This is a bilingual document. An English version follows.
1. Francais
2. English
1. Francais
Nous recommandons a nos clients de nous ajouter a leur liste des fournisseurs en tant que conseillers en matériaux et procédés, formateurs et auditeurs/vérificateurs tel que requis par AS9100. Nous sommes généralement évalués lors des visite. Tous les fournisseurs de service affectant la qualité devraient y apparaitre.
Notre SGQ (système de gestion de la qualité) rencontre les exigences de ISO 9001 et AS 9100. Voici quelques données concernant notre système de gestion de la qualité. Il nous fera plaisir de répondre a vos questions ou vous fournir toutes autres références requises. Voici notre déclaration de conformité.
Politique de qualité: rencontrer les normes, continuellement améliorer la qualité de nos services par
le contrôle et l'optimisation de nos processus et la réduction des variances.
Nous n'utilisons pas d'instruments calibrés, mais nous utilisons des logiciels calibrés, par exemple nos système d'analyse des mesures (Gage R&R) est calibré avec les données de Ford, Gage R&R.
1. Nous avons des politiques formelles et documentées, des procédures et des instructions de travail relatives à la gestion de la non-qualité.
2. La direction de l'entreprise vérifie périodiquement notre système de gestion de la qualité
3. Nous avons un système d'amélioration continue en cours
4. Nous avons la capacité de faire de la conception et faisons des revues de conception
5. Nous utilisons des techniques de contrôle des statistiques (ex. : CSP) pour vérifier les caractéristiques des produits et les capacités des procédés
6. Nous avons un système pour gérer tous les documents reliés à la qualité.
7. Nous avons un système pour contrôler les produits fournis a nos clients.
8. Nous identifions les produits et maintenons une traçabilité à travers toutes les étapes de production, de stockage et d'expédition
9. Nous avons en place des procédures pour contrôler les étapes de services et fabrication
10. Nous avons une inspection formelle et des procédures de vérification pour le matériel entrant.
11. Nous avons une politique d'inspection des produits et services en cours de fabrication et des produits finis.
12. Nous documentons l'inspection pré expédition du service/produit
13. Nous avons des instruments qui nécessitent de la calibration et la faisons selon la cédule établie.
14. Nous maintenons un registre de calibration.
15. Nous identifions et contrôlons les services et produits non-conformes (étiquetés et séparés)
16. Nous avons un programme d'actions correctives et pr/ventives
17. Nous avons un système pour gérer le registre de qualité (interne)
18. Les tendances comme la livraison à date, le pourcentage des commandes qui ont été effectuées et la satisfaction du client sont suivies.
19. Nous avons un programme de plaintes clients.
2. English
We recommend that our customers add us to their list of suppliers as: materials and processes consultants, trainers and auditors as required by AS9100. We are generally evaluated during onsite visits. All service providers affecting the quality should appear in the list of controlled suppliers.
Our products and services conform to the relevant provisions of the ISO 9001 and AS 9100 standards. Here is some data on our system of quality management. We will be happy to answer your questions and provide any other evidence required. This is our SDoC (Suppier's Declaration of Conformity)
Quality policy: to meet the requirements/standards and continuously improve the quality of our services by optimizing and controlling our processes and reducing variations.
We do not use calibrated instruments. We do calibrate our software, such as the Gage R&R using data from Ford Gage R&R calibration.
1. We have formal policies and documented procedures and work instructions concerning the management of non-quality.
2. The Corporate Management periodically checks our system of quality management
3. We have a system of continuous improvement
4. We have the ability to design and make design reviews
5..We use SPC techniques to check product characteristics and the capabilities of processes
6.We have a system to manage all documents related to quality.
7. We have a system to control products supplied to our customers.
8. We identify the products and maintain traceability through all stages of production, storage and shipping
9. We have procedures in place to control the stages of product and services realization
10. We have a formal inspection and verification procedures for incoming equipment and tools
11. We have a policy of inspection of goods and services (in process and finished products)
12. We document pre-shipment inspection of services / products
13. We have systems that require calibration and have established a calibration schedule.
14. We maintain a register of calibration.
15. We identify and control non-compliant services and products (identified and separated)
16. We have a program of corrective and preventive actions
17. We have a system to manage the quality records
18. The trends such as the delivery date, the percentage of orders that were made and customer satisfaction are followed.
19. We have a customer complaints program
Continuous improvement, SPC, CPK, GR&R, Data Analysis
Project/Quality/Process management and validation
Using: Windows: Excel, Access, SQL server, Oracle, Visual Basic, DataPlot, Open Project. Linux.
1. Continuous improvements
2. Quality Plan and Project Management (iso9001 as9100 clause 7.1)
3. Process control
4. Process capability and stability
5. Statistical process control
6. Process based approach
7. Process verification and validation
8. Quality Management Principles
9. Project quality plan
10. Notes on the different types of processes
2. Quality Plan and Project Management (iso9001 as9100 clause 7.1)
3. Process Control (iso9001 as9100 clause 8.2.3)
4. Notes on process capability, stability (if it is not broken do not fix it):
Deming recommended achieving quality through process management, sampling and control (see process databases). He warned against tampering with a stable process in his book titled 'Out of the Crisis'. In his 'funnel experiment' he demonstrated how adjusting a stable process will usually cause increase in process variation.
5. Statistical Quality Control (SQC/SPC)
1- A process in control delivers the best results if left alone (Deming).
See some SPC golf examples (i.e. when should a golfer adjust his game).
2- When to adjust ? only adjust the process if: 1- dataset has points out of specification. 2- dataset has 6 points in a row steadily increasing or decreasing 3- dataset has 14 points in a row alternating up and down 4- dataset has 2 out of 3 points in a row in Zone A (+/- 3 sigma) or beyond. 5- data set has 4 out of 5 points in a row in Zone B (+/- 2 sigma) or beyond. 6- dataset has 15 points in a row in Zone C (+/- 1 sigma). 7- dataset has 8 points in a row in Zone B, A, or beyond, on either side of the center line (without points in Zone C).
3- The 5 rules and analysis of pattern in control charts (a process is out of control and can be adjusted if and only if) : The dataset has sample statistics outside the control limits (Rule 1). The dataset has two out of three consecutive points fall outside the 2 σ warning limits on the same side of the center line (Rule 2). The dataset has four out of five consecutive points fall beyond the 1σ limit on the same side of the center line (Rule 3). The dataset has nine or more consecutive points fall to one side of the center line (Rule 4). The dataset has a run of six or more consecutive points steadily increasing or decreasing.(Rule 5).
From "The Shewhart Control Chart–Tests for Special Causes," Journal of Quality Technology, 16(4), p 238. Copyright © 1986 by Nelson.
The WECO rules:
General rules for detecting out of control or non-random situations
Any Point Above +3 Sigma
--------------------------------------------- +3 sigma LIMIT
2 Out of the Last 3 Points Above +2 Sigma
--------------------------------------------- +2 sigma LIMIT
4 Out of the Last 5 Points Above +1 Sigma
--------------------------------------------- +1 sigma LIMIT
8 Consecutive Points on This Side of Control Line
=============================================== CENTER LINE
8 Consecutive Points on This Side of Control Line
--------------------------------------------- -1 sigma LIMIT
4 Out of the Last 5 Points Below - 1 Sigma
---------------------------------------------- -2 sigma LIMIT
2 Out of the Last 3 Points Below -2 Sigma
--------------------------------------------- -3 sigma LIMIT
Any Point Below -3 Sigma
Trend Rules: 6 in a row trending up or down. 14 in a row alternating up and down
WECO rules based on probabilities The WECO rules are based on probability. We know that, for a normal distribution, the probability of encountering a point outside ± 3sigma is 0.3%. This is a rare event. Therefore, if we observe a point outside the control limits, we conclude the process has shifted and is unstable. Similarly, we can identify other events that are equally rare and use them as flags for instability. The probability of observing two points out of three in a row between 2sigma and 3sigma and the probability of observing four points out of five in a row between 1 sigma and 2 sigma are also about 0.3%.
WECO rules increase false alarms Note: While the WECO rules increase a Shewhart chart's sensitivity to trends or drifts in the mean, there is a severe downside to adding the WECO rules to an ordinary Shewhart control chart that the user should understand. When following the standard Shewhart "out of control" rule (i.e., signal if and only if you see a point beyond the plus or minus 3 sigma control limits) you will have "false alarms" every 371 points on the average (see the description of Average Run Length or ARL on the next page). Adding the WECO rules increases the frequency of false alarms to about once in every 91.75 points, on the average (see Champ and Woodall, 1987). The user has to decide whether this price is worth paying (some users add the WECO rules, but take them "less seriously" in terms of the effort put into troubleshooting activities when out of control signals occur).
ref: NIST/SEMATECH e-Handbook of Statistical Methods, http://www.itl.nist.gov/div898/handbook/, 7july2008.
A sample process stability analysis:
The simplified Pre-Control system
We recommend using pre-control charts to begin controlling the process. Pre-control charts use the requirements or specification limits, rather than the statistical control limits. Since the specification limits are already known a pre-control chart can be created starting with the very first part, it is not necessary to wait until enough parts are produced to accurately calculate the control limits.
1- Draw 2 Pre-control lines in the middle half of specification width by dividing the specification width by 4. Zones 1 (yellow),2 (green),3 (green), 4 (yellow), <1 is red, >4 is red
2- Adequacy of process capability: take a sample of 5 consecutive data point from the process. If all five fall within the green zone, conclude that the process is qualified to run. Even if one of the units falls outside the green zone, the process is not in control.
3- Process control: take two consecutive data point from the process periodically.
3.1 if both data point fall in the green zone, continue.
3.2 if one data point is in green zone & the other in yellow zone, continue.
3.3 if both data point are in the same yellow zone , adjust.
3.4 if both data point are in different yellow zones, stop.
3.5 if one of the data point is in red zone, stop.
3.6 if the process has been stopped: the cause of variation is to be identified, removed, the process re-qualified with the 5 sample rule above (2), before starting again.
4- Frequency of sampling is determined by dividing the average time interval between two stoppages by six.
Process Capability (iso9001 as9100 clause 8.2.4)
Gage R&R (reproducibility and repeatability, iso9001 as9100 clause 8.2):
Trend indications:
The moving average is a trend indicator, it tends to suppress all effects with a duration shorter than the span of the moving average [here 2 days], the longer the span of the moving average, the smoother the trend is, and the less detail on local features of the data retained. Other momentum indicator: EMA exponential moving average [applies weighting factors which decrease exponentially], stochastic oscillator, trend lines etc.
Data analysis iso9001 as9100 clause 8.2.4: NIST/SEMATECH e-Handbook of Statistical Methods, http://www.itl.nist.gov/div898/handbook/, April 2008.
Credit/reference: The following charts are from The NIST's Dataplot (an excelent data analysis tool we use):
6. The process based approach = Process Mapping/Flowchart:
Defines a process as a set of interacting activities, which transforms inputs into outputs. These activities require allocation of resources such as people, capital and materials (project management). The advantage of the process approach is the management and control of the interactions between these processes.The focus is on 1- understanding and meeting the requirements, 2- consider the added value of each process, 3- get the data (show me the data) or process results/performance/effectiveness, 4- continually improve the process by using the objective measurements data. The flow chart below shows a simple flow chart of a complex process simplified for better control.
PDCA: Deming Cycle PDCA also know as the scientific method. 1- Specification, 2- execution, 3-inspection, 4-improvement.
7. Process verification and validation for special processes such as coatings, chemical processing, sealants, (where inspection and testing are insufficient to determine the acceptability of the part)
-Certificates of Conformance (CofC) and inspection are not enough.
-Quality Assurance must
1- verify that the part meets the "PRODUCT specifications".
2- verify that the "PROCESS specifications" have been maintained through the processing of the part.
*It is necessary to understand how well designed a process is at meeting the design requirements of the part/component. Consider the inputs to producing a finished part/component/good: man, machine & equipment, material, methods, measures and environment. Validation examines the robustness of each of these areas in meeting the PROCESS specifications. Invariably, some means of test and inspection will need to be performed to confirm the process capability at meeting the PRODUCT specifications. Often times the inspection and test methods themselves are Special Processes requiring their own verification and VALIDATION. Validation challenges that the process designed to manufacture a product consistently produces product meeting PRODUCT specifications.
Keep in mind that verification and validation are both necessary. I’d like to also offer that Statistical Process Control is also a critical element in assuring product quality and conformity.
* references/credits: Kevin Mader, The Elsmar Cove Discussion Forums > Aerospace and Aviation Requirements > AS9100 Aerospace Standard and Requirements, Validation Of Outsourced Special Processes under AS9100
8. ISO 9001 / AS 9100: 8 management principles:
1-Customer focus. 2-Leadership. 3-Involvement of People. 4-Process approach. 5-System approach to management. 6-Continual improvement. 7-Factual approach to decision making. 8-Mutually beneficial supplier relationships.
9. Project quality plan
******* PROJECT QUALITY PLAN *******
************************************
1 PROJECT QUALITY PLAN PURPOSE
2 QUALITY MANAGEMENT METHOD
2.1 QUALITY PLAN PROCESSES
2.2 PROJECT OVERVIEW
2.3 QUALITY STANDARDS
2.4 QUALITY TOOLS
2.5 QUALITY MANAGER’S RESPONSIBILITIES
3 PROJECT QUALITY ASSURANCE
3.1 QUALITY ASSURANCE PROCEDURES
3.2 PROJECT MONITORING PROCESSES
3.3 PROJECT IN-PROCESS QUALITY MONITORING
4 PROJECT QUALITY CONTROL
4.1 PROJECT DELIVERABLES
4.2 PROJECT QUALITY CONTROL PROCEDURES
4.3 PROJECT DELIVERABLES TEST & ACCEPTANCE PROCESS
4.4 PROJECT DELIVERABLES ACCEPTANCE CRITERIA
5 PROJECT AUDITS & QUALITY REVIEWS
6 MANAGEMENT ESCALATION PLAN
7 QUALITY TEAM ROLES & RESPONSIBILITIES
8 QUALITY PLAN AUDIT LOG
9 QUALITY PLAN APPROVALS
10 APPENDICES
10.1 PROJECT QUALITY PLAN SECTIONS OMITTED
10. Notes on the different types of processes:
Process Predictability: Predictability/Logical/Defined/Deterministic v. Randomness/Undefined/Probabilistic:
Some processes are deterministic, they obey known laws and have a good degree of predictability due to their limited number of variables, for example the behavior of planes, cars, pendulum, physics, engineering, industrial process.
Other processes are un deterministic (probabilistic) they do not obey known laws and are very difficult to accurately predict due to the high number of variables, for example the weather, the stock market, politics, social events. Very powerful computers are required to improve the prediction model.