Thursday, November 26, 2009

ISO 14001 Standards – Nonconformance, Corrective and Preventive Action


ISO 14001 Standards - Nonconformance, Corrective and Preventive Action

ISO 14001:2004 Section 4.5.2, Nonconformance And Corrective Andrequires that organizations establish and maintain procedures that:

Preventive Action,

• Define responsibility and authority for handling and investigating nonconformance

• Take action to mitigate any impacts caused by nonconformance

• Initiate and complete the appropriate corrective and preventive action.

ISO 14001:2004 Section 4.5.2 also states that “…any corrective or preventive action taken to eliminate the causes of actual and potential nonconformances must be appropriate to the magnitude of problems and commensurate with the

environmental impact encountered.”

If any changes in the documented procedures result from any corrective and preventive action, you must implement and record these changes.

Nonconformance refers to any issues that do not meet or comply with the requirements established in the EMS or the ISO 14001 standard. Procedures developed under ISO Section 4.5.2 will provide the mechanism to handle

non-conformances and to ensure steps be taken to prevent a recurrence.

The procedures should include the following key steps:

1. Identify the problem

2. Determine the cause

3. Establish the solution

4. Document the solution

5. Implement the solution

6. Record the documentation and implementation of the solution

7. Communicate the solution.

ISO 14001 Standards Audit

ISO 14001:2004 emphasizes the continuous improvement of an environmental management system (EMS). The standard specifies requirements for an environmental management system to enable an organization to develop and implement a policy and objectives which take into account legal requirements and information about significant environmental aspects. The certification process ensures the conformance of your EMS against the international standard, as well as any organizational specific requirements that have been identified.
The ISO 14001 Standards audit consist of 2 stage registration audit process followed by surveillanceaudits, and ultimately a recertification audit. ISO 14001 Audits include on-site assessments of documents, data, records, activity and personnel. Process audit trails are followed by interviews of personnel responsible for the tasks and reviewing associated activity and records of occurrence. The audit trail will follow interactions between processes as well as the details of the process itself. Following are the stages of the audit process.

Pre-assessmentRegistration Audit – Stage 2Audit Findings• A review of action taken on nonconformities identified during the previous auditA review of the continued effectiveness of the management system in its entiretyThe continued applicability to the scope of registration

The pre-assessment audit is an optional activity, outside of the registration process, it is highly encourages that any organization to undertake to evaluate the readiness to undergo the two stage registration process. That would optimally occur prior to the stage 1 and 2 audits.

Unlike the Stage 1 and Stage 2 activities you have full discretion as to which areas the preassessment should focus on and for the length of the pre-assessment. This activity allows your organization to become familiar with the audit process and helps prepare your employees for the registration assessment.

The auditor conducting the pre-assessment will typically return to the organization for the assessment. Similar to a ‘true’ audit, the end result of the pre-assessment will be a documented report identifying findings observed during the audit and a closing meeting to discuss the issues.

The pre-assessment activity allows you to correct any issues prior to beginning the registration process.

Assessment

New requirements for certification bodies have changed the registration process. Registration is now conducted in two distinct visits- Stage One and Stage Two- each of which has defined requirements that are outlined below.

Registration Audit – Stage 1

The stage 1 audit, conducted at your facility, is primarily performed for planning and determining the readiness of an organization to undergo a stage 2 registration audit. It also facilitates communicating any needs and expectations to the organization. Activities performed at a stage 1 audit include:

• Conducting a documentation review – This review determines if the organization’s EMS documentation adequately covers all the requirements of the ISO standard

• A review of the aspects and impacts and their significance and an evaluation of the facility(s) site specific conditions

• A review of your organizations non-conformance, preventive and corrective action system • An overview of applicable regulations

• Interviewing your organization’s personnel to assess their general readiness to undertake a stage 2 audit

• Confirming the applicability of the scope of the organization’s EMS

• Obtaining evidence that internal audits and management reviews are being planned and performed

• Providing focus for the planning of the stage 2 audit

If during the stage 1 audit any nonconformities are identified, the auditor will request a corrective action response (see Corrective Action Response).
The objective of the Stage 2 on-site audit is to assess your organizations’ adherence to your own policies, objectives, and procedures and to ascertain conformance to the requirements of the ISO 14001 standard. To accomplish this, the audit will address the implementation of all the elements of the standard. Review of documentation and records to support the implementation is an expected part of the assessment process. If non-conformances or opportunities for improvement are identified they will be documented in a report which will be presented to the organization during the closing meeting. The report will include the auditor’s recommendation regarding registration.
Any deviation from procedures or requirements of the standard will be identified as an audit finding, which will be documented in the audit report. The auditor will draw your attention to non-conformities as they arise so there will be no “surprises” at the closing meeting. Findings are categorized into three categories defined as follows:

• A major non-conformity relates to the absence or total breakdown of a required process or a number of minor non-conformities listed against similar areas. A major non-conformity at the Registration Audit – Stage 2 would defer recommendation for registration until that major has been closed.

• A minor non-conformity is an observed lapse in your systems ability to meet the requirements of the standard or your internal systems, while the overall process remains in tact.

• An observation or opportunity for improvement relates to a matter about which the Auditor is concerned but which cannot be clearly stated as a non-conformity. Observations also indicate trends which may result in a future non-conformity.

Corrective Action Response

ISO 14001 Standards requires corrective action responses from all Registration Audits. Once certification is achieved, dependant upon the extent and nature of the findings, your organization may be required to submit a corrective action plan, detailing your intent to correct the non conformity.

The auditor may also recommend that your organization submit objective evidence to support the to verify closure may be required.

It is recommended that all non-conformities are addressed within your internal corrective action system. Typically, opportunities for improvement would be addressed as preventive actions by your organization.
closure of the finding. In certain circumstances such as a major non conformity an on site activity
Surveillance Audits
Company shall conduct Surveillance Audits on an annual or semi-annual basis. The purpose of the Surveillance Audit is to ensure that the EMS continues to conform to both the organizations’ and the ISO 14001 requirements. Certain processes will be reviewed at each surveillance including:
• Internal audits and management review

• Customer and interested parties communications

• Effectiveness of the management system in achieving defined objectives

• The progress of planned continual improvement activities

• Continuing operational control

• A review of any changes made by the organization which may have impact on the registration

• Use of accreditation and certification body logos provided to the organization upon registration

• objectives, targets and programs

• evaluation of compliance

Re-assessment Audits

The accreditation body requires that a recertification audit be carried out every three years. The purpose of the recertification audit is to confirm the continued conformity and effectiveness of the management system as a whole, and its continued relevance and applicability for the scope of activity.

Recertification audits review the performance of the EMS over the registration period, and include a review of previous surveillance audit records. The recertification audit includes the following:

The continued relevancy of the organization’s policy and objectives

The continued effective interaction between the processes of the management system

A review of internal audits, management reviews, document changes during this certification period