Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Bhanu K Bhakhri

"The Journal of Clinical and Diagnostic Research (JCDR) has been in operation since almost a decade. It has contributed a huge number of peer reviewed articles, across a spectrum of medical disciplines, to the medical literature.
Its wide based indexing and open access publications attracts many authors as well as readers
For authors, the manuscripts can be uploaded online through an easily navigable portal, on other hand, reviewers appreciate the systematic handling of all manuscripts. The way JCDR has emerged as an effective medium for publishing wide array of observations in Indian context, I wish the editorial team success in their endeavour"



Dr Bhanu K Bhakhri
Faculty, Pediatric Medicine
Super Speciality Paediatric Hospital and Post Graduate Teaching Institute, Noida
On Sep 2018




Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



Dr Mohan Z Mani,
Professor & Head,
Department of Dematolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
Knowledge is treasure of a wise man. The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help ones reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journalsNo manuscriptsNo authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011

Important Notice

View Point
Year : 2009 | Month : October | Volume : 5 | Issue : 3 | Page : 1815 - 1819

Improving Efficiency In Quality Assurance Documentation Cell With Lean Thinking

FERNANDES F*, PANDE S** , MURTY P N***

* M. Pharm, (PhD) Pharmacy, Behrampur University,*Senior Vice President,Corporate Quality Assurance, Glenmark Pharmaceutical Limited, Mumbai, ***Principal and Professor of Pharmacy, Royal College of Pharmacy and Health Sciences, Behrampur,(India).

Correspondence Address :
Francis Fernandes
E.mail:fransha.ape@gmail.com

Abstract

The pharmaceutical industry is regulated by regulatory agencies like the U.S. Food and Drug Administration (FDA), the European Union (EMEA), WHO and the Ministries of Health of various countries and guidelines such as the Good Practice (GxP) guidelines. The GxP guidelines are primarily Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), ensuring the quality of the processes leading to the final product. The pharmaceutical industry has to comply with regulations from the law and health authorities. This article provides an insight into how lean thinking concepts like 5S can help the Quality Assurance Documentation cell of a Pharmaceutical company and can increase its efficiency of document upkeep, storage, archival, distribution, presentation and retrieval.

What Is 5 S?
The most important tool used in lean thinking is the 5S system. The idea is that a messy workplace, storage place, desk, etc makes it hard to find documents or any other important things and can result in accidents or mistakes.

5S Stands For
1. Sort: Sort the work place into ‘in use’ and ‘not in use’.
2. Set in order: Put items in the system.
3. Shine: Procedure for cleanliness.
4. Standardize: Procedure for how to leave the workplace.
5. Sustain: Ingraining into culture.

Advantages Of Using 5S
 Improves ergonomics.
 Improves safety – no disorders.
 Improves quality _ of storage and identification when needed.
 Gives pride to the work place.
 Easier to take over.
 Reduces changeover times.
 Gives a visible overview of the work place – tools, parts, fixtures etc.
 Time spent on searching is reduced.
 Reduces demand for space.
 Improves productivity.


5S is a tool to create system and order in a company’s work culture. At the same time, 5S expresses the attitude in an organization towards the structure and the system.

With the introduction of the 5S work culture, the work places, shelves, the floor, racks etc. are clearly marked. Every tool or part has a "home" where the component is placed and is clearly identified. Other tools and parts are removed and are stored in the designated position.

Material and Methods

Activities Of The Quality Assurance Documentation Cell In A Pharmaceutical Company

1.Document Distribution
At the time of distribution of a document, necessary entries are made in the document control register which has information about Document name, Document number, Issued by, Received by, Retrieved document no.(if any), Number of copies retrieved, Destroyed by, Date, Checked by details.

2.Batch Manufacturing Record / Batch Packaging Record
• Master copies of the Batch Manufacturing records are kept in the documentation cell and the photo copies of the master copy are issued for regular production on request and for approval by Quality Assurance. All sheets of the photo copies are signed and dated by QA Personnel.
• The executed /completed batch records are submitted back to QA for review.
• After review of the records and QC analytical results, QA releases the batch (Product) for sale.
• All the completed and reviewed batch records are archived in the documentation cell.
• All batch records are retained at for five years after the shelf life of the product.

3.Validation protocol / Report / Summary
• The original copy of the validation protocols/qualification documents such as the Equipment Qualification Protocol/Reports are compiled by QA in the respective qualification files like Design Qualification, Installation qualification, Operational qualification, Performance qualification. Visit reports (if any) are also maintained by QA and are issued to the respective departments along with the qualification files when required.

• After completion of validation, the Protocols and Reports along with the QC results and the Summary report, are prepared and filed by the QA department in the respective validation records.

4.Specifications
• All specifications of Raw material / Packing material / intermediate and finished products are set up by the QC and are authorised by QA. Original documents are filed in the respective master files of the QA Department with a “MASTER COPY” seal in green colour on the text side (backside) of the page.
• Controlled copies of specification are issued to the QC department with a “CONTROLLED COPY” seal in red colour on top of each page on the printed side.

5.Standard Operating Procedure
• Master copies of SOP are filed in the QA department in the respective files with a “MASTER COPY” seal in green colour on the non text side (backside) of the page.
• Different stamps are used for circulating SOP to the concerned departments, either with a “CONTROLLED COPY” seal in red colour or a “DISPLAY COPY" seal in blue colour on top of each page on the printed side as per the need.

6.Third Party Documents Like Technical Agreements, Audit Reports , Compliance Responses Etc
• Separate files are maintained for party/agency.

7.Art works
All documents related to artwork approval, including the specimen samples, are filed and controlled by the QC and QA departments.

8.Stability samples
Details of stability reports are maintained and the records are archived by the QA documentation cell.

9.Log Books : The following log books are maintained

Production Department
- Equipment Operation
- Equipment Cleaning
- Planned Preventive Maintenance of Equipment.
- Temperature and Humidity
- Pressure Differential
- Balance Calibration
- General House Keeping
- Pesto Flash
- Issue and control of stereos
- Issue and control of Punches and dies
- Intermediate log
- Overprinting of Packaging Materials
- pH meter log
- Transfer pump and Transfer line log
- Utility Department
- Purified Water Plant Operation
- Purified Water Plant Regeneration
- Planned Preventive Maintenance of AHUs and Compressed Air

Quality Control Department
- Instrument Operation and cleaning
- Volumetric Solutions
- Reference Standard
- Working Standards
- Reserve Sample
- Control Sample
- Glass ware calibration
- Calculation sheet
- pH meter
- water monitoring log
- Autoclave Calibration
- Sub culturing and destruction of sub culture
- Media Stock Register
- De-fumigation checks log
- Media Preparation
- Media destruction
- Growth Promotion test
- Plate exposure
- UV lamp log
- Raw materials analysis

10. Training Record
The training records of individual personnel are retained till the last record, which has to be signed by them when they expire their date.

The Training Records consist of:
- The Annual Training Schedule
- Training modules
- Individual Training records
- General Training record
- Material/Visual aids/Literature used for Training

11.In addition ,QA also maintains Following Records
- Packing specification
- Monthly reports
- Annual reports
- Medical check-up record
- Pest control record
- Market complaints
- Instrument calibration(External agency)
- Change controls
- Deviations
- Out of specification records

12. Document Retrieval
Revised documents are issued only after retrieval of the superseded Control copy and Display copy from the concerned department. The superceded Master Copies are retained with the "OBSOLETE COPY" stamp in black colour for future reference and the other copies (Controlled and Display copies) are destroyed. A record of issue of documents and retrieval and destruction of the superceded documents, are maintained.

13. Retention of Documents
All documents are retained for at least one year after the expiry of the finished products.

Aim
The main aim of this study was to increase the efficiency and space and to improve the turnaround time for the Document Issuance, Document Retrieval and Document Archrivals for the Quality Assurance Documentation Cell of the Pharmaceutical Company.

General Challenges Observed In The Documentation Cell
1. Increased manpower is required to maintain the documents.
2. Identification, location and retrieval of the documents in the Documentation Cell.
3. Tracking of documents in circulation
4. Delay in document issuance.
5. Space constraints in the Documentation cell
In view of the number of documents handled and the quality of maintenance, it has become increasingly important to follow some proven methodology so that the system works by itself and with desired efficiency. One such method could be the use of the 5S system. How the concept can be implemented, is described below:

Changes done in the Documentation Cell as per the 5S system
Sort: Sort out the work place into four categories a)”in regular use”, b) ”not in regular use”, c) obsolete and d) for destruction.


• Redesign and physically segregate the racks /shelves depending on the volumes and space utilization.
• Identify the documents and arrange each file with a unique number for easy access. for example: Apex documents like Site Master File, Validation Master File, layouts, etc. can be stored separately under category A (which is not in regular use). Documents like Batch manufacturing records, Analytical work sheets, and Standard operating procedures can be stored under category B (which are used frequently).
• Obsolete documents can be placed on higher racks as such documents are normally used for reference purposes.
• Documents for destruction should be reviewed and stored on a separate rack under lock and key so that they can be sent for destruction in bulk.

Set In Order: Put Items In System.
• The labelling /identification system should be designed to have clear classification and ease of understanding. This should be extended to the individual rack and column/shelf.
• The document locator list should be prepared and displayed on each rack so as to know which documents are placed on which of the racks .
Shine: Procedure for cleanliness.
• Develop a new standard operating procedure (SOP) for detailing out the arrangement, numbering system, location allotment, receiving, itemisation/identification, placement, storage, retrieving, issuance and destruction of documents.

Standardize: Procedure For ‘How To Leave The Workplace’.
• Allotment of time slots for the document in and out-system, issuance and receiving so that everyone’s time is saved. Moreover, priority can be given in advance so that documents which are required, are pulled out and are kept ready for reference photocopy or for any other use.
• Reconciliation of the document based on issuance and the receiving record should be done at a certain frequency so that nothing is missed out and all documents are placed at the locations assigned as per the identification number allotted.

Sustain: Ingraining Into Culture.
• Training for all those who are responsible for the document call, The concept, procedures, advantages, dos and donts and safety and security measures should be imparted in order that the compliance is observed throughout and the system works efficiently of its own.
• Validation of the documentation system by challenging the overall document cell systems and mock trials .The turnaround time could be a measurable parameter for assessing the efficacy of the system implemented.








Results

[Table/Fig 1]Some data was collected after the application of lean thinking through the S5 project and that has resulted in several benefits in terms of Documentation Cell efficiency which was measured, retrieval time, space utilization and the man hour utilization. It was noted that there were space problems to store the same volumes of documents, which were addressed by orderly arrangements and by placing the numbered files vertically in the racks. Storage of obsolete documents separately also contributed to more space.
Segregation of documents which are used frequently and which are not used so frequently, helped in the fast retrieval of the documents from the racks. It was found that locating ,retrieval and issuance of the documents was consuming lesser time as compared to when the documents were not arranged as per S5 concepts. The number of persons working in the documentation cell reduced and there was no impact on the efficiency on the working .Although some procedures were added, which were not in practice before.

A labelling system and location list available at each rack, simplified the storage techniques. A document locator list of all the individual items in alphabetical order, is posted on the compactor. The locator sheet details the rack and shelf on which a document is located. The locations are clearly identified, allowing a staff person to walk straight to the location to retrieve the desired document.

New personnel transferred to the document cell were able to perform the job after reading the SOP describing the documentation practices.

It was observed that the understanding among the various operating groups increased and team work prevailed .Priority was defined by production and QC based on the production plan for the next two days and the required documents were arranged in advance, thus reduced the waiting time .In addition, the documents required for regulatory submissions such as specifications, batch records and stability data were also provided as per the plan before the due date, through better planning and interaction.

Reconciliation of documents made it easy to find the missing slot. The documents were arranged at the designated (predefined) location. There were no missing documents and if at all any document was kept back to its location, it was perused or the reasons for not getting the same back were known and was notified for.

Orderly placement of documents in the shelves resulted in better space utilization at the workstations. The staff members could get the required ones when required. Adopting such practices made the workspace (s) clean, presentable and less cluttered.

Conclusion

Maintaining a good document cell suiting the requirements of a Pharmaceutical Industry has been a challenging job. There are a number of documents which need to be referred, used, photocopied, updated and filed on regular basis. In case the documents are not identified, located and placed properly, there are chances of misplacement and more time is required for retrieval of the documents, which ultimately results in inefficiency and poor productivity. Also, the work stations look untidy with lot of documents kept on it. This finally leads to confusion and mistakes.

In a regulatory governed environment, a document cell which works under the Quality Assurance department, has to be developed in such a manner so that upkeep, storage, archival, distribution, presentation and retrieval systems have very little room for inefficiency. This development can be brought in when the procedures followed are trouble free and flawless. This also requires a cultural change, which has shown to be achieved by implementation of the S5 concept as described above.

The implementation is simple and if practiced regularly, yields better returns and improves the overall output without any cost impact or investment. Such practices are also of great importance in handling higher volumes of documents which are generated with time, especially for those organisations which are in the business in regulated markets. Finally, the methodology adopted has proven to bring about cultural change, which will be profitable in the long run.

References

1.
GMP. – Quality up, An online resource of Quality Assurance Procedures, http://www.gmpqualityup.com/
2.
Peterson, Jim & Smith, Roland, PhD. The 5S Pocket Guide, Productivity. 1986.
3.
Osada, Takashi. The 5S’s, five keys to a total Quality Environment. Asian Productivity Organization. 1991. Hirano, Hiroyuki. 5 pillars of the visual workplace. Productivity Prsess, 1995.

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  • Google
  • Popline (reproductive health literature)
  • www.omnimedicalsearch.com