RoHS : SOC

What is RoHS?

RoHS is “Restriction Of Hazardous Substances”.

What is SOC?

SOC is “Substance Of Concern”.

The restricted substances are : Lead (Pb), Cadmium (Cd), Mercury (Hg), Hexavalent chrome (Cr⁶⁺). PBB and PBDE are also considered as restricted substances.

Following limits are allowed:

Substance	Limits in PPM
Lead (Pb)	1000
Cadmium (Cd)	100
Mercury (Hg)	1000
Hexavalent chrome (Cr6+)	1000
PBB	1000
PBDE	1000

These substances were banned in Japan, Europe way back in 2007/2008 with exemptions in some substances due to limitations.                                                                                         Below images are from Google.

                   

Steps to take to confirm if the parts are containing SOC / ROHS.

• -        List out all material BOM used in product / component.
• -        Test from external laboratory and confirm the PPM or % of SOC / RoHS content.
• -        If content is greater than specified requirement, takeup with supplier and ask to RoHS free / Leadfree components.
• -        On developing the parts / components, check once again and confirm the contents.

-        RoHS content is checked periodically, usually once a year.

-        Normally, exporting components / products out of country need to fulfil the requirements of respective country.

-        ELV (End of Life Vehicle) and REACH (Restriction, Evaluation, Authorisation & Restriction of Chemicals) is followed in some countries, namely in Europe.

ELV :                          

                                                                                                                           Image from Google

Substance	Property	Environmental Effect	Effect on Health	Automotive Examples
Lead	1)Heavy, soft metal, with a bluish metallic look. 2)Highly toxic substance. 3)Indestructible and non-biodegradable	1)Poor disposal method of substance containing lead. 2)Lead in fuels after burn causes air pollution	1)Rise in blood pressure. 2)Kidney damage. 3)Disorder of nervous systems.	1)Battery 2)PVC, Rubber 3)Plastic parts 4)Grease 5) Sealants
Cadmium	1)Heavy Metal 2)It is soft and silvery colour	1)Poor waste   disposal methods and leaks at hazardous waste sites. 2)Its particles enter air when we burn coal for energy and household waste.	1)If we consume food contaminated with cadmium it can irritate our digestive system and cause vomiting and diarrhea. 2)If inhaled it can damage our lungs, kidneys and bone disease.	1)Motor brush 2)Relay / switches contact points 3)Plastic parts
Mercury	1) Heavy silvery toxic metallic element. The only metal that is liquid at ordinary temperatures.	1)Power plants, industrial boilers and incinerators are the sources of airborne mercury emissions. 2)Mercury in vaporize form enters air when old vehicles are burnt.	1)Mercury is highly toxic to the nervous systems. 2)Accumulates in tissues of fish and other organisms through mercury-contaminated waters, including humans. 3)Fishing-eating animals may suffer premature death, weight loss and others.	1) Fluorescent lamps
Hexavalent Chromium	1)It is used in various industrial processes. (plating, leatherworking, paper manufacturing and dying) 2)Chromium is used during manufacturing of steel, leather and textile manufacturing.	1)Through coal combustion, chromium will enter air and through waste disposal chromium will end up in soils.	1)Chromium can alter genetic materials and cause cancer. 2)Plants when they absorb chromium concentrations will die after certain limits.	1)Nut/bolt 2)Anti-corrosion surface treatment

If you have any queries with respect this article, please mail: qualitykatta@gmail.com

PPAP - Production Part Approval Process : Levels of PPAP.

There are 5 levels of PPAP. They are summarized as below :

Note : Table taken from PPAP 4th Edition.

Level 1:

Here we need to submit Part Submission Warrant (PSW) only. If you are supplying aesthetic product to your customer, appearance item clause is applicable. Hence you need to additionally submit AAR (Appearance Approval Report).

Level 2:

The requirement under this level is to submit Part Submission Warrant and limited supporting data submitted to customer. Here limited supported data refers to the following minimum documents :

• Product drawing. 
• Layout Inspection report / Inspection report or PDI as per discussion with customer. Submission of type of dimensional report depends on customer expectations. 
• Lab Test reports (Validation reports) in case of assembly product and as per requirements mentioned in the product drawing.
• Raw material test certificates (RMTC). Now a days, customer demand third party reports (NABL) for material confirmation.
• Sample products (as applicable)
• Appearance approval report, if applicable.
• NABL scope of the lab where the tests are conducted certifying and assuring customer that the testing is carried out from qualified laboratory.
• Part Submission Warrant. 

Level 3:

PPAP 4th Edition mentions "Warrant with product samples and complete supporting data to be submitted to the customer." This level 3 is normally considered as default level in automotive industries.  Following are required as part of Level 3 requirements.

• Customer Approved product drawing. 
• Design records. If part is proprietary, drawings are not submitted to customer.
• ECN related documents, if applicable
• Design FMEA (DFMEA)
• Process FMEA (PFMEA)
• Process Flow Diagram (Process Flow Chart)
• Control Plan
• Layout Inspection
• SPC Studies (Pp, Ppk studies)
• MSA Studies
• Appearance Approval Report, if applicable
• Qualified Lab documents (NABL scope of the lab wherein the tests were conducted)
• Product Validation Reports (as applicable)
• Material test reports (Third party lab reports)
• Checking Aids is to be retained at supplier end, but should be part of PPAP document. In almost all cases, customer demand this as additional requirement and wants supplier to submit the checking aids document.
• Customer Specific Requirement Records
•  Part Submission Warrant (PSW)
• Samples products
• Master Sample is retained at supplier (sign off done by customer, as applicable)
• Bulk requirement checklist, if applicable.

Level 4:

PPAP standard mentions "Part submission Warrant and other requirements specified by the customer."  In this level, supplier has to maintain all the documents specified in Level 3 at own premises and only Part Submission Warrant is to be submitted. 

If bulk material is applicable, then bulk material checklist also needs to accompanied along with PSW. The documents are to be submitted to customer on request as and when demanded.

Level 5:

PPAP Standard mentions " Par Submission Warrant with product samples and complete supporting data reviewed at supplier premises. Here the supplier need not submit any document to customer. During PPAP audit, customer audits the process and reviews the documents and sign off PSW if all requirements are fulfilled.

Hope all is understood, if any queries, please revert with your queries on qualitykatta@gmail.com.

Differences between Document and Record

Many a times, it is noticed in day to day working, employees working in industry misunderstand between document and record. Here I would like to narrate the differences in document and record.

Document:

• Document is always live.
• Document can be revised.
• Document has four characteristics: Document number, Revision number and date, Master copy or Controlled copy stamp and Approval signature.

Examples of documents are : Control plan, FMEA, Process flow diagram, DFMEA, Work Instructions etc.,.

Any changes to documents, will call for next revision number and revised date. 

Changed documents are released to respective functions as per distribution matrix.

In some of the industries, document number and form number, both are mentioned. Here form no refers to the formatting structure of the respective documents.

Record:

Record is always dead. Once record is prepared, it cannot be revised. If at all, anyone does so, it is not ethical. 

Records are used for past data retrieving purpose only. 

Record has form number with form revision number and date. It dos not have master or controlled copy stamp.

Examples of record are : Setup approval reports, Production reports, Preventive maintenance reports etc.,.

Hope the above explanation made on the differences and clarity is made on document and record is understood.

Calibration

What is Calibration?:

• Calibration is comparison between a known measurement standard and the measurement using your instrument. It checks the accuracy of the instrument and it determines the traceability of the measurement.

Purpose of Calibration:

• The purpose of calibration is to gain confidence in the results being measured. Accurate measuring devices improve product quality and minimize risk of rejections during manufacturing processes. 
• The purpose of calibration is to minimize any measurement uncertainty by ensuring the accuracy of test equipment or measuring instrument.
• The accuracy of all measuring devices degrade over time caused by normal wear and tear. It may degrade very quickly or over a period of time and this depends on the type of the instrument and the environment in which it is used. Hence it is required to have the instrument or test equipment calibrated at regular intervals based on usage pattern.

When to do Calibration?:

• As recommended by the manufacturer.
• After any accidental drop / fall down during measurement (mechanical or electrical shock).
• Calibrate the instruments in highly critical areas more often than those available in less critical areas so as to prevent high rework costs / high rejections.
• A new instrument - manufacturers certificate is acceptable provided it is traceable to NPL.
• The operating conditions and workload of a measurement device also determine, how often it should be recalibrated.
• Stability history of the measuring device : If the instrument has a long history of being stable, then you can calibrate it less often. On the other hand, if the history shows that the instrument drifts quite often or fails frequently in recalibration, you must calibrate it more often.
• Calibration frequency defined in any regulatory requirement, customer requirement, as applicable.

Calibration Pyramid:

Calibration Agency:

NABL: National Accreditation Board for Testing & Calibration Laboratories

What is NABL?: 

• It is an autonomous society providing Accreditation (Recognition) of Technical competence of a testing, calibration, medical laboratory etc.,. for a specific scope following IEC/ISO17025 and few other relative standards. 
• It is one of the laboratories in India for quality and consistency in the results. 
• All the accredited laboratories have to follow ISO / IEC 17025 standard to maintain quality management system in calibration and testing.

Accreditation: 

• Accreditation is the third party attestation related to a conformity assessment body conveying the formal demonstration of its competence to carry out specific conformity assessment task. 
• NABL accreditation is not a one-time phenomenon. Laboratory accreditation is valid for a period of 3 years only. During these 3 years NABL conducts periodical surveillances of the laboratory on an annual basis. Accreditation can be revoked if the laboratory fails to maintain the standards of NABL requirements.
• NABL accreditation labs are rewarded more business, being an independent third party certification agency. 

What is the purpose of laboratory accreditation?:

• Laboratory accreditation agencies uses specific criteria and procedures to determine technical competence, thus assuring customers that the test, calibration or measurement data supplied by the laboratory or inspection service are accurate and reliable. 
• Laboratories are re-evaluated periodically by the accreditation body to ensure their continued compliance with requirements mentioned in the standard.
• Accredited laboratories usually issue test or calibration reports bearing the accreditation body’s symbol or endorsement, as an indication of their accreditation.

Important guidelines before submitting the instrument for calibration or material for testing to  outside lab:

• Laboratories are performing calibrations and tests outside the scope of accreditation, but the report / certificate issued does not have NABL logo. Hence customers availing services from laboratories should be vigilant and verify the scope of NABL before submitting the instrument for calibration or material for testing. 
• Laboratories can have either all or part of their testing and calibration activities accredited. They normally cover commonly used calibration services or tests in their NABL scope. 
• In most of the cases, people say, we are getting the instruments calibrated from NABL lab, but sometimes, it appears that the instrument range is not in the NABL scope of the lab. 

For example :

Vernier caliper is in the NABL scope for range 0-500 mm only.

Scenario 1:

In this case, calibration is performed by the lab and report with NABL logo is issued to the client. 

Scenario 2:

Let us say, we have Vernier caliper with max range of 1000 mm. In this case also, lab accepts the instrument for calibration, however, the certificate does not comprise of  the NABL logo. This means the client has to be vigilant on the scope of the lab before availing the services.

• Periodically, it is important to obtain the NABL scope from the laboratories in hard copy, however, most of the labs now a days are storing the updated copy of scope on their websites from where it can be downloaded. 

Calibration report Assessment:

1. Check presence of NABL logo on the lab report.
2. Check if the instrument or test equipment name / description, equipment code is correctly mentioned so as to avoid conflict issue during customer audits / internal conflicts.
3. Check for calibration date, due date, range of the instrument is correctly mentioned.
4. The master instrument used for calibration should not be due. For example: If the instrument is calibrated today, the due date of master instrument used for calibration should be after this date.
5. Depending upon the type of instrument, verify the error with respect to the acceptance criteria specified for that instrument.
6. If all above are found OK, mention "Verified and Found OK". The person verifying and conforming OK, should sign on the report with date.
7. If the report if not OK for above sr.no 1 to 4, co-ordinate with laboratory and get is corrected.
8. If the error is greater than acceptance criteria, decision has to be made usage of the instrument based on the application. Standard says, the instrument should be accompanied with error details so that anyone using the instrument considers the error into calculation.

Calibration In Industry:  

A person nominated for calibration activity in any industry has to perform below activities:

• Maintain a list of IMTE (Inspection, Measuring and Test Equipment) containing all the details of instruments, test equipment's, gauges used in the company.
• As per the due date, calibration plan is made and he / she retrieves the IMTE from respective location atleast a week before the calibration due date. Retrieve time can be decided depending upon the distance and lead time taken by the calibration agency.
• Ensure all IMTE are having calibration sticker at any point of point.
• Maintain history for each IMTE. This will help analyse the trends in error / repair history of the IMTE. It enables to take decision to buy the same equipment or go for other option based on the history of the equipment.