Insights on Culture of Quality What have I Learned 22 September 2015
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Transcript of Insights on Culture of Quality What have I Learned 22 September 2015
Insights on Culture of QualityWhat have I learned from Teaching a course on
Culture of Pharmaceutical Quality?
Ajaz S. Hussain, Ph.D. Insight Advice & Solutions LLC
9/20/2015© Ajaz S. Hussain Insight Advice and Solutions LLC 1
Outline
Background
• Breaches in data integrity
• My viewpoints
• About the training program
Challenges
•Breaches – being detected currently are not necessarily new;
•GMP remediation's slow and/or ineffective (repeat violations)
•Assumptions and blind-spots; irrational decisions and behaviors of Management and Staff
Questions
•Why criticality of CGMPs not widely appreciated as expected by the customer (US FDA)?
•What “norms” provide reasons to rationalize cGMP deviations?
•How a company can re-build lost credibility? Better option improve credibility?
Insights
On the three questions posed
9/20/2015© Ajaz S. Hussain Insight Advice and Solutions LLC 2
Critical Importance of Data Integrity
My Viewpoints on ‘Culture of Quality’
Training Program on ‘Culture of Quality’
Background9/20/2015© Ajaz S. Hussain Insight Advice and Solutions LLC 3
Data Integrity: One of the most important and
relevant topics currently discussed
“Testing into compliance, data manipulation, data deletion/ record
destruction, misreporting, disregarding failing and/or questionable
results, all leading to possible breaches in the integrity of critical
data, has become one of the most important and relevant topics
currently discussed by industry and regulators from around the
world.”
Carmelo Rosa. Data Integrity, Essential Part of a Quality System. DIA Multicenter International Data Integrity Workshop. 13-14, Nov. 2014. Bangalore, India.
9/20/2015© Ajaz S. Hussain Insight Advice and Solutions LLC 4
My Viewpoints
Education, Training & Experience
B. Pharm. (Mumbai)., Ph.D. (Cincinnati)
Teaching Pharmacy @ Ohio Northern University & University of Cincinnati
US FDA
Sandoz (Biosimilars)
Philip Morris International (Plant based vaccines & Harm reduction)
Wockhardt (Biosimilars & Complex Generics)
Since 2013 - Insight Advice & Solutions LLC (50%)
Since 2014 - National Institute of Pharmaceutical Technology & Education (50%)
Culture of Quality Training
Effective training [and resolution of issues] requires us
to make effort “Dil Se”; “without ‘finger-pointing”
A framework based on ‘Behavioral Economics’, as
opposed to ‘Ethics/Morality’, developed
Highlight consequences of biases, blind-spots and
irrational behaviors & showcase importance of
System!
Linked to current and emerging regulatory
expectations; but not focusing on specific regulatory
requirements
See authors LinkedIn and Slideshare sites for
additional information
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Decision under risk and uncertainty are
subject to a “framing effect” – and it is
powerful. How we ask a question –
“framing” -can influence how people
react to it. This can also affect our
memories of the event. We are subjected
to many other biases. We are
predictably irrational!
Professor Kahneman’s System 1 and System 2 of human cognition conceptualized
9/20/2015© Ajaz S. Hussain Insight Advice and Solutions LLC 7
Behavioral Economics:Predictability Irrational Behaviors The psychological principles that govern the
perception of decision problems and the evaluation of probabilities and outcomes produce predictable shifts of preference when the same problem is framed in different ways.
Reversals of preference are demonstrated in choices regarding monetary outcomes, both hypothetical and real, and in questions pertaining to the loss of human lives.
… A man [or woman] could be judged irrational either because his [her] preferences are contradictory or because his desires and aversions do not reflect his/her pleasures and pains.
Amos Tversky and Daniel Kahneman. The framing of decisions and the psychology of choice. Science. 1981 Jan 30;211(4481):453-8
Daniel Kahneman and Amos Tversky. Prospect Theory: An Analysis of Decision under Risk. Econometrica, 47(2), pp. 263-291, March 1979
Losses have a bigger emotional impact than an equivalent amount of gain.
People often make decisions to avoid a loss (short-term) at the expense of gains (often long-term)
Company finances are allocated differently –R&D is a “Gain” or “Investment” where as Operations are “Costs” or “Losses” (in the extreme)
This imbalance creates many challenges in the day-to-day operations - which, among others, is what a Culture of Quality must address
Case example: Testing into Compliance
An analyst in a Quality Control (QC) laboratory, after the requisite training is doing dissolution test for a modified release dosage form. The results he obtains are ‘out of specification’ (OOS).
Per SOP, analyst has to file a deviation report so that an investigation can be initiated. He does so.
Later in the day the Head of operations calls the analyst and his supervisor.
Here are some messages to consider on Leadership Emphasis and Message Credibility
Emphasis/Message Credibility L1: Head of Operations is
upset that the analyst did not do his job carefully. The
product is FDA approved and process validated. On
previous occasion after a lengthy investigation it turned
out to be an assay error. Complete the investigation
quickly and release the batch on time.
Emphasis/Message Credibility L2: The Head of Analytical
department learns about what happened. He calls the
supervisor (in the discussion above). He is concerned
that when the owner of the company will learn about
this it will not look-good (for him, and his Analytical
department). He tells the supervisor – add as many
resources as needed for the investigations and get it done quickly.
9/20/2015© Ajaz S. Hussain Insight Advice and Solutions LLC 8
Humans tend to select [irrational] risky option more often in response to negatively framed problems; this effect is more pronounced when there are [easy] “reasons to rationalize”
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Attitude toward
performing the behavior
Process validation is
done so quality is good;
Test prone to error
“Batch failure means I made
a mistake”
Subjective norm
Documentation not critical;
Compendial testing sufficient
Regulators collect & test samples – no
issue there
“Testing into compliance”
In general – low empowerment is
a significant challenge (low
perceived behavioral control);
plus reasons to rationalize….
Additional Information
CoQ Framework and Blind-spots - for more detail click on the following
Explaining the Behavioral Economics context of Culture of Quality
Product Quality & Patient Safety USP Workshop Mumbai 12 June 2015
Good Regulators of Pharmaceuticals (GRP) 22 October 2014
Dr Venkateswarlu Memorial Lecture 2015
Chemometrics Pharmacometrics Econometrics of QbD. Swiss Pharma-6 2012
Excipient Knowledge Management Mumbai 12 March 2015 Part 1 & 2
If the links above fail to connect to the information please use: http://www.slideshare.net/a2zpharmsci
9/20/2015© Ajaz S. Hussain Insight Advice and Solutions LLC 10
About the Culture of Quality Training
Conducted for?
3 companies; WL, Import Alert (US FDA)
1 Company; significant FDA 483
2 Companies; Proactive (before US FDA Inspection)
> 3000 management & staff at facilities in the states of Goa, Gujrat, Karnataka, Madhya Pradesh, Maharashtra, and Telangana and in the Union Territory of Dadra and Nagar Haveli.
Key issue: Preventing “Breaches” in data integrity
Learning Objectives
Provide an opportunity to improve understanding of Culture of Quality (CoQ) and how it relates to Quality Management System (QMS) and compliance with Good Practices (GXPs)
Focus on Why and not 21 CFR;
Specifically to appreciate the value of systems approach to quality, identify behaviors that strengthen it and behaviors that need to change
Specifically to appreciate the value of systems approach to quality, identify behaviors that strengthen it and behaviors that need to change
9/20/2015© Ajaz S. Hussain Insight Advice and Solutions LLC 11
Changing incorrect attitudes & mindset – “Quality is Good” &”US FDA targeting India”
Regulator heterogeneity
Overcoming blind spots & irrational decisions
Challenges9/20/2015© Ajaz S. Hussain Insight Advice and Solutions LLC 12
Overcoming the challenges
Starting point – agreement & commitment of Top management build a Culture of Quality
Deliberate breaches in data integrity is cheating and fundamentally against the basic principles of professional conduct and of India’s founding principle – “Satyamev Jayate”
Nothing is perfect (so avoid “zero tolerance” slogans) –improve awareness and mastery and remove fear to identify, report and correct errors.
Walk the talk – not “Quality Policy on the Wall”
Emphasizing Why by sharing examples from authors experience on topics such as:
“We make two products – medicine and evidence”; both must be better than “placebo”; data integrity distinguishes between legitimate and criminal intent
Testing is not sufficient to assure quality; case examples of harm caused by violating cGMPs and why it is hard to detect harm; “lack of reports of harm is not evidence of no harm”
Quality must be by design; i.e., by intent and working consciously; ‘plan-do-check-act’
Systems approach to quality is a must; what is a System, what is systems thinking, how to make a Quality Management System effective
9/20/2015© Ajaz S. Hussain Insight Advice and Solutions LLC 13
Good Culture of QualityWhen employees can say without hesitation:
We do our best to develop products that meet the needs of patients – we
develop our products consciously – this Quality by Design.
We recognize that nothing is perfect and there will be some errors in our design,
systems and procedures, or we may make mistakes in following set procedures.
It is normal, easy and rewarding to work within our quality management system,
without fear, to detect, correct and to learn from errors.
In doing so we act consciously in the interest of patients – especially when no
one is looking, and continually improve our quality by design and aim for right first
time.
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A simple framework for CoQ
Quality by Design
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One example of impact assessment: One month after completion of
training (anonymous survey via Survey Monkey).
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•Leadership emphasis
•Message credibility
•Peer involvement
•Employee empowerment
Re-shaping the Environment
•Quality is normal
•Quality is easy
•Quality is rewarding
Re-setting the Norms
•Commitment to the System
•Knowledge based
•Understanding & controlling variations
•Safe-guards + pride of workmanship
Ensuring effective QMS
•Fear removed
•Mastery
•Awareness
Promoting proactive behaviors
Score-card; Key Areas of
Improvement and
Recommendations
Illustrative Score Card: For a
company currently in cGMP
remediation.
Stars & color codes
Good progress, continue efforts
already initiated
Blind-spots, current efforts need
additional considerations
Blind-spot + new targeted
projects/efforts needed
Why a growing cluster of cGMP issues [in India]?
What “norms” & behaviors need to change?
How a company can strengthen culture of quality?
Questions9/20/2015© Ajaz S. Hussain Insight Advice and Solutions LLC 18
Why a growing cluster of cGMP issues?
Are the cGMP issues now being noted “new”?
Not likely – rigor and frequency of US FDA inspections changed; More “unannounced” inspections & an increased fear component (for operators)
Improved ability (of a few investigators) to conduct a through “IT” system review; Large “regulator heterogeneity” blatantly visible
Incorrect organizational assumptions – “FDA Approved”, “Process Validated”; push for
“speed” and uninformed “Lean” programs to improve efficiency
Systemic weakness in QMS – inadequate systems thinking – and a general disregard for
the intrinsic (as opposed to just satisfy FDA) value of documentation and assurance of
data integrity; Quality by Design - much misunderstood & “file first and figure it out later”
Local regulatory norms providing addional reasons to rationalize deviations from cGMPs
and attempt to justify interpretation of “adulteration” narrowly to analytics
9/20/2015© Ajaz S. Hussain Insight Advice and Solutions LLC 19
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Why a growing cluster of cGMP issues? Holes in the system
Holes not filled or
filled after FDA InspectionBreaches
Reasons to rationalize irrational behaviors
‘Framing” effects & irrational decisions
Opportunity & “not harming anybody”
Namesake QMS
(A folder of papers – often written by consultants)
Ineffective training &
inadequate supervision
Inability to say NO or to
explain what is required
Push for results!
Assumption:
‘Quality is
Good”;
“FDA approved,
validated, past
inspections
okay”
What “norms” & behaviors need to change?
Differing “quality” to Quality Unit; quality is everyone's responsibility
‘Regulator heterogeneity’ is often used as an excuse; Adherence to commitment is a Management responsibility
Defense of domestic vs. export quality; this is the time to commit to ‘One Quality Standard” –and a plan to achieve it in a reasonable time period
Policies and SOP’s written by consultants to satisfy FDA; Systems thinking is essential to strengthen QMS
“First to file” without systematic preparation to mitigate risks; now a automatic “red flag” for data integrity at FDA
Reliance on “defaults” – 10X, 3-batches,etc., without questioning their relevance; Life-cycle approach to process and analytical method validation a must
Check-box training; need to improve training across the board and ensure it is effective in providing ‘mastery’, improving ‘awareness’ and reducing “fear” and irrational behaviors
Quality policy “on the wall”; management must walk-the-talk
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How a company can strengthen culture of quality?
It starts with the Top management! Walking the talk
Leadership emphasis (and metrics), message credibility, peer involvement (top management) and employee empowerment (reveres the need for all decisions to come to the top)
Aiming high – not just to satisfy the next inspection; effective QMS
Appreciation for the System, Theory of Knowledge (Plan-do-check-act), Knowledge of Variations (common/special cause). Incentivize rational behavior (System 2- working consciously) and pride of workmanship
Preventative controls
Effective training to improve awareness, ensure mastery, and reduce fear
Nothing is perfect – avoid slogans such as “Zero tolerance”
Make it normal, easy and rewarding to detect, report and correct errors
9/20/2015© Ajaz S. Hussain Insight Advice and Solutions LLC 22
Summary
Background
• Breaches in data integrity
• My viewpoints
• About the training program
Challenges
•Breaches – being detected currently are not necessarily new;
•GMP remediation's slow and/or ineffective (repeat violations)
•Assumptions and blind-spots; irrational decisions and behaviors of Management and Staff
Questions
•Why criticality of CGMPs not widely appreciated as expected by the customer (US FDA)?
•What “norms” provide reasons to rationalize cGMP deviations?
•How a company can re-build lost credibility? Better option improve credibility?
Insights
On the three questions posed
9/20/2015© Ajaz S. Hussain Insight Advice and Solutions LLC 23