How is Your QC Boosting Business Results?

Copyrights ©2014. CVMark Consulting. All Rights Reserved.
How is Your QC Boosting
Business Results?
Shridhar Lolla
May 2014

QC is a Critical Link
• QC practice is carried out by the set of most qualified
and intelligent scientific staff.
• QC process is perhaps the most complex, time
consuming and expensive component of a drug
manufacturing system.
• Simplifying the complexity of managing activities
within QC value chain can dramatically reduce the TAT
and improve cost effectiveness while protecting real
quality concerns.
• Often an improvement in QC process can dramatically
improve throughput of manufacturing system.
25-05-2014 2

Manufacturing Lead Time
Impact of QC could be Dramatic!
Reference: PHARMI
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The Usual View of Manufacturing Flow
QC is often seen outside the main flow!
QC is not at all seen in the main flow!
Blending Compression Coating Packing
Or QC is seen just as an interfacing element in the flow!
Blending Compression Coating Packing
QC QC QC
25-05-2014 4

QC is Complex
Details can be mind boggling!
• Abridged Flow Diagram (QC)
• Spaghetti diagram*
Movement of a sample within QC lab is often
Crisscross and complex
Conduct
Test
Assign Test Select SOP
Collect
Sample
Capture
Data
Generate
COA
Other
Instruments
PH
Electronic
Balance
Chromotogra
phy
Solvent Standards Reagent
25-05-2014 5
*By Waters

The Usual Way
Working in QC in not always Cool!
• QC accumulates samples till sufficient numbers accumulate to make a
campaign.
– Till then, several batches accumulate in quarantine (hold areas)
• Samples are tested in a sequence to obtain a reasonably good TAT.
– However, the batches being tested and analyzed in QC are not often the one that are
late in production to meet customer due date.
• Invariably ,there is pressure from sales and delivery teams to change the
priority in QC
• QC frets and fumes to change its priority, but agrees to new priority
keeping aside the one it already scheduled.
• In reality, not many samples are delivered in right priority and right time.
• Subsequently, Retest, OOS and OOT become the hot spots of QC’s time
and effort.
• Often QC operates in reactive mode.
25-05-2014 6

Running a QC Operation is Complex
Improving TAT is much more Complex!
• Too many products, too many tests, too many
resources, too many SOPs, too many flows…
• Uncertain arrival of samples, variation between
skill levels of staff, unpredictability in results, too
many retests…
• Too many urgencies, too many priority changes,
unstable planning… There is huge pressure to
improve QC operations.
• There are too many things to improve… often QC
has a long list of improvement projects.
– QC team is busy improving everything
25-05-2014 7

Current Mode of Improving QC Operations
Divide and Conquer!
• Trying to improve everything
• Every link in the chain (Process) is being
optimized.
• Undesired Effect
– Fire fighting, large batches, errors, delays
25-05-2014 8

The diagram below depicts the key dilemma within QC lab. On the one hand it must diligently
follow cGMP guidelines in order to ensure high quality of drugs, on the other hand it must
constantly reduce the TAT so that manufacturing can respond faster to meet more of market
demand cost effectively. The first one is a business continuity (sustainability) need while the
second one is business growth need. Both needs must be fulfilled to have a well run company.
Averaging the two or compromising on any one is not the solution! The bad thing is that more
and more organizations are compromising and running away from finding a win-win solution. It
is not unusual that plants strictly follow cGMP norm in the first half of the month and then, run
disregarding all norms to get maximum throughput in the later half of the month. A well run
organization must find a creative solution to this dilemma.
Dilemma Inside QC Labs
Compromise… what’s hurting the Gx World!
Follow cGMP
Guidelines
Reduce TAT
Ensure High
Quality
Respond faster
to demand
Have a well
run company
25-05-2014 9

Insight-1
Actual view of Manufacturing Flow
Blending QC Compression QC Coating QC Packing
QC Process is an integral part of the manufacturing flow and
hence has direct and significant impact on overall Leadtime,
Throughput and Revenue of the Business
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Insight-2
Non Tech time >> Tech time
Reference: PHARMI
QC Cycle Time
Tech Time Logistical / Managerial Time
25-05-2014 11

Insight-3
Performance of QC is dictated by the weakest link
• A chain is no stronger than the weakest link
• Trying to improve strength of each link other than the
weakest one, will not increase strength of the Chain
• Likewise, capacity (throughput, number of samples
processed in QC Lab per month) and hence, the Lead Time
is dictated by the weakest link along its value flow.
25-05-2014 12

Follow The North Star
Align QC to Promise Made to Customers!
• Manufacturing provides priority to all the batches
in production as per the urgency of delivering to
the promise made to the customers
• QC is given a near term firm priority list
• Based on the priority list, QC allocates its tests
and streamlines its operations
• The QC operates in a way that maximizes the
throughput of manufacturing without
compromising due to performance.
25-05-2014 13

Manage by the Weakest Link
Identify the Weakest Link!
Blending Compression
• Depending on how the workflow in QC lab is, the weakest link can
vary from one organization to another, and also one lab to another
in an organization
• Most often, testing, analysis and even approval have been found as
the weakest links.
Conduct
Test
Assign Test Select SOP
Collect
Sample
Capture
Data
Generate
COA
25-05-2014 14

Leverage the Weakest Link!
• Remember:
– 10% improvement in the strength of weakest link (without affecting
quality) improves the TAT and throughput by 10% for the complete
manufacturing.
– Analysts and chemists in QC lab know their job well
• Now when attention of the team is directed on the weakest
link, they come out with all their experience and creativity to
suggest various improvement steps.
• The ideas are Prioritized
• Top 2 or 3 ideas are picked up for immediate implementation
to obtain quick results
25-05-2014 15

Synchronize!
• Since the weakest link determines performance of complete QC operation as well
as manufacturing, all support must be provided to leverage its performance
• Management and all support functions need to facilitate the team working on the
weakest link to improve its performance
• Easy and quick gains are often provided by reducing waste, work variability,
improving upkeep of instruments, improving workflow and having right people at
the weakest link
• Any interruption to the work at the weakest link is quickly analyzed and dealt with.
• Doing just a few things better at the weakest link improves performance above
10%
• Performance of the weakest link is evaluated after each improvement action
• If the link continues to be the weakest one, other ideas are systematically
implemented and institutionalized
• This is the time to think of using tools of TQM, Lean, Six Sigma etc., at the weakest
link and if needed, targeted and accelerated training is provided to the team on
improvement tools
25-05-2014 16

Elevate and Follow Through!
• Elevate the Weakest Link
– If the link remains the weakest even after several improvements i.e. it
still decides the throughput of the system, think about elevating the
capacity of link
• Placing more resources, machine, night shift, outsourcing activity to other
labs etc.
• … the Next Link
– Once the link does not remain the weakest one, identify the next
(weakest) link that decides the throughput (number of samples per
month) and follow the above process of leveraging, synchronizing and
elevating its capacity
Thus Build the Process of Ongoing Improvement!
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The Process of Ongoing Improvement!
Identify
Discover
Leverage
Analyze
The
Weake
st Link
Synchronize
Implement
Elevate
Expand
25-05-2014 18

The Impact
Overall Benefits!
• Manufacturing
– Throughput (Increase by 5-30%)
– Lead time (Reduced by up to 30%)
– WIP (less by 10-25%)
– On time Delivery (improvement by up to 25%)
• QC Lab
– TAT (reduction by up to 50%)
– Retest ( reduction up to 20%)
– Capacity (increase by up to 50%)
25-05-2014 19

Improving Operations in Gx Industry
The Source of Exhaustive Application!
Details:
Print Version:
https://www.createspace.com/4
194640
Ebook:
https://www.smashwords.com/
books/view/325264
Visit: http://www.time2change.co.in
Write : lolla@cvmark.com
Phone : +91 94480 70081
25-05-2014 20

How is Your QC Boosting Business Results?

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