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How is Your QC Boosting Business Results?

Shridhar LollaMay 2014

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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.

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Manufacturing Lead TimeImpact of QC could be Dramatic!

Reference: PHARMI

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The Usual View of Manufacturing FlowQC is often seen outside the main flow!

Blending Compression Coating Packing

Blending Compression Coating Packing

QC QCQC

Or QC is seen just as an interfacing element in the flow!

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QC is not at all seen in the main flow!

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QC is ComplexDetails can be mind boggling!

• Abridged Flow Diagram (QC)

• Spaghetti diagram*Movement of a sample within QC lab is often Crisscross and complex

Conduct TestAssign Test Select SOPCollect

SampleCapture

DataGenerate

COA

Other InstrumentsPH Electronic

BalanceChromotogra

phy Solvent Standards Reagent

*By Waters25-05-2014

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The Usual WayWorking 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.

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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

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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

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Dilemma Inside QC LabsCompromise… what’s hurting the Gx World!

Follow cGMP Guidelines

Reduce TAT

Ensure High Quality

Respond faster to demand

Have a well run company

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.

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Insight-1Actual view of Manufacturing Flow

Blending Compression Coating PackingQC QC QC

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-2Non Tech time >> Tech time

Reference: PHARMI

Tech Time Logistical / Managerial Time

QC Cycle Time

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Insight-3Performance 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.

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Follow The North StarAlign 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.

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Manage by the Weakest LinkIdentify the Weakest Link!

• 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 TestAssign Test Select SOPCollect

SampleCapture

DataGenerate

COA

Blending Compression

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Manage by the Weakest LinkLeverage 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

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Manage by the Weakest LinkSynchronize!

• 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

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Manage by the Weakest LinkElevate 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

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Thus Build the Process of Ongoing Improvement!

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Manage by the Weakest LinkThe Process of Ongoing Improvement!

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IdentifyDiscover

LeverageAnalyze

SynchronizeImplement

ElevateExpand

The Weakest Link

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The ImpactOverall 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%)

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Improving Operations in Gx Industry The Source of Exhaustive Application!

Details: Print Version:

https://www.createspace.com/4194640

Ebook: https://www.smashwords.com/books/view/325264

Visit: http://www.time2change.co.inWrite : lolla@cvmark.comPhone : +91 94480 70081

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