learned from the airline industry
“Automated flight controls in airline cockpits have become so reliable that safety experts say pilots personnel could become inattentive to rare malfunctions that can lead to crashes.”
Pilot Personnel “NO-NOS” and “Prohibited Actions”
“…the consistent theme is that the role of pilots personnel is changing” and “…training programs need to be refreshed and refocused to take advantage of new research and technology.”
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Consider the following
The Quality Unit is highly trained, well motivated and supported by the company’s Leadership
There is a steady free flowing river of well established Policies, Protocols and Procedures (3-Ps)
Quite rightly so, you folks are intimately knowledgeable of your facility, manufacturing operations and Quality Controls & the scientific test data in support of the manufacturing processes, and
At least 5-days a week, 51-weeks out of the year, or more, you’re in your facilities
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Back in the day (12/1997)
regarding computer based system
The Building Management System monitors manufacturing
support system alarm conditions e.g., DP, WFI. There are 600
“critical” alarmed events (from March 1996 to December 1997);
~ there is no record to document corrective measures taken in
response to the alarm conditions and
~ the Quality Unit has not performed an assessment with respect to
the alarmed events and there is no record to document final
resolution of the alarmed events
(Note – the critical alarmed events were unknown to the Quality Unit)
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…if the above is true….
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It brings to mind that
the Quality Unit…
They don’t know what
they don’t know!
So then…absolutely nothing happens without
“Leadership is essential to establish and maintain a
company wide commitment to quality and for the
performance of the pharmaceutical quality system.”
Q10 Pharmaceutical Quality Systems
ICH Guidance, May 2007
In my opinion, leadership resides in all levels within an
organization i.e., from the shop floor personnel up to the
decision makers and the folks with the purse strings.
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also with Leadership
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“Quality should be in our DNA”
all that said and as a point of reference
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April 1991 - A highly respected
FDA Investigator mentioned
during routine inspections we
(FDA) inspect about 5% of a
manufacturing operations
So then what is it that we (FDA)
don’t see that is below the water
line and is the company aware of
the other 95% that we may never
see
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Thank You Kindly !!!
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Thomas J. Arista, Field Investigator National Expert Pharmaceutical/Biotechnology FDA/Office of Regulatory Affairs (ORA) Office of Operations (OO) telephone: 214.253.4920 email: [email protected]
