Saturday, October the 10, 2015

Quality, a Lifestyle for Success

Full day workshopHabib University, Karachi

Dr. Iftikhar A. JafriChief Operating Officer, PharmEvo

Thanks & References:

Mary Oates, 2012Global Quality Operation Pfizer

Guy Villax, 2014, Pharmaceutical Technology

1 Quality of Product &Safety of Consumer

2Birth of Quality Culture

5 Quality Culture Indicators

6Closing Words

3 Criticality of Quality Culture

4Maintaining Quality Culture

Quality Drugs: A Continuous Concern

Quality Culture is the keystone

Product Quality

Product Efficacy

Patient Safety

Claim

Promise

DELIVERY

SUPPLY

SYSTEM

CONTROLS

Ensures every product meets quality standards

Is it enough ???

Your decision impacts product quality Uncounted decisions taken daily

Every decision is not supported by SOPs

Complexmanufacturingenvironment

Potential risks

Does compliance not guarantee?

Is compliance not enough?

Are System & Controls meaningless?

Is Experience not bullet proof?

An environment where every person understands Product Quality & Patient Safety

Without quality culture, product & public safety cannot be assured

Single most important indicator to determine the ability of delivering the quality drugs

QUALITY

CULTURE

Quality is built in from the beginning

Risk to providing quality medicines are understood & mitigated

Performance is monitored in real time & course corrections are made as needed

CoQ

An eagerness to solve problem

Share learning and drive to RFT

Issues are escalated and resolved collaborately

CoQ

No pointing of finger or laying blame

Difficult decisions are made to do the right things

Don’t care about obstacles for right things

CoQ

Report mistakes fearlessly

Learn from mistakes

Quality is everyone’s responsibility

CoQ

Birth of Quality Culture

Does not happen by accidentIt has to be created

Relevant process & control must be in place Understood & Followed

Numerous workarounds

Numerous waivers

Lack of ControlPlease close your eyes & try to visualize the

operation floor

Kindly remember

Quality culture builds on the expertise & processes in the organization and results in behaviors & decision

making that will result in quality outcome

Doing the right things and doing things right

is valued above cost & speed

Continuous improvement is the priority resulting in eagerness to

identify & address issues

Must create an environment in which

Culture driven by leadership … Must provide the fundamentals to product quality

Strong management oversight

Adequate resources

Training of colleagues

Maintenance of plant & equipment

Focus on continual improvement

An organization capable of making right decisions to protect product quality

Provide Fundamentals

Is Quality Culture Measurable?

The concept is not new

• What’s your inner (gut) feeling whether it exists or not?

Challenges of current environment urged to quantitatively evaluate

• A semi-quantitative tool was developed that uses data gathered mainly frominterviews of employees across all levels in the firm together withobservations of operations and review of supporting documentation

The tool can be used both internally & externally

A relationship with a third party was under evaluation

Due diligence identified the acceptability of all relevant systems, controls and processes at a potential partner

The quality culture assessment identified significant weaknesses

Cont’d

Hypothetical External Example 1

Particularly, on this basis the business agreement was not pursued

The potential partner later experienced significant quality failures

Hypothetical External Example 1

Open, eager to learn, committed to continuous improvement, management focused on delivery of quality product

Systems & controls were inadequate but culture was strong

Third party partnership under evaluation

Cont’d

Hypothetical External Example 2

When combined with existing culture, product quality was assured

The firm worked diligently to improve systems, resulting in acceptable controls

Hypothetical External Example 2

Management must proclaim the value of escalating issues & opening deviation

investigations

Management must help employees recognize

deviations & implement a process for effectively

raising them

Management must establish a monitoring

mechanism and track and publish metrics

What if Lack of Culture: Symptoms & Actions

Management must celebrate an increase in deviations and hold accountable those who do not bring them forward

Management must ensure that deviation investigations get to true root cause and define full scope of the issue

What if Lack of Culture: Symptoms & Actions

Management must ensure that holistic corrective actions are implemented to prevent recurrence

Management must reinforce the criticality of continuous improvement

What if Lack of Culture: Symptoms & Actions

Its about behaviors, not SOPs

• Without a strong quality culture, risks to product quality cannot be fully mitigated

Criticality of Quality Culture

Quality culture cannot be externally imposed and is not introduced only through changes to GMP systems• Quality culture cannot be changed in the

near-term but can be lost very quickly if focus on it is lost

Criticality of Quality Culture

Management must be vigilant in keeping the organization focused on the right behaviors and decisions

Pressures exist and culture can change quickly if not protected• Supply demands• Supply chain complexity• Cost reduction

Maintaining Quality Culture

May result in organizational & procedural changes

The risk of such changes must be understood and mitigated• Risk assessment tools can be utilized• Assessment may indicate the risk is too great to take• Can be utilized retrospectively

Cost Pressures

May erode quality culture by driving decisions that can adversely affect product quality

Early indicators should be in place• Quantitative (e.g. over-due items)• Decision-making at the operational level

If early signals indicate potential impact, corrective actions should be implemented immediately

Cost Pressures

Quality Pyramid based on safety

Resource & System Maturity

1 • An expedited compliant becomes overdue

2 • ↑ in number of operator errors/ batch

3 • ↑ in Doc. Errors corrected before lot release

4 • ↑ in # of unplanned quarantine shipments

5 • ↑ in % employee turnover

6 • Relative degree of experience with staff

Quality indicators from the Pyramid characterized by key focus area

Leadership Quality

1• Leadership drives programs that enhance

quality culture, RFT. etc.

2

• % of reported near misses addressed, this means action defined & communicated & colleague rewarded for reporting

Quality indicators from the Pyramid characterized by key focus area

Change Impact

1 • ↑ in number of rejected lots

2 • ↑ in % complaints per units produced

3• # of capital projects linked to GMP or compliance being

delayed

4• ↓ in process robustness/ capability (% products that have

defined capabilities that are tracked

Quality indicators from the Pyramid characterized by key focus area

Regulatory Impact

1

• Self-identified risk areas (Internal Audits)-step back from tactical findings from audits &look more across the board

Quality indicators from the Pyramid characterized by key focus area

Cultural Aspects

1 • ↓ in compliance to training curriculum

2 • ↓ in investigation effectiveness ratio

3 • Feedback loop

Quality indicators from the Pyramid characterized by key focus area

Resource Availability

1 • ↑ in average disposition cycle time

2 • ↓ in % PM completed on time

3 • Minimum staffing requirements met

4 • Staffing per workload unit

Quality indicators from the Pyramid characterized by key focus area

Keep walking & talking on…Respect values

Come out from fear to reportCelebrate mistakesBe knowledgeable

Understand your product & process

Closing words

Thank you of your attention