Lean Techniques

8/9/2019 Lean Techniques

1/4

Lean Techniques: The QC Lab canReduce Product Lead Times

Tom DeWit

Pzers quality control (QC) laboratory in

Puurs, Belgium, has been applying lean techni-

ques to reduce the total throughput lead time

for products across the entire supply chain for

several years. In 2010, the QC laboratory metan ambitious target to cut standard lead times.

Following that, the lab moved on to the new

Pzer global manufacturing initiative called

lean laboratory, which involves adopting new

ways of working and a deeper internal custom-

er engagement to achieve realworld results.

The lab began its lean journey in 2007,

engaging in several agile manufacturing projects

and endtoend value stream assessments. In

2009, the lab set its sights on reducing lead times

by 25% for eight major products. In 2010,having met that target, it looked to the next level

of quality improvement, the Pzer lean labora-

tory initiative. A global model, lean lab is

currently being rolled out across Pzers entire

manufacturing organization; the Puurs lab was

included in implementation at the rst 12 sites.

New Ways of Working

What has allowed the lab to set, meet, and reach

new improvement targets is a lean approach thatemphasizes broader colleague involvement and

engagement to establish a highly effective and

collaborative approach to problem solving. At

one time, for example, a project lead might have

said, I will determine how to improve results,

and I will have it all worked out for you toimplement tomorrow.

This method may have worked in that it

generated some degree of improvement, but it

did not always produce the optimum solution.

Because the decision was made without seeking

the insight of the colleagues charged with

improving results, it didnt have buyin from

the very individuals who would ultimately carry

out the process.

In 2009, the lab initiated a more collaborative,

leancentered process that focused on engaging

colleagues in the reduction of lead times from the

start. Through brainstorming sessions and kaizen

bursts, which focus activity on a particular

process in the value stream, the lab used dene,

measure, analyze, improve, and control method-

ology to analyze its value stream and identify

ways to improve existing processes. Other

activities included:

conducting an inventory of eight high

volume products, realizing that throughputimprovements for this group would apply

to the remaining products;

determining where tests involving these

highvolume products were performed

within its 13 chemical and microbiological

laboratories;

Tom DeWit is manager, chemical laboratory, qualityoperations, Pfizer Inc. in Puurs, Belgium; reach him [email protected].

This article was previously published in December/January2011 in Pharmaceutical Formulation & Quality.

Copyright 2011 John Wiley & Sons, Ltd.Qual Assur J2011; 14, 7275

DOI: 10.1002/qaj.479


2/4

establishing baseline lead times using

historical data and identifying focus areas,

representative tests, products, and labora-

tory impact; and

engaging QC supervisors and analysts from

the various laboratories to map out the current

value stream and to identify areas of opportu-

nity for developing the future state value

stream map.

The lean concept invites colleagues to give input

and bring forward ideas for consideration that

may challenge the usual way of working. Just

because a process has always been done a certain

way does not necessarily mean that is the best way.

As expected, the colleagues who perform the work

involved in carrying out a specic process, in this

case test analysis, have the greatest insight into

where, why, and how frequently they were able to

identify nonvalue added activities and their

resulting impact on process robustness.

For example, colleagues pointed out that test

results might wait up to two days before being

doublechecked, as required by an independent

analyst. Their suggestion: optimize the process to

enable doublechecking within 24 hours; this

waiting period was soon whittled down to

between 12 and 24 hours. They created a spaghetti

diagram that mapped the movement path within a

laboratory during the execution of a test (Figure1).

This visual evidence claried the amount of non

value added activity that existed, while making it

easy to see how colocating materials and

equipment needed for a particular test into one

area would minimize wasted movement and time.

In order to stick to this tighter time frame,

colleagues took on the responsibility of planning,

scheduling, and organizing their individual work-

ows. In this way they operated as self

directedteams, fullling the promise of a previously

launched initiative. Analyst teams now operate as

if theyre running their own business; by scheduling

their work, colleagues know whats coming in and

are able to organize workow without the involve-

ment of a supervisor. Daily huddles enable them to

discuss, review, and iron out any issues.

Achieving a 25% reduction in lead times

involved many changes to the value stream map

(see Figure 2). One area targeted for improve-

ment was the creation of a continuous workow

to execute postanalysis tasks, such as calcula-

tions, data input into the laboratory information

management system, and doublechecking and

approval activities.

There were also many opportunities to elim-

inate extra approval steps and wait times. The

collective efforts of the laboratory teams not only

helped achieve the target, but also maintained an

ontime delivery rate to customers of greater than

90% for the eight products, which represent 60%

of all manufactured seminished lots.

This notable success could be considered the

harvesting of lowhanging fruit. Now the lab

teams are stepping up efforts as part of the Pzer

global manufacturing lean laboratory initiative.

Through a multiphase approach, the teams

expect to improve quality, productivity, and

effectiveness by looking at not only the value

stream but also the volume of products coming

into the lab in order to level the workow and use

standard work teams.

In cases with high predictability in the

incoming volume of work, the company applies

a lean technique called rhythm wheels, which

allows it to set a xed schedule for executing

certain tests such as weekly pH testing. The train

testing method is better suited to less predictable

incoming workloads, especially in cases in which

testing is dependent upon maximum capacity

being reached or approaching deadlines.

Because leveling the workow enables the

company to work with standard teams, it can

plan ahead more accurately for the time and

equipment needed to perform and analyze

the required tests. Embracing lean has also

yielded another signicant benet: increased

customer engagement and transparency. Theprocess is not yet entirely transparent, but the

company has made substantial progress toward

that goal.

Achieving Stretch Targets

Throughout 2010, the Puurs lab continued to

stretch its targets for reducing total throughput

QC Lab can Reduce Product Lead Times 73

Copyright 2011 John Wiley & Sons, Ltd. Qual Assur J2011; 14, 7275DOI: 10.1002/qaj


3/4

lead times. The labs overall goal for 2010, in

addition to reducing lead times for its initial

group of eight highvolume products, is to

achieve a similar reduction across 80% of all

the products and volume handled by Puurs QC.

Establishing a reduced time schedule for allproducts is among its targets for 20112012.

Toward that end, the lab has established a

benchmark: to match or beat its sterility testing

lead time; 13 or 18 working days within a climate

controlled environment is typical, depending on

the particular sterile product. Once this goal is

accomplished, the lab can assure its customers ofresults for any product within two weeks.

Figure 1. Spaghetti diagram

Figure 2. Lead time reduction

T. DeWit74



4/4

Another quality initiative focuses on those

troublesome testing processes that result in

atypical outcomes and lead to additional analyses

and followup QA investigations. Atypical out-

comes may be caused by a number of factors,

including broken equipment, test methodology,

or awed sample preparation.

Regardless of their cause, the result of such

occurrences is always rework and the potential

for detailed and sometimes lengthy laboratory

investigations. The subsequent impact of such

delays affects customer service levels. Getting it

right the rst time, which optimizes processes,

achieves a smoother workow, and minimizes

outcomes that require QA investigations, is the

focus of this initiative.

The quality improvements accomplished

to date, like those the lab is working toward,

require a new and different mindset and collab-

orative approach to problem solving. The most

important element is the early engagement of

key colleagues involved in the process, giving

them both responsibility and accountability

for making improvements that support overall

lab objectives.

These lean efforts incorporate best practices

that are in place throughout Pzers global

manufacturing network. Reducing lead times

means nurturing a culture of continuous im-

provement that focuses on the customer and

advances the companys collective efforts in

quality, productivity, and effectiveness.

QC Lab can Reduce Product Lead Times 75


Lean Techniques

Documents

Transcript of Lean Techniques