MANAGEMENT REVIEW

HERNY PRASETYA
20 May 2015

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 HISTORY
• It was a requirement of ISO 9001:1994 and even standards
before this.
• So it has been around for some time.
• Requirement of later versions of ISO 9001, including the year
2000 and current 2008 versions.
• FDA’s Quality Systems Approach to GMP – September 2006
• ICH Q10 Pharmaceutical Quality System – June 2008
• EU GMP Guide Chapter 1 point 1.6 (implemented by 31
January 2013) Cited : 1.6 There should be periodic management review,
with the involvement of senior management, of the operation of the
Pharmaceutical Quality System to identify opportunities for continual
improvement of products, processes and the system itself.

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 MANAGEMENT REVIEW
• Per ISO 9000-1 “guidelines for use” – The Management Review. “One of the
important activities that executive management of the organization need to carry
out, is a systematic evaluation of the status and adequacy of the quality system,
in relation to expectations of stakeholders”. The Management Review addresses
this requirement.
• The US FDA requirements for performing a Management Review. “Management
with executive responsibility shall review the suitability and effectiveness of the
quality system at defined intervals and with sufficient frequency according to
established procedures to ensure that the quality system satisfies requirements
… and the manufacturers established quality policy and objectives. The dates and
results of the quality review shall be documented”.
• Per ISO/EN 46001, Management review. “Management with executive
responsibility shall review the quality system at defined intervals … to ensure its
continuing suitability and effectiveness in satisfying the requirement of this
international standard versus the stated quality policy and objectives … of the
organization. Records of such reviews shall be maintained”.

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ICH Q10- Pharmaceutical Quality System

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ICH Q10- Pharmaceutical Quality System

Content : § 2 Management Commitment

• Management Commitment
• Quality Policy, Quality Planning
• Resource Management
• Internal Communication
• Management Review
• Management of Outsourced Activities and
Purchased Materials
• Change in Product Ownership

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 ICH Q10 – Management Review
• “Senior management should be responsible for
pharmaceutical quality system governance
through management review to ensure its
continuing suitability and effectiveness.”
• “Management should assess the conclusions of
periodic reviews of process performance and
product quality and of the pharmaceutical quality
system.”

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 WHY
• The top management of a company ought to be aware of the
regulations associated with their business.
• the CEO was strictly liable for the violative conditions at the
company whether or not he delegated regulatory compliance
to a specific function.
• Thus, management has a vested interest in knowing the
effectiveness of the QMS and the state of cGMP compliance of
their operation.
• No less than monitoring and reviewing the performance of
sales territories, management must be continually informed
and afforded the opportunity to intervene with timely
decisions when QMS metrics appears unfavorable.
• No news is not necessarily good news.

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 WHY
Management that is out-of-the-loop may sound something like
this:
• “A repeated NRA observation? I thought we resolved that
problem.”
• “Are we ready for an NRA inspection? Quality had better be
sure we are.”
• “Backlog of overdue investigations again? Dedicate a team to
close them ASAP.”
• “Why were they removed from the approved supplier list? We
need that supplier.”

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 SO…….
• QMS should be owned by Top Management and not the Quality Assurance
(QA) Manager or QA Department.
• It is the role of Top Management to
– lead an organisation,
– provide a vision, policy, objective and plans/strategies
– be clear on its direction and control the resources/organization needed to
achieve these objectives
– balance between cost against compliance
• Coupled with the fact that a QMS today should be aligned with business
needs then Management Review is Top Management’s chance to review
their QMS.
• One of the QA Manager’s roles is to operate the QMS on a daily basis and
provide feedback on its performance to Top Management.

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 WHAT TO BE REVIEWED - FDA
• The appropriateness of the quality policy and objectives
– Are these still suitable for the organization?
• The results of audits and other assessments
– What audits have you had or have you done? Any areas of concern? Any
areas to praise? Anything to learn?
• Customer feedback, including complaints and recalls
– Are we giving the customer what they want? Not only product of the
right quality, but are we giving them what they want and when they want
it?
– What do your customers think of you? Note –complaints is not the only
thing that you should consider!
Customer Satisfaction
• The analysis of data trending results
– What data do you have on process performance and product conformity?
Any positive or negative trends?
• Conclusions of process performance and product quality monitoring

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 WHAT TO BE REVIEWED
• The status of actions to prevent a potential problem or a
recurrence
– How are we doing with closing down any Corrective Actions and
Preventive Actions?
• The effectiveness of process and product changes including
those arising from corrective action and preventive actions
• Any follow-up actions from previous management reviews
– Actions outstanding from previous reviews
• Any changes in business practices or regulation that may affect the
quality system
– such as the volume or type of operations
– Is anything going to change soon? New shift patterns, new equipment,
new customers, etc.
– Any changes in regulation, is there any system to anticipate

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 WHAT TO BE REVIEWED
• Training program and personnel qualification
– Has training program conducted as plan, how to develop training
needs, personnel qualification meets requirement?
• Productivity of personnel
– Is personnel absenteisme under control, measure on productivity
• Manufacturing
– Any non value added activity or process during manufacturing
– How is production yield trend, any investigation in place in case of OOT
• Preventive/productive maintenance
– Execution versus plan
– Machine breakdown hours
• Cost

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 Application of Management Review of Process
Performance and Product Quality Throughout the Product
Lifecycle

PHARMACEUTICAL TECHNOLOGY COMMERCIAL PRODUCT

DEVELOPMENT TRANSFER MANUFACTURING DISCONTINUATION

Aspects of Aspects of Management review Management

. review
management review management review should be a should include such
can be performed to should be performed structured system, as items as product
ensure adequacy of to ensure the described above, stability and product
the product and developed product and should support quality complaints.
process design. and process can be continual
manufactured at improvement.
commercial scale.

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 PHARMACEUTICAL INDUSTRY

• Is a business
• Business purpose :
– materializing continuous customer satisfaction, ensure
long-term, healthy profit for thee business and promote
the growth
– satisfaction of employees, convenience to the societies,
and improved profits to business associates, shareholders
and all other parties related to the business.
• Organized and systematic activities

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 Objective of Systematic Activity

• operating the whole units of a company effectively

and efficiently
• to supply goods and/or services of quality expected
by customers
• at right time and at right price,
• Tools :
 clear Vision and Strategy,
 Business Process Mapping, and
• IMPLEMENTING Pharmaceutical Quality
System

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 Business Expectation

1 Production of perfect, defect-free products

2 Development of new products/new technologies

3 Reduction of production costs

4 Introduction of advanced production technologies

5 Consumption of less material and energy in production

6 Elevation of customer satisfaction (CS)

7 Prevention of product-liability (accidents)

8 Improvement of financial structure

9 Environmental protection, pollution prevention

10 Tributes to mankind, elevation of employee satisfaction (ES)

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 How……..
All persons

System Of all divisions

At every stratum

With PQS concept

Method

strive to attain ...

By using QRM Methods

Q(Quality):Quality improvement

C(Cost):Cost reduction

D(Delivery):Delivery execution
Purpose
S(Safety):Safety maintenance

M(Morale):Morale boosting
E(Environmental):Environmental protection

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What to Monitor and Review

Compliance Productivity

Customer
Finance
satisfaction

People EHS

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 Example (1)

KPI 2014 2015 2016 2017 2014

strategy/Action Plan
Compliance
Quality System Effectiveness %

Audit Findings - Critical

Audit Findings - Major

Batch rejection rate %
Right First Time %
Critical Complaint Rate %
Recall rate %

CAPA Effectiveness %

Deviation Notice Total

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 Example (2)

KPI 2014 2015 2016 2017 Strategy/

Productivity Action Plan

Manufacturing Lead Time day

Overall Equipment
%
Effectiveness
Absenteism %
Volume per FTE
Inventory Turn

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 Example (3)

KPI 2014 2015 2016 2017 Strategy/

Customer Service Action Plan
Backorder %
Service level %
Complaint %
EHS
Near miss amount
Accident incident number
Environmental Regulation
Violations
number

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 Example (4)

KPI 2014 2015 2016 2017 Strategy/

Finance Action Plan
Cost of good sold %
Cost of material %
Overhead/Fixed cost %
Scrap material %

Rejected batch %

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 Example (5)

KPI 2014 2015 2016 2017 Strategy/

People Action Plan
Talent Development %
Improvement Skill %
Training %
Adherence to SOP %

Adherence to Safety regulation %

Employee turn over

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 HOW TO BUILD DATA
• Monthly report from each department
• Report includes
– All metrics including Quality Metrics
– Target
– Achievement or fallback
– Out of trend report

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 Who Should Attend
• Top Management should attend.
• Site Head
• Heads of Production, Quality Control, Quality
Assurance, Purchasing, PPIC, Engineering
• Human Resources, Finance, Research and
Development, Information Technology,
Regulatory

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 OUTCOME
• Improvements to the quality system and related quality
processes
– [From the information that has been discussed – where are there areas
where worthwhile improvements can be made?]
• Improvements to manufacturing processes and products
– [Are there any improvements that can be made to our processes and
products?]
• Realignment of resources
– [Here is the beauty of Top Management performing these reviews – as
they control the resources! In order to make the improvements stated
above then what resources are needed to achieve these?]

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 Effective Management Review
• Performance metrics are procedurally established
– The metrics should answer four basic management
questions about the compliance and operational
performance:
1) How well is the system being managed?
2) What unacceptable event or trend has the system detected?
3) What are the product quality and cGMP compliance implications
and risks?
4) Where should we target specific action?
• System owners present objective metrics; functional
areas own the performance
• Functional leadership and empowered decision makers
are present and active

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 FREQUENCY
• ISO 9001, the source of Management Reviews, doesn’t state.
• FDA’s Quality System Model that states
– Firstly “when developing and implementing new quality systems, reviews should
take place more frequently than when the system has matured”.
– “outside of scheduled reviews, the quality system should typically be included as a
standing agenda item in general management meetings”
• In operation :
– It is up to the organisation
– every month, every quarter
– every year will be too long for it to really make a difference/ improvement
– As long as not “meetings for meetings sake”
• Best practice : meeting between every 1 and 3 months.
– This generally allows time to gather useful data, take actions between reviews and
even
– hopefully see the results of these actions at the next review.

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THANK YOU

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