Environment Monitoring and Measurement

Environmental monitoring and measurements are helpful in environmental assessments , as well as in many circumstances in which human activities carry a risk of harmful effects on the environment. All monitoring strategies and programs have reasons and justifications which are often designed to establish the current status of an environment or to establish trends in environmental parameters. Knowledge gained from this information can be used to implement corrective and preventive action. Key characteristics are those that the organization needs to consider to determine how it is managing its significant environmental aspects, achieving objectives and targets, and improving environmental performance. In order to ensure valid results, measuring equipment should be calibrated or verified at specified intervals, or prior to use, against measurement standards. Refer ISO 14001:2004 Clause 4.5.1

Criteria for auditing Monitoring and Measurement process during EMS Audits

Auditing Monitoring and Measurement process during EMS Audits based on following criteria

I. Waste water Discharge Quantity and Quality (COD, BOD, pH……) every works shift/Day/ Month/Year

II. Reduce, Recycle, Reuse of treated water in the plant and /or outside plant.

III. Air Emissions (Quantity and Quality) in ambient air and through stack in atmosphere.

IV. Waste generation and disposal from time to time

V. Consumption of natural , nonrenewable resources like water and electricity

VI. Trends of key characteristics of operations, objective targets and environmental performance

VII. Use of adequate instruments, equipments, methodologies for measurements

VIII. Calibration of Instruments, equipments, methodologies – retain records.

TYPES OF EMERGENCY SITUATIONS

Emergency situation for a facility and its operations may be described as a hazardous situation which requires action to control, correct and return the site to a safe condition and also requires timely action to protect people, property and the environment from harm.

TYPES OF EMERGENCY SITUATIONS

► Industrial disasters are disasters caused by chemical mechanical, civil, electrical or other processes failures due to an accident, negligence or in competence in an industrial plant which may spill over to the areas outside the plant or within causing damage to life property & environment

► Chemical Disasters are occurrence of emission, fire or explosion involving one or more hazardous chemicals in the course of industrial activity (handling) storage or transportation or due to the natural events leading to serious effects inside or outside the installation likely to cause loss of life & property including adverse effect on the environment

► A chemical accident or emergency refers to an event which r results in the release of a substance hazardous to human health and /or the environment, i.e. short term or long term. These events can cause illness, injury, disability or death to human beings, often in large numbers & can result in the extensive damage to the environment with considerable human & economic costs

Examples of types of emergencies are:

    - fire (including generation of toxic combustion products)

   - explosion (including BLEVE)

   - spill (of hazardous solids & liquids)

   - gas leak (flammable, toxic, asphyxiant, pressurized or refrigerated liquid)

   - structural failure

   - natural event (including earth quake, storms, tides etc)

Factors contributing to the emergency situation

• ·          Characteristics of the chemicals used
• ·         Storage conditions of the  raw materials
• ·         Equipment failure
• ·         Lack of awareness on the msds &emergency preparedness plans
• ·         Lack of involvement on the periodical testing of emergency
• ·         Preparedness plan

LEVEL OF EMERGENCY

► There is no direct correlation between the size of a release & scale of emergency

► Eg: A small release of chlorine gas may affect the people outside the boundary of the facility and can be categorized as an external emergency

► A large release of an alkali that  is contained within a bunded area could be classified as a local

► LOCAL EMERGENCY : is an emergency where the impacts on people, property &environment are expected to be confined to a specific location within the facility and no escalation is expected  eg: ruptured drum in ware house, leaking flange or seal, small fire in a bag store .

► SITE EMERGENCY: is an emergency where the impacts on people, property & environment are expected to be confined to spread or affect all parts of the facility but not off site

► EXTERNAL EMERGENCY: An emergency where the impacts on people, property & environment are expected to impact within the facility & beyond the boundary of the facility eg: bomb threat, a large tank bund fire, BLEVE of a large liquefied gas storage, toxic gas release, transport incident

OBJECTIVE OF LCI (Life Cycle Inventory)

The objective of a LCI (life cycle Inventory) is -

► to create a mass balance  which accounts for an in put  &out put to the overall system
► to establish a base line of information on a system’s overall resource use, energy consumption & environmental loading
► to identify the stages within the life cycle of a product or process where a reduction in resource consumption  & environmental output can be achieved
► to compare the system’s input &output associated with alternative products, processes or activities
► to identify the areas to be addressed during the life cycle analysis
► to guide  development of new product, processes or activities which conserve the resources and minimize adverse impact on the environment.

CRANE TESTING SEQUENCE

CRANE TESTING SEQUENCE

1. STARTING BY HYDRAULIC & PNEUMA TIC
2. 15 TON AT 6.5 MTR RADIUS
3. 15 TON 10.5 MTR RADIUS, SPEED 18MTRJMIN
4. MAIN HOIST BRAKE TEST
5. BOOM BRAKE TEST

PROCEDURE FOR INSPECTION, TESTING AND CERTIFICATION OF LIFTING TOOLS & TACKLES

QUALITY & SAFETY ASSURANCE PLAN FOR INSPECTION OF LIFTING TOOLS AND TACKLES

PPE

1. PPE is mandatory for inspection of lifting tools and tackles.

2. Company provides Helmets, Safety Glasses, Gloves and Full Body harness to its inspection personnel.

SAFETY

A safe system of work should be developed to ensure the safety of personnel engaged in the job in addition to carrying out of a good quality and accurate inspection, examination or test. Legally, every employer must ensure the safety and health at work of all his employees. He should provide and maintain a safe system of work that is safe and without risk to health. The safe system of work should be worked out under the advice of a registered safety officer.

Applicability of Design in Pharmaceutical manufacturing industry

Applicability of Clause 7.5.2 

Exclusion of cl. 7.5.2 in case of pharmaceutical manufacturing industry is not permissible. In fact requirement of validation has been prescribed in Schedule M of Drugs and Cosmetics act and is applicable to all types of pharma manufacturing industries. Hence no pharmaceutical manufacturing (whether responsible for D&D or not) company can claim design exclusion. If the CB auditors accept such exclusions then they would not be considered competent for auditing Pharma (Scope IAF 13) sector. Further all significant changes in respect of new/changed formulation  new equipment, new process, new raw materials (including changes in suppliers of significant raw materials) / components, new test/ measurement methods as applicable), new computer systems (as applicable), new facility and or facility services, etc, would require the changes to be validated as appropriate. The organization would require documenting its system for validation to cover all necessary technical and regulatory requirements and it is expected that the CB’s auditors audit these aspects for all pharma manufacturing units.     

Continuous Improvement Tools - Total Quality Management

Elaboration of TQM 

►Total - made up of the whole

►Quality - degree of excellence a product or service provides

►Management - act, art or manner of planning, controlling, directing,….

    Therefore, TQM is the art of managing the whole to achieve excellence.

Conclusions of Stage 1 Audits

With respect to purpose & intent of Stage 1 audits, one of the requirement of ISO 17021 and BMS is -
Stage 1 audit shall be performed -….

1. To review the allocation of resources for stage 2 and agree with the client on details of the stage 2.
Evidence of this review shall be available
2. An audit report is produced at the end of stage 1 and is communicated to the client, including the
identification of findings that could be nonconformities during the stage 2 audit.
With respect to Point 1 above -
• During the ICC File Reviews & also from the audit reports sampled during the last UKAS & ANAB audits, it was seen that the Stage 1 audit reports do not demonstrate whether & how the audit team has reviewed the allocation of resources for stage 2 and agreed with the client on details of the stage

Auditing Shifts in Certification Process

1. In case of management systems like EMS & OHSMS, when product or service realization processes operate on a shift basis, the extent of auditing of each shift (read outside normal working hours) depends not only on the processes done in each shift but also the level of control of each shift that is demonstrated by the client.

Legal Compliance as a part of Accredited ISO 14001: 2004 certification

1 INTRODUCTION

1.1 This document is intended to provide useful information on the relationship between an

 organisation's accredited Environmental Management System (EMS) certification and that organisation's degree of compliance with applicable environmental requirements. 

 The intended audience for this document includes organisations that have or are implementing an EMS, government authorities and environmental regulators, accreditation bodies, accredited certification bodies (or CABs – Conformity Assessment Bodies) and other stakeholders. 

Conditions for conducting Stage 2 audits after Stage 1 audit

1. Nonconformities, as observed during the Stage 1 audit, to be handed over to the client
management by end of Stage 1 audit (or within max 2 calendar days from the last date of
the Stage 1 audit).
2. The client shall be given a maximum period of 90 days to respond to the Stage 1 NCRs
(both Major as well as Minor).
3. The audit team leader shall inform the client that proposed NC closure actions (correction,
root cause & corrective actions) need to be provided for review within max. 90 days.
4. In case the client is able to implement the actions in totality & submit the evidences of
implementation for review, the audit team shall acknowledge & close the NCRs prior to the
Stage 2 audit. Effectiveness of actions can be further reviewed & commented during the
Stage 2 audit. Even otherwise, the client is required to submit the proposed actions for the
Stage 1 NCRs before planning the Stage 2 audit.
In all cases, the closure actions for the Stage 1 audit NCRs shall be submitted by the
client and accepted by the audit team, at least in principle, prior to the planning of Stage
2 audit. Effectiveness of actions can be further reviewed & commented during the Stage
2 audit.

The Stage 2 audit to be planned within 180 days from the last date of Stage 1 audit,
however, this does not absolve the requirement either to close or to submit the proposed
actions for in-principle acceptance of the Stage 1 NCRs within 90 days. 

Competency requirements for EMS auditors and other positions involved in 14001 certification

ISO/IEC TS 17021-2 was published on August, 15th 2012. IAF has confirmed that the ISO/IEC TS
17021-2 document is endorsed as a normative document to be applied in conjunction with ISO/IEC
17021, and the deadline for implementation is two years after publication.
This ISO/IEC document does NOT affect BVC clients certified to EMS (ISO14001)
This memo details the implementation requirements for this Technical Specification, including
expectations from global accreditation bodies – UKAS and ANAB. Additional requirements from local accreditation bodies must be addressed at local level.

Current approach for EMS auditors:
Technical areas are built around 39 IAF scope categories (Product Environmental Codes) with
relevant guidance notes for each PEC (technical area) aligned with the seven aspect-specific
competency requirements within ISO 17021-2:
• emissions to air
• releases to land
• releases to water
• energy
• waste
• uses of raw materials & natural resources
• physical attributes.

Audit durations for transitioning existing QMS and EMS certifications to 2015 versions

BACKGROUND

In 2015 both ISO 9001 and ISO14001 are being revised and are due to be issued in September 2015.

The revisions incorporate a change in structure, aligning them to the ISO/IEC Directives, Part 1, Consolidated ISO Supplement 2013 - Annex SL which brings significant changes to both the content and the expected method of auditing to achieve the expected results.

The International Accreditation Forum (IAF) has produced guidance for certification and accreditation bodies to manage the transitions from the existing versions of the standards to the 2015 versions. The following is an extract from these documents:

“Where transition audits are carried out in conjunction with scheduled surveillance or recertification (i.e. progressive or staged approach), additional time is likely to be required to ensure that all activities are covered for the existing and new standards.”