RAPS 2020 Convergence

TUV USA will be participating in the Regulatory Affairs Professionals Society Convergence Virtually

Contributed by: Kristen Newhall

TUV USA is attending the Regulatory Affairs Professionals Society in September 2020.

According to their website, The RAPS is “the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics, and nutritional products.” 

Founded in 1976, their mission is to improve and sustain a competent worldwide regulatory workforce that advocates good regulatory practice and policy to progress and advance public health.

One of RAPS’ goals is to actively support professionals in the regulatory field. Therefore, when the COVID-19 pandemic quickly made it impossible for such a large gathering of people to congregate, the organizers took a different approach from previous years. This year, all the convergence activities, including the educational sessions and booths, are entirely virtual. Instead of shaking hands and speaking face to face, visitors and professionals will be conversing via video chat and the educational programs will all be broadcast. Exhibitors have virtual booths and a video link that anyone can log into to talk with a representative. Pamphlets and flyers will be replaced with PDFs and short videos. RAPS has developed a great deal to overcome the stress of transitioning such a large convention to a virtual arena. 

RAPS starts Sunday September 13, and runs through Wednesday September 16, 2020.

Scully Signal Company Completes Virtual Audit

Scully Signal Company was one of the first companies worldwide to successfully complete TÜV® Virtual Recertification Audit.

In April 2020, Scully Signal Company successfully completed a rigorous three-year recertification audit through TÜV USA, Inc., which is part of German-based TÜV NORD Group—one of the world’s most recognized ISO 9001 certification agencies.

Ed Sullivan, Certified QMS Lead Auditor, conducted an extensive, three-day virtual audit via Microsoft® Teams meetings, extensive document reviews, and real-time video footage of Scully’s processes and procedures. Mr. Sullivan audited Scully’s incoming inspection and manufacturing operations as well as Engineering, Customer Service, and other departmental standards throughout the company’s US-based facility.

“I was impressed,” said Mr. Sullivan. “We were able to review all of the procedures in great detail, and the level of commitment and support that all of the stakeholders showed at Scully was amazing. They have made a commitment to quality that is clearly evident throughout the company, from the CEO to the technicians on the factory floor. I was pleased to be one of the first TUV auditors to be involved in a virtual audit.”

Chris Hristov, Quality Assurance Manager at Scully, was instrumental in organizing the process and implementing technology to enable the virtual audit through online meetings, file transfers, and camera sharing. He stated, “As a diverse team, all of us at Scully bring unique perspectives to the challenges we face and welcome change and continuous improvement. Whether in person or virtually, we are committed to quality, innovation, and the organization’s heritage of protecting people and the environment.”

Scully has been ISO 9001 certified since 1996 and was one of the first organizations certified to the ISO 9001:2015 requirements in 2016. “We have a long history of commitment to quality and safety,” said CEO Katrina Scully Ohl. “It’s part of our DNA, so it is critical that we ensure the proper culture, organizational structures, procedures, and focus on continuous improvement are in place to deliver on our promises. This is not a piece of paper—this is a way of doing business that we embrace.”

About Scully Signal Company

Founded in 1936 by Francis P. Scully, Scully Signal Company is a third-generation, family-owned manufacturing company that engineers and manufactures self-checking fluid detection and delivery systems. Scully equipment and service support are world-renowned for enabling the reliable and safe loading, transportation, and storage of valuable liquid resources.

TÜV NORD Lebanon: Employees are safe

by Svea Fricke, Corporate Communications TÜV NORD GROUP

Yesterday at least 135 people died in the Lebanese port city in the explosion of 2,750 tonnes of ammonium nitrate and 250,000 people lost their homes. Now it´s clear: All TÜV NORD Lebanon employees are well. "We are relieved, but at the same time our thoughts go out to the families of the victims and to the many people who have been injured by this tragic accident", says Harald Reutter, Member of the Board.

TÜV NORD has a long-standing partnership with Lebanon. Initially as a branch of TÜV NORD Hellas, last year TÜV NORD Lebanon was founded in the form of a joint venture. The team around Managing Director Shadia Moubarak has its office in Beirut.

TUV USA, Inc. looks to growth with appointment of new Program Manager

Salem, New Hampshire -- TUV USA, Inc. announced today that it has appointed Mr. Yuksel Eyyuboglu as its Program Manager for their Food Safety Division.

“We are delighted to welcome Yuksel Eyyuboglu to the TUV USA Family. Yuksel will take over the responsibilities of the Program Manager and Operations Manager for the Food Safety division. He has proven expertise in the field of Food Safety certification and with his enthusiasm to grow and succeed, he will give further growth to our Food Safety division,” says Hakan Sen, TUV USA Managing Director.

His role will include the development of services, sales, and marketing activities across the food division, nationwide, and globally. Advising Executive Management on market opportunities and related staffing, training, and investment needs.

Mr. Eyyuboglu holds a M.Sc., Food Science & Engineering from Aegean University, Izmir, Turkey, and was formerly the program manager with SAI Global Northamerica. Yuksel has an impressive work history and a list of accolades that includes SQF Auditor of the Year (2016 - SQFI International Conference) and BRC Auditor of the Year (2017 – Food Safety Americas Conference).

TUV USA Remote Auditing During COVID-19

 As the coronavirus spreads more widely, we are receiving ever more questions about the performance of remote audits. Because of the current situation, the standard owners have made a large number of special arrangements, which mean that remote audits can be performed in more situations than before. We would now like to answer some of your questions and have put the most important information together for you here. 

2nd notice to customers re: coronavirus outbreak

TUV USA is tracking closely the updates related to the COVID-19 outbreak and taking appropriate actions, prioritizing the safety of our office personnel, audit team, personnel working for organizations certified by TUV USA and the members of society in general. The actions also aim to minimize the impact on our activities and ensure that the required audits are performed so the certifications of our customers are maintained.

We have been discussing with the accreditation bodies and regulatory authorities in the past days and we are happy to communicate that the remote assessments have been accepted for most of the certification schemes under the condition that a Risk Analysis is performed addressing the requirements of the IAF document ID 3:2011 Informative Document for Management of Extraordinary Events or Circumstances Affecting ABs, CABs and Certified Organizations and other standard’s specific requirements.

Read more by downloading the document.

Actions for customers affected by the coronavirus (COVID-19) pandemic

What is TUV USA’s process for managing the clients that are affected by the coronavirus (COVID-19) Outbreak?

• A Notice has been sent to customers on how TUV USA is managing the affected organizations.
• TUV USA will operate according to the procedure GOP 030 Management of Crisis.
• A Specific Crisis Management Plan is established for the COVID-19 Outbreak.
• The Plan contains a Risk Analysis of the customer’s certification
• Actions will be determined based on the result of the Risk Analysis

I am an auditor, what if customers communicate that their sites are affected and the audit cannot take place?

• Please, inform the respective project manager
• Please, understand that the virus outbreak is an exceptional situation and the audit might be cancelled for the dates that were previously agreed with the customer and you might need to re-schedule the audit according to the accreditation rules and notifications from scheme owners.

I am an auditor, what if I start presenting symptoms related to the corona virus or concerns were identified in the area where the company I am scheduled to audit is located? 

• You won’t be required to travel
• Please, communicated the related Project Manager

What are Project Managers expected to do when communicated by clients and/or auditors that the scheduled audit cannot take place?

The project Managers shall contact the customers and request:

• A copy of their policy or an official statement regarding visitors on their facilities (e.g. auditors)
• The policy shall contain a date when the clients will start allowing visitors to their sites
• Request the clients to complete the Questionnaire GOP100F022
• Send the required information obtained by the customers to the Quality Manager

What happens to the information provided by the organization? 

• Will be used as input to the Risk Analysis and determination of actions

What are the possible courses of action? 

• Where the risk to maintain certification is considered high, a course of action will be determined case by case.
• Where the risk is determined to be low, it will depend on the standard. We may have the assessments completed remotely were it is allowed.

What do I do for auditing scenarios not covered by this Notice 

• Please, contact the Quality and Accreditation Manager Ricardo De Souza

I am an auditor what is required to complete a desktop audit? 

• Where a remote assessment is allowed, please refer to the specific procedures applicable for each certification scheme.

What happens if the remote audit result for a recertification audit is not satisfactory?

• The client’s certification must be suspended.