Process Questions

Type

How do you maintain your Quality Management data?

How do you audit your Quality Management data?
Which operations/processes do you want to streamline for Quality
Management?
Which operations/processes do you want to eliminate for Quality
Management?
Are there any time-intensive Quality Management operations/processes that
need to be addressed?

Process
Process
Process
Process
Process

Do you have security requirements on who can enter data for Quality
Management? (for example, by company? by cost center?)
Process
Do you have security reports on who can run Quality Management reports? (by
company, by cost center, and so on)
Setup,Process
Will there need to be terminal security for Quality Management?

Setup

Do you run security reports on a regular basis for Quality Management?

Process
Do you have documentation on your current system security requirements for
Quality Management?
Process
Map each GL user to a menu structure. Will any new ones need to be created
Setup,Process
for Quality Management?
Do you review requirements for validation rules, allowing certain Quality
Management accounts to be valid with only certain other values.
Setup
Does a current process baseline already exist for this process, and is it
available for review?
Process
Do policies and procedures exist?
Process
Who or what group/organization is the primary Customer for this process?
What is the key output of the process?

Process
Process

What is the Customers request or event that launches the process?

Process

What are the event mechanisms, or allowable ways in which the event may be
recognized (causing the process to begin)?
Process
How is the Customers request fulfilled? (for example, how to recognize that the
process has been completed?)
Process
What are the business functions that must be accomplished in order to
complete the process?
Process
List and classify each business function by type (a combination of Manual or
System-assisted, and Internal or External) and responsible agent (owner).
What decision steps are involved in the process, what are the outcomes and %
likelihood for each outcome?
What are the key decisions that drive the process?
Create a pareto chart of causes or decision drivers of outcomes ("x" % of the
time "y" happens because...).
What are the policies that govern how the process will function?
What are the constraints that limit or control the process?
Do standards exist for process steps?

Process
Process
Process
Process
Process
Process
Process

What technology and tools are needed at the business function (process step)
level for data gathering, measurement or inspection?
Process
What are the system transactions (list by "type" such as: control, status,
movement, logistics, change, quality, balancing, and reconciliation)?
Process
What is the primary information captured and used?
Process
What is the source of each set of key information?
Process
What are the data capture methods?
Process
Does a schematic exist that depicts all storage points for material?

Process

Does a schematic exist that depicts all storage points for information?

Process

What types of security and controls are used regarding key information?
How is data entry audited?

Performance
Performance

What are the activity drivers and how are they measured and valued?
Where are the process bottlenecks?

Performance
Performance

What are representative transaction volumes for key process steps?

Performance

What are the drivers of transaction volume surge and peak loads?
Performance
How stable is the transaction throughput?
Performance
What are the control points for performance measurement and management?
Status? Value? Location?
Performance
How do you measure value for key process steps?
Performance
How do you measure efficiency?
Performance
How do you measure response or service to the customer?
Performance
How do you measure the stability of key process steps?
Performance
What are the opportunities for improving the process?
Performance
Where are the current weak areas?
Performance
What are the redundancies (particularly data entry)?
Performance
What are the reasons for acquiring the new application system relevant to this
business area?
Performance
What families of products or inputs carry the most value through the process?
Do you monitor serial cycle history (like multiple passes through testing or
debugging)?
Do you maintain statistical process controls (SPC)?
Do you maintain SPC for supplier production processes?
What are the key variables and attributes that are monitored during
production?
To what extent are Cp, Cpk and other process capability statistics maintained
and used?

Performance
Process
Process
Process
Process
Performance
Process

To what extent are correlation statistics maintained?

How do you alert the appropriate personnel when quality nonconformance
occurs?
Process
Does the quality system take or recommend action based on sampling or
analysis of a series of outputs?
Process
How do you integrate your quality systems with other operating subsystems
(like Purchasing, Inventory, Manufacturing, and so on)?
Process

What are the operating systems transactions from which quality results must be
collected?
Process
How is failure data collected? What % is being entered manually?
Do you collect information "on everything", and not just failures (tests run,
environmental factors, etc.)?
Do you collect time-to-failure statistics?
Is the current system transparent across suppliers (for both collection and
reporting)?
Do current procedures call for logging time spent debugging or troubleshooting
failures?
When gathering quality collection results from test or other automated
equipment, how do you filter, screen or otherwise avoid a lot of unimportant
excess data?
Do you need to be able to back out any collected results?
Is Cycle time a quality collection element?
How do you gather failure analysis data from Suppliers and translate codes
between systems?
Are collection elements derived from other elements (like Symptom Code from
comparison of results to specs)?
Is the current system able to auto-populate collection elements?
Describe how quality results must be collected in "background" (for example,
no operator intervention)?
Are collection elements ever calculated as a function of other elements (in
addition to constants)?
Do you capture and report Supplier process factors that are affecting product
quality?
What collection import programs are in use?

Process
Process
Process
Process
Process

Process
Process
Process
Process
Process
Process
Process
Process
Process
Process

Describe the procedure and level of difficulty encountered when new quality
collection elements must be added to existing plans.
Process
Are field info (like returns) incorporated?
Process
What is the linkage between service systems, RMAs and serialized items?
Will you accept obsolete products for return?

Process
Process

Are inspection control areas organized in these ways: internal (for

characteristics), external (like packaging and handling), source process and
administrative process (documentation)?
Setup
Are test and inspection instructions available at critical steps throughout the
supply chain?
Setup
What sampling programs are in-place and what is their basis?
Setup
What types of "holds" are used after a quality event has occurred and before
disposition is made?
Setup
What criteria is used to "pass" material during inspection?
Process
What percent of material passes during the first inspection?
Performance
Do you track "first-pass" inspection?
Performance
Does the system prompt suggested test or debug steps based on preliminary
collection results?
Process
How is the Supplier quality event capture through corrective action managed?

Process

Are action rules and systematic notifications used when in-house quality events
occur? Are these filtered by parameters in any way?
How are material review board workflows enabled?
Are responsibilities for dispositioning nonconformances established by name?
Department? Role?
What percentage of material is returned for re-work?
What percentage of material is scrapped?
How long does it take you to disposition discrepant material?
What are the policies governing repair vs. replace?

Process
Process
Process
Performance
Performance
Performance
Process

Is the corrective action loop closure automated or based heavily on manual

methods and transmittal of hard-copy forms?
Process
Is the corrective action loop based on any workflow technology?

Process

To what extent are system-based supplier certification records maintained?

Process

Do you track corrective actions from MRB or Supplier audit event through
analysis, action, change control (like ECO), and pre-control planning?
Do you need to collect Symptom, Cause and Action codes along the corrective
action loop?
Do all process outputs serve as events for other quality or management
processes?
Do you measure re-work production volumes or costs?
Do you do re-work off-line or during production?
What are the components of enterprise wide quality costs and how are they
gathered (including sources)?
Do you collect actual costs for re-work and repair orders?

Process
Process
Process
Performance
Process
Performance
Performance

How do you cost parts and labor for repairs to returned repairs?

Performance

Do you automatically take credit for returned goods in payables?

Process

Does failure-based system cover in-house as well as Suppliers so that a total

picture (denominator) of production can be captured?
Process
Is there an integration with generalized reporting, especially graphics, paretos,
and so on?
Process
Do you track PPM (parts per million) tracking the business functions?

Process

Are Pareto charts produced like: assembly type by diagnostic symptom?

Process
Is there product line quality information retrieval without resorting to manual
entry?
Process
For Pareto charting, can you perform an initial selection to determine a subset
from the universe of parts to include?
Process
Do time series charts include USL/LSL and UCL/LCL lines?

Process

Is it necessary to plot multiple characteristics on the same time series chart?

Process
What out-of-control conditions do you monitor (and what patterns) on control
Process
charts?
Must collections plans be grouped for reporting purposes?
Process

Is it necessary to be able to report/chart/query results from a "list" of quality

Collection Plans rather than from just one plan at a time?
Process
Does current charting system print multiple charts on the same page?
Process
Is it necessary to consolidate across systems?
Process
To what extent are Serial/Lot history records maintained?
Process
Is serial genealogy a business requirement?
Process
Do you currently report total defects per unit and defects per million for each
Supplier-related material transaction?
Process
Are failure analyses reported by problem and product?
Process
Are there delays between quality event occurrence and reporting/analysis?
What are the average delays by: reason? Product Family? Process?
What are the primary quality analysis reports in use? How are they used? By
whom? Frequency?
How are quality collection plans revised, improved and generally updated
based on corrective action cycles?
To what extent can collection plans be user-defined (including key
information)?
Do you maintain Specifications by Item & Operation?
Do you maintain Specifications by input characteristic?
Do you maintain Specifications by a combination of Item and input
characteristic? Supplier? Customer?
Are variable inspection modes limited to first article or is 100% inspection
used?
Is it necessary to store schematics and other drawings on-line as electronic
documents for inspection purposes?
Do you maintain on-line specifications using: target values? Validation ranges?
Lists of values?

Performance
Performance
Process
Setup
Setup
Setup
Setup
Setup
Setup
Setup

Do you maintain USL/LSL and UCL/LCL ranges on-line, and, if so, for what
elements or characteristics are they maintained?
Setup
Do you have the capability to determine what quality characteristics must be
entered based on other entries or actions?
Setup
Do you need the results on quality collection to initiate another program (like
transfer material to a hold area (subinventory)?
Setup
Must it be possible to link collection results together (for instance to calculate
yield across several alternate paths within a routing)?
Setup
To what extent are systematic incoming inspection quality collection plans used
Setup
to inspect Supplier products?
Do you reuse system-assisted, pre-built Quality Plans to simplify receiving
inspection?
Setup
What are the important characteristics and elements you plan to collect? (class
by type: identification, reference, variables, attributes)
Setup
Is data gathering restricted to subsets by family or other grouping to reduce
volume?
Setup
To what extent can elements be user-defined on collection plans (including
lengths and precision, and validation logic)?
Setup

Must users develop collection plans that vary by site or organization for the
same transaction?
Setup
What are the types of predefined actions you can specify to be taken based on
quality events (electronic mail, alerts, display to operator, etc.)?
Setup
Do you capture Supplier site and process audit results (Non-conformance,
Corrective Actions)?
Process
How do authorized supplier lists tie in with the quality system?
Setup
Do you maintain Supplier certification status optionally at site, site-product and
site-process levels?
Setup
Do you have difficulty viewing Serial or Lot history with the current system?
Is it necessary to be able to maintain "history" records?
Do you maintain quality event and corrective action history for Serial/Lot/Item
from receiving through WIP, rework, finished goods and material returns?
When characteristics or elements are no longer tracked, what happens to
history? How is further input prevented?
To what other systems is quality information exported?
How do you determine which products and business processes require quality
control and reporting?
What are the key indicators that are measured with the domain of the quality
management system?

Setup
Setup

Setup
Setup
Process
Performance
Performance

What is the frequency of data collection and reporting by representative

product? Family of products? Business process?
Performance
How are reporting responsibilities assigned?
Performance
What are the drivers for updating reporting requirements?
Performance
How do you manage and control quality information dissemination?

Performance

Does operating policy support concurrent engineering methods by linking

Supplier-generated quality characteristics and specifications plus Supplier
corrective action history to Engineering prototype development?
Process
Do you compare quality trends to trends in productivity, supplier compliance,
plant and equipment utilization and custom satisfaction?
Performance
How does the quality management system interface with total preventive and
predictive maintenance programs?
Performance
Are quality control programs linked with design-of-experiments?
Do you segregate suspect material for planning purposes?

Performance
Setup

Do you segregate suspect material for costing and/or scrapping purposes?

Setup

MSI Response

Log Nonconformance
Assign Owner
Segregate Nonconforming Material
Review Nonconformance
Approve Nonconformance
Record Disposition
Disposition Implementation
Close Disposition
Close Nonconformance

Type of non confirmation

Supplier Non-Confirmation
Receiving Non-Confirmation
Work in Process Non- Confirmation
Customer
Non-Confirmation
capture nonconformance
and
disposition costs