Production restart after unplanned Shutdown using QMS

Production restart after unplanned Shutdown using QMS

When it rains, look for rainbows, when it’s dark, look for stars Oscar Wilde

These days the heart sinks for many when our internet network stops suddenly. During peak summer afternoon, when suddenly electricity goes off, we sweat and crib the local government and electricity board for their inefficiency. Due to lockdown, suddenly the meeting of many lovers has stopped! When we are on a highway and our car suddenly breaks down, we get helpless.

Something similar happens in the industrial environment when few machines or the entire plant goes under unplanned breakdown. It is easy to recover after planned shutdown as organizations make prior arrangement for the startup. But globally, COVID 19 has put the entire industry in a mess as everything halted suddenly and now when slowly situation is coming back to normal, it is a mammoth task for each industry (Large, Medium, small) to restart efficiently.

For organizations, these are testing times to check the strength of their Quality Management System (QMS). In the coming few months, organizations will somehow manage to come out of this desperate situation but how efficiently, effectively and prudently, organizations will transform to the ‘New Normal’ will depend upon the depth and maturity of their existing management system and how intelligently they will use in this crisis time.

As per IATF 16949: 2016, Clause 3.0, there are few definitions related to Maintenance & shutdown.

Production shutdown: Condition where manufacturing processes are idle; time span maybe a few hours to a few months

Total productive maintenance: a system of maintaining and improving the integrity of production and quality systems through machines. equipment, processes, and employees that add value to the organization

Why Strong QMS is need of the hour?

  • Expectations of customers and relevant interested parties still remain the same!
  • Low morale of employees and relevant stakeholders
  • Nobody (including top management) knows the right answers to the present situation
  • The high cost of production
  • Low Productivity
  • Unavailability of skilled manpower
  • The bad condition of machines, fixtures, gauges, measuring instruments, tooling etc.
  • Unreliable supply chain
  • Unpredictable government guidelines

How QMS can help to restart the factory after unplanned shutdown?

The strength of QMS lies in its systematic approach to

  • Engage all relevant stakeholders
  • Understanding their needs and expectations
  • Conducting risk analysis
  • Taking appropriate actions
  • Reviewing the results
  • Taking actions to improve it further

To restart the production after unplanned shutdown, the challenges and possible actions using QMS can be divided into 6M & 1E (Management, Man, Machine, Material, Method, Measurement, Environment).

Management:

Possible Challenges Possible Solutions ISO 9001/IATF 16949 Clauses
Profitability -Low-cost automation

-Multiskilling

-Leakages & wastages to be identified and controlled

-Implement techniques of Industry 4.0

7.1.3.1- Plant, Facility & Equipment planning
Employee Morale -Frequent Management Review Meeting (MRM) to review the dynamic environment.

-Town Hall / Open House with employees to understand their concern

9.3- Management Review

7.4-Communication

Restoration of ‘New Normal’ -Review Risk analysis document and update as per existing scenario

-Review existing contingency planning document and make amendments

-Sharing REAL status with Customers, Employees and relevant interested parties like suppliers, bankers etc.

6.1- Risk Analysis

6.1.2.3- Contingency planning

7.4-Communication

 

Dealing with Government, Legal Requirements Regular review of statutory & regulatory requirements in MRM 8.6.5-Legal Requirements
The high cost of production as reaching to 100% production level will take time -Initiate company-wide Improvement tool like Kaizen, Quality Circle

-Initiate company-wide cost saving projects and low-cost automation

-see the possibility of introducing techniques of Industry 4.0 like IoT (Internet of Things)

7.3.2-Employee motivation & empowerment

10.3- Continual Improvement

Man:

Possible Challenges Possible Solutions ISO 9001/IATF 16949 Clauses
Employee Morale Listening to their concern and offer possible solutions like food, shelter, sanitization, medicines, timely salary etc. 7.3.2-Employee motivation & empowerment
Non-availability of Competent manpower at organization and supplier end: Production, Quality, Maintenance etc. -Regular review of the skill matrix as per available manpower. Where needed, take customer approval.

-Reverify competency.

-Quick supplier audit to verify their competency level

-Review existing Control Plan as per process flow and revise as per the available resource

-Reapproval of control plan from the customer

8.7-Customer concession

7.2-Competency

8.4.2.4.1- Supplier Audit

8.5-Control Plan

Health history of employees -Periodic health check-up at entry

-Take commitment from employees once they are out of the factory

7.3.2- Employee motivation
Upgrade skill of available manpower -Quick MSA (Measurement System Analysis) study for the qualification of inspectors at different stages.

-On-job training to unskilled/semi-skilled workers

7.1.5.1.1- MSA

7.2-Competency

Communication Make effective use of smartphones for communication inside/outside the factory/office 7.4-Communication

Machine:

Possible Challenges Possible Solutions ISO 9001/IATF 16949 Clauses
Preventive maintenance of machines Review existing preventive maintenance checklist and revise it as per existing condition and do the quick maintenance 8.5.1.5-Preventive Maintenance
Calibration of measuring instruments Recalibrate/Revalidate/Reverify the instruments before use 7.1.5.2-Calibration
Condition of utilities like Generator set, Cooling tower, Compressor -Call service provider on SOS basis

-Do internal maintenance where possible

8.5.1.5- TPM
Poor Health of machines/ Breakdown -Restart the production based on Planned shutdown review criteria

Process revalidation with the competent team

Condition-based monitoring of furnaces, Banbury etc.

-quick Predictive Maintenance

Process capability of the machine

-Review Machine Manuals and restart production

-Detailed job setup of machines/process where critical parameters are to be controlled

8.5.1.4- Verification after shutdown

8.5.1-Control of Production

8.5.1.5

8.5.1.3-Job Setup

Material:

Possible Challenges Possible Solutions ISO 9001/IATF 16949 Clauses
Out of Shelf life material Stock Monitoring at all stages

Revalidation of material from the approved laboratory; if needed approval from the customer/Supplier

8.5.4- Preservation

 

 

 

Non-availability of material from approved suppliers -Selection & Approval of new suppliers or customer waiver for getting material from unapproved suppliers

-Re-approval of sub-suppliers where needed (Steel, Fabric etc.)

8.4.1.2- Supplier Selection

8.7- Control of NC product

 

Condition of in-process material -Disposal of defective material with proper identification and traceability like Green Tyre in Tyre Industry, phosphated material etc. 8.5.2- Identification & Traceability

8.7- Disposal

Impact of sanitization on raw material and finished product at organization and supplier end -Internal/external approval/ Lab testing of fumigated material

Layout inspection of initial components

-Quick visit supplier end and inspect before starting despatches

7.1.5.3

8.6.2-Layout Inspection

8.4.2.4.1- Supplier Audit

Condition of BOP’s like plated, rubber, sheet metal and finished product in inventory -Reject/Segregate/Rework/Repair/Reprocess

-Manufacturing Process Audit / Product audit

 

8.7- Control of NC product

9.2-Internal Audit

Availability of critical Spare parts Review the critical list again and make them available for continuing production 8.5.1.5- TPM

Method:

Possible Challenges Possible Solutions ISO 9001/IATF 16949 Clauses
Re-layout due to social distancing -Involve New Development Team for reviewing the process again

-Review of Control Plan

-Re-MSA

-Review of FMEA

-Re-SPC

-Review effectiveness of Fool Proofing

-Quick System and Process audit

7.1.5.1.1-MSA

8.3-New Development

8.5.1.1- Control Plan

9.1.1.2- SPC

10.2.4- Error Proof

9.2- Internal Audit

How to use Control Plan in the revised condition -On job training

-Increase the frequency of inspection and sample size

-Review & revise Reaction plan

7.2- Competency

8.5- Control plan

Deviation process of the suspected product -Review existing approved personnel and revise as per available manpower

-Improve communication with the customer

8.5.6.1.1- Temporary changes

8.2-customer communication

Availability of procedure, how to restart production after shutdown -Prepare a new procedure if not available

-If available, review it for its effectiveness

-Provide on the job training

7.5 – Documented information

7.2- Competency

Classroom training -Online training and adapt themselves to this new tool for learning 7.2- Competency

Measurement:

Possible Challenges Possible Solutions ISO 9001/IATF 16949 Clauses
Out of calibration instruments measuring critical dimension Recalibrate/Revalidate/Reverify the instruments before use

-Quick MSA study (Attribute/Variable)

-Purchase new Instruments and get it calibrated/validated before use

-Contact with External Laboratory for testing: Preferably ISO 17025 approved

-Identify the despatched finished material

7.1.5.1.1-MSA

7.1.5.2- Measurement traceability

8.4- Supplier

7.1.5.1- Laboratory

8.5.2- Identification

Condition of Master and Limit samples Revalidate/Reverify the samples before use
Availability of approved measuring instruments -Purchase new Instruments and get it calibrated

-Customer approval

8.4- Purchasing

8.7- Control of NC product

 

Non-availability of testing/calibration laboratory (ISO 17025) -Internal deviation for use of non-ISO 17025 certified lab

Customer approval

8.7.1.1- Customer concession

Environment:

Possible Challenges Possible Solutions ISO 9001/IATF 16949 Clauses
Environment conditions (Temperature, Humidity) for the Paint shop, Material Stores, Electronic component, Laboratory etc. -Review existing control

-Get customer approval where needed

-Arrange PPE or make alternate arrangement for Gloves/Mask etc.

-System audit, Manufacturing Process Audit, Product Audit

7.1.4- Environment

9.2- Internal Audit

Desired light intensity at the inspection zone -Review the Standard

-Where possible make alternate arrangement

-Review the competence of personnel performing job

7.1.4- Environment

7.2- Competency

Environment condition at Supplier end -Temporary arrangements like Air Conditioner for Temperature and humidity

-Supplier audit

7.1.4- Environment

8.4.2.4.1- Supplier audit

Once the organization will map their possible challenges as per 6M & 1E, they can identify possible solutions (relevant at this point of time) and can systematically ensure that

  • Customer remains satisfied
  • Employee morale remains high
  • Losses can be minimized
  • The organization can quickly recover themselves and move towards the path of growth again.

Challenges:

  • How effective and mature is the existing Quality Management system?
  • Confidence of Top Management in their QMS.
  • Effective and open communication channel with customers, suppliers and other relevant interested parties.
  • Effective utilization of digital technology.
  • How to keep high morale of the employees?

References:

ISO 9001: 2015

ISO/TS 9002: 2016

ISO 9004: 2018

IATF 16949: 2016

 This is the 55th article of this Quality Management series. Every weekend, you will find useful information that will make your Management System journey Productive. Please share it with your colleagues too.

Your genuine feedback and response are extremely valuable. Please suggest topics for the coming weeks.

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Vikas sharma
Vikas sharma
3 years ago

Great effort in consolidaating the inputs to strengthen and get the best if the QMS in today’s getting the things started after the lockdown and to continue to working in an environment which focuses on hygenics , in self control to follow the social, statutory and regulatory rules which were otherwise just in paper. God has given us this opportunity to refine the things and live in a refined world. Sir Once again thanks for this great efforts of yours towards refining the environment around us.

Ramakrishna Maddali
Ramakrishna Maddali
3 years ago

Bhavya ji ? Whatever you said is absolutely TRUE w. r. t Risk Analysis by adopting 6M, 1E or 7M( E also can be M–i. e., Mother Earth) My apprehension is,this may be taken in true spirit by OEM’s(atleast 3/4th),whereas MSME/SME’s may work on COST Reduction activities, where main focus seems to be on Manpower Reduction… All The Systems will take back seat, till the Normalcy in terms of Economic development is Restored… Your comments are appreciated. Thanks