Concepts Of Industrial Manufacturing Techniques

The scope of this study is to understand and implement the concepts of Just-In-Time Production and Total Quality Control along with Industrial Management and Scientific Management Techniques in Industrial Manufacturing.


Industrial Management – A time-line analysis of the growth of Industrial Management expertise may help show where the world’s industries learned what they know about producing goods. The hallmark of the factory system is efficiency, which is attained by division of labour, interchangeable parts* and efficient resource usage. Factory efficiency will be enhanced by standardization of product design, component parts and tools by the widespread use of engine-driven machine tools.

*Eli Whitney contributed the idea of Interchangeable Parts which means improvements in dependability, reliability, serviceability and productive efficiency.

Scientific Management – Frederick W. Taylor, Frank and Lillian Gilberth are the pioneers of scientific management, they perfected work-study techniques which are as follows:

1) Improved work method – simple and efficient.
2) Improved method is timed – provides time standards.
3) Workers are trained in the standard method.
4) Jobs are scheduled, supervised and controlled with reference to the standard method and time.

Just In Time Production

The Just-In-Time Production idea is simple: Produce and deliver finished goods just in time to be sold. It requires use of computers, tighter controls on inventory, leads to improve quality significantly, productivity and provides visibility for results so that workers responsibility and commitments are improved. Just-In-Time Production is hand-to-mouth mode of operation, with production and delivery quantities approaching one single unit, piece-by-piece production and material movement. The main focus of Just-In-Time Production is on plant modernization, cut setup times, production lot sizes and supplier delivery quantities.

The following points can be covered under Just-In-Time Production:

Scrap/Quality Improvement – Minimum lot sizes lead to lower scrap and better quality, also defects are discovered quickly and their cause may be nipped in the bud, production of large lots high in defects are avoided. When Just-In-Time leads reduce scrap and more good products, the time and money spent on rework drops.

Motivational Effect – There are three kinds of positive response triggered by heightened awareness of problems and their causes. The workers, staff and bosses may generate following ideas:

1) Controlling defects which improve scrap/quality control.
2) Improving Just-In-Time delivery performance (e.g. more convenient placement of parts to minimize handling delays) which further streamlines Just-In-Time Production.
3) Cutting setup time, which are fed back to further reduce lot size.

Indirect Labour Reduction – Just-In-Time inventory control yields indirect benefits as well as directly affects workers and work output. With fewer inventories there is less cost of interest on capital tied up in inventory.

Productivity and Market Response – Just-In-Time Productivity enhances – less lot size inventory, less buffer inventory, less scrap, less direct labour wasted on rework, fewer indirect costs for interest on idle inventory, less space needed to store inventories, less inventory accounting and less physical inventory control all of which lower the input component of the productivity.

A happy ancillary benefit of Just-In-Time is faster market response, better forecasting and less administration. Less idle inventory in the system cuts overall lead time from raw material purchasing to shipping of finished goods. Marketing can thereby promise deliveries faster and forecast demand better. This leads to decrease administrative budget for data processing, accounting, inspection, materials control and production planning.

Total Quality Control

Total Quality Control greatly enhances the quality control aspect of Just-In-Time Production. It means to the people in the plant that, errors if any should be caught and corrected at the source (where the work is performed). The effect of Total Quality Control is, fewer rework labour hours and less material waste in addition of higher quality finished goods. The primary responsibility is assigning quality to the production people and removing it from quality control department.

The categories of Total Quality Control are as follows –

Goals – The operational goal is to sustain the habit of quality improvement and perfection. With a goal of perfection, organizational responsibility for quality is entirely realigned and a host of supporting principles, concepts, techniques and aids are implemented to drive the organization toward the goal.

Basics– The basic principles of Total Quality Control are as follows:

(1) Process Control – It means controlling the production process by checking the quality while the work is being done.

(2) Easy-to-See Quality – Allowing inspection teams from customer plants to inspect manufacturing plant and the demerits discovered should be considered for improvement.

(3) Insistence on Compliance – Management needs to inform manufacturing that quality comes first and output second and insists on it.

(4) Line Stop – Give each worker the authority to stop the production line to correct quality problems. In more mechanized processes line stops may be automatically accomplished by checking devices attached to the equipment (Fool-proof Devices).

(5) Correction One’s Own Errors – The worker or work group that made the bad products should perform the rework itself to correct the errors.

(6) 100 Percent Check – Inspection of every item not just a random sample, intended to apply rigidly to finished goods. (It is not feasible to check every item manufactured as it may be too expensive to do so manually and technologically forbidden to perform automatically)

(7) Project-by-Project Improvement – The point is having a continual succession of quality improvement projects in every work area year after year. The company should have committee to review proposed quality improvement projects. The best projects are to be selected and assigned to project teams to be worked on in the year.

Housekeeping – Good housekeeping should provide an environment conducive to improved work habits, quality and care of facilities.

Less-Than-Full-Capacity Scheduling – Helps assure that the daily schedule will be met. It also avoids pressuring workers, staff and over taxing equipments; thereby avoids errors in quality that could arise from haste. Preventing errors serves to decrease the need for line stops and improves output rate.

Daily Machine Checking – The machine operator must check the machine before starting operation; as faulty machines are often the cause of defectives. This activity of daily machine checking helps in reducing the chances of line stop because of machine breakdown.


By implementing Just-In-Time Production concept by industries, can manufacture and deliver standard quality goods in time to the world market. The full Just-In-Time approach requires effective management to implement key system features as well as daily managerial attention to make the system work. Production, not Quality Control, must have primary responsibility for quality; and everybody, including top management must participate in project-by-project quality improvement.


  • Homer Dansby. Evolution of Japanese Production Control System.
  • Robert E. Fox. Keys to Successful Materials Management Systems: A Contrast between Japan, Europe and the U.S. National Conference Proceedings. American Production and Inventory Control Society. October 1981. 322-26.
  • Y. Sugimori, K. Kusunoki, F. Cho, S. Uchikawa. Toyota Production System and Kanban System – Materialization of Just-in-Time and Respect for Human Systems. International Journal of Production Research. Vol. 15, No. 6 (1977).
  • A. V. Feigenbaum. Total Quality Control: Engineering and Management. New York: McGraw Hill. 1961.
  • J. M. Juran. Product Quality – a Prescription for the West. Part I: Training and Improvement Programs. Management Review. Vol. 70. No. 6. June 1981.


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How 21 CFR Part 11.3(7) Applies to Electronic Batch Records [Video]

When dealing with Part 11 it’s important to understand what an electronic signature actually means

The definition of electronic signatures or e-sigs can be found in 21 CFR Part 11.3(7).

Electronic Signature

An electronic signature or e-sig means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.

Handwritten Signatures

We also need to understand what a handwritten signature means in the context of Part 11.
The definition of handwritten signatures can be found in 21 CFR Part 11.3(8).

Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form.

The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.

Electronic Batch Records

Eric works in a Pharmaceutical company and he is responsible for the filling process of the batch been manufactured.

Each time Eric performs the filling process he has to populate a batch record with the appropriate details

After each step Eric must also fill in his signature and date to verify that he actually performed each task.

Eric is manually handwriting these details and they are legally binding to Eric.

21 CFR Part 11.3(8)

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21 CFR Part 11.3(7)

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Your Guide to Software Validation PQ’s [Video]

Performance Qualification, often abbreviated to PQ, is the set of tests that verifies the system for perform correctly under conditions representing normal use.

Least Understood

The PQ is likely the least understood protocol in a validation exercise. The genesis of the PQ is manufacturing systems validation where PQ shows the ability of the equipment to sustain operations over an extended period, usually several shifts. Those concepts don’t directly translate well for many software applications.

Web Based Applications

However, there are good cases where a PQ can be used to more fully validate. Web-based applications, for example, may need to be evaluated for connectivity (i.e., what happens if a large number of users hit the server at once).

Database Applications

Another example is a database application. Performance can be shown for simultaneous access and for what happens when the database begins to get large. PQ is the place where, as applicable, confirmation is made that the system properly handles stress conditions applicable to the intended use of the equipment.

Validation Plan

There may even be cases where operators can, through marginally different use of the system, can influence the outcome. Critical thinking about what could impact performance is key to developing a PQ strategy.

It may well be the case that a PQ is not applicable for the application. The decision and rationale is documented in the Validation Plan.

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