scholarly journals A Review on Life Cycle Management Approach on Asset Qualification

2020 ◽  
Vol 10 (4) ◽  
pp. 253-259
Author(s):  
Mamta R. Mali ◽  
O.G. Bhusnure ◽  
Shrikrishna T. Mule ◽  
S.S. Waghmare
Keyword(s):  
Life Cycle ◽  
Life Cycle Management ◽  
Management Approach ◽  
Cyclic Process ◽  
Laboratory Equipment ◽  
Drug Products ◽  
Voluntary Standards ◽  
Intended Purpose ◽  
Consistent Performance ◽  
Equipment Qualification

All equipment’s used in the production of products shall be properly Validated, Qualified and Calibrated to demonstrate that it is suitable for its intended purpose. Qualification is an important aspect of the pharmaceutical quality system. When the equipment is properly qualified, verified and maintained, there is the possibility of Consistent performance of the equipment. A well designed qualification program saves valuable time and cost. Qualification is called a cyclic process because it is a never ending process. Appropriate documentation of the qualification program is very important as lack of the documented evidence does not give any meaning to qualification (Not documented it means not done).  The current programs and procedures of equipment qualification used within any pharmaceutical and bioscience industry are based on ‘regulatory requirements’, ‘voluntary standards’, ‘vendor practices’, and ‘industry practices’. The output is considerable variation in the way any pharmaceutical and biotechnological companies approach for the laboratory equipment. The lifecycle management approach of equipment qualification covers entire life cycle for the specification, design, manufacturing, installation, commissioning, qualification (4Qs Model DQ, IQ, OQ, PQ), operation & maintenance of equipment in a risk based life cycle management approach. The goal of any regulated pharmaceutical and bioscience company is to provide reliable and valid data suitable for its intended purpose. Main goal of equipment qualification is to form the basis for written procedures for production and process control which are designed to assure that the drug products have the SISPQ (Safety, Identity, Strength, Purity and Quality) Keywords: Validation, Calibration, Life cycle management approach, Qualification (4Qs Model- DQ, IQ, OQ & PQ), SISPQ (Safety, Identity, Strength, Purity and Quality)

Improving Life Cycle Quality of Navy Vessel through Integrated Management Approach

2013 ◽  
Vol 357-360 ◽  
pp. 2849-2853
Author(s):  
Qv Li Ma ◽  
Zong Ren Xie ◽  
Jian Wei Lv
Keyword(s):  
Life Cycle ◽  
Quality Management ◽  
Integrated Management ◽  
Life Cycle Management ◽  
Ship Design ◽  
Management Approach ◽  
Simulation Environment ◽  
Whole Process ◽  
Definition Of

The life cycle management of navy vessels quality is presented, and the quality of various phases in the navy vessels life cycle is academically described. On the management of phase quality, taking shipbuilding as an example, the definition of the phase quality is provided, requirements of comprehensive quality management are discussed, which include the total-staff participation, the whole process of management, comprehensive approach and concept of quality. On the integrated quality management of the navy vessels life cycle, the mode that staffs participating in the various stages of life cycle, and integrated requirements of ship design, modeling & simulation environment are proposed. Technical support and realization of the quality management of navy vessels life cycle are presented, which has laid the foundation for the realization of the quality management of navy vessel.

scholarly journals AN OVERVIEW OF ANALYTICAL INSTRUMENT QUALIFICATION WITH REFERENCE OF PHARMACEUTICAL INDUSTRY

2018 ◽  
Vol 8 (5) ◽  
pp. 99-103 ◽  
Author(s):  
Devesh Kapoor ◽  
Ruchi B. Vyas ◽  
Diwaker Dadrwal
Keyword(s):  
Pharmaceutical Industry ◽  
Laboratory Equipment ◽  
Voluntary Standards ◽  
Analytical Instruments ◽  
Intended Purpose ◽  
System Suitability ◽  
Design Qualification ◽  
Operational Qualification ◽  
Performance Qualification ◽  
The Way

In the most general sense, validation refers to a process that consists of at least four distinct components or steps: software, instruments, methods or procedures, and system suitability The system, the software, and the method must all be validated, and system suitability is used to keep the process in check. But while the overall process is called validation, some of the steps also are referred to by that same term, as well as other steps such as qualification and verification. Analytical instruments are used for a specific analysis. So regular performance verifications are made to ensure that the instrument to be used is suitable for its intended application. All equipments used in the production of products shall be properly Validated and Calibrated to demonstrate that it is suitable for its intended purpose. The current equipment qualification programs and procedures used within the pharmaceutical industry are based on regulatory requirements, voluntary standards, vendor practices, and industry practices. The result is considerable variation in the way pharmaceutical companies approach the qualification of laboratory equipment and the way they interpret the often vague requirements. The process for instrument qualification follows the 4Qs model approach. It include design qualification (DQ), Installation qualification (IQ), Operational qualification (OQ), Performance qualification (PQ). The goal of any regulated laboratory is to provide reliable and valid data suitable for its intended purpose. Analysts use validated methods, system suitability tests, and in-process quality control checks to ensure that the data they acquire are reliable and that there are specific guidance and procedures available to ensure compliance. Keywords: Qualification, FDA, Instruments, Validation, Calibration, Documentation

scholarly journals Sustainable Potentials and Risks Assess in Automation and Robotization Using the Life Cycle Management Index Tool—LY-MIT

2018 ◽  
Vol 10 (12) ◽  
pp. 4638 ◽  
Author(s):  
Jörg Niemann ◽  
Adrian Pisla
Keyword(s):  
Life Cycle ◽  
Life Cycle Management ◽  
Management Approach ◽  
Self Assessment ◽  
Complex Approach ◽  
Innovative Tool ◽  
Assisted Analysis ◽  
A Company ◽  
Assessment Questionnaire ◽  
Generation Management

In product generation management, the assessment for sustainability, together with risks potential, requires a holistic life cycle management approach, especially when it comes to the question of obsolete management of components. But, so far, the economic impact or benefit of such life cycle related activities is not always obvious. This paper presents a complex approach to identify company unexploited resources by offering the performance exploration of a novel capability and innovative tool named the LifecYcle-Managerial Index Tool (LY-MIT), in order to allow detailed visualization for a company, using seven clustered capabilities in respect to key areas. The assisted analysis of the strength and weakness enables manufacturers, as well as industrial end-users, to sustainably assess and evaluate the productivity potentials and risks of possible life cycle related improvements to their installed base. The research team used the tool on almost 300 sample companies group to identify the robustness of the tool in implementing sustainable change required measurements, mostly based on a self-assessment questionnaire about their capabilities. Only the approach and the results of this instrument usage are presented in this paper.

scholarly journals Product life cycle management approach for integration of engineering design and life cycle engineering

2016 ◽  
Vol 30 (4) ◽  
pp. 379-389 ◽  
Author(s):  
Diana Penciuc ◽  
Julien Le Duigou ◽  
Joanna Daaboul ◽  
Flore Vallet ◽  
Benoît Eynard
Keyword(s):  
Life Cycle ◽  
Product Life Cycle ◽  
Sustainability Assessment ◽  
Material Selection ◽  
Life Cycle Management ◽  
Management Approach ◽  
Product Life ◽  
Product Life Cycle Management ◽  
Cycle Simulation ◽  
Material Choice

AbstractOptimized lightweight manufacturing of parts is crucial for automotive and aeronautical industries in order to stay competitive and to reduce costs and fuel consumption. Hence, aluminum becomes an unquestionable material choice regarding these challenges. Nevertheless, using only virgin aluminum is not satisfactory because its extraction requires high use of energy and effort, and its manufacturing has high environmental impact. For these reasons, the use of recycled aluminum alloys is recommended considering their properties meet the expected technical and environmental added values. This requires complete reengineering of the classical life cycle of aluminum-based products and the collaboration practices in the global supply chain. The results from several interdependent disciplines all need to be taken into account for a global product/process optimization. Toward achieving this, a method for sustainability assessment integration into product life cycle management and a platform for life cycle simulation integrating environmental concerns are proposed in this paper. The platform may be used as a decision support system in the early product design phase by simulating the life cycle of a product (from material selection to production and recycling phases) and calculating its impact on the environment.

Real Savings From a Life-Cycle Management Approach

1997 ◽  
Vol 49 (10) ◽  
pp. 1105-1111
Author(s):  
Jim Crompton ◽  
Tim Boyd ◽  
Tony Lopez
Keyword(s):  
Life Cycle ◽  
Life Cycle Management ◽  
Management Approach

Guidance and Methodologies for Managing Digital Instrumentation and Control Obsolescence

2016 ◽  
Vol 2 (4) ◽  
Author(s):  
Matthew O’Connor ◽  
Bruce Geddes ◽  
Sean Kelley
Keyword(s):  
Life Cycle ◽  
Management Strategies ◽  
Life Cycle Management ◽  
Management Plan ◽  
Management Approach ◽  
Nuclear Technology ◽  
Digital Instrumentation ◽  
Technology Life Cycle ◽  
And Control ◽  
Digital Equipment

New nuclear plant technology will rely heavily, if not exclusively, on digital equipment. Obsolescence of digital instrumentation and control (I&C) equipment is an inevitable part of plant technology life cycle for new and existing plants. Developing an overall strategic plan can mitigate some of the risks associated with obsolescence. Moreover, when developed as a part of an overall life cycle management plan (LCMP), a strategic obsolescence management approach can identify steps that can be taken at early stages of the technology life cycle to cope proactively with the obsolescence of equipment. Recent work within the advanced nuclear technology (ANT) program at the Electric Power Research Institute (EPRI) (O’Connor et al., 2014, “Advanced Nuclear Technology: Guidance and Methodologies for Managing Digital Instrumentation and Control Obsolescence,” EPRI, Palo Alto, CA, Product ID 3002002852) has developed guidance and methodologies for determining when digital obsolescence is likely to occur, the extent to which it can occur, the risks and impacts due to obsolescence, and strategies that can be used to minimize its effects, all in the context of system LCMP. Worksheets for assessing obsolescence risks and the applicability and limitations of management strategies were developed as a part of this work, and can be used to create or supplement a strategic obsolescence management plan.

Sign in / Sign up

Export Citation Format

Share Document