File - Minimum Size Quality Manual R15 2012.09.07
- Minimum Size Quality Manual R15 2012.09.07
The native version of this file is at
The quality manual governs the quality management system.
The quality management system is how business is done.
The purpose of this document is to facilitate the creation and maintenance of a minimum size quality manual.
Say what the quality manual applies to.
Make the quality manual apply to what the organization cares about.
The quality manual is an order from the highest level person who cares about quality to all of that person's subordinates down to the individual level.
Adherence to the quality manual is a condition of employment.
Deliberate or negligent deviation from the quality manual is treated as insubordination.
Quality is the ability to perform satisfactorily in service.
Quality is being suitable for the intended purposes.
Define the terms in plain English.
Make plain English the language of the quality management system.
When definitions can be used to make the unacceptable acceptable it is a quality problem.
The essence of a quality management system is:
Say what you do.
Do what you say.
This means starting where you are, not waiting for the perfect quality manual or quality management system.
"Improve it" means eliminating variation in all of its forms.
Have acceptance criteria for all conditions, actions, and products at all stages. Include timing in acceptance criteria.
A quality problem in any condition, action, or product at any stage is regarded as evidence that the acceptance criteria were not met or that the acceptance criteria were not good enough for the purpose.
Instructions shall prescribe actions to be taken when acceptance criteria are not met and/or are indeterminate.
Flow requirements down to the workers.
Make the flowdown traceable in both directions.
Flowdown includes government requirements and industry standards that apply.
Prescribe the personnel and organizations participating in the quality management system.
Prescribe all activities necessary for the achievement of quality.
Prescribe all systems necessary for the success of the quality management system.
Document the interactions among systems in terms of the inputs, outputs, and constraints.
Assign the duties, authorities, roles, and responsibilities of the personnel and organizations participating in the quality management system.
Perform activities affecting quality in accordance with written instructions appropriate to the circumstances.
Make the instructions require consistent and systematic behavior in accordance with known good practice.
Include acceptance criteria and flowdown in instructions.
Assure that personnel are set-up for success in what they do. Provide the right instructions, supervision, and training.
Establish measures to assure that all quality problems are promptly identified and corrected.
Record all quality problems. Be specific, timely, accurate, reliable. (STAR)
Investigate all quality problems.
Fix the problems.
Fix the processes that created the problems.
Fix the processes that should have detected the problems earlier.
Fix the processes that should have detected the process problems.
Fix the harmful factors of the above.
Apply the fixes everywhere they apply.
Apply the fixes to everyone to whom they apply.
Pre-select all activities to be briefed. Record the brief.
Pre-select all activities to be debriefed. Record the debrief: the good, the improveable, the improvements. Treat the improvables as quality problems.
Quantify rework in dollars. Tell those who are involved in budgeting.
Track the resolution and effectiveness of all investigation results.
When you have a repeat problem fix the investigation process.
When you know about a quality problem tell all of the potentially affected customers right away.
When you can't resolve a problem escalate it in writing to someone who should be able to.
Establish measures to assure that purchasing activities are governed by this manual to the extent that the purchased item is important to quality.
Trace purchased item performance problems back to the purchasing process. Acknowledge that the problem was bought.
(Except for off-the-shelf "commoditized" items, supplier quality is seldom better than purchaser quality.)
Maintain a controlled document system is support of the quality management system.
Make quality documents and records part of the electronic document management system.
Link and interlink related documents and records.
Audit every sentence above. Treat the deviations as quality problems.
Keep sufficient records to provide evidence of the above.
Treat records problems as quality problems.
For details see the other files at