Software Validation

Validation is a critical tool to assure the quality of computer system performance. Computer system software validation increases the reliability of systems, resulting in fewer errors and less risk to process and data integrity.
Computer system validation also reduces long term system and project costs by minimizing the cost of maintenance and rework.

Software Validation commences with a user requirement document (URS). URS is prepared to describe the critical functionalities those are required for our analysis. It is essential that the document is properly scoped in order that the procurement, installation, commissioning, validation, user training, maintenance, calibration and cleaning tasks are all investigated and defined adequately.

To scope and define an adequate validation procedure the URS has to be detailed sufficiently for various assessments to be made. The main assessment that concerns with qualification documentation is the risk assessment. This assessment is only concerned with ensuring that the degree of validation that is proposed; is compliant with the regulatory requirements.

So at this early stage it is required to execute a Validation Risk Assessment protocol against the end user’s requirements. This step is purely to ensure that the more obscure pieces of ancillary equipment and support services are fully understood and their requirement investigated, priced and included in the final issue of the URS; which will be sent out with the Request to Tender. This is an essential stage if the URS is to accurately define what depth and scope of validation is appropriate for the verification that the software will deliver all the requirement detailed in the URS.

The outcome of the Validation Risk Assessment (VRA) drives a split in software validation documentation scope, if the VRA categorizes the software validation as requiring Full Life Cycle Validation (FLCV); then a considerable amount of the software validation effort is put into establishing how the software originated, was designed and developed, in order to establish that its basic concept and development can be considered robust, sound and in accordance with best practices.

The original development plans; code reviews, methods reviews and testing plans must be available to enable this software validation documentation to be executed successfully. Once this proof of quality build is established, validation then follows a more convention path in inspections and verifications.

Software that is not classified as requiring FLCV treatment does not require this depth of verification into quality build history and is validated mainly by the more convention path in inspections and verifications.

Dynamic Testing

Dynamic testing verifies the execution flow of software, including decision paths, inputs, and outputs. Dynamic testing involves creating test cases, test vectors and oracles, and executing the software against these tests. The results are then compared with expected or known correct behavior of the software. Because the number of execution paths and conditions increases exponentially with the number of lines of code, testing for all possible execution traces and conditions for the software is impossible.

Static Analysis

Code inspections and testing can reduce coding errors; however, experience has shown that the process needs to be complemented with other methods. One such method is static analysis. This somewhat new method largely automates the software qualification process. The technique attempts to identify errors in the code, but does not necessarily prove their absence. Static analysis is used to identify potential and actual defects in source code.

Abstract Interpretation Verification

A code verification solution that includes abstract interpretation can be instrumental in assuring software safety and a good quality process. It is a sound verification process that enables the achievement of high integrity in embedded devices. Regulatory bodies such as the FDA and some segments of industry recognize the value of sound verification principles and are using tools based on these principles.

Risk Based Inspection

A Risk Based Inspection (RBI) is basically a risk analysis of operational procedures. It assesses the safety risks and plant integrity that exists and further prepares it for possible inspections. The end result is a document that outlines, measures and defines organizational procedures based on standards, codes and best practices.

Generally, RBI’s are used when a company wants to change the required frequency of inspection for pressure-rate vessels. This is applicable to the mechanical integrity element of a Process Safety Management (PSM) plan.

Equipment used to process, store, or handle highly hazardous chemicals has to be designed, constructed, installed, and maintained to minimize the risk of releases of such chemicals. This requires that a mechanical integrity program be in place to ensure the continued integrity of process equipment.

Elements of a mechanical integrity program include identifying and categorizing equipment and instrumentation, inspections and tests and their frequency; maintenance procedures; training of maintenance personnel; criteria for acceptable test results; documentation of test and inspection results; and documentation of manufacturer recommendations for equipment and instrumentation.

Where there might be a bit of overlap/similarity in RBI and PSM is in the area of mechanical integrity with regard to structural engineering. Structural engineering is an important field of engineering that deals with the integrity of objects such as plant components or structures and serves the industry by performing analytical assessments, experiments, walkdowns or numerical modeling. Some companies specialize in supporting industrial process facilities and power plants.

In plants, the structural challenges are often related to pressure, temperature and dynamic forces. An example is the seismic adequacy of piping or components under power operation. Engineers perform seismic walk downs on a regular basis to screen for the seismic adequacy of systems. Several specialty engineers and contractors have undergone professional seismic training which also allows them to assess safety-related electrical components such as instrumentation and control components, etc.

Proper application of structural engineering expertise can help mitigate issues by ensuring that the plant and components are properly engineered. This will avoid machinery breakdown and costly plant outages. The goal is to support customers to achieve a safer and more efficient work environment along with enhanced plant durability.

Thus, for several aspects of RBI and PSM, an engineering firm with testing labs are ideal in providing a one-stop-resource for structural engineering issues including analyzing a problem, engineering a solution, verification, as well as oversight of fabrication and installation, as required.

Benefits to having Risk Management Services are:

  • Understand and address hazards that pose the highest level of risk to your process facility
  • Ensure compliance with relevant national, local and industry standards
  • Implement best engineering practices
  • Reduce overall level of risk
  • Increase productivity and employee morale
  • Make organization more competitive
  • Decrease insurance premiums
  • Combustible Dust Hazard Analysis (DHA) Explosion and Fire Hazard Evaluation

An onsite assessment provides an experienced engineer to visit a facility, evaluate its compliance with relevant national, local and industry standards and provide recommendations for risk reduction. Additional services can include deflagration vent sizing calculations, desktop reviews, equipment selection guidance, and training of personnel on combustible dust hazards as well as development of process safety programs to address these issues.

Risk-based inspection is a means of using inspection resources more cost-effectively and with confidence. The method ensures that you are complying with current safety regulations and also enables you to make inspection decisions informed by greater information and expertise, thereby saving time and money.

Plant operators face an increasingly complex challenge when managing the integrity of assets: to achieve operational excellence and maximum asset performance while minimizing costs and maintaining the highest safety and environmental standards.

Risk-based inspection principles offer an established methodology for efficient plant maintenance and, with Panorama’s expertise,we can work with you to develop cost-effective management solutions.

Risk Assessment

Many people interchange hazard and risk on a daily basis. Unfortunately, they are actually two different concepts. The difference may not be as much as an issue for the everyday conversation, but when it comes to risk assessment and control, it is extremely important. Below you will gain a better understanding of the difference between the two and why the difference is so important.

The basic difference is that a hazard is something that will cause harm, while a risk is the possibility that a hazard may cause harm. Although they are used synonymously, knowing the difference could save your life or allow you to enjoy it more thoroughly.

In essence, a hazard will not be risky unless you are exposed to enough of it that it actually causes harm; the risk itself may actually be zero or it may be greatly reduced when precautions are taken around that hazard.

The simple relationship between the two is that you have to have exposure to a hazard to experience a risk. Thus, it is vital that you know the level of exposure you are going to have to the hazard to better understand how much risk is actually involved.

Risk Assessment Methods

There are a variety of risk assessment methods for the various categories. When it comes to the difference between hazard and risk, several categories may use different measurements and methods. As an example, the way risk is assessed in human health may be different from the risk assessment for project management.

Why Use a Risk Assessment Method?

A risk assessment is a tool used to determine the potential results from any given hazard. The assessment uses a combination of situational information, previous knowledge about the process, and judgments made from the knowledge and information.Since the risk is the potential damage done by a hazard, there are certain outcomes that any good risk assessment needs to have.

There are six main outcomes that are needed to have an effective risk assessment. By the end of the assessment you should know:

  • Any situations that may be hazardous
  • Which method is appropriate to use when determining the likelihood the hazard will occur
  • Alternative solutions for reducing and eliminating the risk or any negative consequences the may occur
  • More information for making a decision about risk management
  • Estimation for the uncertainly of the analysis

Steps of a Risk Assessment

Step 1: Discover the hazards. You can do this by using several different strategies such as walking around the area, navigating through portfolios and databases, or asking people who are around.

Step 2: Determine who may be harmed and how they may be harmed. After discovering the hazards you will need to determine who may be harmed by them, as well as how they may be harmed.

Step 3: Analyze the amount of risk and how you can control them. You may find that you can simply remove the hazard. If not, then decide which control method will be best to use to reduce the amount of risk.

Step 4: Document your assessment and results. It is important that you document what you find. This is done for legal reasons to protect you, the location, and any possible persons that may be involved. You also want to be sure that you write down your next plan of action – what control measures you are going to take.

Step 5: Regularly review and update your assessment. It is great to think that once the hazard is gone that all risks of harm are gone. This is not true. In some cases the hazard may return and in other new hazards may develop. Regularly checking will keep you and everyone around safe.

Risk Control Methods

Knowing the difference between hazard and risk leads to risk control. Risk is controlled when your business takes actions that help eliminate safety risks as much as you are able to do so. If it is not possible to completely eliminate the risk, controlling your risk may mean that you are taking actions to minimize the risks and hazards within the work environment.

There are four main methods that can be used to eliminate or minimize these risks – avoidance, loss prevention & reduction, transfer, and acceptance.

1. Avoidance

This is by far the easiest way to control any risk. When you decide to use this method, you find all possibly hazardous activities and stop them. It is important that you remember when choosing this option you may also miss out on other opportunities and gains.

2. Loss Prevention & Reduction

Using this method you will reduce the frequency and severity of a specific loss. You may decide to increase security measures or improve maintenance, or you may create rules that require your employees to wear certain safety gear.

3. Transfer

When you choose this method you will create a contract with a third party to deal with that risk. A couple great examples would be hiring a security company to improve security or hiring a cleaning crew to ensure health hazards are cleaned up.

4. Acceptance

This last method is not to be taken lightly. When you feel that transfer or loss prevention & reduction methods are not necessary or are too excessive, this may be the option for you. However, it is important that you understand this could possibly be dangerous for your company. Undergoing too many losses or enduring too many negative consequences can quickly sink your business.

Good Automated Manufacturing Practice for Pharmaceutical Industries

The Good Automated Manufacturing Practice (GAMP) Forum was founded in 1991 by pharmaceutical industry professionals in the United Kingdom to address the industry’s need to improve comprehension and evolving expectations of regulatory agencies in Europe. The organization also sought to promote understanding of how computer systems validation should be conducted in the pharmaceutical industry.

GAMP rapidly became influential throughout countries as the quality of its work was recognized internationally. Over time, GAMP has become the acknowledged expert body for addressing issues of computer system validation.

GAMP’s guidance approach defines a set of industry best practices to enable compliance to all current regulatory expectations. More than simply a strict compliance standard, GAMP is a guideline for life sciences companies to use for their own quality procedures. As a result, it can be tailored to a number of computer system types.

Computer system validation following GAMP guidelines requires users and suppliers to work together so that responsibilities regarding the validation process are understood. For users, GAMP provides a documented assurance that a system is appropriate for the intended use before it goes live. Suppliers can use GAMP to test for avoidable defects in the supplied system to ensure quality product leaves the facility.

The GAMP framework addresses how systems are validated and documented. Companies do not need to follow the same set of procedures and processes of a GAMP framework to achieve validation and qualification levels that satisfy inspectors. Instead, GAMP examines the systems development lifecycle of an automated system to identify issues of validation, compliance and documentation.

As a voluntary program, GAMP offers both challenges and benefits. The top three challenges in implementing GAMP are establishing procedural control, handling management and change control, and finding an acceptable standard among the existing variations.

Establishing procedural control is a challenge in using GAMP guidelines because new frameworks may be necessary to gauge the validity of systems. Most pharmaceutical companies have already established a baseline that adheres to standards and regulations that exist today, but they may not have a procedure to check the processes that are in place. This could cause resistance among software developers who may prefer not to work within the confines of specifications and procedures developed by others. Specifications and procedures developed by previous software developers may hinder ways to adjust computer systems, but varying interpretations of GAMP guidelines allow for multiple solutions.

Another hurdle is change control. In the development or modification of computer systems, companies with even the highest of standards can suffer setbacks along the systems development lifecycle. Sometimes minor tweaks by the software programmer may cause breakdowns after validation changes have been implemented. Internal processes and procedures must be established to guard against these occurrences.

Effective documentation management is fundamental for compliance. Any inaccuracies or missing information renders all other efforts moot. Moreover, implementing a formal document management application may be cost-prohibitive for some organizations. Some companies simply use what’s in the GAMP checklists to evaluate their systems. Today’s environment demands a thorough process to show validation.

The benefits of utilizing the GAMP approach for both users and suppliers include:

  • Improved understanding of the subject with the introduction of common terminology
  • Reduced cost and time to achieve compliant systems
  • Reduced time and resources for revalidation or regression testing and remediation
  • Reduced cost of qualification
  • Enhanced compliance with regulatory expectations
  • Established responsibility for all involved parties

When the FDA introduced its current Good Manufacturing Practices (cGMP) for the 21st century initiative, companies shifted their approach to validation. Formerly, they only had to heed a set of rules that accounted for every piece of equipment that was used. Now they can take a risk-based approach to validation by addressing safety, efficacy and quality in the product considerations. This enables the industry to place its investments where it makes the most sense. The onus ultimately falls on manufacturers to accept greater responsibility to validate their systems having the attendant benefits of cost and time to market savings.

GAMP helps provide a quality product from the manufacturer, and helps to limit the pharmaceutical industry’s culpability by ensuring proper steps were placed to deliver a quality product through validated systems. By incorporating input from the full spectrum of stakeholders, fine-tuning and further development of the process is geared towards benefiting the life sciences industry and the general consumer market.

The tools exist for companies to take the steps needed to reap the benefits of validation. Understanding an early adoption of GAMP can increase a company’s competitive position, especially with the implementation of new technologies. By staying aware of technological innovations, companies are able to increase efficiency, minimize risks and reduce costs.

Wastewater Treatment Process

Wastewater treatment is the process of converting wastewater – water that is no longer suitable for use – into water that can be discharged back into the environment. Its treatment aims at reducing the contaminants to acceptable levels to make the water safe for discharge back into the environment.

There are two wastewater treatment plants namely chemical or physical treatment plant, and biological wastewater treatment plant. Biological waste treatment plants use biological matter and bacteria to break down waste matter. Physical waste treatment plants use chemical reactions as well as physical processes to treat wastewater. Biological treatment systems are ideal for treating wastewater from households and business premises. Physical wastewater treatment plants are mostly used to treat wastewater from industries, factories and manufacturing firms. This is because most of the wastewater from these industries contains chemicals and other toxins that can largely harm the environment.

The wastewater treatment is as follows:

  1. Wastewater Collection

This is the first step in wastewater treatment process. Collection systems are put in place by municipal administration to ensure that all the wastewater is collected and directed to a central point. This water is then directed to a treatment plant using underground drainage systems or by exhauster tracks owned and operated by business people.

  1. Odour Control

At the treatment plant, odour control is very important. Wastewater contains a lot of dirty substances that cause a foul smell over time. To ensure that the surrounding areas are free of the foul smell, odor treatment processes are initiated at the treatment plant. All odor sources are contained and treated using chemicals to neutralize the foul smell producing elements. It is the first wastewater treatment plant process and it’s very important.

  1. Screening

This is the next step in wastewater treatment process. Screening involves the removal of large objects that in one way or another may damage the equipment. Failure to observe this step, results in constant machine and equipment problems. Specially designed equipment is used to get rid of grit that is usually washed down into the sewer lines by rainwater. The solid wastes removed from the wastewater are then transported and disposed off in landfills.

  1. Primary Treatment

This process involves the separation of macrobiotic solid matter from the wastewater. Primary treatment is done by pouring the wastewater into big tanks for the solid matter to settle at the surface of the tanks. The sludge, the solid waste that settles at the surface of the tanks, is removed by large scrappers and is pushed to the center of the cylindrical tanks and later pumped out of the tanks for further treatment. The remaining water is then pumped for secondary treatment.

  1. Secondary Treatment

Also known as the activated sludge process, the secondary treatment stage involves adding seed sludge to the wastewater to ensure that is broken down further. Air is first pumped into huge aeration tanks which mix the wastewater with the seed sludge which is basically small amount of sludge, which fuels the growth of bacteria that uses oxygen and the growth of other small microorganisms that consume the remaining organic matter. This process leads to the production of large particles that settle down at the bottom of the huge tanks. The wastewater passes through the large tanks for a period of 3-6 hours.

  1. Bio-solids handling

The solid matter that settle out after the primary and secondary treatment stages are directed to digesters. The digesters are heated at room temperature. The solid wastes are then treated for a month where they undergo anaerobic digestion. During this process, methane gases are produced and there is a formation of nutrient rich bio-solids that are recycled and dewatered into local firms. The methane gas formed is usually used as a source of energy at the treatment plants. It can be used to produce electricity in engines or to simply drive plant equipment. This gas can also be used in boilers to generate heat for digesters.

  1. Tertiary treatment

This stage is similar to the one used by drinking water treatment plants which clean raw water for drinking purposes. The tertiary treatment stage has the ability to remove up to 99 percent of the impurities from the wastewater. This produces effluent water that is close to drinking water quality. Unfortunately, this process tends to be a bit expensive, as it requires special equipment, well trained and highly skilled equipment operators, chemicals and a steady energy supply. All these are not readily available.

  1. Disinfection

After the primary treatment stage and the secondary treatment process, there are still some diseases causing organisms in the remaining treated wastewater. To eliminate them, the wastewater must be disinfected for at least 20-25 minutes in tanks that contain a mixture of chlorine and sodium hypochlorite. The disinfection process is an integral part of the treatment process because it guards the health of the animals and the local people who use the water for other purposes. The effluent (treated waste water) is later released into the environment through the local waterways.

  1. Sludge Treatment

The sludge that is produced and collected during the primary and secondary treatment processes requires concentration and thickening to enable further processing. It is put into thickening tanks that allow it to settle down and later separates from the water. This process can take up to 24 hours. The remaining water is collected and sent back to the huge aeration tanks for further treatment. The sludge is then treated and sent back into the environment and can be used for agricultural use.

Wastewater treatment has a number of benefits. For example, wastewater treatment ensures that the environment is kept clean, there is no water pollution, makes use of the most important natural resource; water, the treated water can be used for cooling machines in factories and industries, prevents the outbreak of waterborne diseases and most importantly, it ensures that there is adequate water for other purposes like irrigation.

In summary, wastewater treatment process is one of the most important environmental conservation processes that should be encouraged worldwide. Most wastewater treatment plants treat wastewater from homes and business places. Industrial plant, refineries and manufacturing plants wastewater is usually treated at the onsite facilities. These facilities are designed to ensure that the wastewater is treated before it can be released to the local environment.

What is Piping and Instrumentation Diagram (P&ID)?

A piping and instrumentation diagram (P&ID) is a drawing in the process industry. A P&ID shows all piping, including the “physical sequence of branches, reducers, valves, equipment, instrumentation and control interlocks.” A P&ID is used to operate the process system, since it shows the piping of the process flow along with the installed equipment and instrumentation.

P & IDs play a key role in maintaining and modifying the process they describe, because it is important to demonstrate the physical sequence of equipment and systems, including how these systems connect. In terms of processing facilities, a P&ID is a visual representation of key piping and instrument details, control and shutdown schemes, safety and regulatory requirements, and basic start-up and operational information.

A P&ID should include the following:

  • Instrumentation and designations
  • Mechanical equipment with names and numbers
  • All valves and their identifications
  • Process piping, sizes, and identification
  • Vents, drains, special fittings, sampling lines, reducers, increasers, and swaggers
  • Permanent start-up and flush lines
  • Flow directions
  • Interconnections references
  • Control inputs and outputs, interlocks
  • Interfaces for class changes
  • Computer control system
  • Identification of components and subsystems delivered by the process

A P&ID should NOT include the following:

  • Instrument root valves
  • Control relays
  • Manual switches
  • Primary instrument tubing and valves
  • Pressure temperature and flow data
  • Elbow, tees and similar standard fittings
  • Extensive explanatory notes

A P&ID involves various symbols to represent all of the included parts, components, and information. Their symbology is defined on separate drawings referred to as “lead sheets” or “legend sheets.” Lead sheets should be customized to each company’s process plants, though in general, the P&IDs are based on a core set of standard symbols and notations. The most important part of the lead sheets is that they are organized logically so that it is possible to easily locate the symbols and tags. While it’s a good practice to have lead sheets for the major equipment in a factory, it may not be necessary because this major equipment already should be tagged and named with general specifications for identification purposes.

Letter and number combinations appear inside each graphical element and letter combinations are defined by the ISA standard. Numbers are user assigned and schemes vary. While some companies use sequential numbering, others tie the instrument number to the process line number, and still others adopt unique and sometimes unusual numbering systems. The first letter defines the measured or initiating variables such as Analysis (A), Flow (F), Temperature (T), etc. with succeeding letters defining readout, passive, or output functions such as Indicator (I), Recorder (R), Transmitter (T), etc.

Below are some piping and instrumentation diagram symbols with letters.


Because a P&ID contains such important information, it is critical to the workings of the process industry that the process plants apply tags or labels to keep track of all of the equipment, piping, valves, devices, and more. Those labels must match the symbology and should not fail, so that the plant’s operations run smoothly and efficiently. That’s why the unique identifiers involved in the P&ID, tagging, and labeling process are critical.

The P&ID and tags ensure that even collections of similar objects have unique tags so that identical valves, pumps, instruments, etc., can be uniquely identified
The P&ID and tags make it possible to assemble the process plant in a structured manner so that additions, deletions, changes, etc., are possible from a whole-unit scale down to a single valve on a pipe at any location.

The P&ID and tags contain scores of metadata that provides, or links to, more details including specifications, materials of construction, data sheets, etc.
Best Practices for Tagging Equipment When Considering P&ID.

Using a numeric-only system for tagging equipment is the best way for process industries to avoid the problems with labeling by abbreviated names. Structured tag systems are more intuitive for every team that deals with the equipment, including developers, operators, and maintenance. The equipment tag format should be a series of three numbers, beginning with an area number, followed by an equipment type code, and then ending with a unique sequence number.

Area numbers represent an area that may be determined by the physical, geographical, or logical grouping location by the plant site
Equipment types are fairly straightforward, but if equipment has multiple functions, users should determine how to select the most suitable equipment type code.

Sequence numbering is the consecutive numbering of similar equipment in any given area, and it’s important to being the sequence at 01 so that all equipment can have it’s own sequence number.

Validation Protocols for Pharmaceutical Industries

For pharmaceutical industries, product quality is paramount. Minor inconsistencies can lead to major disasters. To maintain quality assurance, consistency and risk assessment, industries conduct a validation of processes and equipment. A validation is a documented evidence of the consistency of processes and equipment. Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are an essential part of quality assurance through equipment validation.

DQ IQ OQ PQ protocols are ways of establishing that the equipment which is being used or installed will offer a high degree of quality assurance, so that manufacturing processes will consistently produce products that meet predetermined quality requirements.

Design Qualification (DQ)

Design qualification is a verification process on the design to meet particular requirements relating to the quality of manufacturing and pharmaceutical practices. It is important to take these procedures into consideration and follow them keenly. Along with Process Validation, pharmaceutical manufacturers must conduct Design Qualification during the initial stages. For DQ to be considered whole, other qualifications i.e. IQ, OQ and PQ need to be implemented on each instrument and the system as a whole.

DQ allows manufacturers to make corrections and changes reducing costs and avoiding delays. Changes made to a DQ should be documented which makes DQ on the finalized design easier and less prone to errors. By the use of a design validation protocol it is possible to determine whether the equipment or product will deliver its full functionality and conform to the requirements of the validation master plan.

Installation Qualification (IQ)

Any new equipment is first validated to check if it is capable of producing the desired results through Design Qualification, but its performance in a real-world scenario depends on the installation procedure that follows. Installation Qualification (IQ) verifies that the instrument or equipment being qualified, as well as its sub-systems and any ancillary systems, have been delivered, installed and configured in accordance with the manufacturer’s specifications or installation checklist. All procedures to do with maintenance, cleaning and calibration are drawn at the installation stage. It also details a list of all the continued Good Manufacturing Procedures (cGMP) requirements that are applicable in the installation qualification.

Conformance with cGMP’s requires, that whatever approach is used, it is fully documented in the individual Validation Plan. The IQ should not start with the Factory Acceptance Testing (FAT) or Commissioning tasks, but it should start before these tasks are completed; enabling the validation team to witness and document the final FAT and commissioning testing. The integration of these activities greatly reduces the costly and time consuming replication of unnecessary retesting.

These requirements must all be satisfied before the IQ can be completed and the qualification process is allowed to progress to the execution of the OQ.

Operational Qualification (OQ)

Operational Qualification is an essential process during the development of equipment required in the pharmaceutical industry. OQ is a series of tests which of tests which ensure the equipment and its sub-systems will operate within their specified limits consistently and dependably. Equipment may also be tested during OQ for qualities such as using an expected and acceptable amount of power or maintaining a certain temperature for a predetermined period of time. OQ follows a specific procedure to maintain thoroughness of the tests and accuracy of the results. The protocol must be detailed and easily replicated so that equipment can be tested multiple times using different testers. This ensures that the results are reliable and do not vary from tester to tester. OQ is an important step to develop safe and effective equipment.

Performance Qualification (PQ)

PQ is the final step in qualification processes for equipment, and this step involves verifying and documenting that the equipment is working reproducibly within a specified working range. Rather than testing each instrument individually, they are all tested together as part of a partial or overall process. Before the qualification begins, a detailed test plan is created, based on the process description.

Process Performance Qualification (PPQ) protocol is a vital part of process validation and qualification, which is used to ensure ongoing product quality by documenting performance over a period of time for a certain process.

Equipment qualification through DQ IQ OQ PQ practices is a part of Good Manufacturing Practice (GMP), through which manufacturers and laboratories can ensure that their equipment delivers consistent quality. It reduces the margin for errors, so the product quality can be maintained within industry standards or regulatory authority requirements. When qualification of equipment is not needed very frequently, performing it in-house might not be feasible, so smaller laboratories might benefit from scheduling external equipment validation services on a regular basis instead.

An Introduction to Water Audit in Industries

Water has been an over utilized commodity in the process industry due to its low cost. However, due to increasing environmental regulations and high expectations of environmental performance, water conservation has been on the agenda for industries. Conducting a water use efficiency audit is the first step in determining the most cost effective water conservation projects.
Water audit is the measure of impact the organization has on water resources. Determining an organizations’ water consumption and the amount of water lost from a distribution system is the main aim of Water Audit. Loss of water may be due to leakage and other reasons such as pumping inefficiency, unauthorized or illegal withdrawals from the systems and the cost of such losses to the organization.
Water audit creates a detailed profile of the water distribution system. It maps water intensive units, thus facilitating effective management of water resources with improved reliability. It diagnoses the problems faced to recommend appropriate solutions. It is also an effective tool for realistic understanding and assessment of the present performance level and efficiency of the water management service and the compliance of such a system for future expansion.
Standards and guidelines
Since water is seen as a free commodity there are no specific guidelines available for the same. The Central Water Commission has taken the role to bring out General Guidelines for Water Audit which covers the three main sectors of water use i.e. irrigation, domestic and industrial. These guidelines aim to introduce, standardize and popularize the water audit system for conservation of water in all sectors and improve the water use efficiency.
Categories of Water Audit
Based on the extent of water consumption, Water Audit can be divided into four categories.

  • Large Water users:These users covers large Industries, Agriculture Municipalities and Metros with consumption more than 15 million litres per day.
  • Medium Water Users: These users covers Industrial clusters, Medium Industries and township with demand ranging from 3 million litres per day to 15 million litres per day.
  • Small Water Users: Large Hotels, IT Parks, Theme Parks, Industrial and Private Township with demand of 0.5 million litres per dayto 3 million litres per day.
  • Tiny water Users: All other users with consumption less than 0.5 million litres per daysuch as Commercial complexes, Government Offices/Buildings, Builders, Colonies etc.

Benefits of water audit
Water audit improves the distribution system, spots problems and risk areas and therefore builds a better understanding of water handling system right from source to disposal/treatment. Leak detection programs help in minimizing leakages and tackling small problems before they become major ones. These programs have the potential to-

  • Reduce water losses
  • Improve financial performance
  • Improve reliability of supply system
  • Enhance knowledge of the distribution system
  • Increase efficiency in the use of existing supplies
  • Create Better safeguard to public health and property
  • Improve public relations
  • Reduce legal liability, and reduced disruption.

Efficient use of water can be a part of the environmental strategy of a business, just like reducing the carbon footprint. Analyzing risk and opportunities associated with water allow organization to assess water related risks and opportunities. Water audit is qualitative and quantitative analysis of water consumption and it also help to assess significant social and environmental impacts associated with water scarcity.

Energy Audit – An Overview

Energy Audit is the first step in Energy Conservation and Energy Efficiency Projects for Industrial Plants. Energy Audit is a periodic exercise undertaken by a plant to assess its energy consumption and identify opportunities for Energy Conservation and Energy Efficiency. It also helps plant personnel in modernizing the plant with new technological solutions. It benefits plants cut down production costs.

In India, Energy Audit is quite popular in an Industrial or Commercial Facility. Many companies have realized the potential of energy saving in their plant. However one must realize that Energy Audit is only the first step in the direction of energy efficiency and energy conservation. The recommendations made as part of the energy audit have to be implemented to achieve the energy saving targets.

The energy saving recommendations doesn’t require much investment. In some high cases, the investment may be higher. The plant then takes up the investments in a phase-wise manner, which result in delayed energy saving for the plant. In fact the plant may never take some of the recommendations up. This renders the entire energy audit exercise futile.

Energy Audit works for every single Plant or Commercial Facility, as there is always scope for Energy Optimization through Energy Conservation & Energy Efficiency. Every plant goes through some changes over a period of time. Moreover an external Energy Audit team works across departments and brings in rich experience gained from Energy Audit of several plants. This not only results in gaining fresh perspective of Energy saving possibility by an external team also results in bench-marking based on similar parameters.

Energy Audit gives a positive orientation to Preventive Maintenance, Safety and Quality Control programs thereby improving the overall efficiency and output of existing system.

Nearly all the Industrial Units and Commercial Complexes have a potential to save 10-15% on Energy Bills and additional savings in Thermal Energy.

The evident reason why a plant goes for an Energy Audit is the saving of energy. This saving translates into monetary saving and hence can have a direct impact on profitability of a Company. It is also a step towards sustainability.

However, Energy Audits should look at a more comprehensive approach than just reducing cost. Industries should focus more on reducing their carbon footprint as necessitated by Governing Environmental Laws. Energy Audits must go beyond the conventional approach and adopt newer technologies for Green Power Generation.

With increased environmental awareness the pressure on Industries is mounting to reduce their Carbon footprint by adopting Greener Methods wherever possible. In such as scenario Energy Audit would play a crucial role in offering Industries a comprehensive approach towards a Greener Plant.

There is no specific answer as to how much energy a plant could save post an Energy Audit. An estimate could certainly be provided and in all cases Energy Audit could prove to be useful and economically viable. This is especially true in the present day scenario when Energy costs are ever rising and are expected to rise further.

Each Industrial Plant must carry out Energy Audits for reducing their energy usage by adopting energy conservation and energy efficiency measures.

Energy audit in India – Chemical Industry

Chemical industry is one of the oldest industries in India. Indian chemical sector has grown a long way since its early days of independence.

The chemical industry forms the backbone of the industrial and agricultural development in India and also provides building blocks for downstream industries. This industry is a significant contributor to India’s national economic growth. To know the extent of energy being wasted it is essential to know the amount of energy being consumed.

Energy audit is an inspection, survey and analysis of energy flows for energy conservation to reduce the amount of energy input into the system without negatively affecting the output. The energy audit is the key for decision-making in the area of energy management.

Energy Audit in India – Projections

India is projected to sustain the world’s second-highest rate of gross domestic product (GDP) growth, averaging 5.6 percent per year from 2006 to 2030 (Annual report, 2007 and GOI, 2006 and 2010).

India’s economic growth over the next 25 years is expected to derive more from light manufacturing and services than from heavy industry, so that the industrial share of total energy consumption falls from 72 per cent in 2006 to 64 percent in 2030.

The changes are accompanied by shifts in India’s industrial fuel mix, with electricity use growing more rapidly than coal use in the industrial sector. The Indian chemical industry was the 5th largest in the world, and 2nd largest in Asia, after China. The volume of major chemicals produced in India amounted to 8.3 million metric tons (MMT) in 2011-12.

The energy conservation and utilization of renewable sources are essential factor to fulfill energy demand. Renewable energy and nuclear power are the world’s fastest-growing energy sources, each increasing by 2.5 per cent per year. Among the various sectors contributing to greenhouse gas (GHG) emissions, the contribution of the industrial sector was significant.

Thus, mitigating GHG emissions from the industrial sector offers the best means of reducing overall GHG emissions. Therefore, energy conservation means less reliance on energy imports and, thus, less GHG emissions. It can be achieved either by reducing total energy use or by increasing the production rate per unit of energy used. On the other hand, improving energy efficiency is the key to reducing GHG emissions (Export-Import Bank of India, 2013).

Energy audit is an inspection, survey and analysis of energy flows for energy conservation to reduce the amount of energy input into the system without negatively affecting the output.

Objective of Energy Audit in Chemical Industry:

The primary objective of energy auditing in chemical industry is to determine ways to reduce energy consumption per unit of product output or to lower its operating costs. The present scenario of energy demand in chemical industries is the indication of energy conservation and optimum utilization of renewable sources of energy (BEE).

Considering the scenario of the Indian industrial sector and its energy utilization efficiency, there is urgent need to review manufacturing technologies and the present energy management approach.

Owing to old and obsolete industrial technologies and machinery the extent of energy wastage is very high. Energy Conservation potential in the industrial sector of our nation has been projected between 30 to 40 %.

Good energy management begins with an energy audit. Effective management of energy-consuming systems can lead to significant cost and energy savings as well as increased comfort, lower maintenance costs, and extended equipment life.

A successful energy management program begins with a thorough energy audit. The energy audit evaluates the efficiency of all building and process systems that use energy. Energy audits don’t save money and energy for companies unless the recommendations are implemented.

Audit reports should be designed to encourage implementation, but often they impede it instead. In this paper, the discussion on the scope and objectives of energy audit, types of energy audit, contents of an energy audit, audit methodology and targets and benefits of the energy audit are presented.

Finally a typical case study of chemical industry for energy audit is discussed with a clear and consistent path toward introducing energy management and auditing. The methodology, tools used, results and difficulties encountered during the study are also discussed.

The energy crisis all over the world in the seventies warned mankind and forced it to think about the appropriate utilization of the energy resources on the earth for the sustainable development. In history, the energy crisis had led to many innovations as well as research and development programs in all sectors related to energy. It is well known that energy sector has its own impact on the progress and development of any nation.

The availability of various energy resources and in house capability to use it in the appropriate manner for productive development of a nation is a key factor in the economic growth of the country.

Role of energy audit:

To institute the correct energy efficiency programs, we have to know first which areas in our establishment unnecessarily consume too much energy. An energy audit identifies where energy is being consumed and assesses energy saving opportunities. In the factory, doing an energy audit increases awareness of energy issues among plant personnel, making them more knowledgeable about proper practices that will make them more productive. An energy audit in effect gauges the energy efficiency of plant against “best practices”. When used as a “baseline” for tracking yearly progress against targets, an energy audit becomes the best first step towards saving money in the production plant.

sectoral-comsumption-of-energy

Key points:

  • Although most efforts should be focused on the application of economic, mature technologies there are arguments to support innovation in energy efficiency technology.
  • Public and private expenditure on energy efficiency innovation is increasing globally.
  • Innovation programmes should be long-term and consistent.
  • R&D programmes need to be driven by input from the customer industries.
  • Government support can be used to help bridge the twin valleys of death but care must be taken to ensure that innovations are really aimed at meeting real customer needs.
  • A wide spread of technologies is needed as the failure rate is high.