QUALITY TALK (APR 2020)

Musings on QHSE VOLUME 7 2020 4 TH Edition

About the Author – Er. Ankur Dhir Btech ,MBA TQM, Certified Quality Manager, Lead Auditor 9001,
14001, 22000, 27001,45001, Internal Auditor ISO 13485,IATF 16949, AS 9100 C, NPC empaneled
Consultant On Lean Manufacturing, Approved WCM Assessor, Approved Master trainer ZED ,
Lean Six Sigma green Belt, 7qc tools Champion, 5s assessor he has been in the field of QHSE,
Lean Tqm as a Trainer, Assessor, consultant and have conducted assessments and faced
assessments for his own freelancing as well with organizations of repute

About the newsletter - In its Fifth year this e newsletter is quarterly over email publication catering
to issues related to quality, environment , Health and safety , information security and other
topics related to ISO and non Iso Standards so lets read and try to continually improve our
workplaces feed back and comments are welcome you can mail us at
qual.solutions@gmail.com/dhir.ankur@gmail.com whatsapp:9876157777

Contact us and Learn and share on using social media platforms

Linkedin https://www.linkedin.com/in/ankur-dhir-9b7b374/
Facebook: https://www.facebook.com/dhir.ankur?ref=bookmarks
Twitter: https://twitter.com/dhir_ankur

CENTRAL DEBATE

TIMES OF COVID 19
The coronavirus outbreak is first and foremost a human tragedy, affecting hundreds of thousands of
people. It is also having a growing impact on the global economy. This article is intended to provide
business leaders with a perspective on the evolving situation and implications for their companies.  As
per report of mckinsey published report dated 13 th April 2020 mentions COVID-19 continues to spread
rapidly around the world. Almost every country has reported cases, but the burden is asymmetrically
distributed. 46 percent of new confirmed cases have been reported in Europe and 39 percent in the
United States. To an extent, that’s because countries are at different stages of the pandemic. Some that
were effective at initial containment, such as Singapore and Hong Kong, have seen resurgence and are
implementing additional measures to address it. Others, such as many countries in Western Europe,
have seen the number of new cases plateau or begin to decline and are debating the right approach to
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reopening their economies. Some countries appear to be at the peak of infection and are urgently
building surge capacity in their health systems. In other parts of the world, the number of cases is rising
rapidly. Countries such as Russia and Turkey are seeing a recent acceleration. India too has experienced
a significant increase in the number of cases since the beginning of April and has evolved its response
strategy, including extending the nationwide lockdown. As was writing this article case in INDIA are
touching 10000 and over 250 deaths and lockdown increased to 3rd may.

The efficacy of the health-system surge and how it is maintained over time. Countries with rapidly
increasing numbers of cases are finding ways to expand their critical-care capacity massively. Their
ability to do so, and to push mortality from COVID-19 to lower levels, will not only save lives but also
engender confidence in their health systems’ ability to manage a resurgence. Over time, as cases
plateau and then decline, there will be questions about how long to maintain surge capacity while also
guarding against resurgence. Providers will be under pressure to consider the broader context of a
capacity surge; for example, in the United States, the mass cancellation of elective medical procedures
and the associated financial hardship for many providers is likely to force difficult discussions about
which procedures should be allowed to restart, and when. Other effects of surge capacity, on vaccine-
preventable diseases and maternal and child health, will also be critical to monitor.

So what we can do to survive as per mckinsey report marked

for Asia the authors have recommended As companies in the region
resume activity, they may be the world’s first to shape the “next normal.”
What will that look like?
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MSME’s can use GEM to register their products to serve Make In India
Intaitive as supply to PSU is lucarative market
Four dimensions could define it:
Rethinking social contracts. In crises, the state plays an essential and
expanded role, protecting people and organizing the response. This power
shift transforms long-held expectations about the roles of individuals and
institutions. MSME ‘s in INDIA HAVE TO USE GOVT BUYING PORTOLS LIKE
GEM and register them same to survive and get business opportunities.
Defining the future of work and consumption. The crisis has propelled new
technology across all aspects of Asian life, from e-commerce to remote-
working and -learning tools, including Alibaba’s DingTalk, WeChat Work, and
Tencent Meeting. ZOOM meetings is the highest downloaded app in
apr2020 this means business have moved to digital so businesses have to
shift business strategy as consumers have New working and shopping
practices will probably become a permanent fixture of the next normal.
Mobilizing resources at speed and scale. Within weeks, China added tens of
thousands of doctors and hospital beds. Several governments invested in
new tools to map transmission and rolled out huge economic-stimulus
plans. Asia has a proven ability to mobilize resources in a crisis. In INDIA
DIGITAL INDIA HAVE INCREASED ITS Bandwidth and several APPS/Software
are available to enable remote working and creating digital /virtual
workplaces.
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Moving from globalization to regionalization. The pandemic has exposed
the world’s risky dependence on vulnerable nodes in global supply chains.
China, for example, accounts for about 50 to 70 percent of global demand
for copper, iron ore, metallurgical coal, and nickel. We could see a massive
restructuring as production and sourcing move closer to end users and
companies localize or regionalize their supply chains.

Reference: https://www.mckinsey.com/business-functions/risk/our-
insights/covid-19-implications-for-business
In a sense, the Covid-19 pandemic has changed the way we work,
shop and communicate with people more than any other disruption
(including technological ones) in the recent past. As more people start
working from home, they are sticking to basics, stepping outside only
to buy essentials and are constantly worried about the risks of getting
infected in crowded places like malls and supermarkets. So businesses
have recalibrate their long term and short term strategy.
STUDENT INFORMATION
QUALITY SOLUTIONS ARE CONDUCTING DAILY WEBINARS/Training FOR
INDUSTRY RELEVENT TOPICS which are free of cost only in case certification is
required an nominal fees are charged from participants to provide a digital certificate
after taking an online exam so show ur interest by mailing us at
qual.solutions@gmail.com or WhatsApp at our no 9876157777
These topics duration varies and links would be shared to those who are interested and
2 hours before the session is going to start.
The Topics planned
Date Topic Relevant audience
TBA Role of Top Management Proprietor/CEO/Directors/MR
in ISO standards based
on QEHS
Risk Management for Proprietor/CEO/Directors/MR/QA/Producti
quality management on/engg graduates/diploma
7 qc tools ( Basic) MR/ MR/QA/Production/engg
graduates/diploma
7 qc advanced Tools MR/ MR/QA/Production/engg
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ISO 9001 Awareness
IATF 16949 Awareness
5s foundation course
Kaizen the key to suceed
ISO 14001 Awareness
ISO 27001 Awareness
ISO 45001 Awareness
(APR 2020)
VOLUME 7 2020 4 TH Edition
graduates/diploma
Proprietor/CEO/Directors/MR/QA/Producti
on/engg graduates/diploma
Proprietor/CEO/Directors/MR/QA/Producti
on/engg graduates/diploma
Proprietor/CEO/Directors/MR/QA/Producti
on/engg graduates/diploma
Proprietor/CEO/Directors/MR/QA/Producti
on/engg graduates/diploma
Proprietor/CEO/Directors/MR/QA/Producti
on/engg graduates/diploma
Proprietor/CEO/Directors/MR/QA/Producti
on/engg graduates/diploma
Proprietor/CEO/Directors/MR/QA/Producti
on/engg graduates/diploma

IF ANY OTHER TOPICS ARE NEEDED TO BE TAKEN UP KINDLY REVERT ON MAIL

OR WHATSAPP NO
We can also organize digital webinars for customer specific on their internal training
platforms/ hosted service provider do discuss your requirements for us to provide our
detailed proposals.

Covid-19 lockdown gives e-learning a boost

As schools across the country scramble to move classes online, remote
learning, which has otherwise seen slow adoption in traditional classrooms,
will get a jumpstart
Detailed report can be read at https://www.forbesindia.com/article/coronavirus/covid19-
lockdown-gives-elearning-a-boost/58559/1

E-learning has the potential to be a harbinger of social change in India. With more than 400
million Internet users and more than 330 million connected smartphone users, and being the
world’s second social site user, India has immense opportunities to grow and tap the potential
of technology in the field of education. There is an increasing realisation that initiatives like
Digital India will have a major role to play in shaping elearning.

Further reading https://www.thestatesman.com/opinion/computerised-classroom-1502876819.html

With many schools and colleges closed due to the Covid-19 outbreak, companies such as Byju's,
Unacademy and Vedantu are offering free access to live classes.

https://www.livemint.com/companies/news/covid-19-impact-online-learning-companies-see-spike-in-
number-of-stude
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NEWS RELATED TO STANDARDS

How This Specially-Abled Kerala Man Became India’s 1st ISO Certified Auto Driver. For complete news
report read https://www.thebetterindia.com/222966/kerala-hero-man-first-iso-certified-auto-driver-
specially-abled-inspiring-india-ser106/

Sreekanth’s ‘Hello Buddy’ auto provides its users with phone charging facilities, free Wif-Fi,
reverse cameras and even newspapers in English, Malayalam and Tamil!

‘Hello Buddy’. Is INDIA’s first ISO 9001 certified

auto .

This news corelates usage of ISO in getting new

business as early 2002 Japan had it first certification
in service domain.

Resource from ISO Freely available ISO Standards in read-only format

to support global efforts in dealing with the COVID-19 crisis.
https://www.iso.org/covid19 and
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BIS has also made around 14 standards freely available to
fight covid 19 https://www.bsbedge.com/IndianStandardsonCovid19
Also several standard making bodies across the globe have their covid 19 response ready by
providing free resources case studies, research papers which you can access digitally

1. www.bsigroup.com
2. www.afnor.com
3. www.asq.org

Tableau-to-offer-90-days-of-free-e-learning

During this unprecedented time, in an effort to help students to build skills for the future,
Tableau is now offering 90 days of free eLearning. 

According to their website, “As the global economy recovers, data skills will be in high
demand. So, now is a great time to learn Tableau. And that’s why, to gain the ability to
confidently answer the questions you have of your business’ data during this
unprecedented time, or build your skills for the future, we’re giving you 90 days of free
eLearning.”

To get this 90 days free, users just have to create an ID and log in to your TableauID
account and can start learning and build their Tableau skills. In order to avail it, users
also have to enter an access code — ‘2020elearning’

Happy learning.

MEDICAL DEVICES REGULATION IN INDIA

The Indian medical industry is in focus due to the Covid-19 pandemic and the
consequent increase in demand for testkits, ventilators and other medical
equipment. The Medical Device Rules, 2017 (the ‘Rules’) under the Drugs and
Cosmetics Act, 1940 (the ‘Act’) govern the Indian medical device industry.
These Rules came into effect on January 1, 2018. The Rules are applicable in
respect of:
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1. Substances used for in vitro diagnosis and surgical dressings, surgical bandages,
surgical staples, surgical sutures, ligatures, blood and blood component bag with
or without anticoagulant covered under sub-clause (i) of section 3(b) of the Act;
2. Substances including mechanical contraceptives (condoms, intrauterine devices,
tubal rings), disinfectantsand insecticides notified under sub-clause (ii) of section
3(b) of the Act;
3. Devices notified from time to time under sub-clause (iv) of section 3(b) of the Act.
The government had notified 37 categories of devices under the sub-clause (iv)
Section 3(b) of the Act for stricter regulation under the Rules. The devices which
did not come under the notified categories earlier, required a ‘no objection
certificate’ from the Drugs Controller General of India (‘DCGI’). However, a
notification issued by theGovernment on February 11, 2020 which came into
effect on April 1, 2020 has made it mandatory to register all devicesand
provided a new procedure for the same. On the same date government vide
another notification amended the definition of Medical Devices which also came
into effect on April 1, 2020.
Definition of Medical Devices
In accordance with the notification of February 11, 2020 by the Ministry of
Health and Family Welfare (“MOHFW”), the definition of medical devices has
been amended to mean – any instrument, apparatus, appliance, implant,
material or other article, whether used alone or in combination, including
software or an accessory, intended by its manufacturer to be used specially for
human beings or animals by any pharmacological or immunological or metabolic
means, but which may assist in its intended function by such means for one or
more of the specific purpose of:

1. Diagnosis, prevention, monitoring, treatment or alleviation of any disease or

disorder;
2. Diagnosis, monitoring, treatment, alleviation or assistance for, any injury or
disability;
3. Investigation, replacement or modification or support of the anatomy or of a
physiological process;
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4. Supporting or sustaining life;
5. Disinfection of medical devices; and
6. Control of conception
Every device that comes under the purview of this definition is further classified
by the Central Drugs Standard Control Organization (“CDSCO”) on the actual
risk; based upon the intended use and purpose:

 Class A – low risk medical devices such as absorbent cotton wools, surgical
dressings, alcohol swabs, etc.
 Class B – low moderate risk devices such as thermometer, blood pressure
monitoring device, disinfectants, etc.
 Class C – moderate high-risk devices such as implants, haemodialysis catheter etc.
 Class D – high risk devices such as angiographic guide wire, heart valve, etc.
The classification for the medical devices in these categories is based upon the
Part I of the First Schedule of the Rules. All notifications regarding these can be
accessed through the CDSCO website but for the time being, the classification
has to be assessed by the applicant from the Part 1 of First Schedule of the
Rules. The regulation with respect to manufacture of Class A & B devices is
done through the State Licensing Authority, which is the State Drugs Controller
and for Class C & D is done through the Central Licensing Authority, which is
the DCGI.

Process for Registration

Through the notification dated February 11, 2020 the government has
mandated the registration of all devices, except for the notified categories,
through the procedure set down in Chapter IIIA of the Rules. In effect,
combined with theamendment of the definition, all medical devices require
registration for manufacture and import from April 1, 2020onward. The
manufacturers can simply submit their applications for grant of registration of
the medical device throughthe CDSCO website
(https://cdscomdonline.gov.in/NewMedDev/Homepage) by submitting the
following information:
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1. Name of company or firm or any other entity
2. Name and address of manufacturing site (for devices manufactured in India)
3. Details of the medical devices (Generic Name, Model No. Intended Use, Class of
Medical Device, Material of Construction, Dimensions (if applicable), Shelf Life,
Sterile or Non- Sterile Status, Brand Name (only if registered under India’s trade
mark law).
4. Certificate of compliance with respect to ISO 13485 standard accredited by
National Accreditation Board for Certification of Bodies or International
Accreditation Forum in respect of such medical device.
5. A duly signed undertaking stating that the information furnished by the applicant
is true and authentic.
6. Specifications and standards of medical device (for imported devices only)
7. Free sale certificate from country of origin (only for imported devices)
After the submission, the registration is completed and the registration number
is allotted which is required to bemandatorily printed on the medical devices.
This is an expedited and simplier method for registration of those medical
devices which did not fall under the previously notified 37 categories of medical
devices. Regardless of the expediency, in order to ensure safety and quality
standards, the Central Licensing Authority has been given the power toverify
the documents at any point of time and investigate the quality or safety related
failure or complaints.

One of the key features of this new regime under Chapter IIIA of the Rules is
that the certificate of compliance with ISO-13485 (Medical Devices- Quality
Management Systems) has been made mandatory for registration. Any importer
or manufacturer shall now be required to mandatorily have this certification of
ISO-13485. This will ensure that quality standards are maintained and no faulty
devices are being sold in the market. It is also mandatory that this certification
is maintained throughout the validity of license.

Apart from the registration of the medical device, for the manufacture or
import, a separate license has to be obtained from the authorities. The same
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can be obtained within a period of 180-270 days from the date of application.
The applications for the license are submitted through the portal of CDSCO
mentioned above. For a license to import, the application has to be submitted to
the DCGI. For the license to manufacture Class A & B medical devices, the
application has to be submitted to the State Licensing Authority. For license to
manufacture Class C & D medical devices, the application has to be submitted
to the DCGI. The entire process for the same is regulated through the Rules as
well.
Exemptions from Registration
To provide a smooth transition for registration of all medical devices which were
previously unregulated, the government has made such registration voluntary
for a period of 18 months from the commencement of the Chapter IIIA of the
Rules. Further, the government has also added an exemption under the Eighth
Schedule of the Rules for thecomplete application of the Chapter IIIA for a
certain period of time, with respect to:

 Obtaining a compulsory license for manufacture or import of the Class A and

Class B medical devices for a period of 30 months, which ends on August 11,
2022.
 Obtaining a compulsory license for manufacture or import of the Class C and
Class D medical devices for a period of 42 months, which ends on August 11,
2023.
As such, after October 1, 2021 all medical devices will mandatorily have to be
registered but the license for manufacture, import and sale of the medical
devices not covered in the notified 37 categories, will be exempted till the time,
as given above.

Consequence of Non-Compliance Before Deadline

If any manufacturer or importer fails to comply with the requirement for
registration of the medical devices before October 1, 2021 or obtaining the
license before August 11, 2022 for Class A & B, and August 11, 2023 for Class C
&D, they will be held in violation of the Rules and the Act.
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Following the implementation of the amendment of February 11, 2020, it will be
easier for authorities to regulate theindustry. The Legal Metrology (Packaged
Commodity) Rules, 2011, requires every importer or manufacturer to state the
date of import or manufacture, as the case may be, on the label of the medical
device. Hence, if the registration number of the medical device is not present on
the label of devices imported or manufactured on or after October 1, 2021, the
DCGI can cease the device and take appropriate action against the importer or
manufacturer. The violation of the Rules along with its amendment, can lead to
initiation of criminal prosecution under the Act which can lead to imprisonment
or fine or both. For example, manufacture or sale of substandard devices is
punishable with imprisonment of 10 years, which may extend to life
imprisonment.

https://www.indialegallive.com/special-story/medical-
devices-regulation-india-95413
BURNING TOPIC
What are benefits and barriers when performing remote audits?
Thanks to the fast advances in technology, conducting remote audits is becoming more popular
among organizations. Businesses already include high-tech strategies that allow audit teams to
receive and share data, conduct interviews, and make observations with organizations from all over
the world without the need of commuting for several hours to the audit site. Certification bodies will
certainly have to adapt to this new situation. In fact, the last version of ISO 19011:2018, Guidelines
for auditing management systems, includes new specifications for conducting remote audits in order
to carry out this transition to e-auditing.

What is a remote audit?

A remote audit, also known as an e-audit, is exactly the same as an audit but using electronic means
to remotely obtain audit evidence and evaluate it objectively in order to determine the extent of
conformity to the audit criteria.
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Remote audit techniques are similar to those used in person but, for instance, you can share files via
email, Google drive, Box, etc. In addition, the company can provide documents by sharing its
desktop screen or via video conference using Skype, Zoom, etc., which is also used for interviews
together with the phone. Surprisingly, reviewing documents and records virtually can be even more
effective than doing so onsite.

Some areas that can present difficulties during a remote audit involve manufacturing processes or
product storage. In these cases, remote audits can use live video or even surveillance video to
gather the necessary audit evidence.

Conducting a remote audit does not mean that all the work should be performed offsite; some of the
work can still be conducted onsite. E-auditing means that, if possible, auditing activities will be
configured to be conducted away from the auditee’s location, considering that sometimes employees
are still not familiar enough with methods used in a remote audit in order to obtain the required audit
evidence.

Benefits of remote auditing

There are several reasons why conducting remote audits can be beneficial for auditing companies.
Here you can find the most relevant ones:
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Barriers of conducting remote audits
When it comes to the barriers that an organization needs to face while conducting a remote audit,
we can find the following:

Remote audits are not approved by IAF AND ISSUED GUIDANCE ON SAME HOWEVER SECURE
INTERNET CONNECTIONS< DATA SECURITY ISSUES are stumbling blocks to eauditing 
The reason is that some accreditation and certification bodies still have not decided how much of the
required audit time can be conducted remotely in order to collect reliable audit evidence and trust the
audit results. For instance, they have clear concerns about performing an entire audit without visiting
the location, and certain doubts about the reduction of on-site hours that would be spent in virtual
work. On the other hand, auditors conducting the remote audits should have the necessary technical
knowledge to deliver this kind of audits, which means extra effort for the certification and
accreditation bodies to train auditors on these techniques. Having all of these factors in
consideration, accreditation and certification bodies can see remote audits as being more of a
headache than a real benefit.

Issues with technology. Depending on the location of the auditee and technology used, one of the
main challenges organizations can run into is logistics. Sometimes, network connections are not
very reliable, or the auditee can have difficulties with accessing the VPN to log into a database in
order to show evidence. In addition, due to network issues, interviews and meetings can be
interrupted, taking some time to reconnect and solve all the network problems.
Lack of involvement. Other issues related to performing remote audits include process owners who
become unavailable due to having a meeting already scheduled, or even lack of attention from the
auditees, possibly since they are performing other tasks while the audit is being conducted. Auditee
companies can play a big role here, delivering awareness sessions for their employees and
preparing employees with the necessary tools to be e-audited.
Trusting the audit. Some auditors want to perform on-site audits because they believe they can trust
the audit only if auditors have physical access to audit evidence.
For example, remote audits can be seen by auditors as not suitable for auditing facilities, since a site
walkthrough can provide key information for the identification of issues within the company. It is
definitely easier for the auditee to hide their issues and even possible nonconformities during an e-
audit, where the auditor is not physically present, and usually auditees know in advance what is
going to be audited and how. Also, in remote audits, non-verbal communication cannot be used by
the auditor to detect possible confusing messages during an interview, sometimes crucial to detect
any inconsistencies or concealed problems.
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Insufficient auditor training and experience. Lack of training and/or experience of the auditor
conducting remote audits can lead to an inability to collect sufficient audit evidence and, thus,
assess it objectively. It is crucial for a virtual team to have the necessary knowledge to correctly
conduct audits using the technology.

Remote audits are the future of auditing

Remote audits have come to stay; their advantages are unquestionable over the traditional methods,
although there are still some barriers to overcome. Traditional audits, even when they have been
well planned and executed, may cause a certain amount of inconvenience and disruptions to the
organization being audited. In addition, business managers are increasingly finding these e-audits
very attractive, since reductions in costs and resources are undeniable using virtual methodologies.

Do reply with your comments what do you feel about remote auditing .

SOME INSPIRATION
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HUMOUR IN LIFE
Updated ISO Glossary

 ISORE – Eye strain from writing procedures and job tasks.

 ISOAP – Detergent used to get everything in tip-top shape for audits.

 ISO-SO – a ‘here nor there’ not very urgent non-conformance.

 ISOCIAL – The bash thrown to celebrate passing your ISO audit.

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 ISODA – Drinks that are enjoyed at an isocial.

 ISOB – Tears that come from getting one too many non-conformances in the audit.

 ISOHAPPY – The pure happiness of conformity and improvement.

 ISONO-NO – The mistakes and mishaps that result in a non-conformance.

 ISORRY – The response that is often made when it comes to CAPA.

 ISOMETRICS – How quality management steps are measured.

 ISOLATION – The feeling that management often has when new systems are introduced.
Source: https://www.isotracker.com/blog/the-lighter-side-of-iso-quality-standards/

WHATSAPP HUMOUR

This weekend, we as Auditor reviewed the process in kitchen and found following major observations
and NC.

1. There is no SOP.

2. There is no budgeting documents

3. There is no indexing of products.

4. No bin cards were displayed.

5. No Annual, monthly or quarterly stock taking has been carried out for many years.
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6. No Inspection has been carried out for years.

7. No balance sheet and Profit & Loss statement ever made.

8. Weighing scales not existing and for the scales existing no calibration done.

9. No handing over /taking over files.

10. No policy file .

11. No quality assurance of cooked and non cocked material

12 No certificate of fire safety

13 No water testing report

14 No audit was done by inhouse team or external auditors.

Then my wife came and ask my competency documents and here we found Major NC...😟😟

IF YOU WANT CONTRIBUTE YOUR STORIES/ARTICLES DO WRITE US AT qual.solutions@gmail.com with

your brief profile to be shared .

I hope you liked our newsletter suggestions , feedback, brickbats are welcome .This has been a delayed
edition as we were watching whole pandemic scenario but we will be regular with special monthly
newsletters in your inbox hope you find them informational and motivate to keep learning and
developing new ideas .

BE PREPARED AND BE SAFE

LETS TOGETHER FIGHT CORONAVIRUS AND LEAVE THE WORLD A BETTER PLACE
BE ALERT

BE SAFE

MAINTAIN SOCIAL DISTANCING

FOLLOW GOVT RULES

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