Work Place Health and Safety Guidelines

Mandatory Vaccination for Industrial Workers and Families – Announcement from TN Govt

It is now mandatory for employees as well as their family members to take both doses of Covid-19 vaccine to access workplaces or industries, the Tamil Nadu government has notified today. Notification is issued by TN Health Department (TN DPH).

These guidelines on Covid-appropriate behaviour for workplaces, industries, and factories have mandated many instructions to be followed by businesses at work places.

Key Guidelines :

  • All staff and family members must be vaccinated with two doses OF CIVID 19 vaccine
  • All workplaces and industries with more than 300 employees or 10,000 sqft space should appoint a qualified health inspector, ‘at their own cost’, for monitoring and to coordinate/implement health activities on the premises. 
  • Covid-19 health team must be created on the premises and awareness measures must be held for employees
  • Screening process must include asking the employee for any Covid-19 related symptoms, if family members have symptoms, checking body temperature and checking if the staff is quarantined for having symptoms. 
  • Guidelines say that mask-wearing is mandatory at all workplaces, and administrations must monitor mask compliance through supervisors and managers, including CCTV monitoring. “Anyone without mask must be sent out of the workplace, guideline says.
  • Guidelines insist on maintaining social distancing, hand-washing facilities, and hand sanitation as well to be maintained at work places.
  • In canteen and dining area, the workers must be divided into groups and meals and tea timings should be split across the groups.
  • In quarters and dorms, Covid appropriate behaviour must be followed .

Download the Guidelines Released by TN DPH from here :

Source :

https://www.newindianexpress.com/cities/chennai/2021/jul/25/both-covid-vaccine-doses-must-for-staff-family-members-health-dept-2335008.html

The Occupational Safety, Health and Working Conditions Code, 2020 No. 37 of 2020 announced by Ministry of Labour and Employment has mandated implementation of OSH Code at work places by businesses.

Work Place Health and Safety from now onwards will have more dimension towards Health related focus than the Safety focus that earlier Factories Act had earlier.

Work places should focus on creating Health and Hygiene monitoring teams and more and more employees should be trained towards internalising the practices from now. Businesses should have to focus towards internalising Mental Health Counsellors too slowly and gradually.

All these are interlinked to Work Place Productivity and businesses will have to slowly start addressing multiple challenges that may arise at work place on people related issues.

INFOSAN Alert dated 01st July 2021 – FSSAI announcement

Detection of Salmonella in dried Oregano from Chile [Updated on:05-07-2021]

International Food Safety Authorities Network (INFOSAN) Alert

International Food Safety Authorities Network – INFOSAN issued an alert regarding the detection of Salmonella in Sweden in dried oregano from Chile. The International Food Safety Authorities Network (INFOSAN) is a global network of national food safety authorities, managed jointly by FAO and WHO.

This product has been imported to India by Keya Foods International PVT LTD and distributed within India. 

The Food Safety and Standard Authority of India (FSSAI) on July 1, 2021 has advised all states food authority to recall the dried Oregano from the market, as the INFOSAN detected of Salmonella in dried Oregano from Chile. 

Therefore, All the state food authorities are advised to take necessary actions including complete recall of the product from the market. All the consumers are advised not to consume the product and return back if purchased, to the store/shop of purchase. 

Download FSSAI notification from here

Medical Device – Product Recall

Ventilator Recall by Philips – Recall Announcement / Alert from CDSCO

Medical Device Alert on Ventilator of Philips Announcement from CDSCO

Following message is shared by National Coordination Center (NCC) –Materio vigilance program of India(MvPI)Indian Pharmacopoeia Commission(IPC), Ghaziabad, Autonomous body of Ministry of Health and Family Welfare, Govt of India:

Dear Healthcare Professionals,

As CDSCO has issued Medical Device Alert on Philips Ventilator, kindly go through the link shared below to know more about the alert :

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzM3MQ==

Kindly update NCC MVPI team whether the said ventilator make is available/used in your hospital premises.

If yes, kindly send the feedback to the following email ids, by submitting duly filled “Field Safety Correction Action Form” shared below :

https://www.ipc.gov.in/images/FIELD_SAFETY_CORRECTIVE_ACTION_NOTIFICATION_FSCA_FORM.pdf

Please email your feedback along with duly filled field safety form to :

Kindly request your hospital team to take immediate necessary action as mentioned in alert notice.

Downloads :

About CDSCO – https://cdsco.gov.in/opencms/opencms/en/Home/

About IPC – https://www.ipc.gov.in/

About MVPI Program Launched by IPC :

Ministry of health and family welfare, Government of India has approved the commencement of Materiovigilance Programme of India (MvPI) at Indian pharmacopoeia commission on July 6, 2015 to monitor the safety of medical devices in the country. Indian Pharmacopeia Commission is functioning as National coordination center for MvPI and various steps and strategies have been made by NCC including launching of reporting tools to report MDAE, enrollment of new Medical Device Adverse Events Monitoring Centers and many others are in pipeline.

Training and workshops are organized in different regions of the country to improve the adverse event reporting practice and the attitude of healthcare professionals. NCC in collaboration with Central Drug Standard Control Organization, National Health System Resource Centre and Sree Chitra Tirunal Institute for Medical Sciences and Technology provides training and technical support to the stakeholders and this guidance document will be an important tool for conducting Materiovigilance activities. We are hopeful that this document will support to ensure
the safety and efficacy of medical devices in the country by illuminating various components of MvPI.

For more information about MVPI, download the document below :

Role of Hospitals and other Healthcare Organisations in reporting Adverse Events to IPC :

Hospitals and other Healthcare organisations have to report adverse events caused by drugs or devices to IPC under PVPI or MVPI program.

Since many of the Hospitals and Healthcare organisations are Certified , Accredited for many Quality and Patient Safety Programs in the country , Certification or Accreditation Programs calls for mandatory reporting of Adverse Events caused by Drugs or Devices to Patients, Employees etc.

Since the Ventilator is Recalled by the manufacturer on “Health and Safety Grounds”, Healthcare organisations which have been using the cited make of the Ventilator have to share the feedback to MVPI Cell of IPC in the format shared above. These are the Globally defined Regulatory Protocols and all healthcare organisations have to follow the same.

FSSAI’s mandate for Food Businesses in the country

FBOs to mention FSSAI Licence No. on Invoice / Bills from Oct 1st, 2021

Come 1st October 2021 Food Business Operators (FBO) to mention FSSAI License or Registration number on every invoice.

The Food Safety and Standards Authority of India (FSSAI) has made it mandatory for the FBO’s to declare the 14-digit FSSAI License or Registration number on cash receipts/purchase invoices/cash memo /bills etc.

As per the order dated 8th June 2021, FSSAI mentioned that declaration of the License or Registration number will facilitate the consumers to complain about any grievance with the FBO. Since complaints remain unresolved due to lack of specific information, this move will help consumers who can lodge an online complaint against a particular food business using the FSSAI number.

The Food Safety and Standards Authority of India (FSSAI) has issued a latest order in this regard 8th June 2021 which can be downloaded here.

Licensing and Registration Authorities are directed to widely publicise the policy and shall ensure its implementation mandatorily with effect from October 2, 2021, the FSSAI order says

Mentioning of FSSAI number shall also improve the overall awareness, the Regulator said. If not mentioned, it will indicate non-compliance or non registration/licensing by the food business.

Stating that the food business ecosystem is large, the regulator said 14-digit FSSAI number of any food business operator is not “easily visible and available on consumer/service recipient.”

If the FSSAI number is not available to consumers, expecting him to complain with complete coordinates is an uphill task. Even regulators find it difficult to trace the origin of complaint and attend to it promptly.

No database can be created without a unique locator code, which in case of food safety is the FSSAI number.

Presently, FSSAI number is compulsory to be displayed on packaged food labels but the issue lies especially in case of establishments such as restaurants, mithai shops, caterers, even retail stores.

Further, the regulator said that it is amending the Food Safety and Standards (FSS) Licensing and Registration of Food Businesses Regulations to mandate display of ‘food safety display boards’ at all times at prominent places in case of restaurants.

However, there remains a deficit of mechanism for consumer to know the FSSAI number of the service/product provider.

In case of pre-packaged food where the manufacturer’s FSSAI number is printed on the pack, there exist a deficit of track and trace mechanism whereby the path of the package from a manufacturer to consumer can be traced. The invoice helps establishing this trail. With mentioning of the FSSAI number will help in improving traceability for food products, the regulator added.

Announcement for Environmental Testing Laboratories

Announcement from Ministry of Environment, Forests & Climate Change

MINISTRY OF ENVIRONMENT, FORESTS AND CLIMATE CHANGE – NOTIFICATION

Mandatory NABL Accreditation and OHSAS Certification

The Central Government orders says :

  1. Recognition of private laboratories and recognition of their analysts shall be done by the Central Pollution Control Board here after as per the Environmental Protection Act 1986
  2. All environmental laboratories shall obtain accreditation from the National Accreditation Board
    for Testing and Calibration Laboratories
    Accreditation ISO 17025 :2017 for all criteria testing
    parameters as defined by Central Pollution Control Board along with Certification for Occupational
    Health and Safety Management System – ISO 45001:2018 before submission of application to the
    Central Pollution Control Board for consideration of the said application under the provisions of
    the Act, for –
    (i) fresh or renewal of recognition of laboratory;
    (ii) changes in the name of Government Analysts; and (iii) shifting of laboratory premises.
  3. The recognition of laboratory shall be granted for the validity period of accreditation under ISO 17025:2017 and for the testing parameters accredited therein.
  4. The recognition of laboratory shall be granted for the validity period of ISO 45001:2018 certification from a recognised agency and shall be valid for the same premises of its operation for which the application is made.

Full notification can e downloaded from the link below

Source : http://moef.gov.in/en/

Mandatory Hallmarking of Gold Jewellery

Has come into force from 16th June 2021 – Announcement from Ministry of Commerce

Mandatory Hallmarking of Gold Jewellery has come into force from today – 16th June, 2021.

Key announcements made by Ministry of Commerce :

  1. Hallmarking will be initially be starting from 256 districts of the country which have Assaying Marking Centres.
  1. Jewellers with annual turnover upto Rs 40 lac will be exempted from mandatory Hall Marking.
  1. Export and re-import of jewellery as per Trade Policy of Government of India – Jewellery for International Exhibitions, Jewellery for Government approved B2B Domestic Exhibitions will be exempted from mandatory Hall Marking.
  1. Gold of Additional carats 20, 23 and 24 will also be allowed for Hall Marking.
  1. Watches, fountain pens and special types of jewellery viz. Kundan, Polki and Jadau will be exempted from Hall Marking.
  1. Jewellers can continue to buy back old gold jewellery without hallmark from consumers.
  1. In order to give adequate time to the manufacturers, wholesalers and retailers of Gold Jewellery, there would be No penalties till August end.

Old jewellery can be got hallmarked as it is, if feasible by the jeweller or after melting and making new jewellery.

A committee constituting of representatives of all stake holders, revenue officials and legal experts will.be formed to look into the issues that may possibly emerge during the implementation of the scheme.

Ministry has announced that constructive suggestions are always welcome and implementation should be effective.  It may be noted that Hallmarking of Gold Jewellery was earlier set to begin from 15th June 2021.

Under Hallmarking scheme of Bureau of Indian Standards, Jewellers are registered for selling hallmarked jewellery and recognise testing and Hallmarking centres. BIS (Hallmarking) Regulations, were implemented w.e.f. 14.06.2018. Hallmarking will enable Consumers/Jewellery buyers to make a right choice and save them from any unnecessary confusion while buying gold.

At present, only 30% of Indian Gold Jewellery is hallmarked.

The Hallmarking of jewellery / artefacts is required to enhance the credibility of gold Jewellery and Customer Satisfaction through third party assurance for the marked purity/fineness of gold , consumer protection. This step will also help to develop India as a leading gold market center in the World.

It is to be noted that there has been 25% increase in A&H centers in the last five years. The number of A&H centers have increased from 454 to 945 in the last five years. At present 940 Assaying and Hallmarking centers are operative. Out of this 84 AHCs have been setup under Govt. subsidy scheme in various Districts.

Presently A&H Centre’s can hallmark 1500 articles in a day, the estimated hallmarking capacity of A&H Centre’s per year are 14 crore articles (Assuming 500 articles per shift &300 working days).

According to World Gold Council, India has around 4 lakh jewellers, out of this only 35,879 have been BIS certified.

Source : https://pib.gov.in/PressReleseDetail.aspx?PRID=1727399

World Accreditation Day 2021

Accreditation Day Greetings to All Stakeholders

World Accreditation Day 2021

Theme – Accreditation: Supporting the Implementation of the Sustainable Development Goals (SDGs)

09 June 2021 marks World Accreditation Day (#WAD2021), a global initiative established by IAF and ILAC to promote the value of accreditation. This year’s theme is Accreditation: Supporting the Implementation of the Sustainable Development Goals (SDGs). 

The SDGs are at the core of the United Nations’ 2030 Agenda for Sustainable Development, a broad and ambitious plan of action with the overarching objective of leaving no one behind. Accreditation, in collaboration with other quality infrastructure institutions, provides the technical foundations that are critical to the functioning of developed and developing societies. It enables industrial development, trade competitiveness in global markets, efficient use of natural and human resources, food safety, and health and environmental protection.

Global Businesses are getting into implementing Sustainable Business Solutions, following Sustainable Business Practices. ISO has released many Management Systems Standards in the recent years for businesses to learn, implement internally.

These are linked to CSR Reporting, ESG Reporting and Sustainability Reporting for Listed companies and top 1000 companies with high market capitalisation in stock exchange in India.

Sustainability Accounting Norms are already released globally for reporting in organisations Accounting Audit Reports.

Recently we saw some Global Investors making announcements on their Investment priorities in India where the Investors said their investment decisions will be linked to the sustainable business practices adopted by businesses.

Businesses of all sizes – MSMEs or large scale orgns need to LEARN, UNDERSTAND, IMPLEMENT these solutions internally to ensure the Health and Wellbeing of Communities which will become the Global Priority now.

Its hightime that Accounting Professionals , Management Systems Consultants join hands together to deliver good Sustainable Business Practices, Solutions to businesses .

Value Added , in its 30 years of Consulting journey, had seen the saga of Certifications, Accreditations and impact made by these market place recognition programs on businesses for their business growth. We have facilitated , guided more than 500 + organisations to implement multiple Management Systems Certifications, Accreditation Programs fro many sectors.

It would be interesting to see the rise and Sustainable Business Practices at the market place from now.

We shall be organising series of Knowledge Sessions on these Standards and how these get integrated into the business practices of organisations.

Happy Accreditation Day Celebrations to Industry and Stakeholders !

World Accreditation Day 2021 Celebrations

Word Accreditation Day Celebrations 2021 – Organised by Consultants Consortium of Chennai

World Accreditation Day 2021

Theme – Accreditation: Supporting the Implementation of the Sustainable Development Goals (SDGs)

09 June 2021 marks World Accreditation Day (#WAD2021), a global initiative established by IAF and ILAC to promote the value of accreditation. This year’s theme is Accreditation: Supporting the Implementation of the Sustainable Development Goals (SDGs). 

The SDGs are at the core of the United Nations’ 2030 Agenda for Sustainable Development, a broad and ambitious plan of action with the overarching objective of leaving no one behind. Accreditation, in collaboration with other quality infrastructure institutions, provides the technical foundations that are critical to the functioning of developed and developing societies. It enables industrial development, trade competitiveness in global markets, efficient use of natural and human resources, food safety, and health and environmental protection.

IAF and ILAC have published a joint WAD 2021 statement by the IAF and ILAC Chairs, a brochure and a poster:

In addition, three videos with the themes of People, Planet and Prosperity will be released on the IAF-ILAC Youtube channel in mid-May. These three pillars group the SDGs according to common goals and are reflective of publications from UNIDOOECD and UNDP.

The Public Sector Assurance and Business Benefits websites, which contain case studies, research and supporting materials demonstrating the benefits and value of accreditation, also now feature an option for searching by SDG. 

While the COVID-19 pandemic may again disrupt physical WAD events, we encourage everyone to celebrate with us online using the hashtag #WAD2021 and to contact your local accreditation body for further details on local media and online seminars and programs they may be organising.

Source : https://www.iaf.nu/articles/World_Accreditation_Day_2021/685

About Consultants Consortium of Chennai – CCC :

Consultants Consortium of Chennai (CCC) is an Association of Management Systems Consultants, registered under the Tamil nadu Societies Registration Act, 1975.

The Key Objective of CCC is to work in alignment with the National Quality Mission launched by the Government of India by educating the industry about the role and importance of Standards, Certifications and Regulations in the country as well as in the global markets.

CCC strives to encourage Responsible Consulting through Members of its Association and focus is to Standardize Consulting Practices in alignment with changing market and industry needs in a dynamic manner.

The focus is also to identify areas and industries in which the consultants in the profession of Management Systems Consulting can contribute to the betterment of the society and the country and to promote Management Systems Consulting in such areas or industries.

One of the core objectives is to collaborate with various Industry platforms, Trade Associations, Chambers of Commerce, Management Associations, Apex Bodies of Government or Quasi Government Organization to contribute to the betterment of the industry initiatives, which will in turn contribute to the betterment of the society.

Webinar Series organised by CCC :

CCC has organised #WAD2020 successfully. Same initiative is planned by CCC for 2021 as well.
CCC has tentatively scheduled a week long sessions with following topics :

Registrations :

Entry is free for all Management Systems Consultants, Technical Experts, Industry Experts, Professionals, Industry Members, Academia , Students, Members of Trade & Industry Associations

Program Dates are listed above.

Registration Link :

Prior Regn is a MUST for Participation. All regd participants will get email confirmations 2 days before the commencement of the sessions.

For queries on Regns, email can be sent to :

Ms Rama Venugopal – contact@ccc-consultants.org – +919840870532
Mr D Srikanthan – secretariat@ccc-consultants.org – +919003056539

Do visit CCC Website for regular updates – http://ccc-consultants.org/wad-2021-celebrations/

Customers Quality Systems – Supply Chain getting Trained

Orientation Program for IVD Manufacturers about Various Quality Systems Programs implemented by their User Industry – Hospitals, Med Labs , Other Healthcare Organisations

Supply Chain is showing interest to learn about various Quality Systems implemented by their Customers

Customers Quality Systems – Supply Chain getting Trained

Got a call from an IVD Manufacturer last week expressing interest to get his team trained on various Quality Management Systems followed by healthcare organisations.

I first thought I heard it wrong, I thought he was seeking training for his team on Med Dev QMS. When I asked the question, he said NO and his question is about getting his team members understand a little about various QMS Programs implemented by their customers like NABL, NABH , CAP, QAI Programs.

I was a little surprised and asked him for the reason for choosing a topic like this, though I could quickly guess where he would be heading to. He has mentioned that they are supplying their products to multiple categories of healthcare organisations . Each one comes up with some Certification, Accreditation program that they are implementing. Having implemented Med Dev QMS & Product Certification Programs in house, he felt that its appropriate for his team to acquire some basic knowledge about their Customers Quality Systems Programs and ensuring that as Vendors to the respective healthcare orgns, they would prefer to provide necessary inputs, information that are needed by these Healthcare Organisations (HCOs) during their Quality journey.

This is what is emerging across the globe. Many businesses / sectors are ensuring that their Supply Chain is also in sync with their Quality Systems Journey. When a Mfrer or a Service Provider delivers a Product or a Service to end user / customer, as a finished good, he/she has to doubly ensure that his supply chain also maintains high Quality Standards. It becomes imperative for the Vendors, Suppliers , Stakeholders who are part of the supply chain to be in sync, in alignment with the Quality Systems adopted by their customers.

Similarly, businesses that are seeking support from suppliers, should also make an effort to understand the Quality Systems – be it Product or Systems Certifications, implemented by the Suppliers in their respective organisations. This is the fundamental requirement of Vendor Evaluation in any business. Understanding the Suppliers Quality Systems Programs Matters for Businesses too ! Many Regulated Business Sectors, across the globe, have initiated this exercise of bringing the Supply Chain under some Quality Standards, Systems Programs. Automotive Sector was the 1st sector to introduce this almost 2 decades ago. Many other sectors which are under Regulatory Control are slowly introducing this concept.

This manufacturers/suppliers, being the suppliers to many healthcare organisations, come under the supplier category to these businesses. Healthcare Sector being regulated (be it Products or Services) in the country now, Supplier Quality Compliance will become a norm sooner or later.

We have customised a 3 day program for the IVD Mfrer’s team comprising of :
– Technical Team
– Sales Team
– Customer Support Team
– Management Team

The program was designed in such a manner to provide them a bird’s eye view on various Healthcare Certification, Accreditation Programs that are currently available in India for healthcare businesses to choose.

We have also designed a session on Minimum Standards that are adopted in the country as Regulatory spec which addresses basic QMS to be implemented by Med Labs in the country.

It was interesting session fielding questions from IVD Mfrers about Quality Systems Programs in HCOs.

  • Some interesting questions posed by them :
  • For a start up lab, Is there a bare minimum period required to get the accreditation, if all the criteria is met?
  • Is there any minimal number of parameters in scope of testing for applying certification ?
  • What is the difference betn Certification & Accreditation Program when most of the quality mgmt systems clauses are similar ?
  • Is it compulsory to do ILC ? Frequency ?
  • When there are multiple Certification , Accreditation Programs available for Med Labs, how to differentiate and choose a relevant, appropriate program for HCO

Matured Participants and the Quality of the interactions was highly invigorating .

Were actually surprised when they were asking questions related to :
– Voluntary withdrawal from Accreditations :
– Suspensions criteria
– Eligibility of the HCOs to reapply
– Normal scenarios , reasons for such actions taken by Accreditation Bodies
– Any penalties , punishments for non compliances

Some screen shots from the session :

3 days of orientation program came to a close today. Bird’s eye view of all National , International Certification, Accreditation Programs , Minimum Standards – Regulatory requirements were covered. Program was well received and appreciated by the participants.

Informative, customised content, pretty detailed, well explained, looking forward to detailed sessions

Some feedback received by the end of the session.

Moving forward, Quality Systems Implementation Programs become more inclusive in nature in near future. Businesses will ensure Quality of their Supply Chain and Suppliers will show more interest to learn about their Customers Quality Systems Implementation Programs. More inclusive it becomes, supply chain gets strengthened and end users will be assured of better Quality & Safe Products and Services.

Session was handled by :
Dr Srivatsan , Expert – Healthcare Quality Management Systems
A A Srinivasan – Principal Consultant
Chithambaranathan – Associate Consultant

Posted by :

Rama Venugopal
Executive Director
Value Added Corporate Services P Ltd
Click Here for More Updates

Medical Testing Labs Quality Infrastructure

Medical Testing Labs Quality Infrastructure in India

Covid 19 Testing Criteria – Introduction of Rapid Antigen Testing by ICMR

ICMR is the Regulator for monitoring Covid Testing Strategy in the country.

Testing Strategy for Testing masses has undergone many changes in a dynamic manner since the beginning of the pandemic in the country.

ICMR has introduced Accreditation of the Med Testing Labs by NABL, as the eligibility criteria for Labs to conduct Testing .

Accessibility of Testing Labs to communities became the biggest stumbling block. Lots of calls, conversations across the markets asking for testing access. Urban markets stopped responding at some point, as the pressure became too much. Semi urban and rural markets didn’t have any access to testing at all.

Why are the labs not doing testing ?
Why is it that the testing facilities are not accessible to all ?
Who can actually do the Testing ?
Where are Testing Labs ?

The above were the questions asked by many on daily basis.

I have written an article in the News Letter of Andhra Chamber of Commerce about ICMR’s announcement about allowing only Accredited Labs in the country to do testing, the current Quality Infrastructure of Medical Labs in the country which actually determines the eligibility of the labs to qualify for testing. Its this lack of Quality Testing Infrastructure in the country that has restricted Medical Labs to qualify for Covid 19 Testing criteria.

ICMR has recently relaxed the norms to increase accessibility of basic Covid screening Test to all and introduced Rapid Antigen Test (Screening Test) as well to reduce the dependence on RTPCR Testing. This will ensure that screening test is made available to all.

Sharing the article published in Andhra Chamber of Commerce’s News Bulletin here .

Source : https://andhrachamber.com/pub/E-Bulletin_May_2021.pdf

About the Author

Ms Rama Venugopal
Executive Director
Value Added Corporate Services P Ltd

Email – rama@valueadded.in