1. Standard / procedure description
  2. The sections which follow give a detailed outline of the procedures for each review/audit type (i.e. management and technical reviews, inspections, walkthroughs and audits).

    1. Overview
      1. When to do what

Figure 1 below illustrates the way in which the various reviews and audits are used and how they differ from each other. The processes have two main distinctions, as follows.

Figure 1: Reviews and Audits

      1. Review status register

A review status register shall be created to record the progress of reviews. The register shall record at least the following details for each review performed.

      1. Mandatory and optional practice

Mandatory - in the conduct of QMS projects the following activities are mandatory.

Optional (recommended) -in the conduct of QMS projects the following activities are optional but recommended.

Optional - in the conduct of QMS projects the following activities are optional only.

      1. Partial or complete reviews

Reviews are designated in the objectives as being either partial or complete reviews. Partial reviews examine only those elements which have changed. Partial reviews can only be done after a complete review.

When a document, software item or other project item is developed, it undergoes a review (technical review) to validate its content, and compliance with the applicable standards. (For documents, approval can only occur after the review and any follow-up actions have been resolved.)

This review must be a full review of the item. That is it must review the entire content of the item. If the item is later modified in some way another review must be performed. This review may elect to cover only the changed portion of the material. Such reviews are referred to as partial reviews.

The following applies to partial reviews.

 

    1. Management review process
      1. Purpose

A management review is the formal evaluation of a project by a designated review team to determine whether the project is proceeding according to the project and quality plans.

During the review meeting the whole review team examines plans, or the progress against applicable plans, standards and/or guidelines. Each problem area is recorded. When critical data and information cannot be provided, an additional meeting shall be scheduled to complete the management review process.

The results of the review are published in a report which is filed in accordance with Std-03.

While management reviews can be done at any time, they are normally done at the end of each phase of the project.

The objectives of the management review process are as follows.

      1. Initiation
        1. Initiating event
        2. Management reviews are scheduled activities; their timing is determined by the project and quality plans. Unscheduled management reviews may be called by the project manager, project steering committee or quality manager.

        3. Staffing
        4. The review leader for scheduled management reviews is nominated by the project manager, unless specified otherwise in the project or quality plan. The review leader for unscheduled management reviews is determined by the party initiating the review in consultation with the project manager.

          A management review shall consist of at least three people. The roles and responsibilities of these people are given below.

           

           

          Role

          Responsibility

          Review leader

          · Issue the review notification.

          · Produce and distribute the review material in advance.

          · Chair the review meeting to ensure its objectives are met.

          · Issue the review report.

          · Prepare for the review by studying the distributed material.

          · Participate in the review to ensure its objectives are met.

          Recorder

          · Record the action points and decisions during the review.

          · Reflect any changes to the review objectives and/or agenda in the review report.

          · Prepare for the review by studying the distributed material.

          · Participate in the review to ensure its objectives are met.

          Reviewer(s)

          · Prepare for the review by studying the distributed material.

          · Participate in the review to ensure its objectives are met

        5. Notification

Participants in a management review shall be given at least five working days notice of the review. The review notification shall include the following information.

Where a management review determines that subsequent meetings are required to complete the review date & time decided by the meeting (notification is not required).

        1. Input material

The input material shall be made available to the participants by the review leader at least two working days prior to the review.

The minimum input to the management review is as follows.

        1. Objectives

The objectives of a management review may vary considerably. An example set of objectives that may be used by a review leader follows.