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.

Introduction

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.

Conclusion

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.

References

  • 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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Changes to equipment and documentation is an integral part of the whole GMP process in any regulated facility. In this article we will discuss how equipment is designed in a GMP facility and how good documentation practices are an essential part of quality assurance and GMP.

The content of this article has been taken from module 7 of our eLearning module on Good Manufacturing Practices (cGMP) within the life sciences.

You can view this module in full by viewing the video below.

cGMP eLearning Module – Compelling, Engaging and Interactive

 

Equipment

All equipment is designed, constructed and located to suit their intended use and to facilitate easy maintenance and cleaning.

Equipment is installed in such a way as to prevent any risk of error or of contamination, and cleaned according to detailed and written procedures and stored only in a clean and dry condition.

Production equipment should be designed in such a way as not to present any hazard to the products.

The parts of the production equipment that come into contact with the product must not be reactive, additive or absorptive to such an extent that it will affect the quality of the product and thus present any hazard.

Any defective equipment should, if possible, be removed from production and quality control areas, or at least be clearly labelled as defective. When not in use, equipment should be covered to ensure it remains clean.

Balances

Balances and measuring equipment of an appropriate range and precision should be available for production and quality control operations.

All measuring devices are required to be calibrated and checked at defined intervals by appropriate methods, and adequate records of such tests should be maintained.

Utilities

Fixed piping should be clearly labelled to indicate the contents and where applicable, the direction of flow.

Water pipes used in production (e.g. Purified Water, Water for Injection) are sanitised according to written procedures that detail the action limits for microbiological contamination and the measures to be taken.

Electrical circuits should be identified, and a record maintained of the load on each circuit to prevent inadvertent overload.

Documentation

Good Documentation Practices are an essential part of quality assurance and GMP.

It is important for a manufacturer to get the documentation right in order to get the product right.

GMP Documentation e.g. Site Master File, Specifications, Batch Manufacturing Formulae, Batch Manufacturing Records, Processing, Labelling, Packaging, Testing Instructions, Standard Operating Procedures, Protocols, Technical Agreements, Records, Certificates of Analysis, Reports etc. should contain the following attributes of a good document:

They should be:

  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate
  • Complete
  • Durable
  • Corroborated
  • Version Based
  • Accessible
  • And Authorized

Change Control

Change to GMP documentation, equipment, processes, systems, instrumentation, test methods, etc. are required to be controlled under a formal change control program.

This program must consist of Quality oversight to review the proposed changes, evaluate the potential impact of the change, determine any potential risk to product quality, and to establish the required level of supplemental validation/documentation required for the change.

In many instances, changes will also require submission to the Health Authority for approval of the change.

For example, changes impacting the submission documentation are subject to post approval change guidances according to the Health Authority regulations.

Change Control is a critical aspect of the GMP systems.

If you want to learn more about cGMP or if you want to evaluate our eLearning module for your company you can find more information here.

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The enduring assets of a laboratory’s work are the records that document those activities. When laboratory records are used to support a regulatory function, they are considered to be legal documents.

Laboratory Data Integrity – eLearning Course

 

For records to be considered reliable and trustworthy they must comply with the following criteria:

  • Legible and Understandable – they must be able to be read and understood for the lifetime of the record, without having to refer to the originator for clarification. The information may be needed in five, ten or twenty years’ time, perhaps after the originator is no longer available
  • Attributable – who made the record or created the data and when?
  • Contemporaneous – the record must be made at the time the activity was performed
  • Original – the information must not be written on a post-it, piece of scrap paper, sleeve of a lab coat etc. and then transcribed.
  • Accurate – no errors or editing without documented amendments
  • Complete – All the information and data associated with the analysis is included
  • Consistent – All elements in the sequence of analysis must be date & time stamped and must be in the expected order
  • Indelible – Records are made on to controlled documents, such as laboratory notebooks or controlled worksheets, or saved to electronic media
  • Available – over the entire lifetime of the record for review, audit and inspection

1. Legible and Understandable

A record that cannot be read or understood has no value and might as well not exist. All records should be composed so they conform to grammatical convention which should be consistent throughout.

It is best to avoid buzzwords, cliques and slang as these are prone to change with time and are often not understood outside a particular locality. It is always good practice to have any record reviewed by a second person as this can often highlight any ambiguities.

2. Attributable

The identity of the person creating a record should be documented. For paper records this is normally done by the individual signing and dating the record with their signature.

As the record you may be signing may be a legal document, you should clearly understand the implication of your signature. A signature should be individual to a specific individual and the practice of signing someone else’s name or initials is fraud, and is taken very seriously.

3. Contemporaneous

All records must be made at the time an activity takes place. Delaying writing up, for example until the end of the day, will inevitably affect the accuracy of that record as details can be forgotten or miss-remembered.

4. Original

All records must be original; information must be recorded directly onto the document. This avoids the potential of introducing errors in transcribing information between documents.

If information from an instrument is printed out, by the instrument, that printout is the original record and should be signed, dated and attached to the record.

5. Accurate

The record must reflect what actually happened. Any changes should be made without obscuring or obliterating the original information, the use of whiteout or correction fluid is prohibited.

Any changes made to a record should be signed by the person making the change and dated to show when it was made and a written explanation should also be provided. Remember, the record may be needed after you have left the company and cannot be contacted for clarification.

6. Complete

The record must contain all information associated with the analysis of the sample, including system suitability tests, injection sequences, processing methods, sample preparation procedures and results.
This must also include any reinjections or repeat analysis performed on the sample.

Remember the position of the regulatory authorities for something that needs to be done is – ‘if it isn’t documented it’s a rumour’. However, failing to disclose reanalysis or reinjection of samples will undermine confidence in the reliability of the records.

7. Consistent

Consistency in this context refers to the sequence of the component events, which the analytical method comprises, being performed in a logical order.

For example it is not possible to commence the HPLC run before the samples have been prepared, therefore the balance printout for the sample weights should be date/time stamped at least one or two hours prior to the sample injection time, to allow time to prepare the samples. Therefore all date/time stamps should be in the expected sequence.

In order to avoid confusion in this respect, it is worth ensuring all instruments that produce date/time stamped printouts are time synchronised. This is best done by reference to a standard reference time, such as a national online time server.

8. Indelible

Indelible means the record must be legible for the lifetime of the record and once it has been made it cannot be removed.

Hand written entries of information should be made in ink and not pencil which can be erased

If printouts are made on thermal paper, which darkens with time, a photocopy should be made; this should be certified as an accurate copy of the original print and attached

If print outs are attached to a page they should be

  • Secured to the page with acid free glue and industrial strength Sellotape
  • Signed and dated across the attachment and the page
  • Annotated with a reference to the document

9. Available

All records should be available for inspection, audit and review for the lifetime of the document. If a document is requested during a regulatory audit, it should be produced within thirty minutes.

Therefore, the laboratory should establish an easy to reference archive system. Records should be archived so as to preserve their integrity, such as

  • Secure facility with restricted access
  • Effective fire suppression
  • Protection from dampness or humidity
  • Controlled access to Document

Check Out Our Laboratory Data Integrity eLearning Module

If you are looking for a way to train your staff on the importance of data integrity in a regulated environment check out oureLearning Course.

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