June 26, 2011

sasadmin

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The Compliance Audit

Audits can be divided into two categories by purpose:

Compliance and performance. A compliance audit looks for conformance  to a set of rules. The rules may not always be questions.

Regulatory audits. Are in fact compliance audits – compliance with EASA regulatory requirements its parts and subparts being an ideal example.

Certain areas of the business, (In aviation these are many)  can be described as high risk. For these activities audits play a significant role, to establish ongoing conformity with company processes and procedures.

What is the difference between compliance and conformance?

Conformance associated with a standard or drawing form fit or function for example.

Compliance takes this to a higher level for example the requirements were met during the production or delivery of the product or service.

Compliance audits are designed to give assurance that activities have been performed properly.  Compliance Audits are off course reactive.

Compliance audits also tend to be subjective in respect that they pass or fail
The compliance audit in fact requires a lower level of auditor competence.

The audit is presented typically as a completed checklist of observed conditions at the time of the audit.

We should understand that inspection type auditing  is not without its own shortcomings.

It is an unknown if the compliance will be satisfactory next week or next month.

The major shortfall of the compliance audit is that it does not test the process or procedures developed to deliver the requirement.

As a result some assumption is made on behalf of the auditor.

The management is obligated to perform an annual review but often the detail which is required to be subjective is not always available.

NOTE

Whilst often this does not become an issue it remains a weakness.

Compensation for compliance audits may be found in System or Process audits.

Compliance audits may discourage innovation.

Compliance to the rules

Effectiveness and suitability of the process and procedures to achieve and deliver the organisations goals.

A performance audit looks more at the organisations effectiveness  for efficiencies and business results.

A performance audit recognizes that all is not perfect, For example whist we do  the best we can with the resources available, there may be un acceptable shortfalls.

In a performance audit the rules are challenged, whilst the underlying principles driving those rules are accepted and not challenged

This type of auditing goes beyond compliance . It ?rst requires a deep understanding of the controls that are desired. it then examines the many
methods being used to achieve those controls.

Auditor Competency plays a significant role in delivering effective process audits when considering Types of Audit in Aviation and the difference between compliance and conformance.

Building on the foundation of compliance auditing. data is gathered in the ?eld.

This “data” must be analyzed to determine if there are gaps when considered against expectations.

Note that the gaps may not be non conformity with regulatory requirements but in actual fact non conformity with the organisations  desired outcome.

Are procedures user friendly (effective)? Do established systems have the necessary scope to deliver.  (Auditor Competency plays a significant role in delivering effective process audits)

Performance audit applications -Performance (systems or process)  audits  are most appropriate for internal use.

You have control over your own corporate destiny and the resources being used. You make market decisions.

By analyzing patterns and repetitive findings. internal auditors can determine the possible causes of the observed non conformance.

Performance audits can also be applied externally to supplier relationships. In most cases, this is harder titan the internal audit. The di?iculty may be due to lack of trust. unavailability of information, geographic separation. or all three.

In certain circumstances. performance audits may be applied to regulatory or award relationships.

Management is the control of resources. The goals of quality, safety, environmental oversight, and efficiency are all driven by the same set of rules:

This is the Plan-Do-Check -Act (PDCA) approach

Product Audits

Audits may also be classified by scope. as product, process, and system audits.

A product  audit is quite similar to an inspection, where the completed item or task is examined to required characteristics. Sometimes, the finished item is even destroyed, as various characteristics are measured. Paperwork associated with the building of those items is also examined.

They focus on completeness of the finished  process, activity  or services and
do not require extensive training for the auditors.

Their usefulness is in allowing verification of the completeness of the process.

Process Audits are performance audits.

With the release of the revisions to the ISO 9000 family of standards, there is increased interest in the process approach to manage an organization.
Quality Management Principles accept that , ‘A desired result is achieved more efficiently when activities and related resources are managed as a process.
This increased attention to processes naturally leads to increased attention to process auditing. Yet, many approach the process audit as if it were a small system audit.
Auditing the processes is not the same as process auditing. There are similarities in the two forms of the audit, and there are fundamental l differences.
Products come from processes. Every organization performs a series of steps to accomplish its goals or objectives.
Those products can be tangible. They can be intangible, such as a an overall pleasant experience.  ISO refers to these as the four product categories  services. software. hardware. And processed materials.‘

Process Audits

Process audits are short but intense. Rather than examine entire systems within or across the facility. you look at only a single process

The process audit examines an activity to verify that the inputs, actions, and outputs are in accordance with defined  requirements The boundary (scope) of a process audit should be a single process, such as marking, stamping, cooking, coating. or installing. It is very focused and usually involves only one work crew.

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Compliance, Conformance, Regulatory audits, EASA regulatory requirements