Business Model
Also known as the Quality Manual, this document addresses requirements from ISO 9001:2008 and fulfills 4.1, 4.2.1b, 4.2.2c [sequence and interaction described throughout], & 5.4.2a).  While this is nice, the really important thing is to recognize it is our "Business Model".  This means we are focused on our business first, with ISO 9001:2008 serving as a platform to make sure we have covered all the bases as it relates to business performance.

Revision: 4/16/2009                                                                Effective Implementation Date: 5/1/2005

 

Typical process flow and for the most part processes directly interacting with one another.

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The Master Control Plan serves as a table of contents for all of the documents that can be accessed directly through this site.  All other documents are controlled by e-Docs or Prime.

 

 

SCOPE 4.2.2a
Precision sheet metal fabrication, manufacturing and electro-mechanical assembly for customers in various industries such as:

electronics, telecommunications, computers, medical, food service and transportation.

QUALITY POLICY 4.2.1a, 5.1b & 5.3
Promote customer satisfaction and continual improvement by being productive and resourceful,

while producing quality products delivered on time.

 

QUALITY OBJECTIVES 4.1e, 4.2.1a, 5.1c, 5.4.1, & 8.4

OBJECTIVE KEY PERFORMANCE MEASUREMENTS DIRECTLY IMPACTED BY IN-DIRECTLY IMPACTED BY

Productivity

Average Performance Rate of 100%

Production Personnel & Those Developing Quotes

All employees

Resourcefulness

A management assessment of Capacity utilization

Production Personnel

All employees

Quality

First-pass Yield at inspection of 100%

Purchasing, Production, Programming/Development, Quality, Shipping, Quoting, and Order Entry

All employees

On-time Delivery

On-time Delivery Report showing we are on-time 90%

Purchasing, Production, Programming/Development, Quality, Shipping, Quoting, and Order Entry

All employees

Customer Satisfaction Reduction in negative feedback on the Opportunities & Incidents Log from quarter to quarter All Employees All Employees


Where not already noted, the reports and/or charts covering specific measurements for each of these objectives includes the goals and/or targets used to ensure the business model (QMS) is effective. See the Monitoring & Measurement section of this document to understand how we use these measurements to ensure the filter (policy) is driving behavior.

 

MONITORING & MEASUREMENT
(Beyond The Daily Grind)
8.1a-c, 8.2.3, 8.4a, 8.4b & 8.4c

Modeled after Deming's Plan, Do, Check, Act

STUDY
Management, responsible for fulfilling the activities related to the measurements shown, assesses the results to confirm we are heading in the right direction and/or to identify the actions needed to right the ship and to identify improvement opportunities.

ACTION
Establish action items using a closed-loop process (having a built in memory jogger for follow-up). These can involve things like action item lists or memos maintained by management and/or those mechanisms called for in Improvement Systems and/or Planning & Realization. Remember: things that get measured get done!
Things to think about as part of "STUDY":
- What does each measurement tell us?
- Why does it say that?
- What makes us think it will be okay if we leave it alone?
- What are we doing about it, if we decide something needs to be done?

Charts & reports should include the reason the results look they way they do and what has been done to improve or sustain them so management can assess and determine if further action is needed.

FOLLOW-UP
Using the closed-loop process employed in the "ACTION" section, follow-up on the action items raised to make sure they are staying on track, to provide direction, and to verify the action taken worked. REMEMBER TO ALLOW ENOUGH TIME FOR EFFECTIVE IMPLEMENTATION (in-place and working long enough to prove it will meet the desired result now and in the future).

In some cases, we find what we are trying to do is not working. When this is the case, try taking it in another direction to resolve the issue. It is okay to abandon a cause, as long as it will not have an adverse effect on us or the customer and we realize resolution is not feasible.

VALIDATION
Management, responsible for fulfilling the activities related to the measurements shown, summarizes the issues identified, actions taken, and results of follow-up for upper management. Upper management assesses the effectiveness of actions taken and determines if more action is needed and if what was learned can be applied in other areas. Those needing further attention are re-introduced into this process at the "ACTION" step.

MANAGEMENT'S "BIG PICTURE" PERSPECTIVE

(Management Review, Auditing, Data Analysis, & Improvement)

NOTES: (related to Management's "Big Picture" Perspective
I. Management Review is an assessment of the actions (summary or highlights of departmental data as described in "VALIDATION" below) taken by area management to determine if further action is necessary. Management Review occurs at least once per year with the goal being to complete a review once every 6 months. The schedule for Management Review is maintained by the ISO Management Representative. The Management Review Matrix addresses all of the requirements of 5.6 in the ISO 9001:2008 standard as it relates to expected inputs and outputs, and includes a review of the quality policy to assess continuing suitability (5.3d).
II. The internal audit process (defined in the Audit Procedure) tells us how effective our business model is. Auditors work with area personnel to identify which documents are driving behavior and which ones need to be improved so we can be more effective as an organization.
III. The types of data analyzed at Pi-Co and what we do with it is described below. Corrective Action, Preventive Action, and Continual Improvement processes are described in the Improvement Systems procedure.
COMMUNICATION & FOCUS 5.1a, 5.2 & 5.5.3
Management ensures personnel understand the importance of (are focused on) meeting customer requirements by posting the objectives or through employee meetings and by ensuring product is produced to meet customer requirements outlined in the order and/or drawing(s). In other words, customer requirements are determined (Customer-Related Processes), conveyed to our work force (order and/or drawing), and met (product produced to those requirements) with the aim of enhancing customer satisfaction. Management also ensures personnel are aware of any applicable statutory/regulatory requirements. Employee meetings, training courses, and/or memos addressing these types of issues are the means used for communicating with the employees. The effectiveness of the management system (Business Model and supporting documents) is communicated to employees through postings and/or through employee meetings.

RESPONSIBILITY, AUTHORITY, AND TRAINING 5.5.1 & 6.2

What someone is supposed to do (responsibility), what they can do (authority), and how we make sure the are competent (training) is covered in Training.

MAINTENANCE 6.3, 6.4, & 7.5.1c

For the most part handled by the maintenance department as defined in the Production Process Overview.  Maintaining the computer system, including back-ups is handled by the IT department.

MONITORING AND MEASUREMENT DEVICES 7.5.1d & 7.6

Selection and use is facilitated by the process calling for monitoring or measurement, with the Production Process Overview pointing out those processes and calibration is handled per Calibration.

VALIDATION OF PROCESSES 7.5.2

Those processes where we cannot or do not verify the product produced meets requirements is considered to be a "special process and requires validation.  Welding is the only special process at Pi-Co.

CUSTOMER PROPERTY 7.5.4

For the most part, it is treated like everything else.  With the necessary controls referenced in the "receiving" portion of the Purchasing procedure.  

 

And Now, Things We Have To Deal With Because They Makes Sure We Can Sustain Our Business Model

(maintaining our quality management system)

MANAGEMENT REPRESENTATIVE 5.5.2
The ISO Management Representative (person designated as such on the Organization Chart) has been given the responsibility and authority by management to:
- ensure an effective quality management system is in place (this Business Model and supporting documentation) and is being maintained (through internal audits and by measuring key performance objectives);
- report to top management on the performance of this system and any need for improvement (management review and reporting on the objectives); and
- ensure personnel are aware of customer requirements (see Communication & Focus in this document).

DOCUMENT CONTROL 4.2.3

(required procedure 4.2.1c)

With respect to quality management system (QMS) documents (this manual and associated procedures), Document & Records Control and the Master Control Plan (a master list of documents noting the revision status that is embedded in Document & Records Control) cover document control requirements.  While the main documents defining the QMS are controlled as defined above, additional QMS documents (customer documents, how we control the Router, CNC programs, etc.) are controlled per the Document Control Matrix.

RECORDS CONTROL 4.2.4

(required procedure 4.2.1c)

While the records section of the Master Control Plan addresses the procedural aspects of records, there are a few other things that need to be considered.
- A record is evidence we maintain to show conformance to a requirement and/or to show our system (this Business Model and supporting documents) is operating effectively.
- When completing a record, we need to make sure we write clearly. If the record is not legible (readable), then it will not be able to act as the evidence it is intended to be.
- We also need to be able to identify the records (i.e., understand they are records) and retrieve them. The records section of the Master Control Plan is the road map to all records (including those called for throughout ISO 9001:2008). From this list, we are able to identify which documents are records. This, coupled with the fact the records section of the Master Control Plan includes our method of indexing each record and who we should see if we need access to them (retrievability), ensures we are in control as it relates to records.

REQUIRED PROCEDURES 4.2.1c

There are six documented procedures required by ISO 9001:2008 and we have covered them all.  Document Control (4.2.3 as described in the Document Control section above), Records Control (4.2.4 as described in the Records Control section above), Internal Audits (8.2.2 with relational perspective provided in note II of Management's Big Picture Perspective above), Control of Nonconformance (8.2.3), Corrective Action (8.5.2 with relational perspective provided in note III of Management's Big Picture Perspective above), and Preventive Action (8.5.3 with relational perspective provided in note III of Management's Big Picture Perspective above).

DID YOU KNOW!
The little numbers shown throughout this document are clause numbers from ISO9001:2008 being fulfilled by the activities related to the step or note referencing the clause. An example of this is the "Nonconformance Control" box (shown above) with "8.1b & 8.3" referenced. This means the notes or documents referenced, address the requirements of 8.1b & 8.3 of ISO9001:2008. It should also be noted that, hyperlinked, italicized, and/or blue words are references to documents describing a particular process in greater detail.

THE STUFF WE LEFT OUT! 4.2.2a (exclusions)
At Pi-Co, we have excluded Design and Development 7.3, as we are a contract manufacturer do not perform these activities. References to Servicing have also been omitted, as we do not perform servicing.

 

THE LAST WORD ON THE QUALITY MANAGEMENT SYSTEM 4.1 & 4.2.1d
This quality manual (Business Model) and the documents that support it (referenced in this document or in those that support it and/or those documents included in the Master Control Plan) are the processes needed for the quality management system (QMS) at Pi-Co. These documents define or make reference to the sequence and interaction of our processes, the criteria/methods needed to ensure effective operation and control of these processes, and the resources/information needed (including the provision of additional resources as needed) to operate and monitor these processes. This QMS includes the monitoring, measurement, and analysis activities necessary to ensure our processes will achieve the desired results now, looking for and acting on continual improvement opportunities as they arrive. Simply put, the documents we need to effectively plan, operate, and control our processes are in place.