The Procedure for Control of Materials Including

TEMPLATE OPERATING PROCEDURE No 4

The Procedure for control of materials including non-conforming product

Authorisation and Amendment Record:

Issue Date of Reason for re-issue Prepared Authorised No. Issue by: by:

______Operating Procedure No: …….. Issue: …… Dated: ………… Page 1 of 14 The procedure for control of materials including non-conforming product

1. Purpose and scope

The purpose and scope of this procedure is to ensure that:

(a) Any items, component, subassembly or raw material that is to be incorporated

into …………. Plc product can be readily identified to type, drawing or part

number. That items of similar appearance cannot inadvertently get mixed or

substituted.

(b) There is no requirement or advantage in providing any form of traceability for

…….. plc products/services. If there was a particular contract requirement to do

so, special controls would be introduced.

(OR where it is a contract or legal requirement, items or material will have

traceability to the raw material certificate, OR foundry certificate, OR forge

certificate, OR material analysis, OR test certificate, OR certificate of

conformity, etc) that was provided by the original supplier, (OR to the

supplier/date of delivery/order No.) (OR where it is a contract or legal

requirement, ……………. Plc products [OR the following models ……, ……,

……,] are manufactured and tested into identifiable lots or batches. These will be

supplied with appropriate documentation pertaining to the identify and test results

of the individual lot or batch).

______Operating Procedure No: …….. Issue: …… Dated: ………… Page 2 of 14 (OR ………plc have identified that the ….., ….., ….., and ……. ranges of

models [OR food products, OR electric fans, OR ……..] are safety critical [OR

are susceptible to failure on one component i.e. ……………] and will be

assembled, [OR processed OR manufactured] and supplied as identifiable

batches and lots [OR with lot traceability]. This is in order that if a potential

problem batch is identified by customer complaint or return, ………. plc can

arrange a withdrawal or replacement and return of the suspect batch).

(c) ….. plc will ensure an adequate system for inspection status, i.e. can readily

identify whether materials, items, sub-assemblies or final products are good, bad,

suspect (OR on hold, OR quarantined) or reject (OR scrap).

(d) When items identified as suspect (OR placed on hold/quarantine) that there is a

prescribed and controlled procedure to ensure they are reviewed and controlled

through rework, repair or disposal.

(e) Where items (OR materials OR services) are supplied by the customer to assist

…. plc manufactures the final product (OR supplies the required service) that

these are positively identified to prevent misuse, substitution, loss or

deterioration.

2. Responsibility

It is the responsibility of the Director and all managers to ensure this procedure is

implemented fully and effectively. The supply of a defective product from …….. plc can

have a dramatic effect on customer confidence (OR cause fatal accident, OR ……..), this

______Operating Procedure No: …….. Issue: …… Dated: ………… Page 3 of 14 procedure must therefore be enforced rigorously. All staff and operatives with ………

plc must follow this procedure. Any members of ………. plc staff or operatives can and

must place items under temporary ‘hold’ if they are concerned that they do not conform

to the required specification.

Items under temporary ‘hold’ can be released only by the operative who placed them on

hold, or any manager. Items under formal ‘quarantine’ or ‘rejected’ can only be released

by the Quality Manager or the Director (OR ……….) and then only by completing the

prescribed records. No member of the Production Management has authority to release

items from ‘quarantine’ or ‘reject’. Staff and operatives will ensure there are sufficient

labels attached to clearly identify the product, or where appropriate, its inspection status.

As a pallet or container becomes empty all staff shall ensure that redundant labels are

removed. The Quality Manager is responsible for re-ordering the Inspection Status

labels. If they are not available for a short period temporary labels may be used from

white card.

3. Implementation (typical Production Manufacturing Shop or Site Installation [OR

Maintenance])

3.1 Control or Identity

The majority of …. Plc products are quite unique in size, shape, etc. and cannot

be mixed or substituted.

The only items that can get confused are:

………. and ……….

______Operating Procedure No: …….. Issue: …… Dated: ………… Page 4 of 14 ………. and ……….

Only these items will have an identity number stencilled on the part (OR label

tied, attached or adhered, etc).

(OR whilst …… plc range of products is different in size and shape it is possible

for an inexperienced operative to get them mixed. In order to prevent this

happening and as an aid to training a series of boards are conveniently placed at

the middle of the production shop with an example of each part affixed to the

board and identified. By placing an item by the board, the part number of any

part can be very quickly identified.)

(OR once ……..plc is placed into sub-assemblies or onto the specified production

lines and become work within a specific process they cannot be mixed or

substituted. Hence only the raw materials and components are identified. This

may be by individual label or part number on the larger products, but the majority

are identified to type by labels on the tote bins, pallets or bags.)

(OR the items made by …….. plc are one-offs or small batches. With the job is a

‘Travelling Job Card’ (OR ‘Planning Sheet, OR ………) detailing the work to be

carried out. This card also identifies the drawings with the items and appropriate

material identity. If the identity of any material is not clear it will have a small

identity card/label attached or marked directly onto the item, with permanent

ink/paint). (OR some of the products made by …… plc are safety critical.

Therefore a formal controlled list of safety critical items is maintained. All of

these items will have the identity number marked onto the item, a batch number

and also motif to identify the supplier of that component and the year/month of

manufacture. This is specified as a requirement of our Purchase Order onto our

______Operating Procedure No: …….. Issue: …… Dated: ………… Page 5 of 14 suppliers. This level of control is essential both to enable product withdrawals

and also to throw the product liability [consumer protection] back onto the

original supplier.)

3.2 Control of material, including non-conforming product

Within ……. Plc we have introduced a simple coloured card/labelling system to

identify the inspection status of components.

(a) A yellow label identified as ‘hold’ see Form ….( OR Annex …..) This is

a temporary label for use by any member of ……….plc staff, or for an

operative to be able to use, where items are considered suspect or

awaiting test or awaiting further components, coat of paint, check by

customers representative, awaiting goods inward clearance, awaiting

suppliers certificate of conformity, confirmation of customer’s

specification, formal order documentation, customer’s returns awaiting

checking, etc. Items can be placed on ‘hold’ by any member of ..plc

staff. It can be removed only by the person placing it into ‘hold’, or any

……..plc Manager or Director.

(b) An orange label identified as ‘quarantine’ see Form ……(OR Annex

………) This is where items are confirmed as not to the required

specification. They must then go through a simple but formal review

procedure before they can be reworked, repaired, scrapped, etc. (see

Operating Procedure ….). Any member of …..plc staff can quarantine

items. It can only be lifted by the QA Manager or the Director (OR

……….) with the appropriate completed authority and record forms.

______Operating Procedure No: …….. Issue: …… Dated: ………… Page 6 of 14 (c) A red label identified as ‘reject’ see Form …… (OR Annex ….) These

items are not suitable for ….plc products; the label will not be removed

whilst the items are within …..plc. They will be sent for disposal, or

returned to the supplier with the red ‘reject’ label securely fixed. If

appropriate instructions may be given to ‘ruin’ or ‘slight’ the product by

painting or spraying red (Or chiselling across the working face or

stamping ‘R’ onto working face OR chopping off the connecting wires,

OR ……..) to positively prevent their re-introduction into the

manufacturing process. A ‘Reject’ label can only be fixed by an

approved Inspector, a Manager or a Director.

(d) A blue label identified as ‘special’ see Form……(OR Annex …..) It will

generally only be authorised by the Goods Inward Inspector, the Quality

Manager or the Director. This label will be used for the following:

* to positively identify ‘free issue’ or customer supplied products to

prevent its misuse, substitution or loss. At the completion of the

order/contract all excess ‘free issue’ material must be returned to the

customer. It will only be disposed of following written instructions or

permission from the customer;

* to identify all special batches where lot traceability has been requested;

* to identify items or batches that are special, have unique properties and

must not be mixed with normal production;

* special marking or assembly trials or items under development; also can

be used to identify ‘first offs’ for critical examination or machining trials;

* for use to identify test supplies taken by laboratory staff;

______Operating Procedure No: …….. Issue: …… Dated: ………… Page 7 of 14 * for use to identify ‘Approved Visual Standards’. The inspection of item

…… is a subjective visual inspection. To provide guidance to acceptable

standards on the features, acceptable surface defects, cosmetic

appearance, etc. acceptable examples of product are provided. These are

clearly identified and authorised using the label above, (OR there are

three examples of this approved visual standard. All three have been

approved, signed and dated by a representative of the customer and the

Quality Manager [OR ……..] of ……. Plc. The customer has selected

and holds one, the Quality Manager holds another and there is one

available at the place of work). Care should be taken not to damage the

visual standard. If it deteriorates it should be replaced. The blue label

will stay on the item whilst it is within …………..plc.

(e) (OR ………plc machines from various diameters of metal and

[OR plastic] bar stock that are held in racks in the bar stores. It is

vital that these are readily identifiable to type and specification of

material. Hence wherever practical the ends of the bar will have a

colour code painted onto the end. Care must be taken when doing

this as some stockists have their own colour codes. The colour

codes are shown at Form …..(OR Annex ….) at the end of this

procedure. A copy of the latest issue of this …………. will be

displayed in a plastic cover on the wall in the bar stores and in the

machine shop. This will be personally controlled and updated by

the Quality Manager to ensure it is the latest issue. Care must be

taken by machinists when sawing bars that the material identifying

codes stays with and on the bar left in stock. If there is a usable

______Operating Procedure No: …….. Issue: …… Dated: ………… Page 8 of 14 ‘cut-off’ that can be returned to store the code should be repainted

onto the end. All material without the paint code, such as angles,

plate must have the material identified on the item by permanent

labels or by ‘paint stick’. Material ordered or set aside for specific

jobs will have the job number affixed or painted onto it.) [ OR

the majority of bar or plate used by …………. plc is mild steel (

OR plastic, OR concrete OR ……….. ) to general spec ……….. ,

. This will not be colour coded, however all other material will be

carefully identified and coded ]

(OR useable bar stock off-cuts are put in the bin [OR shelves, etc.]

marked ‘Unidentified and uncontrolled material’. This material is

to be used for machine setting up or development trials. It may be

used on low cost, low duty jobs [where the customer has not

specified specific grade or material] on the instruction of the

Director or Quality Manager [OR Project Engineer, OR ……] this

will be detailed on the Job Card records and initialled and dated by

the Director [OR ……….., OR ……………])

(f) A green label identified as ‘Accepted/Passed Test’ see Form …. (

OR Annex ….) This is an OPTIONAL label. Due to effective

controls introduced within ….plc, it can generally be assumed that

any items without a hold, quarantine or other specified label is in

fact either acceptable material or work in progress. It may be used

to very clearly identify batches or items that have been subject to

______Operating Procedure No: …….. Issue: …… Dated: ………… Page 9 of 14 critical examination or test and have passed. It may also be

specified on individual Job Cards to be attached to each item or

batch for certain Quality Critical products (OR batches to be

supplied to Sony, Hitachi and Aiwa will always be subject to a

formal verification inspection and a ……plc green label neatly

completed and fixed to each item or packing box).

(OR ………plc products are supplied as home aids to the

handicapped. The customer particularly needs assurance that the

product has been carefully tested hence every product will have a

…plc green label attached. The label will be NEATLY completed

and signed off with an identifiable signature.) The green label will

only be affixed and signed by the operative or member of staff

either inspecting or testing the product.

(g) (OR …….plc wishes to positively identify items that have been the

subject of a concession/waiver or have been sold as sub-

standard/seconds. Such items will be marked (OR stamped) with a

‘C’ or ‘S’ as appropriate.)

(h) A white label identified as ‘Uncontrolled’. This is an optional

general-purpose label that may be attached if appropriate to items

that are outside the QA control system. Can be attached by any

member of ……. Plc staff. Typical examples are competitors’

______Operating Procedure No: …….. Issue: …… Dated: ………… Page 10 of 14 products, drawing office samples or exhibition pieces. This label

will generally stay on the item whilst it stays within

……………plc.

3.3 Where possible or practical items that are under ‘quarantine’ or ‘rejected’

will be segregated to a designated area. In some cases due to size of

product (OR explosive building limits OR chemical hazards, OR ……….)

it is not possible to physically segregate. In these cases special care should

be taken to ensure each item or container is clearly identified as

‘quarantine’ or ‘reject’.

3.4 In some cases it is essential (either to meet client’s critical delivery date, or

to keep operatives productively employed) to work on material under

‘hold’ or ‘quarantine’. If the Works Manager or Director wishes to take

this risk of subsequent rejection, they must authorise its use by a signed

and dated memo. The items must retain their identity and inspection status

as ‘hold’ or ‘quarantine’ until the items are subsequently accepted or

rejected.

3.5 All entries onto labels, both identity and inspection status, must be clearly

legible and in permanent ink, paint, engraving, moulded in, stamped, etc.

(OR as an additional improvement to labelling items, where specified it is

permitted to use a ….plc approved work mark to confirm items have been

personally inspected and are accepted. This is a rubber stamp [Or a metal

punch]. These are shown on Form…. (OR Annex …..). The Quality

______Operating Procedure No: …….. Issue: …… Dated: ………… Page 11 of 14 Manager has a record book identifying the unique work mark number to

the member of staff, date of issue and signature and date of withdrawal.

To prevent any conflict any work mark withdrawn, is scrapped and not re-

issued, also the identity number or initials will never be re-introduced).

3.6 It has been found that certain members of ………..plc staff have unusual

or illegible signatures. The QA Manager retains a control book of

inspectors, operatives and staff who can complete Quality Records. This

is known as the “Squiggle list”. It identifies the name of the authorised

signatory, with an example of signature and an example of initials.

3.7 Certain items received (OR used or made) at …..plc has a limited shelf

life. As these are received (OR made) they will be identified on their

……. with indelible ink or paint with their withdrawal date (or have a label

attached with date of retest, withdrawal, etc.

3.8 When items are identified as ‘Quarantined’ or ‘Reject’ they will then

become subject to the review and control of Operating Procedure 7.

3A Implementation (Typical Service Business)

3A.1 ….plc does not manufacture products but provide a service. The identity

of the specific service being provided is very clear from the documentation

(OR work order OR job requirement OR job file, OR …..) held by the

provider.

______Operating Procedure No: …….. Issue: …… Dated: ………… Page 12 of 14 3A.2 The inspection status of work (OR each document) is clear from the

progress of signatures on the control documents. From simple

examination of the documents it can clearly be identified which

item/service has been issued, which is in progress, which has been

completed and signed off and what has been verified. Not must also be

taken of Operating Procedure 8, reference ‘Control of Contract

Information, Drawings and Specifications’, with regard to control of mail

and other documents. (OR to have full control of incoming documents,

and also documents between departments or individuals, each document

will have small transmittal slip stapled or securely attached [OR be

stamped with rubber stamp]. This will show Project/Job number, who to

see it for information, who to action it, who to file it, with space available

for initials and date to confirm it has been seen or actioned.)

3A.3 As an additional Inspection Status control we have a ‘Quarantine’ label.

These can be applied to doubtful or non-conforming files or envelopes,

etc. to prevent despatch.

3A.4 Occasionally the customer provides ………...plc with copies of their

specifications (OR examples of products, OR confidential

documents/records). To prevent loss, misuse (OR unauthorised copying),

these will be identified by a ‘Blue’ Special Control label see Form……(

OR Annex ……)

______Operating Procedure No: …….. Issue: …… Dated: ………… Page 13 of 14 3A.5 Within the documents held are old or obsolete documents, brochures,

standards, wall charts, etc. These are held for general and background

information only. These are identified with a stamp stating ‘uncontrolled

copy for info only’.

______Operating Procedure No: …….. Issue: …… Dated: ………… Page 14 of 14