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.

MEDPRO The Innovative Audit Processing Tool

Contributed by: TÜV NORD CERT GmbH

In response to the transition from MDD 93/42/EEC to MDR EU 2017/745, TÜV NORD CERT GmbH has developed the MEDPRO system. With MEDPRO, TÜV NORD Cert GmbH offers its customers and auditors worldwide an innovative, web-based audit tool for the simple and joint processing of audits - from audit planning to certificate release.

Available standards in MEDPRO

Currently, MEDPRO can be used to support audit and certification activities for ISO 9001:2015, EN ISO 13485:2016, MDSAP, MDD 93/42 EEC, and (in future) MDR EU 2017/745. Additional standards will be integrated moving forward.

 

MEDPRO includes a variety of features that greatly simplify the exchange of certification related information involving customers, auditors, and our project management team. An overview is provided below, showing the process steps the auditor and project manager will communicate with the customer via MEDPRO in order to jointly prepare, execute and post-process the audit activities:

Audit preparation (customer information, updates, etc.) 

• Company data n Processes & Products
• Location data

Audit planning

• Audit scheduling Audit results (audit conclusion)
• Action management

Advantages, at a glance 

• Ability to check your basic information for accuracing, inlcuding the processes, shifts and location data 
• Ability to coordinate and process the audit schedule and action plans with your auditor
• Storage of your data exclusively on TÜV NORD Group owned and certified data systems
• Protection of your data with SSL encryption

Timeline

The MEDPRO system will be made available to all customers, working with the previously mentioned standards, starting 01.10.2019.

How it works: You need an internet connection and access details for MEDPRO. Your account will be activated by your project manager after talking to you.

Further information about MEDPRO can be found on our website

If you have any questions, please contact our team.

 

TUV USA employees obtain CPR Certification

Contributed by: Jenifer Bartoszek

TUV USA recently welcomed William Devereaux of Technical Medical Training located in Burlington, Massachusetts to their Salem, New Hampshire office for CPR Training. Several employees participated in the Adult, Child and Infant CPR & DFIB training and are now CPR certified.

CPR (Cardiopulmonary resuscitation) is an emergency procedure that combines chest compressions often with artificial ventilation in an effort to manually preserve intact brain function until further measures are taken to restore spontaneous blood circulation and breathing in a person who is in cardiac arrest.

According to the American Heart Association, someone in the U.S. dies every 43 seconds from heart disease, stroke or another cardiovascular disease.

Medical emergencies can happen anywhere at any time. From heart attacks to seizures, help will quickly come from employees who have had CPR training and can provide temporary relief and help prevent any fatalities.

TUV USA is committed to making our workplace safe for our employees.

BRC Food Version 8 Key Changes

BRC announced it would be updating to version 8 in August 2018, which will then go into effect February 01, 2019. This new version encompasses changes in order to integrate the GFSI (Global Food Standard Initiative) and the FSMA (Food Safety Modernization Act) rules. With these new changes, we feel it is important for everyone to be as prepared as possible.

One major change that BRC has implemented is that there are now nine sections instead of the previous seven sections for auditing. The two new sections are 'Production Risk Zones' and ‘Traded Goods’. ‘Production Risk Zones’ cover High Risk, High Care and Ambient High Care Requirements and ‘Traded Goods’ includes items that are stored at a facility but not manufactured there.

Other additions to the standard includes measuring the food safety culture of the site, incorporating Pet Food Manufacturing, more robust food defense, cyber security measures, added requirements for assessing the food safety hazards on the HACCP plans, a more comprehensive pest management requirements and adopting a whistle-blower reporting system.

The BRC standard now features additional color-coding options to help auditors and the site personnel in preparation for the audit.

In addition, the BRC has added voluntary modules such as:

1. Meat Supply Chain

2. Gluten Free

3. Global GAP

4. FSMA Preparedness

If you or someone you know is interested in BRC Certification please contact us.

Charity Begins Within

Maybe we are in this boat ourselves, but every holiday season seems to bring about a strong feeling of thankfulness and gratitude for all we have and all we have been blessed with in life. It is this realization, which makes this time of year the easiest time to give back to those in need. We here at TUV USA are proud that for the 3^rd year in a row, we have been able to participate in donating to Toys for Tots due to the generosity of our selfless employees. The abundance of gifts that we accumulated will no doubt bring joy and happiness to many children this holiday season. We are confident that the small flame we have started will no doubt burn brighter in years to come. Wishing everyone a Happy Holiday Season and a Hopeful New Year.