“The Journey to Quality Excellence”eservices.personalcarecouncil.org/Meetings/2016...Consider...

transcript

“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

PCPC - Alexandria, VA 2

…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

PCPC - Alexandria, VA

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!

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?

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

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

Mindful of the challenges and your audit,

have you ever had that feeling…

need a

bigger

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.

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

Being mindful

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

“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?

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

Wall Street Journal - 11/22/13

“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

“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

Similar to the concern with Airline

Pilots and flight automation, have

we become so automated and

due to the automation we have

1.inadvertently become less attentive

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.”

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

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)

…if the above is true….

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.

also with Leadership

“Quality should be in our DNA”

all that said and as a point of reference

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

Thank You Kindly !!!

Thomas J. Arista, Field Investigator National Expert Pharmaceutical/Biotechnology FDA/Office of Regulatory Affairs (ORA) Office of Operations (OO) telephone: 214.253.4920 email: thomas.arista@fda.hhs.gov

“The Journey to Quality Excellence”eservices.personalcarecouncil.org/Meetings/2016...Consider...

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