1. How to Implement an IG Manufacturing Quality Procedure System
Internal Audits

2. Learning Objective Plan an internal audit
Participate in an internal audit
Complete non conforming product reports
Complete an internal audit summary
What to do about the results

3. Internal Audit Preparation
Determine the audit schedule for each area
Should have strategic direction and approval of senior management
Determine the area to be audited
Gather the relevant documentation
Process documentation
Product quality control records
Non conforming product reports
Field Service reports
Checklists
Preparation is the key to ensure that the audit goes smoothly, all issues are addressed and that there is proper representation from the area being audited.

4. Lead Auditor Audit management capabilities
Audit team leader experience
Personal attributes
Audit experience
Acts a facilitator – understands the system, procedures, instructions and documentation
Summarizes discussions and action items including areas of responsibility
Requires an auditor with a substantial amount of experience that demonstrates leadership capabilities. Proper education and experience in auditing functions is a pre-requisite to ensuring a successful meeting.

5. Checklists Provides guidelines to ensure nothing gets missed
Acts as a notepad
Records results & actions

6. Documentation Review
Review the documents which are relevant to the area being audited
Manuals
Procedures
Quality control forms
Supplier data sheets
Non conforming product reports
Field Service reports

7. Documentation Review Procedures Instructions Forms and Data Sheets
Quality System
Quality System
Summary version of how the company meets the established standard
Procedures
A series of actions defining methods and responsibilities for two or more people, conducted in a certain order or manner, to perform a general activity
Shows the who, what and where of an activity
Instructions
A series of actions defining methods and responsibilities for one person, conducted in a certain order or manner, to perform a specific activity
Shows the how to of an activity
Forms and Data Sheets
May be customer or company originated
Standards (collection of specifications, drawings or processes which serve as a basis to which materials, products or work should conform
Guidelines (recommended courses of action)
Procedures
Instructions
Four levels of documentation
Forms and Data Sheets

8. Documentation Review Quality System Procedures Instructions
Manuals which include objectives and guidance in order to direct desired courses of action
May include a quality policy statement
May include an organizational chart detailing reporting chains and inter-relationship of each department.
Procedures
Form the core of instructional documentation for the company
Instructions
Generated as need through the operating procedures
Forms and Data Sheets
Generally referenced in operating procedures and work instructions
Manuals
Quality control forms
Supplier data sheets
Non conforming product reports
Field Service reports

9. The Physical Audit Audit Schedule Objective evidence Non conformances
Observations
Sample selection
Audit trails
Questioning techniques

10. The Physical Audit
Observations by participants of processes and final products
Written memos & reports
Sample selection
Samples can be increased in an area is in question or decreased if time is a factor
Should not disrupt operations

11. The Physical Audit Non conformances Minor Major Observation
Audit trails
Objectivity
Examples
Confirmation

12. The Physical Audit Non conformance & Corrective Actions
Who was present
Area of nonconformance
Date & unique ID#
Details of problem
Root cause analysis
Course of corrective actions
Who is responsible for corrective action?
How will the effectiveness be verified?
Verified by auditor

13. The Physical Audit Root Cause Analysis
Don’t assume what the problem is, prove it.
Keep asking “why did that occur?” When the answer to the question can no longer be attributable to another event, you have the root cause.

14. Seal Adhesion Failures Was the glass clean? Yes
No – soap residue, cork pad residue, Low e edge deletion, water temperature, etc.
Was the product stored properly?
No – where was it stored, why was it stored there (new employee, storage area not available, contamination, etc.)
Was the sealant batch checked for adhesion?
No – Why wasn’t the batch checked (time, new employee etc.)
Could it be a supplier manufacturing issue? No
Keep asking questions until there are no more questions to ask. Also look for one more “why”. Remember non conformances can be caused by more than one condition so keep an open mind!

15. Objective Evidence Physical examples of non conformance
supplier, product ID, lot numbers
Equipment
Final product
Statements from employee with direct responsibility for area of concern
Note the specifics. Use an example such as adhesion failure for sealant, failure of desiccant test

16. The Physical Audit Minor Non conformances
Minimal occurrences where the supplier does not meet requirements of the standard or their own documented quality system
Situation where a procedure or instruction has one or several incidences where it is not being completely followed
A piece of manufacturing equipment is found to be past the required calibration date

17. Unidentified final product defects by the shipping doors
The Physical Audit
Major non conformance
Many occurrences where the supplier does not meet the requirement of the standard or their own documented quality system
An occurrence that in all probability will cause defective product to be shipped to the customer
Minor non conformances are too numerous or non conformance is too serious
Unidentified final product defects by the shipping doors
Ask students for other examples of minor and major non conformances. What would they do if they discovered a minor non conformance? What would they do if they discovered a major non conformance? What if it was a health & safety issue? Do they know what to do? Do they know who to report to?

18. The Physical Audit Observations
A poor practice observed by the auditor that unchecked may become a minor non conformance if not corrected
Used as a warning tool for the company

19. Audit Summary Summary report of the audit results
Number of samples reviewed, sampling restrictions
Non conformances written as minor or major c/w corrective actions and designated an individual to be responsible for implementing the corrective actions and determining effectiveness
Record who was present
Determine next meeting

20. Verification
Corrective Actions must be verified by the auditor as implemented and effective

21. Continuous Improvement
Audits can be used as one of the vehicles for continuous improvements
Opportunities for the auditor to recommend continuous improvement
Can be used to focus departmental responsibilities

22. Internal Quality Audits
Say What You Do!
Do What You Say!
….and
Be Able to Prove It!!!!