How to do coherence of documents and standard management

Purpose:

To have coherence between all the documents like Customer Inspection Standard of parts with Control Plan, Operation Standard, Inspection Standard & Packing Standard. Defining the standards properly can prevent rejection and rework and thus Improve OEE and COPQ.

Responsibility :

S.NoActivity  ResponsibilityFrequency
1Review of the Standards/ Format/ WI/ Procedures etc.  Quality Incharge / MRIn the event of a change, Once in a year, Customer-specific requirement, Customer complaint
2Updating of standards  Quality Incharge/MRAfter every change
3Issue of the revised standard  Quality Incharge/MRAfter every change

Procedure: 

CASE-I  Procedure for Standard Management:

  1. Are the Control Plan, Operation Standard and Inspection Standard available for all the parts? If not discuss with the concerned department and ensure availability for all the parts.
  2. If not available, make draft documents in coordination with the concerned department and send documents for Plant Incharge approval.
  3. If available, Check for the coherence of customer inspection standards, Drawing with the control plan, inspection standard and operation standard and inspection reports.
  4. Update the Master list of documents.
  5. Distribute the documents to the concerned department. 

CASE-II  Request for Modification :

  1. Receive the document change request form for modification and check the implementation feasibility. 
  2. If feasible, modify the document and prepare change points in the document.
  3. Take the approval of document change request from the Plant in charge.
  4. Distribute the modified document to controlled copyholders. ( Control copy stamp with Red color and Master copy stamp with Blue color )
  5. Receive old copies from controlled copyholders and destroy the old controlled copies.
  6. Preserve the master copy of old documents duly identified with an Obsolete stamp.
  7. Issue new or modified format with the implementation date.
  8. Collect the old format, confirm the implementation and record the change date.
Document coherence matrix and  coherence of documents

Procedure to make process control standards(QA process charts)

Do you make and review process control standards, Inspection specifications, and Operation instructions for all products that are shipped to SMC / MSIL / Tier 1?

Sub Question
Availability of documents (control plans, operation standards, inspection standards) for all parts under- supply
Procedure for preparation and control of documents defining following: – department in charge of making, the person in charge of making, a person in charge of authorizing – revision rule & revision history (internal & customer) – Document Control Numbering – retention period; – Distribution matrix – Obsolete documents handling
Master copies of the controlled documents
Master list of documents (control plans, operation standard, inspection standards) with latest revision nos

Procedure to control standards. -Process control standards -Inspection specifications -Operation instructions

Do you have consistency to keep process control standards, inspection specifications, operation inspection and parameter chart?

Sub Question
All Product and process parameters are mentioned in the control plan
Reference of WI, sample size, checking frequency, checking method, boundary samples & Poka Yoke are defined in the control plan
Consistency among documents (process control standards/control plans, operation standards, inspection standards and customer inspection standards)

Retention period of documents:

The retention period is the amount of time an organization keeps documents and records for audit purposes and to fulfill customer requirements.

DocumentsRetention Period
Maru A PartsPart Life + 11 Years
Fit-FunctionPart Life + 11 Years
Drawing, Control Plan, PFMEA, PFD & OSPart Life + 11 Years
Safety and Regulatory5 Years
Internal Audit and MRM3 Years
Training Records2 Years
Calibration Records2 Years
Inspection Records1 Year
Production Records1 Year
Maintenance Records 3 Years
Equipment History CardEquipment Life
NPD Records5 Years

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