Staying Connected - July 2010

Quality Audits

At Affinity, quality audits are a regular occurrence.  With well over 100 active OEM partners, Affinity is audited by customers several times a month.  Coupled with internal audits, twice-yearly ISO audits and occasional FDA inspections, quality audits really are a regular occurrence at Affinity Medical.

What is a Quality Audit?

Quality audits are a systematic examination of a quality system.  Audits can be carried out by an internal or external auditor or a team of auditors.  Quality audits are not only an important part of an organization's quality management system but they are required by the U.S. FDA and to meet ISO 13485 requirements.

U.S. Code of Federal Regulations (21CFR820.22) states: “Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.”

Affinity maintains ISO 13485 certification

ISO Certification

Affinity Medical achieved ISO certification less than a year after starting in business.  Founders, Mary Phillipp and Bob Frank, felt it important to earn ISO certification as quickly as possible in order to demonstrate the company’s dedication to quality.  “We only had a handful of employees so it was a major commitment to spend the time and money to achieve ISO certification nine months after starting the company,” said Affinity founder and President, Mary Phillipp.  “Our efforts paid off and our Quality Management System is a cornerstone of our business.”

ISO Audits

BSI (British Standards Institute) was chosen as ISO registrar and has audited Affinity at least twice a year since granting certification.  “We’ve learned a lot from our BSI auditors,” commented Affinity Quality Manager, Cindy Oldynski.  “Each audit uncovers areas where we can make improvements and we do just that.”

“We have been fortunate to work with the same ISO auditor for five years.  Our auditor has gotten to know our business and our quality system which not only saves time each audit.  The time saved getting to understand our business is used to delve deeper into our quality system,” said Cindy.

Affinity is an FDA registered
medical device manufacturer

FDA Audits

For many medical device companies, the prospect of a FDA audit can be intimidating.  “The FDA has conducted audits less frequently than our ISO registrar and we have never received a 483 Warning Letter.  Our Quality Management System is continually audited so we have confidence in our system and procedures,” commented Cindy.  “We’re always prepared for audits so we’re not intimidated by the prospect of a FDA audit.”

Customer Audits

Most of Affinity’s OEM partners conduct on-site audits at least once every two years with many auditing annually.  Customers typically schedule audits for one day, but a new OEM partner may schedule additional time if it is their first audit of our quality system.

“Every customer audit is different,” said Cindy.  “Some audit to FDA or ISO standards while others focus their audit on procedures and activities used to produce their products.  We place great importance on customer audits and make the entire Affinity team available to the auditor or audit team.”

Internal Audits

ISO 13485-2003 section 8.2.2 requires internal audits.  “The organization shall conduct internal audits at planned intervals to determine whether the quality management system

  • Conforms to the planned arrangements, to the requirements of this International Standard and to the quality management system requirements established by the organization, and
  • Is effectively implemented and maintained.”

While audits conducted by those outside Affinity are required and valuable, Affinity’s internal audits may be the most valuable in confirming that Affinity’s quality system is effective.

Affinity has ten trained auditors representing every area of the company.  The Quality Manager establishes an audit schedule each year which is approved by Mary Phillipp.  The schedule ensures that all elements of the quality system to be audited every year.  To help ensure impartiality, auditors are assigned to review system elements in which they do not work or control.

Results of internal audits, including status of CAPAs and trends, are reviewed during Affinity’s quarterly Management Review meetings

Affinity Quality Procedures

Affinity procedures conform to ISO 13485, CFR 820.30 and Medical Device Directive

Supporting the Quality Management System are Affinity’s procedures.  Procedures are controlled documents and are categorized as follows:

  • Quality Procedures
  • Engineering Procedures
  • Operational Procedures
  • Regulatory Procedures

Affinity procedures are tightly interwoven with references within procedures to other procedures.  Because of this, Affinity does not share procedures except on-site when audited.  “Customers have full access to our procedures when conducting an audit,” said Cindy Oldynski.  “Our procedures and supporting Quality Forms need to be viewed as a system.  When customers audit us, we can show the relationship between our procedures, supporting forms and how these relate to how their product is manufactured.”


Affinity is audited regularly and frequently.  Because of customer audits, ISO audits and internal audits, Affinity has a high degree of confidence that its Quality Management System is both effective and in compliance with FDA and ISO requirements.

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Meet Doug McLaughlin – Manufacturing Engineer

Doug McLaughlin – Affinity
Manufacturing Engineer

One of the newest Affinity employees is Doug McLaughlin, our Manufacturing Engineer.  Doug joined Affinity on the first day of summer, June 21st.

Before joining Affinity, Doug was employed as a Senior Manufacturing Engineer by a nearby cable and harness manufacturer that specialized in complex military wire and cable assemblies.  “I would bid on jobs and when we received the order, I would take the project from womb to tomb,” said Doug.  “I love solving problems, working with customers and applying my IPC/WHMA-620 experiences to produce the highest quality products.”

Asked for his thoughts after working at Affinity for a month, Doug said, “The people here are so friendly and have such an affinity for cables.  I am very impressed with the attention to quality and on time delivery.  With the large variety of cable assemblies produced here, it is not easy to keep on time delivery over 95%, but Affinity does it.”

Doug reports to Affinity Director of Engineering, Bob Frank.  Bob said “Doug has already had an impact.  He has acted as a bridge between engineering and manufacturing, is working on new production fixtures and is part of our lean team.  Doug is quiet and does not ‘toot his own horn:’ he just gets things done.”

Growing up in Santee, California, Doug and his family moved to Temecula when he was in middle school.  About four years ago, he and his family moved to Lake Forest which is about twenty minutes from the Affinity plant.

Majoring in Information Technology, Doug also completed the Cisco Networking Academy.  He said “The more I studied information technology, the more I realized that it wasn’t for me.”  Doug plans on continuing his education with the goal of earning a degree in Business and Engineering.

Talking about his family, Doug said, “Elva is my beautiful wife and we have two beautiful daughters.  Five year old Kayla is an artist who also likes cars and sports and Chloe, my two year old likes to figure out how things work.”

When asked what he liked to do besides work, Doug replied, “I used to race radio-controlled cars but now am getting more into RC airplanes.  It’s fun to modify them and take them to the desert with the kids.  We like to go dirt bike riding and camping in the desert whenever we can.” 

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Lunch and Learn – An Affinity Program at Your Facility

Affinity’s Lunch and Learn program is another way we can stay connected and help our friends and customers.  Choose from one of our three programs and gain additional insight and perspective about custom medical cable assemblies and connectors.

Our programs last about forty-five minutes, with the time divided between learning and lunch.  Affinity will provide lunch for your group.  There is no cost or obligation, except we require a group of at least four of your team members to attend the session and a meeting room with a digital projector.  Each attendee will receive a copy of the training material.

  • Off-The-Shelf or Custom Medical Connectors – A discussion of three connector options: off-the-shelf, custom or hybrid.  We’ll discuss the advantages and disadvantages of each including performance, cost and availability.
  • ANSI/AAMI EC53 Compliance – Establishing the basis for medical cable and leadwire specifications.  We’ll discuss the standard, its intent, and how it can be applied to medical cable design and connector design.
  • Strain Reliefs – A discussion of how strain reliefs affect both electrical and mechanical performance of medical cables.  We’ll show samples of off-the-shelf and custom strain reliefs and discuss the advantages and disadvantages of each.

Lunch and Learn sessions are offered free of charge and are conducted by Bob Frank or Hank Mancini, both with well over 20 years experience manufacturing medical devices and cable assemblies.

For more information or to schedule a Lunch and Learn session for your team, contact Hank Mancini at 949-477-9495 or email to

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Announcements, Information, and Trivia

Julius Caesar Augustus –
Image source Wikipedia

August - the 6th Month

August was originally named Sextilis in Latin, because it was the sixth month in the ten month Roman calendar.   Under the Gregorian calendar, we observe August as the eighth month of the year.  July and August are the only two consecutive months each with 31 days.

Around 750 BC, March was the first month of the ten month year.  About 700 BC, it became the eighth month when January and February were added at the start of the year.  August originally had 29 days, but Julius Caesar added two days when he created the Julian calendar in 45 BC.   In 8 BC, Sextilis was renamed in honor of Augustus.

Besides being commonly known as the “last month of summer vacation,” August is also the month in which Bolivia, Singapore, Ecuador, Pakistan, Korea, India, Indonesia, Estonia, Uruguay and Malaysia gained their independence.

Not quite as notable, August is celebrated as National Psoriasis Awareness Month and National Goat Cheese Month!


The United States is the third
largest producer of petroleum

Second Most Plentiful Liquid on Earth

Petroleum is the second most abundant liquid on earth.  Only water is more plentiful.  In 2008, the United States produced approximately 8.5 million barrels of oil per day while we used about 19.5 million barrels per day.

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


Affinity Customer Care -
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 take care of our OEM customer partners.

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

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