Extraordinary measures due to COVID

#1
Hello,
Please help me with the below topic: Extraordinary measures due to COVID. Is it something required by IATF? What will the auditor search for?
Excepting the health and safety documents what other documentation and actions are necessary? Shall in be analysed also in the contingency planning? If so how?
Is it something to check during the internal audits?
Is mandatory to perform a management review for this subject?

Thank you in advance,
 
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#2
I wrote a Preventive Action that describes all of the things we put in place that were recommended by the CDC. It will remain open until there is a vaccine or a cure.

In the body of the PAR is:
_________________has added the Risk of Covid 19 through our Risk Management system. OTD is only one small component of COVID-19 risk. _________ has determined that this is also a Risk Issue personnel loss with an overall impact on our business. Below you will find mentioned, several actions we have taken to mitigate risks from COVID-19. We have also assessed the Risk, assigned it a Probability Number (See COTO Log).

• Leadership
o Management has reviewed the Essential Services definition and determined that our company is Essential, and therefore will continue to operate during this pandemic.
o Management is ongoingly monitoring local, state, and federal regulation and advisory changes.
• Planning/Risk
o This risk action “Covid 19” was created to manage and document the activities performed to monitor and mitigate the risks from COVID-19.
• Infrastructure
o Resources
 Personnel
 Guidelines were set up to instruct personnel what to do in case they felt ill.
 Guidelines were set up to instruct personnel to inform the company immediately if they tested COVID-19 positive.
 Guidelines were set up on use of Face Masks and Social Distancing
 Guidelines were set up on Work Area Cleanliness
 Guidelines on the suggested use of rubber gloves and hand Sanitizer/Washing hands
 Signs posted conspicuously throughout the business place with CDC Covid 19 Information
 Environment
 CDC approved cleaning chemicals and hand sanitizer obtained.
 SDS records added for these chemicals.
 Cleaning schedule for custodial usage set up and implemented, with attention to Common areas, Offices and Bathrooms.
 All doors and machine handles are included.
o Competence
o Awareness
 Mask & social distance rules implemented, with posters placed at key points in building.
 Hand sanitizer stations placed throughout the Organization/ Building.
 Formal Training has not occurred but will be scheduled and a record kept.
• Operation
o Customer Communication
 Emails should be sent to all customers informing them of our essential status, and that we are taking steps to monitor our supply chain and protect our employees to prevent a business stoppage. (Suggestion)
o Supply Chain
 Vendors should be asked to inform us immediately of any awareness of a potential/known supply interruption, etc. (Suggestion)
o Production
 Workstations were configured to be 6ft apart.
 Hand sanitizer stations placed near common equipment, to include all entrance and exit doors to the facility
• Performance
o Remote audit risk evaluated for upcoming audits.
 Company internet bandwidth determined to be adequate for remote audits.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#3
If a Business Continuity and Disaster Recovery program is used it might make sense to use that process to document what your plans are.
 
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