The Oriel STAT A MATRIX 14-Step Implementation Process is a proven approach that takes an organization through the quality management system (QMS) development and implementation process and compliance/registration in a timely, effective, and efficient manner.
The chart below and the following notes describe the Oriel STAT A MATRIX 14-step implementation process and the deliverables of each step. Oriel STAT A MATRIX can participate in any or all of the steps, as required.
Description of the Process
The following paragraphs describe typical Oriel STAT A MATRIX efforts for each of the 14 steps. Oriel STAT A MATRIX can participate in any or all of the steps, as required.
- Management Orientation - In this part of the process, Oriel STAT A MATRIX provides the client’s executive staff with a basic understanding of ISO 9000 standards, procedures, and registration requirements as they apply to executive management and to company/departmental processes and interactions.
Deliverable: Management Understanding of ISO Registration Process
- Baseline Evaluation - This activity is designed to create a baseline set of observations that will define the gap between what is required for ISO registration and where the organization now stands. This is a macro-level analysis performed in a relatively short period of time by a team of two or more auditors.
Deliverable: Baseline Evaluation Report
- Management Planning - In this session, the Oriel STAT A MATRIX team facilitates the executive staff in comprehending the results of the baseline evaluation, assessing the resources and allocations necessary for a successful program, and developing an action plan for ISO 9001 registration.
Deliverable: Action Plan
- Responsibility Matrix - The EMC, together with senior management, prepares a responsibility matrix that defines each applicable ISO 9001 element and specifies the individual(s) with primary and secondary responsibility for accomplishing that element.
Deliverable: Responsibility Matrix
- Form and Train the Steering Committee - Oriel STAT A MATRIX helps prepare selected executives and department heads to serve as the company’s ISO 9000 steering committee. At this point, the organization’s ISO management representative is identified. The recommended follow-on training is decided on a case-by-case basis.
Deliverable: Steering Committee Selection and Training
- Macroflowcharting (Process Mapping) - In “war room” style, we flowchart every function of the operation, from the time a request for proposal or quotation arrives to the time the product or service is delivered. This flowchart, in its final form, is included in the quality manual, and aids both your personnel and the third-party auditors during the registration audit.
Deliverable: Macroflowchart of Company Operations
- Identify Specific System-Level Procedures - Using the applicable ISO 9001 standard, the responsibility matrix, and the macroflowchart, the Oriel STAT A MATRIX team, together with the ISO 9000 steering committee, identifies procedures that must be documented to achieve ISO registration.
Deliverable: List of System-Level Procedures To Be Documented
- Prepare System-Level Procedures (SLPs)
- Flowchart System-Level Procedures - Each system-level (cross-functional) procedure (SLP) identified in step 7 must be fully flowcharted. Oriel STAT A MATRIX demonstrates and teaches the proper flowcharting techniques by working directly with various teams to fully flowchart selected SLPs. The client’s teams then flowchart the remaining procedures. (NOTE: Oriel STAT A MATRIX’s philosophy is to use the ISO 9001 registration process as a series of opportunities for improvement, and this is the phase where the organization can make the most significant improvements. When flowcharting, we thus demonstrate techniques to improve processes by eliminating redundancy, non-value-added activities, and superfluous paperwork, as opposed to just documenting processes.)
Deliverable: Flowcharts of Required SLPs
- Walk Through, Document, and Validate SLPs - Individuals responsible for flowcharting must then document the corresponding SLPs that accompany each flowchart. To help prepare the procedures for audit review, Oriel STAT A MATRIX will:
• Help develop a company-specific template for procedures.
• Read and review typical flowcharts and documented procedures.
• Walk through sample procedures to confirm accuracy and adequacy.
• Provide suggestions for improving the documentation.
• Repeat the process after your staff makes corrections.
Deliverable: Completed System-Level Procedures
- Write Quality Manual - Oriel STAT A MATRIX facilitates the management team in preparing a draft form of the quality manual. By preparing the manual after the SLPs have been completed, we can streamline the effort by using the responsibility matrix and SLPs to most effectively develop the manual.
Deliverable: Draft Quality Manual
(NOTE: Oriel STAT A MATRIX can assist in identifying a registrar according to your registration objectives and customer desires.)
- Flowchart, Improve, Document Instructions - Oriel STAT A MATRIX briefs personnel in formatting, writing, and preparing work instructions. Your personnel then write the instructions, train your personnel in their use, and implement and audit the instructions. Oriel STAT A MATRIX consultants review instructions and assist your personnel in preparing the instructions. (NOTE: If requested, Oriel STAT A MATRIX will help write and audit the instructions. However, we recommend that the client undertake the bulk of this effort to demonstrate to your organization the level of management commitment. “Ownership” of the new or revised procedures is further reinforced by your personnel performing the training and auditing. Oriel STAT A MATRIX can review a selected sample of instructions to assure that the process was fully understood and implemented properly.)
Deliverable: Instruction Writing and Training
- Train Personnel and Conduct Internal Audits - Throughout the program, as new SLPs and work instructions are introduced into the system, Oriel STAT A MATRIX consultants can participate in initial audits; Oriel STAT A MATRIX can also help develop appropriate audit checklists and records, and integrate the process into the master audit cycle. During this phase, the client realizes numerous opportunities for systems improvements and simplification of documentation. The client’s personnel should be trained in how to recognize systems/processes/functions that affect end-product or service quality, and how quality-related functions interact with and affect the overall company quality system. At this point, the client has a smooth and coherent internal audit system, an initial set of audit records, and improved procedures and instructions. (NOTE: To demonstrate management commitment, the client should perform the bulk of this effort. In addition, “ownership” of the new internal audit system by your personnel reinforces “buy-in” at all employee levels during internal audits.)
Deliverable: Documented and Validated Internal Audit System
- Perform Preassessment Evaluation - Oriel STAT A MATRIX staff members who are registered lead auditors and auditors, and who were not part of the team developing the quality system, review your documented quality system prior to the preassessment audit. They then conduct audits of the site(s) to identify nonconformances. We can provide advice for remedial action, while a registrar is prohibited from doing so. We then submit a formal report detailing our observations and required corrective actions.
Deliverable: Audit Report
- Take Corrective Action and Review Results - The client corrects nonconformances and notifies ORIEL STAT A MATRIXof actions taken and dates completed. Oriel STAT A MATRIX spends one day (or more, if necessary) confirming that nonconformances found during the preassessment audit were properly corrected per registration requirements. If all items are corrected and no new nonconformances are uncovered, Oriel STAT A MATRIX then reviews the actions and signs off that the facility is ready for registration audit.
Deliverable: Corrective Action Review
- Registration Audit - Oriel STAT A MATRIX can remain on-site during the registration audit to help answer questions and correct nonconformances before the auditors leave.
Deliverable: Assistance During Registration Audit