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The benefits of implementing a recognized Quality Management System (QMS), such as ISO 9001, and achieving quality system certification or accreditation have been extensively researched and widely reported.
Richard C. Randall specializes in assisting small and medium size businesses:
- Develop and implement quality management systems,
- Perform Internal Audits and Management Reviews,
- Achieve ISO 9001 / AS9100 quality system certification or ISO 17020 / ISO 17025 accreditation,
- Maintain a quality management system that consistently produces measurable improvements,
- Create a “Strategic Plan” for accelerated growth.
Whether acting in the role of consultant or a contracted member of the Quality Management Team, Randall will work with management to find the best “fit” for the organization. And where a situation warrants, replacing himself with a member of his team who is more experienced in the client's specific industry.
How it Works
Randall offers a simplified approach using the “Plan, Do, Check, Act” cycle (also known as a “Deming circle/cycle/wheel” or “Shewhart cycle”), with an affordable, “up front” cost structure.
Most small and medium size companies can complete this process and be ready for a 3rd party audit in as little as 2 months (for ISO 9001:2015). However, the actual timeline varies depending upon several factors, such as:
- Whether you have a Quality Management System - or parts of a system - already in place.
- How much time your personnel can devote to working on the Quality Management System implementation.
While the initial QMS development and implementation can be approached as a “project”, once it is fully implemented, it must be maintained.
Stage 1 - Planning / Documentation Development
The first step is to plan how the Quality Management System (QMS) will be structured. And a major decision is whether to implement a “hard copy” system of document management, a basic “online” system, or a Wiki system.
If employees are working in a harsh environment, where computers simply aren't practical, then the decision should be to use “hard copy” documents in production areas - with the option of a basic “online” system for administrative personnel. This type of system is extremely difficult to effectively maintain, so it is discouraged.
If employees have access to computers… including field personnel with an ability to access the Internet (e.g., Tablets, iPads) then the best solution is a “Wiki” Knowledge Management System (KMS). Randall uses and deploys a Wiki called “DokuWiki”. “DokuWiki” can quickly be configured to provide virtually “foolproof” (Poke Yoke) document control… and is extremely simple to maintain.
Documentation development includes the minimum required “documented information”. All documentation development is performed off-site and supported through telephone / e-mail / Skype interviews.
- ISO 9001:2015 - $3,000 (Incl. the documented Quality Policy, Objectives, Scope & template for Management Review Meeting Minutes)
- AS9100C - $6,000 (Incl. Quality Manual and six minimum required procedures & template for Management Review Meeting Minutes)
- ISO 17020:2012 - $6,000 (Incl. Quality Manual and several minimum required procedures)
- ISO 17025:2005 - $7,000 (Incl. Quality Manual and several minimum required procedures)
Stage 2 - Implementation (Do)
Upon the completion of Stage 1, the company is given an “Action Item” / “Task List” of activities to be completed in order to implement their new Quality Management System (QMS). The “Action Item” / “Task List” is reviewed with the company through telephone and/or Skype to ensure that:
- all of the actions / tasks are understood,
- responsibilities are assigned for their completion (as defined by the company management), and
- a time line / schedule is agreed.
The actions / tasks typically include, but are not limited to:
- implementing documented procedures (e.g., training),
- generating records,
- defining measurable quality objectives for all core processes, and begin metrics data collection.
All Quality Management System (QMS) standards require the monitoring, measuring, and analysis of data demonstrating that the processes are “effective” in achieving “planned results”. So many companies use the “implementation” stage to:
“What is not measured, is not managed.”
~ Joseph Cubby
- Identify “core” processes,
- Determine the “measurable objectives” that demonstrate whether each “core” process is “effective” in its role to achieve compliance with customer requirements, and
- Begin gathering metrics data (e.g., “On-Time Delivery”).
Where a process is found not achieving its objectives, the company must implement actions necessary to improve the performance of that process - leading to it fully achieving its objectives.
This stage will include up to four scheduled “follow-ups” / consultations (up to 5 hours total) provided via telephone / Skype.
Stage 3 - Internal Audits and Management Reviews (Check)
Once top management of the company feels confident that the documented Quality Management System (QMS) has been fully implemented, this must be verified through an “internal” audit. This is an on-site activity that involves interviewing employees, observing processes, and verifying that records are being properly completed.
In addition, the “internal” audit will review all quality-related performance metrics… to verify that the associated processes are “effective” in achieving “planned results”. Where a process is found not meeting its objectives, the audit will verify that actions necessary to achieve planned results have been implemented.
Upon completion of the internal audit, a formal internal audit report is generated, identifying any nonconformities, and presented to management.
This is immediately followed by a “Management Review”, where the “internal” audit report, any nonconformities, process metrics, etc. are presented to management for review. A record of the management review, along with any actions that arise from the review, is formally recorded.
The duration of an internal audit depends upon factors such as the number of employees and number of processes to be audited. The internal audit should be similar to the anticipated 3rd party certification audit. Similarly, the duration of the management review is dependent upon the amount of resulting discussion and number of action items resulting from that meeting.
Price: $1,600/Day + Travel & Living expenses
Stage 4 - Corrective Action and Follow-up
Any nonconformities arising from the “internal” audit, requiring corrective action, must be addressed. The “corrective action” process involves a formal “root cause analysis”, identifying and implementing actions to prevent the nonconformity from recurring, and verifying that the “corrective action” taken was effective.
This stage will include scheduled “follow-ups” / consultations provided via telephone / Skype to review the “corrective action(s)” taken along with any record(s) to ensure they were performed as required.
The time involved is dependent upon the number and nature of corrective actions to be reviewed.
Pricing: $200 / Hour
Certification / Accreditation Assistance
Upon completing Stage 4, and closing ALL resulting corrective actions, your company is ready for a 3rd party Certification / Accreditation audit. For those clients who have completed the 4 Stages mentioned above, Mr. Randall offers the following services at NO additional cost:
- Assistance in evaluating and selecting an appropriate 3rd party certification / accreditation body
- Assistance in negotiating a quote from the selected certification / accreditation body
While the cost of registration / accreditation is generally competitive among all Certification / Accreditation bodies, there can be some significant “hidden” costs. For example, selecting a Certification / Accreditation body with local auditors can eliminate airfare and hotel costs.
Because the audit / certification process can be intimidating for many who have never experienced a 3rd party audit, Mr. Randall offers an additional service of assisting in the actual certification / accreditation audit as a co-host.
Price: $1,400/Day + Travel & Living expenses
Also, since almost every company receives nonconformities from their 3rd party audits… especially during their first few audits, when Mr. Randall is a co-host of the audit, he will assist in the corrective action process and response to the certification / accreditation body (via telephone / e-mail / Skype) at no additional cost.
Randall also offers “Strategic Planning” sessions to assist companies in defining pathways to achieve major goals. While some companies have 5 or 10 year “Strategic Plans”, these can quickly become meaningless in today's fast changing world. As a minimum, goals should be annual, but ideally, quarterly.
Randall requests management to define 3 major goals / objectives to be achieved during a specific time-frame. Randall then hosts an full day meeting with the management team to perform a “root cause” analysis identifying obstacles preventing the company from achieving those goals. Once the “root causes” are identified, action items are created to remove those obstacles. Once focused on the goals, and with the obstacles clearly identified, most companies experience growth at a greatly accelerated pace.
Price: $1,600/Day + Travel & Living expenses
Feel welcome to contact Richard Randall directly for a proposal, at:
☎ (720) 840-1314