IQC Services

2023-01-07T22:54:00.000-08:00

What is Risk Analysis

It is investigation of all available information about product and its associated processes to identify hazards and to estimate risk.

Failure Mode Effect Analysis(continued)

2019-08-09T04:46:00.002-07:00

Failure Mode Effect analysis also helps in :

Correctly identifies failure modes for product functions
Use data currently available in company to calculate ability to detect product design related failure modes
Accurately predict the likelihood of a design related root cause resulting in specific failure modes.
Identify severity rankings for specific failure modes for product designs and manufacturing risks.
Use local and or end user level effects to identify and manage product and manufacturing risks.
Identify current controls for the design and manufacturing processes.
Identify corrective actions that will improve manufacturing and design controls and eliminate the root causes of the identified Potential failure mode.
Identify specific features producing functions for each manufacturing process steps and potential failure modes for each of these steps.
Identify root manufacturing causes for potential process failure modes.
Assess the effectiveness of manufacturing controls to detect process failure modes.
Determine the likelihood that a specific cause will result in process failure mode and the effects of that of failure mode on process and product.

IQC Services: Failure Mode and Effects Analysis-FMEA

2019-08-09T04:19:00.003-07:00

IQC Services: Failure Mode and Effects Analysis-FMEA: Failure Mode and Effect Analysis(FMEA) is one of the most powerful and practical reliability tool in manufacturing today.Many companies use...

IQC Services: Failure Mode and Effects Analysis-FMEA

2019-08-07T08:52:00.002-07:00

IQC Services: Failure Mode and Effects Analysis-FMEA: Failure Mode and Effect Analysis(FMEA) is one of the most powerful and practical reliability tool in manufacturing today.Many companies use...

Failure Mode and Effects Analysis-FMEA

2019-08-07T06:46:00.001-07:00

INTRODUCTION

Ahigh Quality Product that conforms to intended purpose that usually results in High customer satisfaction. The best way to achieve this is to builtd Quality in design upfront in manufacturing itself rather than restoring to rigorous inspection later on.

A useful quality Engineering Tool for that purpose is Failure Mode effect Analysis (FMEA).

Failure Mode and Effect Analysis (FMEA) is one of the most powerful and practical reliability tools in manufacturing today .Many companies used FMEA to successfully improve product designs and Manufacturing processes. It has been referenced in USFDA Pre-production quality planning bulletin (FDA 90-4236) and in ISO 9001 quality standards as an effective tool for ensuring quality product design and manufacture. New standards for medical device risk analysis (EN 1441 and ISO 14971-1) as well as FMEA(IEC 812) specifically address the application of FMEA .It can also be use for product development,design and manufacturing. It also focuses on design and process FMEA .It can also be used to improve field service efforts and the system. It also helps in identifying potential failure modes,assess the risk of failure,evaluate possible causes and implement solutions. It also helps to establish priorities and organize resources to correct potential problems.

FEMA can be used to:

Design your products right the first time.
Improve the control over your design process
Reduce the cost and improve the quality of your manufacturing processes.
Reduce the time to get your products to market.
Focus on function based features during product deign and manufacturing planning.
Eliminate non value added manufacturing steps
Prevent costly and time consuming engineering design changes
Improve product performance and customer satisfaction
Establish and verify manufacturing process capability
Improve product design validation process
Implement effective manufacturing controls such as SPC,control plans and CpK calculations.
Develop manufacturing specifications that meet your product design requirements.
Integrate design and process FMEA into TQA and reliability program
Predict potential design and manufacturing related problems early,before they occur so you can take corrective actions before damage is done.
Use FMEA to avoid costly product field failures.
Apply a systematic approach to integrating information from customer service, field complaints, reliability studies, quality and inspection data and testing data to improve new product designs and manufacturing processes.

Quality Management Practices for Organizational Excellence

2015-12-09T02:34:00.000-08:00

To achieve Organizational Excellence one must inculcate Quality Management Practices.The final product is Organizational Excellence which is outcome of two main components which are blended together by all stakeholders.These components are Strategy and Culture. In short we have to cultivate "Quality" as Strategy and "Quality" as Culture,if we have attain Organizational Excellence.It is conscious and deliberate step or plan of action to develop an organizational distinctive competence."Quality" as culture of behavioral pattern of all the stakeholders in terms of belief,values and attitude.For competitive organization of future,to achieve and sustain Quality management,Quality as Culture and Strategy as scientific pursuit is essential to achieve it.

Detection,Prevention and spiral of progress in Quality

2015-03-23T09:51:00.002-07:00

Spiral of progress in Quality

Four Absolutes of Quality

2015-03-22T12:36:00.001-07:00

FOUR ABSOLUTES OF QUALITY:

Four absolutes of Quality Management for quality improvement process are:

1.Quality is conformance to requirements:

All the requirements of products and related services should meet the customers requirements and the management should provide necessary resources to meet the requirements.The emphasis should be," Do it Right the FIRST time and every TIME".

2.The System of Quality is Prevention:

The system that produces Quality is Prevention.That is eliminating errors before they occur.Training,discipline,example and leadership produces prevention.Management must consciously commit themselves to prevention oriented work environment.

3. Performance Standard:Do it right the FIRST Time and Every Time.Leadership must help others in their pursuit for Conformance to requirements by allocating resources for training,tools,providing time etc;to all employees.

4. The measurement of Quality is price of Non conformance:
Non-conformance is management tool for diagnosing organization's effectiveness and efficiency.

Cost of Quality-slides

2015-03-22T11:08:00.002-07:00

Profit improvement through Quality

2013-02-15T00:11:00.001-08:00

Cost of Quality may vary from company to company.It may in the region of 20% of sales for a manufacturing company and 30% of operating expenses for a service company.

HIDDEN COST OF FAILURE:
Materials 40%
Employees Cost 20%
Selling Expenses 20%
Administration 04%
Excise and Taxes 12%
Dividend to shareholders 02%
Retained profit to reserves 02%

TOTAL 100%

Each of these heads can have all the three components,natural cost of operating business(COB),Cost of prevention or cost of control(COC),and cost of internal and external failures(COF).
The cost of materials,estimated at 40%,includes not only the material essential to produce a product(COB) but extra material put in to be sure that the customer is satisfied all the time(COC) and cost of material wasted in the plant.The cost of employees essential to run the business(COB) but also the cost of employees required to ensure that the business is run properly(COC) and the employees who take care of the consequences of errors and mistakes.Let us take case of inventory carrying costs.The cost of inventory that the company considers optimum for running the business is COB.The cost of extra inventory held specifically with a view to avoid line stoppages when the storage of a particular material is anticipated or the cost of carrying safety stocks is COC and carrying less inventory because of failure to meet some forecast is COF.

Planning to reduce cost of Failures:
The first important step to reduce cost of Failures is commitment of management to concept of quality management.The philosophy of QUALITY FIRST must be communicated to all employees,just not in words but in deeds also.Once quality is put a head of cost, the management of quality has also got to be put on the same if not higher footing than management of Finance.Hence Quality Planning-equivalent to budgeting in finance,Quality Control-equivalent to controls in finance to keep expenses within budget.Quality Improvement--equivalent to projects for profit improvement to make the financial results of thee company better than those forecasted in the budget.

For reducing cost of failure,employees should learn to do things right the first time every time.For this there is need for training and education on large scale.Various support systems should be in place for its implementation.Higher management should take keen interest in it's implementation. To make this system successful,employees should be motivated to publish success stories of the results coming out of this system.People should be rewarded if substantial cost benefit is noticed by implementation of this system.

Hurray!!!

2013-02-14T05:12:00.002-08:00

Hurray! I have one of the top 10% most viewed @LinkedIn profiles for 2012 in India.

Cost of Quality

2013-01-18T02:13:00.005-08:00

Cost of quality is a measure to draw attention of top Management,who has a constant eye on the bottom line and understand the language of money better than indices,percentages,volumes of rework and rejections.Once this cost is brought to the notice of top Management,this will ensure how money is wasted on avoidable operations because of non conformance to quality.Hence they get interested in reducing the cost of improving Quality.Cost of quality includes compilation of all expenses,a company is forced to incur, as a result of failure to meet quality requirements.There are two types of expenses. One type of expense the company incurs willing to achieve Quality.This is not undesirable.In fact it is essential for achieving Quality.The other type is not desirable. The company does not incur the expenses willingly but is forced to spend when something goes wrong.This is the type of expenses that can be and should be saved.

Cost of Quality is a measure of quality. the importance of measurement cannot be overemphasized.Measurement is also useful and essential.Without measurement one cannot even know if there is improvement or not.Measurement creates an awareness of the problem.Measurement leads to analysis and analysis can lead to problem elimination.In fact measurement is the starting point for any improvement.

Components of cost of quality:Cost of quality can be categories into:
1.Cost of Prevention
2.Cost of Appraisal
3.Cost of internal Failures.
4.Cost of External Failures.
The first two are incurred for achieving Quality.The other two are incurred because of failure on part of someone or other.
Cost of Prevention:
1.Market Research
2.Product qualification
3.Process validation
4.System development
5.GMP
6.Quality Education
7.Any other preventive action.
Each of the above can help an organization in preventing problems of quality>hence these form part of Cost of Prevention.

Cost of Appraisal-These include the following:
1.Incoming material Testing
2.In-process Quality control
3.Product testing and Inspection.
4.Quality audits
5.Field Testing.

The above operations help an organization in finding out if its products and services meet the predetermined requirements.

Cost of Internal Failures:
When a product or services fails to conform to requirements,an organization has to spend on correcting the situation.All costs incurred due to such failures,if detected internally,fall under this category.This item includes:
1.Rejection.
2.Rework or reprocessing
3.Re-inspection
4.Scrap.
5. machine downtime.
6.Breakdown maintenance
7.Problem Solving.
8. Expediting.
9.Overdue accounts receivables.
10.Excess inventory.
11.Overtime.
All these are avoidable expenses.If there are no failures,there would be no expenses on any of these counts.

Cost of External failures:When internal failures are not addressed,the organizations has to incur much expenditure to take care of the consequences. All these fall under the category of cost of external failures.prominent under these categories are:
1.Complaint handling
2.product liability cost.
3.Return products
4.Unplanned field service.
5.Recall costs.
In addition to these tangible costs,several intangible costs,difficult to quantify fall under this cateogy.These are all the same very important:
1.Loss of customer goodwill.
2.Bad Publicity
3.Fall in Market share
4.Low employee Morale.

Interrelation of these components:
External failures result from failure to detect errors or defects internally.High cost of external failures would indicate inadequate testing. Thus if cost of appraisal is increased,part of external failures can be brought into category of internal failures.This reduces the expenses as a failure detected in house costs much less to correct than failure detected by customer.Appraisal cannot reduce percentage failure rate,it can only assess If one has reduce failure rate,one has to analyse the problem,arrive at root cause and eliminate the same..In short prevent defects from recurring.Prevention should be emphasized at all stages of operation.
To make interrelationship between components more clear,let us assume cost of Quality of the company at the start of Quality improvement process to be as follows:

Cost of Prevention: 2%
Cost of appraisal : 4%
Cost of internal Failure: 4%
Cost of External failures:10%
Total Cost of Quality: 20%
When the management sees that the cost of external failures is too high,it increases testing to catch failures in house.If it increases inspection by 50%,result is external failures are now detected internally.So the figures now stands at:

Cost of Prevention: 2%
Cost of appraisal : 6%
Cost of internal Failure: 5%
Cost of External failures: 5%
Total Cost of Quality: 18%.

But this can be only temporary measure,so the emphasis is now on prevention.Once these preventive measures are in place,the cost of Quality picture can be transformed to something like this:

Cost of Prevention: 3%
Cost of appraisal : 6%
Cost of internal Failure: 2%
Cost of External failures: 1%
Total Cost of Quality: 12%.

Once the processes become stabilize, the cost of appraisal can also be reduced and picture looks like this;

Cost of Prevention: 3%
Cost of appraisal : 3%
Cost of internal Failure: 2%
Cost of External failures: 1%
Total Cost of Quality: 9%.

For company with sale of over 50 cr, these savings will mean an additional of over Rs.5 cr to the profit before tax with very little investment on prevention efforts.

Investment in Quality Improvement yields better returns than any other investment.

Enlarged scope of Quality Management

2013-01-17T09:06:00.000-08:00

In Quality Management phase,quality considerations are applied to all the processes in the company, just not the products and services going out to the customer.An intermediate being used in the product must be subjected to Quality checks as strict as if not more than those performed on the ongoing product and incoming materials. In the same way a service provided by one department or to another sector of companies must be critically examined as the quality of service provided to the ultimate customer.The intermediate going into the product or a component going into the assembly of a machine has to be quality if one wants the finished product or the machine to be conforming to quality.If service provided by,say maintenance department to production is not right,how can one expect the product made on a improperly maintained machine to comply with its requirements.
Due to interdependence of all departments in a company,an error in one department may only be seen in the next.

Quality Conscious management knows, well maintained plants inspire quality consciousness among their work force.This has greater impact on workmen and staff as cleanliness and orderliness in production.

Most Quality experts believe that 80% -85% of quality problems are caused by management and only.12%-15% are caused by workmen.When defects occur,one need to analyse why it occurred.
Quality is team effort of all departments in company.One department is interdependent on another one.Hence if quality is affected in one department,it gets affected in all departments.

Major product spiral starts from:
1.Marketing
2.Designing
3.Procurement of material and equipment.
4.Production
5.Quality CONTROL/Quality Assurance.
6.Transportation.
7.Sales
8.After sales service.

QUALITY IS IN-BUILD IN ALL THESE STAGES AS OUTPUT OF STAGE BECOMES INPUT OF NEXT STAGE.

Total Quality Management

2013-01-10T03:58:00.001-08:00

Total Quality Management is a process

It can be categorized into three measure factors like Quality Management,Quality Planning and Quality Improvement.If any of these three factors go missing,then TQM in any organization cannot be successful.Total Quality Management is a must for any organization which needs to survive in today's competitive environment and also sustain leadership in it's own field.

Let us look at each of these factors in detail.
Quality Management:It is a strategy of Management to achieve and improve Quality.

Let us start by defining Quality.Some define it as luxurious,shining,expensive,pleasant and so on.A toilet soap is quality as it has pleasant odor.But pleasant odor to one need not be pleasant to some other person.Some people define quality as reliability fitness for use and durability.These are subject description/perceptions which do not add value to consumers.

quality needs to be defined as conformance to standards or requirements.Requirements can be obtained from Voice of customer which gets translated into requirements or specifications.With this definition there cannot be any ambiguity at all.This can be further translated into Quality of Design and Quality of Conformance.

Quality of Designs deals with REQUIREMENTS and Quality of conformance deals with with how often do we need to meet these requirements.Quality of Design involves all the people in Organization like sales/Marketing/Research and Development/Finance/Manufacturing/Planning/Purchase.Whereas the Quality of conformance is the main responsibility of Quality Management.
Birth of Quality Function:
After industrialization,people were appointed by organization to assess the quality of products manufactured.This resulted in testing the products and categorized them into release,reject and rework.This function was named as quality control.
Quality Assurance:
Techniques like Statistical quality control were used by organization to assure quality of product by removing defects during process rather than end of the production cycle.
However to have better control on quality of product,SQC was further used at suppliers end,so that the quality of incoming raw material was assured and used in production process to further tighten and assure the quality.
In short the emphasis was on prevention rather than cure.

QMS

2012-06-16T21:40:00.000-07:00

Quality Manual is the important reference point for Quality System of an Organization.

Documentation

2012-06-13T05:54:00.000-07:00

All activities done should be documented. If it is not documented then the activity is not done.Documentation is important in good Manufacturing Practices.

Innovation

2012-06-11T01:37:00.004-07:00

Any activity or thing which is done uniquely and which will benefit organization or society as a whole is Innovation!!!

Learning Process

2012-05-17T07:23:00.002-07:00

Leaning is continuous process.It never ends.The day one stop learning,he/she become dead wood.Do not miss any opportunity where by one can add knowledge,what ever may be the age.Always share knowledge otherwise it become garbage!!!!

Build QUALITY brand

2012-05-15T00:23:00.002-07:00

Develop,"Quality", brand in personality if one wants to be successful in Quality Organization.

Visit to Xian Janssen Pharmaceutical Ltd

2012-05-14T02:29:00.002-07:00

Visit to Xian in Year 2002 for conducting training at Janseen Cilag Pharmaceuticals Ltd China with Q.A personnel

Visit to Sydney Australia

2012-05-14T02:22:00.002-07:00

Visit to Sydney Australia to attend Marketing conference held in 2002.

Gargrave near Manchester U.K

2012-05-14T02:14:00.002-07:00

Meeting held at Gargrave a suburb 150kms from Manchester in year 2001 for harmonization of formula and label claims for CIDEX* a product of Advance Sterilization Products.

Tribute to Mothers on Mother's Day

2012-05-13T10:45:00.004-07:00

Since today is Mother's day,it is pertinent to express deep sense of gratitude to them for taking trouble to inculcate the ,The Quality"temperament in what ever they do for upbringing of their off-springs to make them responsible citizens of tomorrow

Quality Policy

2012-05-13T02:37:00.002-07:00

Quality Policy should be displayed at all prominent places in organization and people should be aware as well as understand and practise it.It shows how organizations give importance to QUALITY

Importance of Training

2012-05-13T01:09:00.003-07:00

A well trained personnel in Quality and Manufacturing organization help immensely in preventing Quality issues on shop floor.