Staying Connected - January 2011

Moving a Company

Within a week of publishing this edition of Staying Connected, Affinity Medical Technologies will move into a newly renovated and much larger building.  Moving a company is difficult.  Moving a company with little or no disruption to our OEM partners is a lot more difficult.



Affinity’s home for the past ten years

The Rationale Behind Affinity’s Move

When Affinity moved in 2000 from a 5,000 sq. ft. facility into a 24,000 sq. ft building there was a lot of extra room.  “Affinity was growing and I wanted to make sure we had ample room to grow,” said Affinity President, Mary Phillipp.  “We only had 30 employees and 48 OEM customers when we moved into the building on Reynolds.  But, we figured that if we treated our customers as our partners and manufactured the highest quality products possible, we would grow.  And, thanks to the continued support of our OEM customers, grow we did.”


Affinity’s new home in Costa Mesa, CA
is nearly twice the size of the Irvine plant

“As our business grew, so did the number of employees and amount of production equipment,” said Mary.  “About two years ago, it became apparent that with continued growth we would need more production space.  One way to gain space would be to add a third shift.  We also considered building an addition onto our current building.  But, at the end of our analysis, moving to a larger facility made the most sense.”

Opportunity Becomes Win-Win Situation

With the industrial real estate market in the area depressed, Affinity had many attractive options to consider.  Many suitable buildings were available with attractive lease rates.  “We looked at a lot of different properties and in the end chose a building that had nearly double the space and was also closer to the majority of our production team members,” said Mary.  “This seemed like a win-win situation.”

Considering our OEM Partners

“Months before we even chose a building, we started considering how to make our move as transparent to our OEM customers as possible,” Mary said.  “We formed a cross-functional relocation team and tried to look at our move from our customer’s point of view.  After fully evaluating every aspect of our move, we came to the conclusion that it made more sense to validate our new facility and our key production processes, rather than re-validate individual products.”

“Many production moves have had a detrimental effect on customers” said Affinity Business Development Manager, Hank Mancini.  "Before joining Affinity, I worked for a large medical device manufacturer that was always consolidating and moving production.  In most instances, the only thing that was actually moved was the product.  Because those moves generally involved different equipment, different employees, different processes and a different quality system, product revalidation was required.  In many instances it was months before full production resumed and customers suffered.”

“Affinity’s move is different,” said Hank.  “We’re moving our people, equipment, processes and Quality System to a new building about five miles away.  The only thing changing will be the building in which we manufacture.  Because of this, our relocation team decided to focus efforts on establishing a comprehensive facility validation plan.”



V-0271 Affinity Master Validation Plan
for facility relocation

Senior Project Engineer, Matt Pathmajeyan, authored the Master Validation Plan for Affinity’s move.  The purpose of the plan is:

  1. To assess and determine qualification requirements for the relocation of Affinity Medical Technologies, LLC
  2. To provide criteria for facility acceptance at new location
  3. To group and provide rationale for calibration, installation verification and installation/operational qualification of equipment
  4. To verify that controlled processes continue to perform within established limits when relocated to the new facility
  5. To verify that all quality documents and regulatory agencies are properly notified of Affinity’s relocation or intent to relocate to the new facility
  6. To verify that Affinity’s systems are not affected by the relocation by performing an audit to Affinity’s Quality Plan

The plan was reviewed and approved by management and members of the relocation team.

“To summarize our planned activities after relocation of equipment to our new facility, all equipment (aside from common bench top and portable tools) will undergo some level of installation verification and/or operational qualification,” said Matt.  “We’ve cataloged and evaluated every piece of equipment we own to determine what level of activity is appropriate.”

Scope of Master Validation Plan

Within the Master Validation Plan, individual plans have been formulated for the following areas:

  1. Information Services
  2. Utilities
  3. Installation & Calibration Verification
  4. Molding Machines
  5. Test Lab Verification
  6. Cable Cut and Cable Strip Equipment Verification
  7. Ultrasonic Welding Equipment Verification
  8. Label Printer Verification
  9. Process Qualifications
  10. Regulatory Affairs/Quality Assurance Verification
  11. Affinity System Quality Control Audit


Every piece of equipment owned by
Affinity was evaluated to determine what
ction was necessary before being used
for production in the new facility

New Site Validation

Besides considering production equipment, processes and its Quality System; Affinity will validate the new facility.  Using the facility layout, the availability of power, water, compressed air, HVAC and lighting will be confirmed.  The validation will also confirm the accuracy of the facility layout, evacuation plan, placement of fire extinguishers and the security system.  “We’ll be confirming and documenting that the facility was built to our specifications and all services are correctly located and working properly,” said Matt.

Calibrations


Portable equipment such as
Ciris test devices will not have
Installation Qualification performed,
but will be recalibrated

We have a lot of equipment that will be recalibrated after the move,” said Affinity Quality Manager, Cindy Oldynski.  “Our outside calibration service will be sending in a team to work over the weekend to make sure all calibrations are done before we resume any validation or production activity.”

Process Validations

Key processes will also undergo verification as a result of Affinity’s relocation.  These verifications will monitor established processes over a set number of production lots to ensure that the processes continue to remain within established limits as specified in assembly instructions, drawings, or Affinity procedures.  Affinity will make no changes to specifications, procedures or processes as a result of our relocation.

Audit of Quality Control Plan

In addition to qualifying equipment and processes, Affinity will conduct audits to its Quality Control Plan, QAMT-01, to ensure that each “critical to process step” is under control.   The Affinity quality team will audit all 19 sections of its QCP plan.  A pre-determined number of samples from each process will be audited after relocation to ensure that the outputs of the system remain consistent with the outputs before the move.

Distribution of Master Validation Plan

Affinity will distribute copies of its Master Validation Plan to customers upon request.  Once all the validation activities are carried out, a Summary Report will also be available upon request.  Details of the results of validation activities will not be distributed, but can be viewed at Affinity as part of a customer audit.



Affinity’s produces a wide variety of
products for a large number of OEM customers

Summary

“Affinity produces a high mix of products for a large number of different OEM customers.  It would be nearly impossible to perform qualifications on each product that Affinity manufactures and therefore we have developed our Master Validation Plan to address the requalification of equipment and verification that our processes remain robust and unchanged as a result of our facility relocation,” said Matt Pathmajeyan.

The Affinity relocation has been planned so that it is as transparent as possible to its OEM partners.  Plans and contingencies have been established.  Outside services have been evaluated and contracted to move equipment, files and furniture.  Affinity team members have been organized and trained.   “We will begin our move on Thursday, February 3rd and expect to resume production on Monday, February 7th,” said Affinity President, Mary Phillipp.

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Meet Maria Alcaraz – Affinity Quality Supervisor

“Maria joined Affinity as Quality Supervisor in early November and is a great addition to the quality team,” said Affinity Quality Manager, Cindy Oldynski, Maria’s supervisor. “I don’t know how we got along without her.”

“One of the things that attracted me to Affinity was knowing that it is a solid company in a stable industry,” said Maria.  “During my three interviews, my impression was that Affinity is company with a lot of positive energy and a strong atmosphere of team work and cooperation.  I was really happy when Cindy offered me the position.”

As Quality Supervisor, Maria supervises 20 team members from the shipping department, receiving inspection and final audit.  One of Maria’s daily challenges is prioritizing and coordinating inspection and testing workflow so that products are released to be shipped to customers on time.


Maria and Affinity Material
Supervisor, Sue Alessi, confer
on the day’s workflow through
testing and inspection

When asked what her biggest challenge has been since joining Affinity, Maria said, “Staying on top of all the day-to-day tasks has been my biggest challenge.  Everything at Affinity moves fast and unless you stay on top of things, it is easy to fall behind and that’s not acceptable.”

“My short-term goals are to learn more about all the different products that we produce at Affinity.  I want to become familiar with all of our processes in order to fully support our quality activities.  I also want to be able to identify any gaps in our systems so that I can make recommendations for improvements,” said Maria.  “My long-term goal is to obtain my QA Management Certificate for Medical Devices.  This requires completion of six modules including: Introduction to Medical Device QA, Regulatory Affairs, Quality Auditing, Document Control, and Regulations for Clean Rooms.  I expect to finish all six modules by this September.”

Maria also earned a Certificate in Materials Planning and Inventory Controls by taking APICS classes.  “Understanding materials and inventory planning has helped me in my Quality Supervisor position,” commented Maria.

Maria was born and grew up in Mexico City.  Her family moved to California when she was a teenager.  Realizing that becoming fluent in English was important, Maria took English as a Second Language classes which she says was a good decision.  “Becoming fluent in English has been one of the best decisions that I have ever made,” said Maria.

Maria, her husband and their two teenage children live in nearby Anaheim.  When asked what she likes to do in her free time, Maria answered, “I love doing things with my family.   We enjoy spending time together.  We like to go for bike rides and playing.  We also enjoy doing yard work together.  My husband always says that it is not how much time we spend together, but the quality of that time.”

Talking about her family, Maria said, “As a mother, one of my priorities is to let my kids know how much I love them.  I also encourage them to always do their best and never settle for second place.”

One of Maria’s hobbies is to read.  “I enjoy reading inspirational books which helps me to recharge my batteries,” said Maria.  “Every day is an opportunity to challenge myself to do better.”

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Announcements, Information, and Trivia

MD&M West - February 8th through 10th, Anaheim, California

Affinity will be exhibiting once again at MD&M West in Hall D, Booth #1392.  Most of the Affinity team will spend time at the show either manning the booth or walking the show to see what is new.

Affinity Presentation at MD&M: Medical Connector Options – Custom or Off-the-Shelf

Affinity Business Development Manager, Hank Mancini, will address design and specification issues associated with various types of medical connectors including custom and off-the-shelf.  The presentation will be held Tuesday morning at 11:00 AM in Theater 1, Booth #639 which is downstairs in Hall E.

The advantages and disadvantages of various types of connectors will be discussed and examples of successful designs will be shown in this 30 minute presentation which is open to anyone attending MD&M West.

Additional information can be found at the following link:
http://www.canontradeshows.com/expo/west11/ibt_MDM_day1_1a.html




Suzann Sitka, Cesar Jara and Candy Golding
- the Affinity Customer Care Team

Affinity Customer Care and
Hours of Operation

At Affinity Medical, we don’t have a customer service department.  In place of customer service, we have Customer Care Coordinators.  While our Customer Care Coordinators perform many of the same functions that customer service representative would, we strive to offer our OEM partners more than that.  The job of our Customer Care Coordinators is to take care of our OEM customer partners.

Affinity’s Customer Care team consists of Candy Golding, Suzann Sitka and Cesar Jara.  Candy is the team supervisor and has over twenty years experience working with medical cables.  Suzann joined Affinity over five years ago.  She has extensive experience having worked for several medical device manufacturers before joining Affinity.  Cesar is the newest member of the team, joining Affinity in mid 2009.

Affinity Medical Technologies Customer Care specialists are available to assist you from 7:00 A.M. until 4:00 P.M., Monday through Friday, U.S. Pacific Time, except holidays.

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Affinity Medical Technologies

New Address:
3545 Harbor Boulevard, Suite 150
Costa Mesa, CA 92626 USA
Phone: +1 949 477 9495
Fax: +1 949 477 9499

Email: Customercare2@affinitymedical.com
Website: www.affinitymedical.com
Blog: http://blog.affinitymed.com