Robust Documentation easy on remote Installation
Mr. Patel shared his experience of how the customer, with the support of perfect documents, installed his advanced & automated processing machine. The OEM virtual assist was much less than five hours for Installation & Commissioning of the machine.
Buy and sell are common words used in our daily routine life. What makes these common words so important in this topic is documentation.
What is a document and its form?
A written, printed, or digital matter offers records or evidence, which serves or is saved as an original file for more extended periods. The document may be in any form whether in paper or digital like Delivery note, Invoice, Guarantee, Warranty, or some other records stored as proof of buying, selling, and maintaining goods. Mostly, human beings no longer recognize the requirement or significance of those documents. However, in reality, the document is a significant paper. If we appear in our day-by-day existence, the record’s requirement performs an essential function.
Documentation in Pharmaceutical Industry
In the Pharmaceutical Industry, documents have prominent importance. In this industry, there different departments from raw material to logistics, etc. Each department has its own documents format. Even the delivery note performs an essential function in the pharmaceutical industry. We will focus on the documents required to forward the equipment from OEM workshop to the client’s site. Until installing the system, how did the customer set up the machines remotely, with the least aid from OEM? The OEM simplest support was strong documentation.
Few are the fundamental industrial files in routine. Let highlight the remaining.
- Design Qualification:
This file consists of the mechanical, electrical details and working methodology of the machine used in the pharmaceutical industry.
- Placement Drawings:
Placement Drawing suggests the installation of the equipment inside the production room. Maintaining adequate space between the equipment for adjustment, modification, maintenance, and smooth flow of material.
- General Arrangement Drawings:
General Arrangement Drawing mentions all of the complete perspectives of equipment like “Front View, Side View & Top View.” The purchaser can get a synopsis about equipment.
- Operation Qualification:
The operation qualification document consists of the running technique of the equipment. Automation, cleaning & maintenance procedure of the system is referred to in those documents.
- Performance Qualification:
This document consists of records associated with the overall performance of the machine; operating with or without material; it’s also part of the equipment validation process.
- Installation Qualification:
Installation qualification shows the method to install the equipment. The assembly drawing is included in the document.
These documents certify that genuine material is used to build the machines. The file contains certificates of the contact part like Motors, Gear Box, Electrical components, etc. as per their standard. Chitra Machinery does lab test for Stainless Steel 316.
- Factory Acceptance Test Protocol:
The document that includes the trial details of the machines occurs at the vendor site before shipping.
- Goods Received Note:
This document records the material or goods acquired by the customer. It suggests the circumstance and quantity of material.
- Site Acceptance Test:
Site Acceptance Test performs at the customer site with and without material.
COVID 19 Pandemic
The significance of documentation is well defined by Mr. G. A. Patel, Managing Director, Chitra Machinery Pvt. Ltd.
Mr. Patel shared his experience of how the customer, with the support of perfect documents, remotely installed his advanced & automated processing machine. It was the time the pandemic strike in India. The first case of COVID-19 in India, which originated from China, was reported on the 30th. January 2020.
Mr. Patel took this pandemic seriously, though the country was stable at that time, expecting everything normal as scheduled in every export job. Chitra Machinery also planned to send the technical person for installing the machines to the origin country of export.
Considering the COVID-19 seriousness and threat that the country can go for lockdown at any particular point as it was pertaining across the globe. As a backup, the alternate team was appointed to perform the remote installation with the support of the documents.
Mid-March, 2020, the machine was exported from the workshop with all of the proper documents March 22, 2020, India faced first look-down. The company was dealing with extreme issues due to this shutdown. In this situation, the only experience can solve the most challenging issues, and Chitra Machinery is capable of it as it has served the pharmaceutical industry for 28 years.
The powerful document also helped to reach the machines at the customer site. The equipment was not like a plug and play. It was the most complex machine; the only technical team can better understand the parameters; placement, installation, alignment of equipment, a jumble of wire, cable and pneumatic pipes, etc. was the main challenge for installation.
Each box was labelled with a packing list, making it easy to locate the primary documents for installations. The documents like Placement drawing, General arrangement drawing, Installation qualification, and operation manual are required for the installations.
The placement and general arrangement drawings state the exact location for installation; with the installation qualification file, it becomes easy to re-assemble the machine, partly dismantled while packing & shipping. After installations, the operating manual guide the operator to run and operate the system for batch production.
Thus the records and every strong document support the customer for installation, right from the Packing list to Operation & First Batch of productions. The OEM virtual support was less than 5 hours for the Installation & Commissioning of the Machine. This installation and Commissioning was possible because, Chitra is equipped with in-house automation system and virtual handling equipment. Company can provide virtual assistance for Software, Hardware, Programming, etc and during breakdown company has the experience to solve with remote access facilities.
Every customized system has its own documentation, and it is the lifeline of the equipment. The industry should understand the importance of these documents, as it requires human resources, efforts, and costs to prepare.
Machine breakdown makes a loss in productions. It is usually beneficial to refer the document first before contacting the seller for a quick service. It will help save time, the provider fee, and loss in the production. The CORRECT & COMPLETE files make the hardest installations smooth by following the steps stated in those documents. Even freight forwarding documents supported Chitra Machinery to forward the shipment to the customer site.
Purchase Team, Engineering & Production Team
“Hello Mr. Patel, we have reviewed your documents, Placement & General Arrangement Drawings. Following the mentioned steps, we have done the installation successfully & the Commissioning is also done successfully. I appreciate your coordination & your powerful documentation. Here is the first batch we have taken as the attached photo”
Mr. G. A. Patel is a Mechanical Engineer with a long-term vision & mission. He has started the Chitra Machinery partnered with Mr. V. M. Patel in 1992. Chitra Machinery expertise in pharmaceutical process machinery like Tablet Granulation, Capsule Formulation, Pellet & Tablet Coating, Ointment, Cosmetic, Food, Bulk Drugs, Chemical & liquid, with an experience of 28 years and goes on. Chitra had installed more than 1000 machines across 65+ countries