Documents That Ensure Effective Planning, Operation And Control

Documents That Ensure Effective Planning, Operation And Control

The ISO 9000 standard requires management system documentation to include documents required by the organization to ensure the effective planning, operation and control of its processes.
The documents required for effective planning, operation and control of the processes would include several different types of documents. Some will be
product and process specific and others will be common to all processes. Rather than stipulate the documents that are needed, ISO 9000 Standards now provides for the organization to decide what it needs for the effective operation and control of its processes. This phrase is the key to determining the documents that are needed.
There are three types of controlled documents, namely:
- Policies and practices (these include process descriptions, control procedures, guides, operating procedures and internal standards)
- Documents derived from these policies and practices, such as drawings,
specifications, plans, work instructions, technical procedures and reports
- External documents referenced in either of the above
There will always be exceptions to this model but in general the majority of
documents used in a management system can be classified in this way.
Derived documents are those that are derived by executing processes;
for example, audit reports result from using the audit process, drawings result from using the design process, procurement specifications result from using the procurement process. There are, however, two types of derived document:
prescriptive and descriptive documents. Prescriptive documents are those that prescribe requirements, instructions, guidance etc. and may be subject to change. They have issue status and approval status, and are implemented in doing work. Descriptive documents result from doing work and are not
implemented. They may have issue and approval status. Specifications, plans, purchase orders, drawings are all prescriptive whereas audit reports, test reports, inspection records are all descriptive. This distinction is only necessary because the controls required will be different for each class of documents.

Operational Control In ISO 14001 Standards

Operational Control In ISO 14001 Standards

Operational Controls over Significant Environmental Aspect Activities, ?4.4.6.a&b – ISO 14001 requires the organization to identify and plan the operations associated with its identified significant environmental aspects in order to establish documented operational control procedures that preclude deviation from the Environmental Policy or not achieving objectives and targets.

Opportunities to apply operational controls can be found by reviewing operations. As shown in the accompanying text box, once the operations that can produce significant impacts are identified, it is a relatively simple step to establish operational control procedures that are consistent with the aims of the Environmental Policy and the objectives and targets and that stipulate operating criteria.

Significant Environmental Aspects of Goods and Services, §4.4.6.c – This requirement of ISO 14001requires careful reading. Here is a parsed interpretation of the Operational Control requirement as it relates to goods and services furnished by others:

“The organization shall identify those operations that are associated with [its] identified significant environmental aspects… The organization shall plan these operations in order to ensure that they are carried out under specified conditions by… [1] establishing and maintaining procedures related to the identifiable significant environmental aspects of goods and services used by the organization and [2] communicating relevant procedures and requirements to suppliers and contractors.”

An easy way to conform to this requirement is to:

1. Identify the operations associated with the significant environmental aspects;

2. Identify the environmental aspects of goods and services furnished by others;

3. Determine how these aspects contribute to the organization’s significant aspect operations;

4. Establish appropriate/relevant requirements for the providers of these services; and

5. Communicate the requirements to suppliers and contractors.

Confusion in conforming to this requirement can arise because it is easy to read sub-clause c) independently of the first sentence of §4.4.6.

This first sentence gives context to the rest of the section in that it requires that we first “identify those operations… associated with the identified significant environmental aspects.” Once we have identified these operations, we look to the significant aspects of goods and services supplied by others and assess their contribution to the potential environmental impact. The accompanying example is offered to help clarify the intent of the requirement.

Monitoring and Measurement In ISO 14001 Standards

Monitoring and Measurement In ISO 14001 Standards

The Monitoring and Measurement section contains two requirements:

1) Measurement and monitoring of environmental performance associated with operations that can have a significant impact on the environment; and

2) Calibration and maintenance of equipment used for environmental monitoring and measurement.

Monitoring and Measuring of Performance — This section calls for a“procedure to monitor and measure… key characteristics of… operations that can have a significant impact on the environment.”

Note that the section does not specifically require the organization to monitor and measure the significant environmental impacts of its products or services. As a practical matter, however, organizations should establish measurements over all environmental aspects that they determine are significant irrespective of whether the impacts relate to an activity, product, or service.

This section also requires the documentation“of information to monitor performance, applicable operational controls, and… environmental objectives and targets.” §4.6,

Management Review, requires that environmental performance and achievement of objectives and targets become inputs into the Management Review (sub-sections c & d).

Calibration and Maintenance — The requirement of having a calibration system is to ensure that measurements are reliable and accurate. A calibration system may be developed following these steps:

· Identification of measurements to be made;

· Identification of equipment, instruments, hardware and software to be used;

· Identification of the testing methods to be used;

· Determination of the accuracy and precision required or desired;

· Definition of calibration procedures;

· Use of the system;

· Establishment of records;

· If equipment is found to be out of calibration, corrective action; and

· Improvement of the system as necessary.

Evaluation of Compliance In ISO 14001 Standards

Evaluation of Compliance In ISO 14001 Standards

The requirement to establish a procedure for periodically evaluating compliance with applicable legal and other requirements falls short of specifically requiring regulatory compliance audits but, in fact, a system of regular regulatory compliance audits may be the most practical means for meeting this requirement of the standard. In the U.S., determination of whether to conduct a compliance audit will be governed in part by the particular jurisdiction’s approach to allowing a legal privilege for the self-assessment audit.

Evaluation vs. Audit – The difference between an evaluation and audit can only be determined by looking outside of ISO 14001. Consulting a dictionary reveals that an evaluation involves a determination of value or worth and that an audit is an examination of accounts done by persons appointed for the purpose. A better definition `is the more specific ISO 19011:2002, Guidelines for Quality and/or Environmental Management Systems Auditing, which defines an audit as a “systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.” Many organizations do not have a system for evaluating regulatory compliance other than their own records and the inspections of regulatory officials. This lack of a verification system can be a risky way to operate. Reports of enforcement actions and consent agreements show that many organizations are blindsided by rogue employees who violate rules and falsify documents to cover up environmental misdeeds. Although ISO 14001 does not prescribe a specific approach to evaluation of regulatory compliance, organizations should consider methods for going beyond verification of records by collecting and evaluating physical evidence.

ISO 9001:2008 Quality Management System Standard

ISO 9001:2008 is the world most successful standard addressing best practice in the application of quality management systems.

The standard is based around the principles of customer satisfaction, continual improvement and the development of a process based quality management system. Although not referenced in the standard itself the ISO 9001:2008 document is underpinned by eight key quality management principles;

• a customer focused organisation
• leadership
• the involvement of people
• ensuring a process approach
• a systematic approach to management
• a factual approach to decision making
• mutually beneficial supplier relations
• continuous improvement

ISO 9001:2008 has been written to ensure that its guiding principles are equally relevant to all sectors of industry and to all types of organisation. Although containing requirements to control the key processes within an organisation, it only requires six documented procedures. The standard emphasises the need for an organisation to continually monitor their own processes and systems, with many clauses making reference to self monitoring or measurement or both. This emphasis aims for an integrated approach to business processes. Instead of operating to a business plan on one hand and a quality management system on the other, the standard aims to integrate both of these functions into one system.

What is a quality management system?
ISO 9001:2008 is a standard that specifies criteria for a quality management system (QMS). A QMS incorporates those elements of an organisations management system that direct and control it with regard to quality. Such a system will need to be supported by top management who will need to be able to demonstrate management commitment.

How do you demonstrate management commitment?
Management commitment is one of the cornerstones of ISO 9001:2008, requiring top management to develop and improve the QMS throughout the organisation. This commitment can be demonstrated by a number of methods including creating a quality policy, conducting management reviews and establishing quality objectives.

What is a quality policy?
ISO 9001:2008 specifies that an organisation must have a quality policy that documents the organisations overall intentions and direction related to quality as formally expressed by top management. Such a policy will include a commitment to comply with ISO 9001:2008, to continuously improve the QMS and to set and monitor measurable quality objectives.

What are quality objectives?
The quality objectives are those targets sought or aimed for by the organisation that are related to quality. These quality objectives must be SMART (suitable, measurable, achievable, reviewed and timely). Examples of quality objectives might be; to reduce machine down time by 20% or to reduce rework costs by ?00 p/m. Whatever quality objectives are chosen they must be meaningful and adequately resourced by the organisation.

What is a management review?
A management review is a key element of how the top management of an organisation can assess its performance in terms of the objectives it sets itself, the requirements set by the standard and how its systems are operating. Normally, a management review is a regular meeting of the top management team and uses the information that the organisation? systems have derived. It is a useful forum to review and revise quality objectives.

What are internal audits and why do I need to carry them out?
Internal audit is one of the key monitoring processes required by the standard and functions as a check on the organisation? systems. It is the opportunity for an organisation to determine compliance to the systems it has established and maintained to meet the needs of its customers and identify opportunities for improvement. Internal audit can be seen as a ealth check?for an organisation.

The ore?of ISO 9001:2008, Product realisation
Clause 7 of ISO 9001:2008 contains the core processes that most organisations carry out. Any clause or sub-clause in section 7 can be excluded from an organisations quality management system if it can be justifiably excluded. Examples of common exclusions are clause 7.3 design and development, clause 7.5.3 traceability and clause 7.6 the control of monitoring and measuring devices. Clauses can only be excluded if their exclusion does not affect the company? ability to provide a product or service that meets customer requirements.

These core processes should be managed and controlled via the quality management system, and are evaluated for effectiveness and suitability by the internal audits with feed back into the management review.

This is a clear demonstration of one of the key principles of ISO 9001:2008, continuous improvement by critical self-evaluation. The output from the self-evaluation is fed into a planning stage to determine actions needed to improve the system. Following the planning and consultation comes the action phase where the proposed changes are implemented. Then the cycle starts again by checking that the changes are effective and meaningful by self-evaluation.

Other requirements of section 7 are;
Product planning to ascertain and then implement the necessary controls and resources to ensure product realisation.

Purchasing control to verify purchased product against comprehensive purchasing information and the selection and evaluation of suppliers.

Production and service provision to ensure that this activity is carried out in controlled conditions and that any processes that cannot be verified during production are validated to ensure capability. Where appropriate the product must be identified, and if required, traceable at all stages of production. Any customer property must be identified and protected from harm and all products must be stored and handled in such a way to preserve product conformity.

Any monitoring and measuring devices needed to provide evidence of product conformity must be identified and if necessary calibrated.

But what about the customer?
All of the clauses in ISO 9001:2008 are in some way focused towards meeting and exceeding the customer? expectations. For example the requirement of management to determine and communicate the importance of customer requirements throughout the organisation, and the review of customer orders to ensure that they can be met. Companies are required to implement methods for effective communication with the client at all stages of the business including ascertaining customer satisfaction after the product or service has been delivered as well as resolving customer complaints.

Finally?
ISO 9001:2008 is widely acclaimed as being the pre-eminent specification for quality management systems, it requires a company to look at itself and ask the question, ‘how can we improve?’ An ISO 9001:2008 management system should be an essential part of any business process, requiring continual improvement by self-evaluation with a goal of ensuring that current and future customer expectation can be met and exceeded.