Learning from Impact of COVID-19 Pandemic and Redefining the ISO 9001:2015 & IATF 16949:2016

Posted on: February 28th, 2021  /  By:  /  Posted in: #QUALiTYViVA, Aarogya Setu, CORONAVirus, COVID19, FMEA, IATF, ISO, ISO 9001:2015, Uncategorized  /  Comment: 1

Corona virus drastically impact on the society and on industries/ organization, and industries/ organization closed because of lockdown, as a measure to contain the corona virus.   

Lockdown also result in non-availability of raw material and spares for machinery use in the organization that are going to restart the business.

There is another issue of migration of workers from one location to other, this also effect on shortfall of manpower to re-start the business.

As industries are going to restart the business, it is time to review and implement the new SOP base on Lesson learn from COVID 19 situation and also to follow the statutory and regulatory requirement.

In India, QCI, Quality Council of India launched Workplace Assessment for Safety and Hygiene (“WASH”) scheme to help the organization to assess the preparedness before and during start of operations.

In ISO 9001:2015 and IATF 16949: 2016 the clause those are required to be review and redesign the quality management system (if required) in view of Corona Virus Disease COVID 19 pandemic, is furnished here with, clause wise, as below:

Clause 4.1 Context of organization – ISO9001:2015 & IATF16949:2016

Internal and external issues related to quality management system and strategic direction of organization in view of Corona Virus Disease COVID 19 required to review for redefining the quality management system including the objectives which gives impact on intended results.

Clause 6.1.2.3 Contingency Plan – IATF16949:2016

Required to update the Contingency Plan by identifying and evaluating internal and external risk from Corona Virus Disease COVID 19 to all manufacturing processes to ensure customer requirement are met.

Clause 6.2 Quality objectives and planning to achieve them – ISO 9001:2015 & IATF16949:2016

Planning on how to achieve quality objectives and changes if any to be carried out in planned manner in view of Corona Virus Disease COVID 19.

Clause 7.2 Competency – ISO 9001:2015 & IATF16949:2016

Competency has been taken up, in view of migration of employee of organization, absenteeism because of Corona Virus Disease and new employee joining in the organization. This does not affect the performance and effectiveness of the quality management system and if so then take action to acquire the necessary competence of person/employee.

Clause 8.4 Control of externally provided processes, products and services– ISO 9001:2015 & IATF16949:2016

Organization can study the extent of impact and re-evaluate the external providers to provide processes, products and services as case may be.

Clause 8.4.1.2 Supplier Selection Process – IATF16949:2016

Supplier Selection Process to be evaluated carefully to check closure of any supplier’s facilities, financial stability, adequate available resources e.g. people, logistic process, customer services, etc.

Clause 8.5.1 Control of production and service provision – ISO 9001:2015 & IATF16949:2016

It is required to evaluate the suitable infrastructure and environment for the operation of processes in the organization e.g. like sanitization, hygiene, isolation area, added facility of disinfection, new SOPs etc. to contain corona virus and to focus on objectives.

Clause 8.5.1.2 Standardized work – IATF16949:2016

Review the standardized work document and requirements for addition of new safety rules to be implemented, because of Corona Virus Disease COVID 19(see last paragraph of this article).

Clause 8.5.1.4 Verification after shut down- IATF16949:2016

This is to be considered for start-up after stoppage of organization activities because of Corona Virus Disease COVID 19 and required to implement necessary action to ensure product compliance.

Clause 9.2.2 Audit programme – ISO 9001:2015 & IATF16949:2016

In many of the organization internal audit, surveillance audit and certification audit could not be taken up and this has required to be rescheduled. For this, organization has to redefine the audit activities like changes in audit plan, audit planning, responsibility etc.as the case may be.

Above is in general review of clauses of ISO 9001:2015 & IATF16949:2016 in view of Corona Virus Disease COVID 19 pandemic and its effects. The organization has to review on the basis of size of organization, competency of people(s) and effect of not reviewing of quality management system on objectives and intended results.

Risk Register

It is advisable to maintain the risk register on risk for covid19 and action taken for its mitigation.

By the way,

To combat with COVID19, one of the best examples from India is use of Aarogya Setu App, a mobile base digital platform.

Author called this Aarogya Setu App as risk intelligence. In India, this Aarogya Setu App can be made part of SOP, for standardized work or as a risk management tool.