SQA CAPA Management Case Study Situation: Client developed a new supplier risk program and in the course of execution identified a need to close 100% of CAPAs in 2009. Unfortunately, the client did not have the resources or bandwidth to complete this project in the timeframe set.
Challenge: Client had never outsourced CAPA management to any third party company in the past. Naturally, the client was concerned about the process by which the CAPAs would be closed, the volume and meeting the timelines defined by client to close a CAPA. read more
A New Decade of Supplier Quality -
In 1999, the theme of the IFPSM World Congress on Supply Chain Management was “2000 and Beyond: Vanishing Borders and Expanding Horizons”. As we embark on a new decade, we find that supply chain borders have vanished and horizons have expanded. We also have found that new challenges have emerged, that everything moves faster, and that financial pressures are forcing more companies to think carefully about where to apply their precious supplier quality management resources. read more
Quality Physician Heal Thyself – Taking a Quality Approach to Supplier Audit Programs -
Doctors can make the worst patients, and Quality Professionals can focus so closely on suppliers’ quality that they miss opportunities for improvement in their own programs. By applying basic quality principles in the evaluation of suppliers, improved efficiency and effectiveness will have an impact well beyond the supplier quality function. read more
Protecting the global supply chain through an effective audit program - Supplier audits are a critical component of ensuring the integrity of
the supply chain. However, evolving supply chains are outpacing
traditional audit program methods. Today, effective supplier audit
programs require a fresh look at the people, processes and technology
involved. read more
The Importance of a Correct Gauge R&R Study - Variation is everywhere in our world. To improve any process or
product, the variation of key critical-to-quality parameters needs to
be measured precisely and accurately. It is amazing how many
organizations fail to consider this aspect of a process improvement
project, capability study, statistical process control chart, on-going
inspection process, or Six Sigma project. read more
Inspectioneering - How many times have we heard this solution to a firefighting situation:
“Let’s add an inspection point to ensure the customer does not receive
bad product.” As logical as this may sound, it is not a valid solution.
Adding inspection is costly and can only lower the risk of shipping bad
product. It does not mean bad product will not be shipped. Setting an inspection point involves two major decisions. read more
Managing supplier CAR sickness: symptoms, causes, cures and prevention - Supplier Corrective Action Requests, or CARs, can be the most
challenging and time consuming of all corrective and preventative
actions. Because, by their nature, supplier CARs are external to your
organization, closing the loop on them is more difficult than with
internal remedial activity. This can lead to either a disproportionate
amount of resources being required or, as is more commonly the case,
CARs that remain open well beyond a reasonable timeframe. For medical
device manufacturers, such “supplier CAR sickness” has quality
financial and regulatory implications. read more
Quality in a Turbulent Environment: SOX (the Sarbanes-Oxley Act) was the regulators’ response to the WorldCom, Enron and similar fiascoes. Are we going to see more regulations after the worldwide economic chaos, which follows some managerial disasters of the last decade? Many works will emerge from the present crisis, mostly in financial and economical concepts. As quality people, involved in implementation and verification of Quality Management principles into businesses, we have to self-assess our ways of selling quality. read more
SQA Emergency Quality Response Team's : 5 Step Plan When Going Inside an Emergency Quality Situation - Emergency Quality Situations can be disastrous for a company both
internally, by un-necessarily straining resources, and externally
through delivering non-conforming product to customers. On the
brighter side, emergency quality situations are usually what kick-start
companies to make the necessary changes to allow a company to grow and
improve for future projects and new system implementations. How do we mitigate loss and make sustainable improvements during an Emergency Quality Situation? read more
Struggling with supplier data - what it is, where it is, and how to get the most out of it - As supply chains of medical device manufacturers evolve and the
supplier quality function within them adapts accordingly, the issue of
supplier data becomes more prominent. This is not just from a
regulatory standpoint, but also stems from a need for the supplier
quality function to leverage available information to reduce costs and
improve quality. read more
Supply Chain Survival in the Healthcare Industry: Managing GMP, the FDA and an increasingly complex supply chain - Of all the FDA warning letters recorded in the last two years that
relate to manufacturing and quality, nearly one in five cite problems
with supplier controls. SQA has spoken with hundreds of large
healthcare companies over this time, and found that supplier quality
management is a universal challenge. Warning letters are only one
symptom of the stresses on the supplier quality function. Poor
supplier controls contribute to a Cost of Quality for typical
pharmaceutical companies that is six times greater than other
industries, such as semiconductor or automotive. Regulatory,
commercial and consumer pressures are underlying factors that can cause
stakeholders to feel that managing the supplier quality function is
more than a matter of business–– it’s a matter of survival. read more
