| The Problem With How Consultants Implement ISO | | | | - Training |
| 9001 Quality Management Systems | | | | - Responsibility & Authority |
| ISO 9001 requires that an organization identify and | | | | - Empowerment, Motivation & Morale |
| implement effective controls over its quality | | | | - Adequate staffing |
| management processes. Businesses will typically | | | | - Health & Safety |
| identify its processes under typical categories such as | | | | Mileu/Environment |
| operational processes, support processes and | | | | - Building & facilities |
| outsourced processes. Collectively the controls | | | | - Environment controls |
| exercised over these processes will make up their | | | | - HVAC and other utilities |
| quality management system (QMS). Many ISO 9001 | | | | - Housekeeping, health & safety |
| Consultants and organizations go about implementing | | | | - Lighting, air quality & noise |
| QMS process controls in a very superficial manner | | | | - Contingency/emergency measures |
| resulting in a system that does not provide any value | | | | Methods |
| to the organization and consequently any return on | | | | - Systems & Procedures |
| the cost of its investment. The main reason they got | | | | - Inspection & Tests |
| certification was to satisfy a customer contractual | | | | - Quality Plans & Checklists |
| requirement. | | | | - Work Instructions |
| But ISO 9001 can do a whole lot more for an | | | | - Bill of manufacture/assembly |
| organization if implemented the right way. Effective | | | | - Technology/automation/robotics |
| risk management control over each QMS process and | | | | - operational and administrative software |
| the interaction between processes can result in huge | | | | - Process flowcharts |
| improvements in an organizations productivity and | | | | - FMEA's & process controls |
| bottom line. | | | | - Drawings & blueprints |
| The Solution: So how does an organization use risk | | | | Measurement |
| management to control its processes? | | | | - Objectives/tracking/review/improvement |
| A process typically has inputs, outputs and | | | | - Standards/codes/regulations |
| value-adding activity. Each of these process | | | | - Specifications/tolerances/criteria/tolerances |
| characteristics use various resources. These | | | | - Operational data/statistics/SPC |
| resources include manpower, materials, machinery | | | | - Efficiency & effectiveness |
| and equipment, facility and environment, methods, | | | | - Customer Satisfaction |
| management, etc. These resources are all variables | | | | - Bench-marking |
| and subject to risk in their use. | | | | Management |
| An organization must identify the nature and degree | | | | - Leadership & Planning |
| of such risk and implement appropriate controls over | | | | - Policies & Objectives |
| them. Tools such as Fishbone analysis or FMEA's | | | | - Commitment & involvement |
| (Failure Mode and Effects Analysis) may be used to | | | | - Organization & resources |
| perform this risk analysis. A discussion on how to use | | | | - Follow-up & review |
| these risk analysis tools will be left to another article. | | | | - Communication |
| Listed below are some of the controls an | | | | How To Use These QMS Process Variables: |
| organization should consider for each of the | | | | - Determine which of these resources variables apply |
| resources used in any QMS process. | | | | to each process identified in your QMS. |
| Materials | | | | - Determine which combination of controls apply to |
| - Inventory management | | | | that process variable - process input, output or |
| - Inspections & Tests | | | | value-adding activity. |
| - Standards & Specifications | | | | - Implement the controls you have identified and |
| - Supplier Management | | | | verify their effectiveness. |
| - Identification & Traceability | | | | This article provides a brief overview to using a risk |
| - Turnover & Preservation | | | | management approach to effectively implementing |
| Machine | | | | ISO 9001 in an organization. Keep in mind that ISO |
| - Capability, capacity and & technology | | | | 9001 is a business management tool. So the benefits |
| - Engineering & support | | | | you get from using it is directly related to how |
| - Inspection, measuring & test equipment | | | | effectively you use it. The risk management |
| - Tools, dies & fixtures | | | | approach is a very powerful way to use ISO 9001 to |
| - Maintenance & supplies | | | | effectively control your business and benefit |
| - Equipment layout | | | | significantly in terms of customer satisfaction and |
| Manpower | | | | profitability. |
| - Skills, knowledge & experience | | | | |